Medicare Program; FY 2015 Hospice Wage Index and Payment Rate Update; Hospice Quality Reporting Requirements and Process and Appeals for Part D…
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Medicare Program; FY 2015 Hospice Wage Index and Payment Rate Update; Hospice Quality Reporting Requirements and Process and Appeals for Part D Payment for Drugs for Beneficiaries Enrolled in Hospice
Proposed rule.
CFR Part: "42 CFR Parts 405 and 418"
RIN Number: "RIN 0938-AS10"
Citation: "79 FR 26538"
Document Number: "CMS-1609-P"
"Proposed Rules"
SUMMARY: This proposed rule would update the hospice payment rates and the wage index for fiscal year (FY) 2015 and continue the phase out of the wage index budget neutrality adjustment factor (BNAF). This rule provides an update on hospice payment reform analyses and solicits comments on "terminal illness" and "related conditions" definitions, and on a process and appeals for Part D payment for drugs, while beneficiaries are under a hospice election. Also, this rule proposes timeframes for filing the notice of election and the notice of termination/revocation; adding the attending physician to the hospice election form; a requirement that hospices complete their hospice inpatient and aggregate cap determinations within 5 months after the cap year ends, and remit any overpayments; and updates for the hospice quality reporting program.
In addition, this rule would provide guidance on determining hospice eligibility, information on the delay in the implementation of the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM), and would further clarify how hospices are to report diagnoses on hospice claims. Finally, the rule proposes to make a technical regulatory text change.
DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than
ADDRESSES: In commenting, please refer to file code CMS-1609-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the "Submit a comment" instructions.
2. By regular mail. You may mail written comments to the following address ONLY:
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3. By express or overnight mail. You may send written comments to the following address ONLY:
4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses prior to the close of the comment period:
a. For delivery in
(Because access to the interior of the
b. For delivery in
If you intend to deliver your comments to the
Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
For general questions about hospice payment policy please send your inquiry via email to: [email protected].
SUPPLEMENTARY INFORMATION: Wage index addenda will be available only through the internet on the CMS Web site at: (http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospice/index.html.) Readers who experience any problems accessing any of the wage index addenda related to the hospice payment rules that are posted on the CMS Web site identified above should contact
Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the
Table of Contents
I. Executive Summary
A. Purpose
B. Summary of the Major Provisions
C. Summary of Costs, Benefits, and Transfers
II. Background
A.
B. History of the Medicare Hospice Benefit
C. Services Covered by the Medicare Hospice Benefit
D. Medicare Payment for Hospice Care
1. Omnibus Budget Reconciliation Act of 1989
2. Balanced Budget Act of 1997
3. FY 1998 Hospice Wage Index Final Rule
4. FY 2010 Hospice Wage Index Final Rule
5. The Affordable Care Act
6. FY 2012 Hospice Wage Index Final Rule
E. Trends in Medicare Hospice Utilization
III. Provisions of the Proposed Rule
A. Hospice Payment Reform: Research and Analyses
1. Beneficiaries Dying Without Skilled Visits in the Last Days of Life
2. General Inpatient Care, Continuous Home Care, and Inpatient Respite Care Utilization
3. Hospice Live Discharges
4. Non-hospice Spending for Hospice Beneficiaries During an Election
B. Solicitation of Comments on Definitions of "Terminal Illness" and "Related Conditions"
1. The Development of the Medicare Hospice Benefit
2. Legislative History of the Medicare Hospice Benefit
3. Hospice Care Today
4. Definition of "Terminal Illness"
5. Definition of "Related Conditions"
C. Guidance on Determining Beneficiaries' Eligibility
D. Proposed Timeframe for Hospice Cap Determinations and Overpayment Remittances
E. Proposed Timeframes for Filing the Notice of Election and Notice of Termination/Revocation
1. Proposed Timeframe for Filing the Notice of Election
2. Proposed Timeframe for Filing the Notice of Termination/Revocation
F. Proposed Addition of the Attending Physician to the Hospice Election Form
G. FY 2015 Hospice Wage Index and Rates Update
1. FY 2015 Hospice Wage Index
2. FY 2015 Wage Index with an Additional 15 Percent Reduced Budget Neutrality Adjustment Factor (BNAF)
3. Proposed Hospice Payment Update Percentage
4. Proposed FY 2015 Hospice Payment Rates
H. Proposed Updates to the Hospice Quality Reporting Program
1.
2. Measures for Hospice Quality Reporting Program and Data Submission Requirements for Payment Years FY 2014 and FY 2015
3. Quality Measures for Hospice Quality Reporting Program and Data Submission Requirements for Payment Year FY 2016 and Beyond
4.
5. Public Availability of Data Submitted
6. Proposed Adoption of the CAHPS(R) Hospice Survey for the FY 2017 Payment Determination
a. Background and Description of the Survey
b. Participation Requirements to Meet Quality Reporting Requirements for the FY 2017 APU
c. Participation Requirements to Meet Quality Reporting Requirements for the FY 2018 APU
d. Vendor Participation Requirements for the 2017 APU
e. Annual Payment Update
f. CAHPS(R) Hospice Survey Oversight Activities
7. Procedures for Payment Year 2016 and Subsequent Years
I. Solicitation of Comments on Coordination of Benefits Process and Appeals for Part D Payment for Drugs While Beneficiaries are Under a Hospice Election
1. Part D Sponsor Coordination of Payment with Hospice Providers
2. Hospice Coordination of Payment with Part D Sponsors and Other Payers
3. Beneficiary Rights and Appeals
J. Update on the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) and Coding Guidelines for Hospice Claims Reporting
1. International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM)
2. Coding Guidelines for Hospice Claims Reporting
K. Technical Regulatory Text Change
IV. Collection of Information Requirements
A. Proposed Changes Related to Hospice Payment Policy
1. Proposed Changes to the Election Statement (
2. Proposed Changes to Inpatient and Aggregate Cap Determination Reporting (
B. CAHPS(R) Hospice Survey
V. Regulatory Impact Analysis
A. Statement of Need
B. Introduction
C. Overall Impact
1. Detailed Economic Analysis
a. Effects on Hospices
b. Hospice Size
c. Geographic Location
d. Type of Ownership
e. Hospice Base
f. Effects on Other Providers
g. Effects on the
h. Alternatives Considered
i. Accounting Statement
j. Conclusion
2. Regulatory Flexibility Act Analysis
3. Unfunded Mandates Reform Act Analysis
VI. Federalism Analysis and Regulations Text
Acronyms
Because of the many terms to which we refer by acronym in this proposed rule, we are listing the acronyms used and their corresponding meanings in alphabetical order below:
ACA Affordable Care Act
APU Annual Payment Update
BBA Balanced Budget Act of 1997
BIPA Benefits Improvement and Protection Act of 2000
BNAF Budget Neutrality Adjustment Factor
CAHPS(R) Consumer Assessment of Healthcare Providers and Systems
CBSA Core-Based Statistical Area
CFR Code of Federal Regulations
CHC Continuous Home Care
COPD Chronic Obstructive Pulmonary Disease
CoPs Conditions of Participation
CR Change Request
CVA Cerebral Vascular Accident
CWF Common Working File
CY Calendar Year
DDE Direct Data Entry
DME Durable Medical Equipment
DTRR Daily Transaction Reply Report
FEHC Family Evaluation of Hospice Care
FY Fiscal Year
GAO
GIP General Inpatient Care
HHS
HIPPA Health Insurance Portability and Accountability Act
HIS Hospice Item Set
HQRP Hospice Quality Reporting Program
IACS Individuals Authorized Access to CMS Computer Services
ICD-9-CM International Classification of Diseases, Ninth Revision, Clinical Modification
ICD-10-CM International Classification of Diseases, Tenth Revision, Clinical Modification
ICR Information Collection Requirement
IPPS Inpatient Prospective Payment System
IRC Inpatient Respite Care
LCD Local Coverage Determination
MAC Medicare Administrative Contractor
MFP Multi-Factor Productivity
MSA Metropolitan Statistical Area
NF Long Term Care Nursing Facility
NOE Notice of Election
NOTR Notice of Termination/Revocation
NP Nurse Practitioner
NPI National Provider Identifier
OIG
PA Prior Authorization
PBM Pharmacy Benefit Manager
PDE Prescription Drug Event
PRA Paperwork Reduction Act
PS&R Provider Statistical and Reimbursement Report
Pub.
QAPI Quality Assessment and Performance Improvement
QRP Quality Reporting Program
RFA Regulatory Flexibility Act
RHC Routine Home Care
SAF Standard Analytic File
SNF Skilled Nursing Facility
TEFRA Tax Equity and Fiscal Responsibility Act of 1982
TrOOP True Out-of-Pocket
U.S.C. United States Code
I. Executive Summary for This Proposed Rule
A. Purpose
This rule proposes updates to the payment rates for hospices for fiscal year (FY) 2015 as required under section 1814(i) of the Social Security Act (the Act). The proposed updates incorporate the use of updated hospital wage index data, the 6th year of the 7-year Budget Neutrality Adjustment Factor (BNAF) phase-out, and an update to the hospice payment rates by the hospice payment update percentage. In addition, section 3004(c) of the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act (Pub. L. 111-152) (the Affordable Care Act) established a quality reporting program for hospices. Starting in FY 2014, hospices that failed to meet quality reporting requirements received a two percentage point reduction to their market basket update. The Affordable Care Act also requires the Secretary to implement revisions to the hospice payment methodology no earlier than
B. Summary of the Major Provisions
In this rule we propose to update the hospice payment rates for FY 2015 by 1.3 percent as described in section III.G.3. The hospice wage index would be updated with more current wage data and the BNAF would be reduced by an additional 15 percent for a total BNAF reduction of 85 percent as described in section III.G.2. The total BNAF phase-out would be complete by FY 2016. In 2010, the
This proposed rule, in section III.H, discusses updates to the hospice quality reporting program, including participation requirements for CY 2015 regarding the CAHPS(R) Hospice Survey, and reminds the hospice industry that last year we set the
More than seven new quality measures would be derived from these tools; therefore, no new measures are proposed this year. Section III.H of this rule also proposes changes related to the reconsideration process, extraordinary circumstance extensions or exemptions, and hospice quality reporting program (HQRP) eligibility requirements for newly certified hospices. Finally, this proposed rule provides: guidance on determining the beneficiary's eligibility for hospice in section III.C; discusses the delay in the implementation of the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM); clarifies appropriate diagnosis reporting on hospice claims. We propose that, effective
C. Summary of Impacts
Table 1--Impact Summary Table Provision Transfers description FY 2015 Hospice Wage The overall economic impact of this proposed rule Index and Payment Rate is estimated to be$230 million in increased Update payments to hospices during FY 2015. Provision description Total costs New Quality Reporting$8.77 million . Requirements for Hospices (FY 2015)
II. Background
A.
Hospice care is an approach to treatment that recognizes that the impending death of an individual warrants a change in the focus from curative care to palliative care for relief of pain and for symptom management. The goal of hospice care is to help terminally ill individuals continue life with minimal disruption to normal activities while remaining primarily in the home environment. A hospice uses an interdisciplinary approach to deliver medical, nursing, social, psychological, emotional, and spiritual services through use of a broad spectrum of professionals and other caregivers, with the goal of making the individual as physically and emotionally comfortable as possible. Hospice is compassionate patient and family-centered care for those who are terminally ill. It is a comprehensive, holistic approach to treatment that recognizes that the impending death of an individual necessitates a change from curative to palliative care.
Medicare regulations define palliative care as "patient and family-centered care that optimizes quality of life by anticipating, preventing, and treating suffering." Palliative care throughout the continuum of illness involves addressing physical, intellectual, emotional, social, and spiritual needs and to facilitate patient autonomy, access to information, and choice" (42 CFR 418.3). Palliative care is at the core of hospice philosophy and care practices, and is a critical component of the
Medicare hospice care is palliative care for individuals with a prognosis of living 6 months or less if the terminal illness runs its normal course. As generally accepted by the medical community, the term "terminal illness" refers to an advanced and progressively deteriorating illness, and that the illness is diagnosed as incurable (please see section III.B for a discussion and solicitation of comments on a possible
The goal of hospice care is to make the hospice patient as physically and emotionally comfortable as possible, with minimal disruption to normal activities, while remaining primarily in the home environment. Hospice care uses an interdisciplinary approach to deliver medical, nursing, social, psychological, emotional, and spiritual services through the use of a broad spectrum of professional and other caregivers and volunteers. While the goal of hospice care is to allow for the individual to remain in his or her home environment, circumstances during the end-of-life may necessitate short-term inpatient admission to a hospital, skilled nursing facility (SNF), or hospice facility for procedures necessary for pain control or acute or chronic symptom management that cannot be managed in any other setting. These acute hospice care services are to ensure that any new or worsening symptoms are intensively addressed so that the individual can return to his or her home environment under a home level of care. Short-term, intermittent, inpatient respite services are also available to the family of the hospice patient when needed to relieve the family or other caregivers. Additionally, an individual can receive continuous home care during a period of crisis in which an individual requires primarily continuous nursing care to achieve palliation or management of acute medical symptoms so that the individual can remain at home. Continuous home care may be covered on a continuous basis for as much as 24 hours a day, and these periods must be predominantly nursing care per our regulations at
Hospices are expected to comply with all civil rights laws, including the provision of auxiliary aids and services to ensure effective communication with patients or patient care representatives with disabilities consistent with Section 504 of the Rehabilitation Act of 1973 and the Americans with Disabilities Act, and to provide language access for such persons who are limited in English proficiency, consistent with Title VI of the Civil Rights Act of 1964. Further information about these requirements may be found at http://www.hhs.gov/ocr/civilrights.
B. History of the Medicare Hospice Benefit
Before the creation of the
FOOTNOTE 1 Connor, Stephen. (2007). Development of Hospice and Palliative Care in
FOOTNOTE 2 Harder, PharmD, CGP,
FOOTNOTE 3 Paolini, DO, Charlotte. (2001). Symptoms Management at End of Life. JAOA. 101(10). p609-615. END FOOTNOTE
As stated in the
The benefit was originally designed to cover hospice care for a finite period of time that roughly corresponded to a life expectancy of 6 months or less. Initially, beneficiaries could receive three election periods: Two 90-day periods and one 30-day period. Currently,
C. Services Covered by the Medicare Hospice Benefit
One requirement for coverage under the Medicare Hospice Benefit is that hospice services must be reasonable and necessary for the palliation and management of the terminal illness and related conditions. Section 1861(dd)(1) of the Act establishes the services that are to be rendered by a
Section 1814(a)(7)(B) of the Act requires that a written plan for providing hospice care to a beneficiary who is a hospice patient be established before care is provided by, or under arrangements made by, that hospice program and that the written plan be periodically reviewed by the beneficiary's attending physician (if any), the hospice medical director, and an interdisciplinary group (described in section 1861(dd)(2)(B) of the Act). The services offered under the
Before the
* Patient and family know of the terminal condition.
* Further medical treatment and intervention are indicated only on a supportive basis.
* Pain control should be available to patients as needed to prevent rather than to just ameliorate pain.
* Interdisciplinary teamwork is essential in caring for patient and family.
* Family members and friends should be active in providing support during the death and bereavement process.
* Trained volunteers should provide additional support as needed.
The cost data and the findings on what services hospices provided in the demonstration project were used to design the
D. Medicare Payment for Hospice Care
Sections 1812(d), 1813(a)(4), 1814(a)(7), 1814(i), and 1861(dd) of the Act, and our regulations in part 418, establish eligibility requirements, payment standards and procedures, define covered services, and delineate the conditions a hospice must meet to be approved for participation in the
1. Omnibus Budget Reconciliation Act of 1989
Section 6005(a) of the Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239) amended section 1814(i)(1)(C) of the Act and provided for the following two changes in the methodology concerning updating the daily payment rates: (1) Effective
2. Balanced Budget Act of 1997
Section 4441(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) amended section 1814(i)(1)(C)(ii)(VI) of the Act to establish updates to hospice rates for FYs 1998 through 2002. Hospice rates were updated by a factor equal to the hospital market basket percentage increase, minus 1 percentage point. Payment rates for FYs from 2002 have been updated according to section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update to the payment rates for subsequent FYs will be the hospital market basket percentage increase for the FY. The Act requires us to use the inpatient hospital market basket to determine hospice payment rates.
3. FY 1998 Hospice Wage Index Final Rule
In the
4. FY 2010 Hospice Wage Index Final Rule
Inpatient hospital pre-floor and pre-reclassified wage index values, as described in the
5. The Affordable Care Act
Starting with FY 2013 (and in subsequent fiscal years), the market basket percentage update under the hospice payment system referenced in sections 1814(i)(1)(C)(ii)(VII) and 1814(i)(1)(C)(iii) of the Act will be annually reduced by changes in economy-wide productivity, as specified in section 1886(b)(3)(B)(xi)(II) of the Act, as amended by section 3132(a) of the Patient Protection and Affordable Care Act (Pub. L. 111-148) as amended by the Health Care and Education Reconciliation Act (Pub. L. 111-152) (the Affordable Care Act)). In FY 2013 through FY 2019, the market basket percentage update under the hospice payment system will be reduced by an additional 0.3 percentage point (although for FY 2014 to FY 2019, the potential 0.3 percentage point reduction is subject to suspension under conditions as specified in section 1814(i)(1)(C)(v) of the Act).
In addition, sections 1814(i)(5)(A) through (C) of the Act, as amended by section 3132(a) of the Affordable Care Act, require hospices to begin submitting quality data, based on measures to be specified by the Secretary, for FY 2014 and subsequent fiscal years. Beginning in FY 2014, hospices which fail to report quality data will have their market basket update reduced by 2 percentage points.
Section 1814(a)(7)(D)(i) of the Act was amended by section 3132 (b)(2)(D)(i) of the Affordable Care Act, and requires, effective
6. FY 2012 Hospice Wage Index Final Rule
When the Medicare Hospice Benefit was implemented, the
E. Trends in Medicare Hospice Utilization
Since the implementation of the hospice benefit in 1983, and especially within the last decade, there has been substantial growth in hospice utilization. The number of
There have also been noted changes in the diagnosis patterns among
Table 2--The Top Twenty Principal Hospice Diagnoses, FY 2002, FY 2007, FY 2012, FY 2013 Rank ICD-9/Reported Count Percentage principal diagnosis Year: FY 2002 1 162.9 Lung Cancer 73,769 11 2 428.0 Congestive 45,951 7 Heart Failure 3 799.3 Debility 36,999 6 Unspecified 4 496 COPD 35,197 5 5 331.0 Alzheimer's 28,787 4 Disease 6 436 CVA/Stroke 26,897 4 7 185 Prostate 20,262 3 Cancer 8 783.7 Adult 18,304 3 Failure To Thrive 9 174.9 Breast 17,812 3 Cancer 10 290.0 Senile 16,999 3 Dementia, Uncomp. 11153.0 Colon Cancer 16,379 2 12 157.9 Pancreatic 15,427 2 Cancer 13 294.8 Organic 10,394 2 Brain Synd Nec 14 429.9 Heart 10,332 2 Disease Unspecified 15 154.0 Rectosigmoid 8,956 1 Colon Cancer 16 332.0 Parkinson's 8,865 1 Disease 17 586 Renal Failure 8,764 1 Unspecified 18 585 Chronic Renal 8,599 1 Failure (End 2005) 19 183.0 Ovarian 7,432 1 Cancer 20 188.9 Bladder 6,916 1 Cancer Year: FY 2007 1 799.3 Debility 90,150 9 Unspecified 2 162.9 Lung Cancer 86,954 8 3 428.0 Congestive 77,836 7 Heart Failure 4 496 COPD 60,815 6 5 783.7 Adult 58,303 6 Failure To Thrive 6 331.0 Alzheimer's 58,200 6 Disease 7 290.0 Senile 37,667 4 Dementia Uncomp. 8 436 CVA/Stroke 31,800 3 9 429.9 Heart 22,170 2 Disease Unspecified 10 185 Prostate 22,086 2 Cancer 11 174.9 Breast 20,378 2 Cancer 12 157.9 Pancreas 19,082 2 Unspecified 13153.9 Colon Cancer 19,080 2 14 294.8 Organic 17,697 2 Brain Syndrome NEC 15 332.0 Parkinson's 16,524 2 Disease 16 294.10 Dementia In 15,777 2 Other Diseases w/o Behav. Dist 17 586 Renal Failure 12,188 1 Unspecified 18 585.6 End Stage 11,196 1 Renal Disease 19 188.9 Bladder 8,806 1 Cancer 20 183.0 Ovarian 8,434 1 Cancer Year: FY 2012 1 799.3 Debility 161,163 12 Unspecified 2 162.9 Lung Cancer 89,636 7 3 783.7 Adult 86,467 7 Failure To Thrive 4 428.0 Congestive 84,333 6 Heart Failure 5 496 COPD 74,786 6 6 331.0 Alzheimer's 64,199 5 Disease 7 290.0 Senile 56,234 4 Dementia, Uncomp. 8 429.9 Heart 32,081 2 Disease Unspecified 9 436 CVA/Stroke 31,987 2 10 294.10 Dementia In 27,417 2 Other Diseases w/o Behavioral Dist 11 174.9 Breast 22,421 2 Cancer 12153.9 Colon Cancer 22,197 2 13 157.9 Pancreatic 22,007 2 Cancer 14 332.0 Parkinson's 21,183 2 Disease 15 185 Prostate 21,042 2 Cancer 16 294.8 Other 17,762 1 Persistent Mental Dis.--classified elsewhere 17 585.6 End Stage 17,545 1 Renal Disease 18 518.81 Respiratory 12,962 1 Failure 19 294.11 Dementia In 11,751 1 Other Diseases w/Behavioral Dist 20 188.9 Bladder 10,511 1 Cancer Year: FY 2013 1 799.3 Debility 127,308 9 Unspecified 2 428.0 Congestive 95,850 7 Heart Failure 3 162.9 Lung Cancer 91,263 6 4 496 COPD 81,944 6 5 331.0 Alzheimer's 79,360 6 Disease 6 783.7 Adult 71,033 5 Failure to Thrive 7 290.0 Senile 60,441 4 Dementia, Uncomp. 8 429.9 Heart 36,817 3 Disease Unspecified 9 436 CVA/Stroke 34,330 2 10 294.10 Dementia In 30,884 2 Other Diseases w/o Behavioral Dist 11 332.0 Parkinson's 25,308 2 Disease 12153.9 Colon Cancer 23,133 2 13 294.20 Dementia 23,108 2 Unspecified w/o Behavioral Dist 14 174.9 Breast 22,986 2 Cancer 15 157.9 Pancreatic 22,267 2 Cancer 16 185 Prostate 21,701 2 Cancer 17 585.6 End-Stage 19,212 1 Renal Disease 18 518.81 Acute 15,900 1 Respiratory Failure 19 294.8 Other 14,337 1 Persistent Mental Dis.--classified elsewhere 20 294.11 Dementia In 13,648 1 Other Diseases w/Behavioral Dist Note(s): The frequencies shown represent beneficiaries that had at least one claim with the specific ICD-9-CM code reported as the principal diagnosis. Beneficiaries could be represented multiple times in the results if they have multiple claims during that time period with different principal diagnoses. Source: FY 2002, 2007, and 2012 hospice claims data from theChronic Conditions Data Warehouse (CCW), accessed onFebruary 14 andFebruary 20, 2013 . FY 2013 hospice claims data from the CCW, accessed onFebruary 27, 2014 .
III. Provisions of the Proposed Rule
A. Hospice Payment Reform: Research and Analyses
In 2010, the
The research and analyses conducted thus far on available
Abt Associates, with its subcontractor
1. Beneficiaries Dying Without Skilled Visits in the Last Days of Life
Hospice clinicians are experts in recognizing changes as a patient is approaching the last few days of life and helping to prepare and support the patient and family. Most individuals approaching end-of-life have noted declines over the several days prior to death. As such, the expectation is that there would be an increased need for hospice services in the days leading up to the hospice beneficiary's death. Although we recognize that prognostication is not an exact science, there are hallmark physical, functional, nutritional and cognitive changes that are typically present leading up the hospice patient's death (see section III.C of this proposed rule).
When looking at skilled visits provided in the last days of life, as reported on the hospice claim, our analysis found that a relatively high percentage (28.9 percent) of hospice decedents who were receiving RHC on their last day of life did not receive a skilled visit on that day (see Table 3 below). This could be explained, in part, by sudden or unexpected death. Expanding this analysis to skilled visits provided in the last two to four days of life, we found that 14.4 percent of hospice decedents did not receive skilled visits in the last 2 days of life and 6.2 percent of hospice decedents did not receive skilled visits in the last 4 days of life. While this could also be explained, in part, by sudden or unexpected death, we are concerned with the possibility that those beneficiaries and their families are not receiving hospice care and support at the very end of life. If hospices are actively engaging with the beneficiary and the family throughout the election period, we would expect to see skilled visits during those last days of life.
Table 3--Frequency and Percentage of Decedents Not Receiving Skilled Visits at the End of Life, Calendar Year 2012 Number of Percentage decedents of decedents with no skilled visits No skilled visits on last day (and last day was 656,355 28.9 RHC) No skilled visits on last two days (and last two 622,334 14.4 days were RHC) No skilled visits on last three days (and last 585,648 9.1 three days were RHC) No skilled visits on last four days (and last four 551,359 6.2 days were RHC) Note(s): Skilled visit was considered to be a visit from a social worker, therapist, or nurse. Source: Beneficiaries whose last days of hospice enrollment were billed to the RHC level of care using 100% of hospice days from the Hospice Standard Analytic File (SAF), Calendar Year (CY) 2012.
Further analysis of skilled visits during the last two days of life found that 10.3 percent of very short stay decedents (5 days or less) did not receive skilled visits during the last two days of life. In contrast, 15.9 percent of decedents with lengths of stay 181 days or longer did not receive visits in the last two days of life. Newer hospices (5 years or less since
Using the provider-level file referenced above, we also found that, on average, hospices did not report any skilled visits in the last two days of life for 9.7 percent of their decedents who died receiving routine home care. /4/ Nearly 5 percent of hospices did not provide any skilled visits in the last two days of life to more than 50 percent of their decedents receiving routine home care on those last two days; the average lifetime length of stay among those decedents was 143 days. We note that the average lifetime length of stay in our provider-level file was 95.4 days (among beneficiaries who were discharged alive or deceased in CY 2012). Furthermore, we found that 34 hospices did not make any skilled visits in the last 48 hours of life to any of their decedents who died while receiving routine home care.
FOOTNOTE 4 The provider-level analysis conducted on whether skilled visits were provided in the last two days of life only examined instances where the decedent was receiving routine home care in the last two days of life. We note that 21 providers did not have any decedents that died while on routine home care. END FOOTNOTE
2. General Inpatient Care, Continuous Home Care, and Inpatient Respite Care Utilization
Medicare Conditions of Participation require hospices to demonstrate that they are able to provide all four levels of care--Routine Home Care (RHC), General Inpatient Care (GIP), Continuous Home Care (CHC) and Inpatient Respite Care (IRC) to be a certified
While the goal of hospice care is to allow for the individual to remain in his or her home environment, circumstances during the end-of-life may necessitate short-term inpatient admission to a hospital, skilled nursing facility (SNF), or hospice inpatient facility for procedures necessary for pain control or acute or chronic symptom management that cannot be managed in any other setting. These acute hospice care services are to ensure that any new or worsening symptoms are intensively addressed so that the individual can return to his or her home environment under a home level of care.
As part of our reform work, we analyzed CY 2012 data to better understand GIP utilization. We found that 77.3 percent of beneficiaries did not have any GIP care in 2012. Using provider-level data for beneficiaries discharged in 2012, we also found that 21.1 percent of hospices did not provide any GIP care to their beneficiaries. While there are appropriate circumstances where a hospice provides no GIP (for example, when a provider only has a few patients, none of whom needs GIP), we are concerned that more than a fifth of hospices not providing any GIP may be an indication that hospice beneficiaries do not have adequate access to a necessary level of care for acute or chronic symptom management. We also found that there were site of service differences such that the longest GIP length of stay was in the inpatient hospice setting (6.1 days) and shortest at in the inpatient hospital setting (4.5 days). Over two-thirds of GIP days were provided in an inpatient hospice setting (68 percent), and about a quarter of GIP days were provided in an inpatient hospital (24.9 percent). Only 5.5 percent of GIP days were provided in a SNF.
As stated in our regulations at
As part of our reform work, we analyzed CY 2012 data to better understand CHC utilization. Overall, approximately 0.4 percent of all hospice days in 2012 were billed as CHC, but that percentage decreases to 0.2 when a large chain provider with a large percentage of its hospice days billed as CHC days was excluded. Although 42.7 percent of hospices billed at least 1 day of CHC, we found considerable variation in the share of CHC days among hospices that provided any CHC. Almost 90 percent of hospices that provided any CHC had less than 1 percent of their days billed as CHC, but four hospices billed more than 10 percent of their days as CHC. Forty hospices accounted for 46 percent of all CHC days and a single hospice accounted for over a quarter of all CHC days. Among hospices who billed for providing CHC, 9.4 percent provided over half of their CHC days to beneficiaries residing in a nursing home. For CHC, a hospice must provide a minimum of 8 hours of care during a 24-hour day, which begins and ends at midnight.
Finally, we analyzed inpatient respite care (IRC) utilization in CYs 2005 through 2012. IRC is provided in an approved facility, as needed, on an occasional basis to relieve the family caregivers for up to 5 consecutive days. Payment for IRC is subject to the requirement that it may not be provided consecutively for more than 5 days at a time. As stated in our regulations at
The variation in the provision of GIP, CHC, and IRC could suggest that the level of hospice care that a beneficiary receives may not always be driven by patient factors. Medicare Conditions of Participation require hospices to demonstrate that they are able to provide all four levels of care--RHC, GIP, CHC, and IRC--in order to be a certified
3. Hospice Live Discharges
Currently, federal regulations allow a patient who has elected to receive
Our regulations also describe that if the hospice patient (or his/her representative) revokes the hospice election,
Prior to 2012, claims data provided limited information about the reason a hospice patient was discharged from a hospice's care. Starting
One study of hospice live discharges in cancer patients noted that smaller hospices and for-profit hospices had a higher rate of hospice live discharges. /5/ Our subcontractors at
FOOTNOTE 5 Carlson MD, Herrin J, Du Q, et al. Hospice characteristics and the disenrollment of patients with cancer. Health
We understand that the rate of live discharges should not be zero, given the uncertainties of prognostication and the ability of patients and their families to revoke the hospice election at any time. However,
4. Non-hospice Spending for Hospice Beneficiaries During an Election
When a beneficiary elects the
In follow up to our initial analysis of hospice drugs being paid through Part D (78 FR 48245-48246), we analyzed the magnitude of
The
Another area of concern in high non-hospice
In addition to analyzing data from Parts A and B of
Table 4--Drug Cost Sources for Hospice Beneficiaries' 2012 Drugs Received Through Part D Component Description Total Expenditures Patient Pay Amount The dollar amount the$48,191,067 beneficiary paid that is not reimbursed by a third party Low Income Cost-Sharing Medicare payments to 117,558,814 Subsidy plans to subsidize the cost-sharing liability of qualifying low-income beneficiaries at the point of sale Other True Out-of-Pocket Records all other 2,366,896 Amount third-party payments on behalf of beneficiary. Examples are state pharmacy assistance programs and charities Patient Liability Amount patient liability 3,120,834 Reduction due to Other reduced due to other Payer Amount benefits. Examples are Veteran's Administration and TRICARE Covered Drug Plan Paid Contains the net amount 217,370,068 Amount the plan paid for standard benefits Non-Covered Plan Paid Contains the net amount 16,985,982 Amount the plan paid beyond standard benefits. Examples include supplemental drugs, supplemental cost-sharing, and OTC drugs paid under plan administrative costs Components' Total 405,593,660 Unknown Unreconciled/Unreported 12,307,603 Difference between total Gross Drug Costs and Reported payer sources (includes sales taxes, drug dispensing fees, and drugs' ingredient costs) Gross Total Drug Costs, 417,901,263 Reported Source:Abt Associates analysis of 100% 2012 Medicare Claim Files. For more information on the components above and on Part D data, go to theResearch Data Assistance Center's (ResDAC's) Web site at http://www.resdac.org/.
The portion of the
Medicare Spending: In total, actual non-hospice
FOOTNOTE 6 MedPAC, "Assessing payment adequacy and updating payments: hospice services",
All-Payer Spending: Under Part D, gross covered drug cost on a claim includes the amount paid by the Part D plan, the beneficiary's cost sharing, and any amounts paid by others on the beneficiary's behalf. These latter amounts include the low-income subsidy amount paid by
Part D spending by all-payers that occurs for hospice beneficiaries during a hospice election, including beneficiary cost-sharing, totaled
On
The dollars spent by Part D and by beneficiaries for drugs covered outside of the hospice benefit for hospice beneficiaries during a hospice election raise concerns about whether some of these drugs should have been paid for by the hospice. We examined drug costs incurred by hospices from 2004 to 2012, using hospice cost report data adjusted to constant 2010 dollars. We saw a declining trend in the drug costs per patient day, with costs declining from a mean of
Table 5--Costs per Patient-Day by Year, 2010 Dollars 2004 2005 2006 2007 2008 Number n = 1,047 n = 1,218 n = 1,490 n = 1,694 n = 1,834 Provider-level drug costs per patient-day Mean$20 $18 $17 $15 $14 Std dev (10) (11) (11) (9) (9) Median$20 $17 $16 $15 $14 1%-99%$21 $19 $17 $16 $15 5%-95%$20 $18 $16 $15 $14
Table 5--Costs per Patient-Day by Year, 2010 Dollars 2009 2010 2011 2012 Number n = 1,882 n = 1,929 n = 2,015 n = 2,054 Provider-level drug costs per patient-day Mean$13 $12 $11 $11 Std dev (9) (7) (6) (6) Median$13 $12 $11 $10 1%-99%$14 $13 $12 $11 5%-95%$13 $12 $11 $10 Source: Freestanding hospice cost reports with HCRIS release date of 1/23/2014. The costs are averaged at the provider-level and adjusted to constant 2010 dollars using the Producer Price Index for prescription pharmaceuticals. Notes: We excluded cost reports with period less than 10 months or greater than 14 months, missing information or negative reported values for total costs or payments, were in the top and bottom 1% of cost per day, were in the top and bottom 5% of provider margins, and where the aggregate of cost centers does not equal total costs as reported.
We will continue to monitor non-hospice
B. Solicitation of Comments on Definitions of "Terminal Illness" and "Related Conditions"
1. The Development of the Medicare Hospice Benefit
Dame Cicely Saunders introduced the idea of hospice care in
FOOTNOTE 7 Story, P., Knight, C. (2004). The Hospice/Palliative Medicine Approach to End-of-Life Care, 2nd ed. UNIPAC One. END FOOTNOTE
In 1972, Dr.
FOOTNOTE 8 Cefalu, C., Ruiz, M. (2011). The Medicare Hospice Benefit: A Changing Philosophy of Care? Annals of
FOOTNOTE 9 Connor, S. (2007). Development of Hospice and Palliative Care in
During Congressional committee hearings regarding the development of a
FOOTNOTE 10 Testimony by
FOOTNOTE 11 Testimony by Congressman
Hospice industry leaders also expressed the importance of hospice program accountability. Hospices would be accountable for and be able to control the quality and delivery of patients admitted for hospice care, instead of having to "broker" the patients out to other providers for reimbursement and convenience. /12/ Hospice advocates stressed the importance of maintaining continuous clinical control over all aspects of care to ensure a successful hospice program and framers of the benefit recognized this fact by requiring professional management responsibility. /13/ Although there were ongoing concerns by HCFA, the
FOOTNOTE 12 Written testimony by Dr.
FOOTNOTE 13
FOOTNOTE 14 Testimony by
FOOTNOTE 15 Comments by Congressman
2. Legislative History of the Medicare Hospice Benefit
After Medicare coverage of hospice care was authorized by the
FOOTNOTE 16 "Hospice Care-A Growing Concept in
FOOTNOTE 17 GAO Letter, "Comments on the Legislative Intent of
Further description of the
1. The patient and his/her family are considered the unit of care.
2. A multidisciplinary team is used to assess the physical, psychological and spiritual needs of the patient and family to develop an overall plan of care and to provide coordinated care.
3. Pain and collateral symptoms associated with the terminal illness and previous treatments are controlled, but no heroic efforts are made to cure the patient.
4. Bereavement follow-up is provided to help the family cope with their emotional suffering. /18/
FOOTNOTE 18 "Background Materials on Medicare Hospice Benefit Including Description of Proposed Implementing Regulations,"
It was also noted that the statute provides that an individual, upon making an election to receive hospice coverage, would be deemed to have waived payments for certain other benefits in addition to choosing a palliative mode of treatment, except in "exceptional and unusual circumstances" as the Secretary may provide (section 1812(d)(2)(A) of the Act). Furthermore, the hospice plan of care must include assessment of the individual's needs and identification of the services to meet those needs including the management of discomfort and symptom relief.
Several Senators testified at a
FOOTNOTE 19 Testimony by Senators
FOOTNOTE 20 Position paper submitted by
3. Hospice Care Today
The Medicare hospice benefit was a unique addition to the U.S. health care system. Prior to the implementation of the
FOOTNOTE 21 Testimony by Dr.
FOOTNOTE 22 "NHPCO Comments on Washington Post Article", Retrieved on
Throughout the development of the
FOOTNOTE 23 Cefalau, C., Ruiz, M. The Medicare Hospice Benefit: A Changing Philosophy of Care? Annals of
FOOTNOTE 24 Cefalau, C., Ruiz, M. The Medicare Hospice Benefit: A Changing Philosophy of Care? Annals of
FOOTNOTE 25 Comments by Congressman
FOOTNOTE 26 Comments by Congressman
FOOTNOTE 27 Testimony by Congressman
FOOTNOTE 28 Hoyer, T. (1998). A History of the Medicare Hospice Benefit.
FOOTNOTE 29 Hoyer, T. (1998). A History of the Medicare Hospice Benefit.
Since the implementation of the
FOOTNOTE 30 Calendar year 2013 expenditures and average spending per beneficiary were calculated using hospice claims data from the
Section 3132(a) of the Affordable Care Act provides statutory authority for CMS to reform the hospice payment system no earlier than
Reports by both the
FOOTNOTE 31 MedPAC, "Assessing payment adequacy and updating payments: hospice services",
FOOTNOTE 32
Ongoing Part D memo guidance has also been issued to clarify existing coverage and payment policies. The most recent Part D guidance was provided in the
FOOTNOTE 33
We believe summary of the "Development of the Hospice Benefit" and the "Legislative history of the Medicare Hospice Benefit" clearly captures the expectation that hospices are to provide holistic and comprehensive services under the
4. Definition of "Terminal Illness"
Since the implementation of the
FOOTNOTE 34
We have defined palliative care--the nature of the care provided under the hospice benefit--in our regulations at
Because hospice care is unique in its comprehensive, holistic, and palliative philosophy and practice, we want to ensure that the hospice services under the
FOOTNOTE 35 Mosby's Medical Dictionary, 8th edition, 2009,
We are soliciting comments on this definition for further discussion and consideration for potential future rulemaking.
5. Definition of "Related Conditions"
Section 1812(d)(2) of the Act provides that an individual, upon making an election to receive hospice coverage, would be deemed to have waived payments for certain other benefits except in "exceptional and unusual circumstances as the Secretary may provide." Comments received on the 1983 Hospice proposed rule specifically asked for further CMS clarification regarding the concept of "related conditions." Specifically, the commenters suggested a more detailed definition of what constitutes care for a patient's terminal illness or related conditions (which is the responsibility of the hospice) and what constitutes care for unrelated conditions (for which out-of-hospice
Therefore, in keeping with the tenets of hospice philosophy described in this section, the intent of the
We solicit comments on this definition for further discussion and consideration for potential future rulemaking.
C. Guidance on Determining Beneficiaries' Eligibility for Hospice
An individual must be certified by the hospice medical director and the individual's attending physician (if designated by the individual) as being terminally ill, meaning that the individual has a medical prognosis of a life expectancy of 6 months or less in order to receive the
* Diagnosis of the terminal condition of the patient.
* Other health conditions, whether related or unrelated to the terminal condition.
* Current clinically relevant information supporting all diagnoses.
We do recognize that making a prognosis is not an exact science. Section 322 of the Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554) amended section 1814(a) of the Act by clarifying that the certification of an individual who elects hospice "shall be based on the physician's or medical director's clinical judgment regarding the normal course of the individual's illness." The amendment clarified that the certification is based on a clinical judgment regarding the usual course of a terminal illness, and recognizes the fact that making medical prognostications regarding life expectancy are not exact. However, the amendment regarding the physician's clinical judgment does not negate the fact that there must be a clinical basis for a certification. A hospice is required to make certain that the physician's clinical judgment can be supported by clinical information and other documentation that provide a basis for the certification of 6 months or less if the illness runs its normal course.
While the expectation remains that the hospice physician will determine a beneficiary's eligibility for hospice, this is not to say that this decision cannot be reviewed if there is a question as to whether the clinical documentation supports or does not support a patient's hospice eligibility as hospice services provided must be reasonable and necessary for the palliation and management of the terminal illness and related conditions. The goal of any review for eligibility is to ensure that hospices are thoughtful in their eligibility determinations so that hospice beneficiaries are able to access their benefits appropriately. CMS' right to review clinical documentation that supports physician certifications has been established in federal court and by the agency in an administrative ruling. (See, for example, HCFA Ruling, 93-1 Weight to be Given to a Treating Physician's Opinion in Determining Medicare Coverage of Inpatient Care in a Hospital or Skilled Nursing Facility (
We are reminding providers that there are multiple public sources available to assist in determining whether a patient meets
If a beneficiary improves and/or stabilizes sufficiently over time while in hospice such that he/she no longer has a prognosis of 6 months or less from the most recent recertification evaluation or definitive interim evaluation, that beneficiary should be considered for discharge from the
D. Proposed Timeframe for Hospice Cap Determinations and Overpayment Remittances
As described in sections 1861(dd)(2)(A)(iii) and 1814(i)(2)(A) through (C) of the Act, when the
The aggregate cap amount was set at
FOOTNOTE 36
The cap amount is multiplied by the number of
While hospices rarely exceed the inpatient cap, in its
FOOTNOTE 37 MedPAC, "Report to
FOOTNOTE 38 MedPAC, "Report to
Abt Associates, our hospice reform contractor, also performed analysis on the number of hospices exceeding the aggregate cap with results similar to MedPAC's, where an increasing percentage of hospices exceeded their caps from 2006 (9.1 percent) to a peak in 2009 (12.8 percent), followed by a decline through 2011 (10.5 percent). However, the analysis shows an increase in 2012, with 11.6 percent of hospices exceeding their aggregate caps. Additionally, analysis of above-cap hospices showed that the average overpayment per beneficiary has increased over time, up 35.2 percent from 2006 (
We also compared hospices' year-end percentage of their aggregate cap total that they had received in
The results from these recent analyses on the hospice aggregate cap highlight the importance of hospices monitoring their aggregate cap and ensuring that the beneficiaries under their care are truly eligible for hospice services. In the FY 2010 hospice wage index proposed rule we solicited comments on the aggregate hospice cap (74 FR 18920-18922). Many commenters wanted more timely notification of cap overpayments. Many also requested that hospices be given access to beneficiaries' full hospice utilization history, as having this information would enable hospices to better manage their aggregate cap. In response to concerns from hospices, we redesigned the Provider Statistical and Reimbursement (PS&R) system in 2011, so that hospices can now easily manage their inpatient and aggregate caps. The redesigned PS&R enables hospices to calculate estimated caps to monitor their cap status at different points during the cap year, and also enables them to calculate their caps after the cap year ends.
Our current practice is for the Medicare Administrative Contractors (MACs) to complete the hospice cap determinations for both the inpatient and the aggregate caps 16 to 24 months after the cap year in order to demand any overpayment. We are concerned about this long timeframe, particularly given that the percentage of hospices exceeding the aggregate cap is increasing, along with the average overpayment per beneficiary. To better safeguard the
Therefore, for the 2014 cap year and subsequent cap years, we propose to amend
Hospices would be provided a pro-forma spreadsheet that they would use to calculate their caps to remit any overpayments. The redesigned PS&R system provides the inpatient days, total days, beneficiary counts, and
We invite comment on this proposal and the associated change in the regulation at
E. Proposed Timeframes for Filing the Notice of Election and Notice of Termination/Revocation
1. Proposed Timeframe for Filing the Notice of Election
A distinctive characteristic of the
Because of this waiver, providers other than the designated hospice or attending physician cannot receive payment for services to a hospice beneficiary unless those services are unrelated to the terminal illness and related conditions. For our claims processing system to properly enforce this waiver, it is necessary that the hospice election be recorded in the claims processing system as soon as possible after the election occurs. A survey of the four
Once an NOE is filed, the hospice election and benefit period are established in the Common Working File (CWF) and in the Daily Transaction Reply Report (DTRR). The CWF is used by Part A and Part B providers, and the DTRR is used by Part D plan sponsors, to determine whether a beneficiary is a hospice patient. This information is necessary for providers and suppliers to properly handle claims for beneficiaries under a hospice election.
Our hospice reform contractor,
In the
FOOTNOTE 39 CMS, "Calendar Year (CY) 2014 Medicare Advantage Capitation Rates and
FOOTNOTE 40 Tudor CG, Wilson L, and Majestic M. "Part D Payment for Drugs for Beneficiaries Enrolled in Hospice--Request for Comments," memorandum issued
The CWF is also used by hospices to identify the current benefit period, which helps hospices determine when a face-to-face encounter is required. We have received requests for assistance from hospices where a beneficiary was previously admitted to and then discharged from another hospice, which had not yet filed the NOE, creating a problem for the current hospice in determining the correct benefit period. This can lead to the current hospice not meeting the face-to-face requirement. Additionally, because of sequential billing requirements, the current hospice would have to cancel its NOE and all its billing for that beneficiary, to allow the previous hospice to input its NOE and billing; once the previous hospice files its claims and records the beneficiary's discharge, the current hospice could then resubmit its NOE and its claims. The failure of the first hospice to file its NOE promptly creates an administrative burden for the second hospice.
In summary, prompt filing of the NOE avoids compliance problems with the statutorily mandated face-to-face requirement. It also avoids creating burdensome situations for hospices when sequential billing requirements are not met. Finally, because
Currently, payment for hospice services begins on the effective date of the hospice election, regardless of when the NOE was filed. A commenter on the
Once filed, the process of posting an NOE to the CWF after direct data entry (DDE) takes 1 to 5 days, depending on the host site. If an NOE is not submitted by DDE, the current policy requires hospices to send it to the MAC by mail or messenger. This policy remains in place; however, hospices may need to use overnight mail or an overnight messenger to ensure that paper NOEs are received by the MAC within the proposed 3-calendar-day timeframe after the effective date of election. Given the extremely low volume of NOEs filed by mail or messenger (an average of 68 per year), we do not believe this proposed 3-calendar day filing of the NOE would be burdensome to hospices. Using a speedier form of delivery will ensure that a paper NOE's filing is not delayed by the transit time needed to get the document from the hospice to the MAC.
We invite comment on this proposal and the associated change in the regulation at
2. Proposed Timeframe for Filing the Notice of Termination/Revocation
Hospices may discharge patients for only three reasons: (1) Due to cause; (2) due to the patient's no longer being terminally ill; or (3) due to the patient's moving outside the hospice's service area. In contrast, hospice patients are free to revoke their election to hospice care at any time. Upon discharge or revocation, a beneficiary resumes the
We propose to revise the regulations at
We invite comment on this proposal and the associated changes in the regulations at
F. Proposed Addition of the Attending Physician to the Hospice Election Form
The term "attending physician" is defined differently in different health care settings. For the
"The term "attending physician" means, with respect to an individual, the physician (as defined in subsection (r)(1)) or nurse practitioner (as defined in subsection (aa)(5)), who may be employed by a hospice program, whom the individual identifies as having the most significant role in the determination and delivery of medical care to the individual at the time the individual makes an election to receive hospice care."
Our regulations at
We require that the National Provider Identifier (NPI) of the attending physician be included on the NOE and on each claim. An attending physician can be a physician or a nurse practitioner, as long as he or she meets the requirements set out above. The hospice patient (or his or her representative) chooses the attending physician, not the hospice. This differs from some non-hospice settings, where an attending may be a clinician assigned to provide care to the patient. We stress that in hospice, the attending physician, who may be a nurse practitioner, is chosen by the patient (or his or her representative), and not by the hospice. This requirement is also included as part of the CoPs at
We have recently heard anecdotal reports of hospices changing a patient's attending physician when the patient moves to an inpatient setting for inpatient care, often to a nurse practitioner. We have also heard reports of hospices assigning an attending physician based upon whoever is available. MACs noted that the NPI of the attending physician reported on claims was sometimes changing, and differed from that reported on the NOE. Additionally, using CY 2010 and CY 2011 data, we found that 35 percent of beneficiaries had Part B claims during their hospice election from more than one physician who claimed to be their designated attending physician. The reports of hospices changing a patient's attending physician are of great concern since the statute emphasizes that the attending physician must be chosen by the patient (or his or her representative). Finally, we have also received anecdotal reports that some hospices are not getting the signature of the attending physician on the initial certification. If a beneficiary has designated an attending physician, that physician must sign the initial certification for
To ensure the attending physician of record is properly documented in the patient's medical record, we propose to amend the regulations at
In addition, we further propose that if a patient (or representative) wants to change his or her designated attending physician, he or she must follow a procedure similar to that which currently exists for changing the designated hospice. Specifically, the patient (or representative) must file a signed statement, with the hospice, that identifies the new attending physician in enough detail so that it is clear which physician or NP was designated as the new attending physician. Additionally, we propose that the statement include the date the change is to be effective, the date that the statement is signed, and the patient's (or representative's) signature, along with an acknowledgement that this change in the attending physician is the patient's (or representative's) choice. The effective date of the change in attending physician cannot be earlier than the date the statement is signed. We believe that such a change would help ensure that any changes in the identity of the attending physician would be the result of the patient's free choice.
We invite comment on this proposal and the associated changes in the regulations at
G. FY 2015 Hospice Wage Index and Rates Update
1. FY 2015 Hospice Wage Index
The hospice wage index is used to adjust payment rates for hospice agencies under the
In the FY 2006 Hospice Wage Index final rule, we implemented a 1-year transition policy using a 50/50 blend of the
When adopting OMB's new labor market designations in FY 2006, we identified some geographic areas where there were no hospitals, and thus, no hospital wage index data, which to base the calculation of the hospice wage index. We also adopted the policy that for urban labor markets without a hospital from which hospital wage index data could be derived, all of the CBSAs within the state would be used to calculate a statewide urban average pre-floor, pre-reclassified hospital wage index value to use as a reasonable proxy for these areas in our
In our
For FY 2015, we would use the 2014 pre-floor, pre-reclassified hospital wage index to derive the applicable wage index values for the FY 2015 hospice wage index. We would continue to use the pre-floor, pre-reclassified hospital wage data as a basis to determine the hospice wage index values because hospitals and hospices both compete in the same labor markets, and therefore, experience similar wage-related costs. We believe the use of the pre-floor, pre-reclassified hospital wage index data, as a basis for the hospice wage index, results in the appropriate adjustment to the labor portion of the costs. The FY 2015 hospice wage index values presented in this proposed rule were computed consistent with our pre-floor, pre-reclassified hospital (IPPS) wage index policy (that is, our historical policy of not taking into account IPPS geographic reclassifications in determining payments for hospice). The FY 2015 pre-floor, pre-reclassified hospital wage index does not reflect OMB's new area delineations, based on the 2010 Census, as outlined in OMB Bulletin 13-01, released on
2. FY 2015 Hospice Wage Index With an Additional 15 Percent Reduced Budget Neutrality Adjustment Factor (BNAF)
This proposed rule would update the hospice wage index values for FY 2015 using the FY 2014 pre-floor, pre-reclassified hospital wage index. As described in the
The BNAF is calculated by computing estimated payments using the most recent, completed year of hospice claims data. The units (days or hours) from those claims are multiplied by the updated hospice payment rates to calculate estimated payments. For the FY 2015 Hospice Wage Index proposed rule, that means estimating payments for FY 2015 using units (days or hours) from FY 2013 hospice claims data, and applying the FY 2015 hospice payment rates. The FY 2015 hospice wage index values are then applied to the labor portion of the payments. The procedure is repeated using the same units from the claims data and the same payment rates, but using the 1983
The
The unreduced BNAF for FY 2015 is 0.062060 (or 6.2060 percent). An 85 percent reduction to the BNAF is computed to be 0.009309 (or 0.9309 percent). For FY 2015, this is mathematically equivalent to taking 15 percent of the unreduced BNAF value, or multiplying 0.062060 by 0.15, which equals 0.009309 (0.9309 percent). The BNAF of 0.9309 percent reflects an 85 percent reduction in the BNAF. The 85 percent reduced BNAF (0.9309 percent) was applied to the pre-floor, pre-reclassified hospital wage index values of 0.8 or greater. The 10 percent reduced BNAF for FY 2010 was 0.055598, based on a full BNAF of 0.061775; the additional 15 percent reduced BNAF FY 2011 (for a cumulative reduction of 25 percent) was 0.045422, based on a full BNAF of 0.060562; the additional 15 percent reduced BNAF for FY 2012 (for a cumulative reduction of 40 percent) was 0.035156, based on a full BNAF of 0.058593; the additional 15 percent reduced BNAF for FY 2013 (for a cumulative reduction of 55 percent) was 0.027197, based on a full BNAF of 0.060438; the additional 15 percent reduced BNAF for FY 2014 (for a cumulative reduction of 70 percent) was 0.018461, based on a full BNAF of 0.061538 and the additional 15 percent reduced BNAF for FY 2015 (for a cumulative reduction of 85 percent) is 0.009309, based on a full BNAF of 0.062060.
Hospital wage index values which are less than 0.8 are subject to the hospice floor calculation. For example, if in FY 2014, County A had a pre-floor, pre-reclassified hospital wage index (raw wage index) value of 0.3994, we would perform the following calculations using the budget-neutrality factor (which for this example is an unreduced BNAF of 0.062060, less 85 percent, or 0.009309) and the hospice floor to determine County A's hospice wage index: Pre-floor, pre-reclassified hospital wage index value below 0.8 multiplied by 1 + 85 percent reduced BNAF: (0.3994 x 1.009309 = 0.4031); Pre-floor, pre-reclassified hospital wage index value below 0.8 multiplied by 1 + hospice floor: (0.3994 x 1.15 = 0.4593). Based on these calculations, County A's hospice wage index would be 0.4593. The BNAF may be updated for the final rule based on availability of more complete data.
An addendum A and Addendum B with the FY 2015 wage index values for rural and urban areas will not be published in the
3. Proposed Hospice Payment Update Percentage
Section 4441(a) of the Balanced Budget Act of 1997 (BBA) amended section 1814(i)(1)(C)(ii)(VI) of the Act to establish updates to hospice rates for FYs 1998 through 2002. Hospice rates were to be updated by a factor equal to the market basket index, minus 1 percentage point. Payment rates for FYs since 2002 have been updated according to section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update to the payment rates for subsequent FYs must be the market basket percentage for that FY. The Act requires us to use the inpatient hospital market basket to determine the hospice payment rate update. In addition, section 3401(g) of the Affordable Care Act mandates that, starting with FY 2013 (and in subsequent FYs), the hospice payment update percentage will be annually reduced by changes in economy-wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act. In addition, section 3401(g) of the Affordable Care Act also mandates that in FY 2013 through FY 2019, the hospice payment update percentage will be reduced by an additional 0.3 percentage point (although for FY 2014 to FY 2019, the potential 0.3 percentage point reduction is subject to suspension under conditions specified in section 1814(i)(1)(C)(v) of the Act). The proposed hospice payment update percentage for FY 2015 is based on the estimated inpatient hospital market basket update of 2.7 percent (based on
Currently, the labor portion of the hospice payment rates is as follows: for Routine Home Care, 68.71 percent; for Continuous Home Care, 68.71 percent; for General Inpatient Care, 64.01 percent; and for Respite Care, 54.13 percent. The non-labor portion is equal to 100 percent minus the labor portion for each level of care. Therefore, the non-labor portion of the payment rates is as follows: for Routine Home Care, 31.29 percent; for Continuous Home Care, 31.29 percent; for General Inpatient Care, 35.99 percent; and for Respite Care, 45.87 percent.
4. Proposed FY 2015 Hospice Payment Rates
Historically, the hospice rate update has been published through a separate administrative instruction issued annually in the summer to provide adequate time to implement system change requirements; however, beginning in FY 2014 and for subsequent fiscal years, we are using rulemaking as the means to update payment rates. This change was proposed in the FY 2014 Hospice Wage Index and Payment Rate Update proposed rule and finalized in the FY 2014 Hospice Wage Index and Payment Rate Update final rule (78 FR 48270). It is consistent with the rate update process in other
There are four payment categories that are distinguished by the location and intensity of the services provided. The base payments are adjusted for geographic differences in wages by multiplying the labor share, which varies by category, of each base rate by the applicable hospice wage index. A hospice is paid the routine home care rate for each day the beneficiary is enrolled in hospice, unless the hospice provides continuous home care, inpatient respite care, or general inpatient care. Continuous home care is provided during a period of patient crisis to maintain the patient at home; inpatient respite care is short-term care to allow the usual caregiver to rest; and general inpatient care is to treat symptoms that cannot be managed in another setting.
The FY 2015 payment rates would be the FY 2014 payment rates, increased by 2.0 percent, which is the proposed hospice payment update percentage for FY 2015 as discussed in section III.G.3. The preliminary FY 2015 hospice payment rates would be effective for care and services furnished on or after
Table 6--FY 2015 Hospice Payment Rates Updated by theProposed Hospice Payment Update Percentage Code Description FY 2014 Multiply by FY 2015 payment rates the FY 2015 preliminary proposed payment rate hospice payment update of 2.0 percent 651 Routine Home$156.06 x 1.02$159.18 Care 652 Continuous 910.78 x 1.02 929.00 Home Care Full Rate = 24 hours of care $= 38.71 hourly rate 655 Inpatient 161.42 x 1.02 164.65 Respite Care 656 General 694.19 x 1.02 708.07 Inpatient Care
We reiterate in this proposed rule, that the
Table 7--FY 2015 Hospice Payment Rates Updated by theProposed Hospice Payment Update Percentage for Hospices That DO NOT Submit the Required Quality Data Code Description FY 2014 Multiply by FY 2015 payment rates the FY 2015 preliminary hospice payment rate payment update percentage of 2.0 percent minus 2 percentage points (-0.2) 651 Routine Home$156.06 x 1.00$156.06 care 652 Continuous 910.78 x 1.00 910.78 Home Care Full Rate = 24 hours of care $= 37.95 hourly rate 655 Inpatient 161.42 x 1.00 161.42 Respite Care 656 General 694.19 x 1.00 694.19 Inpatient Care
A Change Request with the finalized hospice payment rates, a finalized hospice wage index, the
To assist the hospice industry in planning and budgeting, CMS is informing the hospice industry of the aggregate cap amount for the 2014 cap year in advance of the formal CMS administrative notice, which will be issued this summer. Additionally, we have included information about how we calculate the aggregate cap amount so that hospices can compute the amount themselves in the future if they so desire. This information is also in CMS' Internet-Only Manual 100-2, chapter 9, section 90.2.6. The manual can be accessed from the "Manuals and Transmittals" section of CMS' hospice Web site at http://www.cms.gov/Center/Provider-Type/Hospice-Center.html. Please refer to section III.D of this proposed rule on the proposal to expedite hospice cap determinations.
The hospice aggregate cap amount for the 2014 cap year will be
(Step 1) From the BLS Web site given above, the
(Step 2) Divide the
433.369/105.4 = 4.111660
(Step 3) Multiply the original cap base amount (
H. Proposed Updates to the Hospice Quality Reporting Program
1.
Section 3004 of the Affordable Care Act amended the Act to authorize a quality reporting program for hospices. Section 1814(i)(5)(A)(i) of the Act requires that beginning with FY 2014 and each subsequent FY, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements with respect to that FY. Depending on the amount of the annual update for a particular year, a reduction of 2 percentage points could result in the annual market basket update being less than 0.0 percent for a FY and may result in payment rates that are less than payment rates for the preceding FY. Any reduction based on failure to comply with the reporting requirements, as required by section 1814(i)(5)(B) of the Act, would apply only for the particular FY involved. Any such reduction would not be cumulative or be taken into account in computing the payment amount for subsequent FYs.
Section 1814(i)(5)(C) of the Act requires that each hospice submit data to the Secretary on quality measures specified by the Secretary. The data must be submitted in a form, manner, and at a time specified by the Secretary. Any measures selected by the Secretary must have been endorsed by the consensus-based entity which holds a contract regarding performance measurement with the Secretary under section 1890(a) of the Act. This contract is currently held by the
The successful development of a Hospice Quality Reporting Program (HQRP) that promotes the delivery of high quality healthcare services is our paramount concern. We seek to adopt measures for the HQRP that promote efficient and safer care. Our measure selection activities for the HQRP takes into consideration input we receive from the
We also take into account national priorities, such as those established by the
To the extent practicable, we have sought to adopt measures that have been endorsed by the national consensus organization, recommended by multi-stakeholder organizations, and developed with the input of providers, purchasers/payers, and other stakeholders.
2. Measures for Hospice Quality Reporting Program and Data Submission Requirements for Payment Years FY 2014 and FY 2015
As stated in the FY 2012 Hospice Wage Index final rule (76 FR 47302, 47320), to meet the quality reporting requirements for hospices for the FY 2014 payment determination and in the CY 2013 Home Health Prospective Payment System (HH PPS) final rule (77 FR 67068, 67133), to meet the quality reporting requirements for hospices for the FY 2015 payment determination, as set forth in section 1814(i)(5) of the Act, we finalized the requirement that hospices report two measures:
* An NQF-endorsed measure that is related to pain management, NQF #0209. The data for this measure are collected at the patient level, but are reported in the aggregate for all patients cared for within the reporting period, regardless of payer.
* A structural measure that is not endorsed by NQF: Participation in a Quality Assessment and Performance Improvement (QAPI) program that includes at least three quality indicators related to patient care.
3. Quality Measures for Hospice Quality Reporting Program and Data Submission Requirements for Payment Year FY 2016 and Beyond
In the FY 2014 Hospice Wage Index and Payment Rate Update final rule (78 FR 48234, 48256), we finalized that the structural measure related to QAPI indicators and the NQF #0209 pain measure would not be required for the HQRP beyond data submission for the FY 2015 payment determination. The data submission period for the FY2015 payment determination closed on
As stated in the CY 2013 HH PPS final rule (77 FR 67068, 67133), we considered an expansion of the required measures to include additional measures endorsed by NQF. We also stated that to support the standardized collection and calculation of quality measures by CMS, collection of the needed data elements would require a standardized data collection instrument. We developed and tested a hospice patient-level item set, the Hospice Item Set (HIS) to be used by all hospices to collect and submit standardized data items about each patient admitted to hospice.
In developing the standardized HIS, we considered comments offered in response to the CY 2013 HH PPS proposed rule (77 FR 41548, 41573). In the FY 2014 Hospice Wage Index final rule (78 FR 48257), and in compliance with section 1814(i)(5)(C) of the Act, we finalized the specific collection of data items that support the following six NQF endorsed measures and one modified measure for hospice:
* NQF #1617 Patients Treated with an Opioid who are Given a Bowel Regimen
* NQF #1634 Pain Screening
* NQF #1637 Pain Assessment
* NQF #1638 Dyspnea Treatment
* NQF #1639 Dyspnea Screening
* NQF #1641 Treatment Preferences
* NQF #1647 Beliefs/Values Addressed (if desired by the patient) (modified)
To achieve a comprehensive set of hospice quality measures available for wide spread use for quality improvement and informed decision making, and to carry out our commitment to develop a quality reporting program for hospices that uses standardized methods to collect data needed to calculate quality measures, we finalized that the HIS will be implemented in
Hospices are required to complete and submit an admission HIS and a discharge HIS for each patient admission. Hospices failing to report quality data via the HIS in 2014 will have their market basket update reduced by 2 percentage points in FY 2016. Although this has been implemented thus far pursuant to instructions set out in our preamble statements, we are proposing to codify the HIS submission requirements at
Hospice programs will be evaluated for purposes of the quality reporting program based on whether or not they submit data, not on their performance level on required measures. We have provided hospices with information and details about use of the HIS through postings on the Hospice Quality Reporting Program Web page, Open Door Forums, announcements in the CMS MLN Connects Provider e-News (
We provided details on data collection and submission timing at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Hospice-Item-Set-HIS.html.
Submission of the HIS on all patient admissions to hospice, regardless of payer or patient age, is required. The data submission system provides reports upon successful submission and successful processing of the HIS records. The final validation report may serve as evidence of submission. This is the same data submission system used by nursing homes, inpatient rehabilitation facilities and long-term care hospitals for the submission of Minimum Data Set Version 3.0 (MDS 3.0), Inpatient Rehabilitation Facility--Patient Assessment Instrument (IRF-PAI), and Long-Term Care Hospital Continuity Assessment Record & Evaluation Data Set (LTCH CARE), respectively.
We also propose that newly certified hospices that receive notice of their CMS certification number on or after
We propose that in future years, hospices that receive notification of certification on or after
As is common in other quality reporting programs, we propose to make accommodations in the case of natural disaster or other extenuating circumstances. Our experience with other quality reporting programs has shown that there are times when providers are unable to submit quality data due to extraordinary circumstances beyond their control (for example, natural or man-made disasters). A disaster may be widespread or impact multiple structures or be isolated and impact a single site only. We do not wish to penalize providers in these circumstances or to unduly increase their burden during these times. Therefore, we propose a process, for the FY 2016 payment determination and subsequent payment determinations, for hospices to request and for CMS to grant extensions/exceptions with respect to the reporting of required quality data when there are extraordinary circumstances beyond the control of the provider. When an extension/exception is granted, a hospice will not incur payment reduction penalties for failure to comply with the requirements of the HQRP.
Under the proposed process for the FY 2016 payment determination and subsequent payment determinations, a hospice may request an extension/exception of the requirement to submit quality data for a specified time period. We propose a process that, in the event that a hospice requests an extension/exception for quality reporting purposes for the FY 2016 payment determination and subsequent payment determinations, the hospice would submit a written request to CMS. Requirements for requesting an extension/exception will be available on the Hospice Quality Reporting Web site at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/index.html.
This proposal does not preclude us from granting extensions/exceptions to hospices that have not requested them when we determine that an extraordinary circumstance, such as an act of nature, affects an entire region or locale. We also propose that we may grant an extension/exception to a hospice if we determine that a systemic problem with our data collection systems directly affected the ability of the hospice to submit data. If we make the determination to grant an extension/exception to hospices in a region or locale, we are proposing to communicate this decision through routine communication channels to hospices and vendors, including, but not limited to, Open Door Forums,
4.
We are not proposing any new measures for the HQRP at this time. However, we believe future development of the HQRP should address existing measure gaps by focusing on two primary opportunities: to expand measures already in use in other quality reporting programs that could apply to the HQRP and to develop new measures if no suitable measures are ready for implementation or expansion. We are particularly interested in outcome measures for symptom management, particularly pain. We are also interested in measures of patient reported outcomes. We welcome comments and input on future measure development.
CMS is also interested in understanding the current state of electronic health record (EHR) adoption and usage and Health Information Exchange (HIE) in the hospice community. Therefore, we are soliciting feedback and input from providers on topics such as decision support, whether hospices have adopted an EHR, if so, what functional aspects of the EHR do hospices find most important (for example, the ability to send or receive transfer of care information, ability to support medication orders/medication reconciliation); does the EHR used in the hospice setting support interoperable document exchange with other healthcare providers (for example, acute care hospitals, physician practices, and skilled nursing facilities? In addition to seeking public input on the feasibility and desirability of electronic health record adoption and use of HIE in hospices, we are also interested in public comment on the need to develop and the benefits and limitations of implementing electronic clinical quality measures for hospice providers.
HHS believes all patients, their families, and their healthcare providers should have consistent and timely access to their health information in a standardized format that can be securely exchanged between the patient, providers, and others involved in the patient's care. (HHS
We believe that HIE and the use of certified EHRs by Hospice (and other types of providers that are ineligible for the
http://healthit.gov/policy-researchers-implementers/standards-and-certification-regulations
http://wiki.siframework.org/LCC+LTPAC+Care+Transition+SWG
http://wiki.siframework.org/Longitudinal+Coordination+of+Care
5. Public Availability of Data Submitted
Under section 1814(i)(5)(E) of the Act, the Secretary is required to establish procedures for making any quality data submitted by hospices available to the public. Measures reported publicly will not display patient identifiable information. The procedures ensure that a hospice would have the opportunity to review the data regarding the hospice's respective program before it is made public. In addition, under section 1814(i)(5)(E) of the Act, the Secretary is authorized to report quality measures that relate to services furnished by a hospice on the CMS Web site. We recognize that public reporting of quality data is a vital component of a robust quality reporting program and are fully committed to developing the necessary systems for public reporting of hospice quality data. We also recognize that it is essential that the data made available to the public be meaningful and that comparing performance between hospices requires that measures be constructed from data collected in a standardized and uniform manner. The development and implementation of a standardized data set for hospices must precede public reporting of hospice quality measures. Once hospices have implemented the standardized data collection approach, we will have the data needed to establish the scientific soundness of the quality measures that can be calculated using the standardized data collection. It is critical to establish the reliability and validity of the measures prior to public reporting in order to demonstrate the ability of the measures to distinguish between the quality of services provided. To establish reliability and validity of the quality measures, at least four quarters of data will need to be analyzed. Typically the first two quarters of data reflect the learning curve of the providers as they adopt a standardized data collection; these data are not used to establish reliability and validity. This means that, since we will begin data collection in CY 2014 (Q3), the data from CY 2014 (Q3, Q4) will not be used for assessing validity and reliability of the quality measures. Data collected by hospices during Q1-3 CY 2015 will be analyzed starting in CY 2015. Decisions about whether to report some or all of the quality measures publicly will be based on the findings of analysis of the CY 2015 data. In addition, as noted, the Affordable Care Act requires that reporting be made public on a CMS Web site and that providers have an opportunity to review their data prior to public reporting. CMS will develop the infrastructure for public reporting, and provide hospices an opportunity to review their data. In light of all the steps required prior to data being publicly reported, we anticipate that public reporting will not be implemented in FY 2016. Public reporting may occur during FY 2017, allowing ample time for data analysis, review of measures' appropriateness for use for public reporting, and allowing hospices the required time to review their own data prior to public reporting. We will announce the timeline for public reporting of data in future rulemaking. We welcome public comment on what we should consider when developing future proposals related to public reporting.
6. Proposed Adoption of the CAHPS(R) Hospice Survey for the FY 2017 Payment Determination
In the FY 2014 Hospice Wage Index and Payment Rate Update final rule (78 FR 48234), we stated that CMS would start national implementation of the CAHPS(R) Hospice Survey as of
a. Background and Description of the Survey
Before the development of the CAHPS(R) Hospice Survey, there was no official national standard hospice experience of care survey that included standard survey administration protocols. The CAHPS(R) Hospice Survey will include detailed survey administration protocols which will allow for fair comparisons across hospices.
CMS developed the CAHPS(R) Hospice Survey with input from many stakeholders, including other government agencies, industry stakeholders, consumer groups and other key individuals and organizations involved in hospice care. The Survey was designed to measure and assess the experiences of patients who died while receiving hospice care as well as the experiences of their informal caregivers. The goals of the survey are to--
* Produce comparable data on patients' and caregivers' perspectives of care that allow objective and meaningful comparisons between hospices on domains that are important to consumers;
* Create incentives for hospices to improve their quality of care through public reporting of survey results; and
* Hold hospice care providers accountable by informing the public about the providers' quality of care.
The development process for the survey began in 2012 and included a public request for information about publically available measures and important topics to measure (78 FR 5458); a review of the existing literature on tools that measure experiences with end-of-life care; exploratory interviews with caregivers of hospice patients; a technical expert panel attended by survey development and hospice care quality experts; cognitive interviews to test draft survey content; incorporation of public responses to
Thirty-three hospice programs from 29 hospice organizations participated in the field test, which was designed to assess survey administration procedures among hospices of varying size, geographic region, chain status, ownership, and urbanicity. Respondents were primary caregivers of patients who died while receiving hospice care in the prior 2 to 5 months. In all, 1,136 respondents, representing the three main settings of hospice care (home, nursing home, and inpatient, including freestanding hospice inpatient unit, and acute care hospitals), completed the field test survey. Field test survey data were analyzed to identify for removal survey questions which exhibited little variation between hospices or for which there was little room for hospice improvement. Field test survey data were further analyzed to identify composite measures of hospice performance, including Communication, Care Coordination, Getting Timely Care, Treating Your Family Member with Respect, Providing Emotional Support, and Getting Help for Symptoms.
The CAHPS(R) Hospice Survey treats the dying patient and his or her informal caregivers (family members or friends) as the unit of care. The Survey seeks information from the informal caregivers of patients who died while enrolled in hospices. Caregivers will be identified using hospice records. Fielding timelines give the respondent some recovery time (two to three months), while simultaneously not delaying so long that the respondent is likely to forget details of the hospice experience. The survey focuses on topics that are important to hospice users and for which informal caregivers are the best source for gathering this information. These include communications with hospice staff, treatment of symptoms, pain medication, cooperation among caregivers, treating patients with dignity and respect, and spiritual support offered by the hospice. Caregivers will be presented with a set of standardized questions about their own experiences and the experiences of the patient in hospice care. During national implementation of this survey, hospices are required to conduct the survey to meet the hospice quality reporting requirements, but individual caregivers will respond only if they voluntarily choose to do so. As part of national implementation we will launch a Web site intended as the primary information resource for hospices and vendors (www.hospicecahpssurvey.org). The Web site is expected to launch in the summer of 2014. The launch date will be announced at the
The CAHPS(R) Hospice Survey will initially be available in English and Spanish. CMS will provide additional translations of the survey over time in response to suggestions for any additional language translations. Requests for additional language translations should be made to the CMS Hospice CAHPS(R) Project Team at [email protected].
In general, hospice patients and their caregivers are eligible for inclusion in the survey sample with the exception of the following ineligible groups: primary caregivers of patients under the age of 18 at the time of death; primary caregivers of patients who died within 48 hours of admission to hospice care; patients for whom no caregiver is listed or available, or for whom caregiver contact information is not known; patients whose primary caregiver is a legal guardian unlikely to be familiar with care experiences; patients for whom the primary caregiver has a foreign (Non-US or US Territory address) home address; patients or caregivers of patients who request that they not be contacted (those who sign "no publicity" requests while under the care of hospice or otherwise directly request not to be contacted) . Identification of patients and caregivers for exclusion will be based on hospice administrative data.
Hospices with fewer than 50 decedents during the prior calendar year are exempt from the CAHPS(R) Hospice Survey data collection and reporting requirements for payment determination. Hospices with 50 to 699 decedents in the prior year (n = 2,326 in 2012) will be required to survey all cases. For large hospices with 700 or more decedents in the prior year (n = 274 in 2012), a sample of 700 will be drawn under an equal-probability design.
For national implementation, we have assumed an eligibility rate of 85% and a response rate of 50%, based on experience in the 2013 field test of the CAHPS(R) Hospice Survey instrument. These rates will result in an estimated 300 completed questionnaires for each large hospice (700 or more decedents in the calendar year) and between 21 and 300 completed questionnaires for hospices with between 50 and 699 decedents during the calendar year. Assuming a total of 300 completes within each hospice and an intraclass correlation coefficient (ICC) of 0.01, which measures the amount of variability between hospices, we would achieve an interunit reliability of 0.75. Note that in Medicare CAHPS(R) a reliability of 0.75 is regarded as a minimal acceptable standard.
We will move forward with a model of national survey implementation which is similar to that of other CMS patient experience of care surveys.
Hospices will be required to provide their vendor with the sampling frame on a monthly basis. Participation requirements for the survey begin
A list of approved vendors will be provided on the CAHPS(R) Hospice Survey Web site closer to the launch of national implementation. Beginning summer 2014 interested vendors may apply to become approved CAHPS(R) Hospice Survey vendors. The application process will be online at www.hospicecahpssurvey.org. In this rule we propose to codify the requirements for being an approved CAHPS(R) Hospice Survey vendor for the FY 2017 APU.
Consistent with many other CMS CAHPS(R) surveys that are publicly reported on CMS Web sites, CMS will publicly report hospice data when at least 12 months of data are available, so that valid comparisons can be made across hospice providers in
b. Participation Requirements To Meet Quality Reporting Requirements for the FY 2017 APU
In section 3004 of the Affordable Care Act, the Secretary is directed to establish quality reporting requirements for Hospice Programs. The CAHPS(R) Hospice Survey is a component of the CMS Quality Reporting Requirements for the FY 2017 APU and subsequent years.
The CAHPS(R) Hospice Survey is the only nationally implemented survey of civilian patient and caregiver experiences with hospice that includes both a standard questionnaire and standard survey administration protocols. Such standardization is needed in order to establish that the resulting survey data is comparable across hospices and is suitable for public reporting.
The CAHPS(R) Hospice Survey includes the measures detailed below. The measures map directly to the CAHPS(R) Hospice Survey. The individual survey questions that comprise each measure are listed under the measure. These measures are in the process of being submitted to the
Table 9--Hospice Experience of Care Survey Quality Measures and Their Items Hospice Team Communication How often did the hospice team listen carefully to you when you talked with them about problems with your family member's hospice care? While your family member was in hospice care, how often did the hospice team listen carefully to you? While your family member was in hospice care, how often did the hospice team explain things in a way that was easy to understand? While your family member was in hospice care, how often did the hospice team keep you informed about your family's condition? While your family member was in hospice care, how often did the hospice team keep you informed about when they would arrive to care for your family member? Getting Timely Care While your family member was in hospice care, when you or your family member asked for help from the hospice team, how often did you get help as soon as you needed it? How often did you get the help you needed from the hospice team during evenings, weekends, or holidays? Treating Family Member with Respect While your family member was in hospice care, how often did the hospice team treat your family member with dignity and respect? While your family member was in hospice care, how often did you feel that the hospice team really cared about your family member? Providing Emotional Support In the weeks after your family member died, how much emotional support did you get from the hospice team? While your family member was in hospice care, how much emotional support did you get from the hospice team? Getting Help for Symptoms How often did your family member receive the help he or she needed from the hospice team for feelings of anxiety or sadness? Did your family member get as much help with pain as he or she needed? How often did your family member get the help he or she needed for constipation? How often did your family member get the help he or she needed for trouble breathing? Information Continuity While your family member was in hospice care, how often did anyone from the hospice team give you confusing or contradictory information about your family member's condition or care? Understanding the Side Effects of Pain Medication Side effects of pain medicine include things like sleepiness. Did any member of the hospice team discuss side effects of pain medicine with you or your family member? Getting Hospice Care Training (Home Setting of Care Only) Did the hospice team give you enough training about what to do if your family member became restless or agitated? Did the hospice team give you enough training about if and when to give more pain medicine to your family member? Did the hospice team give you enough training about how to help your family member if he or she had trouble breathing? Did the hospice team give you enough training about what side effects to watch for from pain medicine?
In order to comply with CMS's quality reporting requirements, hospices will be required to collect data using the Consumer Assessment of Healthcare Providers and Systems (CAHPS(R))
In the FY Hospice Wage Index and Rate Update final rule (78 FR 48234), we stated that national implementation of the CAHPS(R) Hospice Survey will begin with a "dry run" in the first quarter of CY 2015. Hospices will be required to contract with an approved survey vendor to conduct a dry run of the survey for at least one month during
Beginning
Approved CAHPS(R) Hospice Survey vendors will submit data on the hospice's behalf to the CAHPS(R) Hospice Survey Data Center. The proposed deadlines for data submission occur quarterly and are shown in Table 9 below. Deadlines are final. No late submissions will be accepted. Hospice providers are responsible for making sure that their vendors are submitting data in a timely manner.
Table 10--Data Submission Dates 2015-2016 for CAHPS(R) Hospice Survey Sample months Quarterly data submission deadlines Dry Run (January-March 2015 )August 12, 2015 . Monthly data collection April-June 2015 (Q2)November 1, 2015 . Monthly data collection July-September 2015 February 10, 2016 . (Q3) Monthly data collection October-DecemberMay 11, 2016 . 2015 (Q4)
In the FY 2014 Hospice Wage Index and Rate Update final rule, we exempted very small hospices from CAHPS(R) Hospice Survey requirements. Hospices that have fewer than 50 survey-eligible deceased patients in the period from
c. Participation Requirements To Meet Quality Reporting Requirements for the FY 2018 APU
To meet participation requirements for the FY 2018 APU, we propose that hospices collect data on an ongoing monthly basis from
We propose to exempt very small hospices. Hospices that have fewer than 50 deceased patients in the period from
d. Vendor Participation Requirements for the 2017 APU
We have previously stated that CMS will train and approve vendors to administer CAHPS(R) Hospice Survey on behalf of hospices (78 FR 48233). In addition we stated that hospices will be required to contract with an approved survey vendor and to provide the sampling frame to the approved vendor on a monthly basis.
We propose that approved survey vendors must meet all of the minimum business requirements and follow the detailed technical specifications for survey administration as published in the CAHPS(R) Hospice Survey specifications manual, which will be posted on the Survey Web site. In addition, to the specifications manual, the Web site will include information and updates regarding survey implementation and technical assistance.
We propose to codify the CAHPS(R) Hospice Survey vendor requirements to be effective with the FY 2017 APU (as proposed in
Vendors may not use home-based or virtual interviewers to conduct the CAHPS(R) Hospice Survey, nor may they conduct any survey administration processes (e.g. mailings) from a residence in order to ensure the confidentiality of data.
The following are examples of data collection activities would not satisfy the requirement of valid survey experience for approved vendors as defined for the CAHPS(R) Hospice Survey, and these would not be considered as part of the experience required of an approved vendor for CAHPS(R) Hospice Survey.
* Focus groups, cognitive interviews, or any other qualitative data collection activities;
* Surveys of fewer than 600 individuals;
* Surveys conducted that did not involve using statistical sampling methods;
* Internet or Web-based surveys; and
* Interactive Voice Recognition Surveys.
We also propose that no organization, firm, or business that owns, operates, or provides staffing for a hospice is permitted to administer its own Hospice CAHPS(R) survey or administer the survey on behalf of any other hospice in the capacity as a Hospice CAHPS(R) survey vendor. Such organizations will not be approved by CMS as CAHPS(R) Hospice Survey vendors.
e. Annual Payment Update
The Affordable Care Act requires that beginning with FY 2014 and each subsequent FY, the Secretary shall reduce the market basket update by 2 percentage points for any hospice that does not comply with the quality data submission requirements with respect to the FY, unless covered by specific exemptions. Any such reduction would not be cumulative and would not be taken into account in computing the payment amount for subsequent FYs. We propose to add the CAHPS(R) Hospice Survey to the Hospice Quality Reporting Program requirements for the FY 2017 payment determination and determinations for subsequent years.
* To meet the FY 2017 requirements, hospices will participate in a dry run for at least 1 month of the first quarter of CY 2015 (
* To meet the HQRP requirements for the FY 2018 payment determination, hospices would collect survey data on a monthly basis for the months of
f. CAHPS(R) Hospice Survey Oversight Activities
We propose that vendors and hospice providers be required to participate in CAHPS(R) Hospice Survey oversight activities to ensure compliance with Hospice CAHPS(R) technical specifications and survey requirements. The purpose of the oversight activities is to ensure that hospices and approved survey vendors follow the CAHPS(R) Hospice Survey technical specifications and thereby ensure the comparability of CAHPS(R) Hospice Survey data across hospices.
We propose that the reconsiderations and appeals process for hospices that fail to meet the Hospice CAHPS(R) data collection requirements will be part of the Reconsideration and Appeals process already developed for the Hospice Quality Reporting program.
We encourage hospices interested in learning more about the CAHPS(R) Hospice Survey to visit the CAHPS(R) Hospice Survey Web site: www.hospicecahpssurvey.org. The launch date for this Web site will be announced at the
7. Procedures for Payment Year 2016 and Subsequent Years
In the FY 2014 Hospice Wage Index and Payment Rate Update final rule (78 FR 48267), we notified hospice providers of the opportunity to seek reconsideration of our initial non-compliance decision for the FY 2014 and FY 2015 payment determinations. We stated that we will notify hospices found to be non-compliant with the HQRP reporting requirements that they may be subject to the two percentage point reduction in their annual payment update. The process for filing a request for reconsideration is described on the CMS Web site at: http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Hospice-Quality-Reporting/Reconsideration-Requests.html. We propose to codify this process at
Finally, we also propose to codify at
We invite public comment on all of the proposals in this section and the associated regulations text at
I. Coordination of Benefits Process and Appeals for Part D Payment for Drugs While Beneficiaries Are Under a Hospice Election
The statutory definition of the term "covered Part D drug", as specified in section 1860D-2(e)(2)(B) of the Social Security Act, excludes a drug if payment for such a drug, as so prescribed and dispensed or administered with respect to a Part D eligible individual, is available (or would be available but for the application of a deductible) under Part A or B for that individual. Therefore, drugs and biologicals for which coverage is available under the Medicare Part A per-diem payment to a hospice program are excluded from coverage under Part D. Our previous understanding was that hospice coverage of drugs was very broad and very inclusive. Therefore, Part D payment for drugs furnished to hospice beneficiaries would be rare and the need for controls was not critical.
Section 1861(dd) of the Act states the hospice is responsible for covering all drugs or biologicals for the palliation and management of the terminal illness and related conditions. Our stated intention in the 1983 Hospice final rule (48 FR 56010) was that the hospice benefit provides virtually all care for the terminally ill individual. Despite our intention for a comprehensive and holistic benefit, claims data presented in section III.A.4 in this proposed rule shows that in 2012 there was over
CMS has previously issued a number of policy documents addressing our expectations concerning how Part D sponsors are to ensure that Part D drugs are provided only when those drugs are not covered under Part A or B as so prescribed and dispensed or administered for that individual. Since the hospice benefit was created with the expectation that virtually all care that is needed by the terminally ill patient and all drug needs at end of life would be covered by the hospice benefit, we believed that Part D coverage would be rare, and that hospices would make appropriate determinations consistent with the 1983 Hospice final rule (48 FR 56010 through 56011). Prior to the 2014 Final Call Letter, our guidance included an
FOOTNOTE 41
Following the issuance of this guidance, we received questions indicating our policy statements were being misinterpreted by some parties. The hospice industry expressed uncertainty with the definitions of "terminal condition" and "related conditions," and Part D sponsors were thus uncertain about whether payment should be the responsibility of either the hospice (Part A) or the plan (Part D). Therefore, on
1. Part D Sponsor Coordination of Payment With Hospice Providers
Many commenters on the
Specifically, we are considering amending
To facilitate the communication and coordination, CMS reports hospice election information to Part D plan sponsors on the Daily Transaction Reply Report (DTRR). This information includes a hospice indicator, a hospice start date and a hospice termination date. Updated data are reported to reflect a new benefit period or a termination/revocation date. Because communication and coordination between the Part D sponsor and the hospice are necessary to determine coverage for drugs for beneficiaries who elect hospice, we expect that sponsors will promptly upload the DTRR data into their systems. As noted previously in CMS-issued Part D guidance, only a single hospice benefit period can be reported on the DTRR. As a result, sponsors need to store the hospice data in their systems so historical data are available when needed for claims adjudication and adjustments. Sponsors also can access additional hospice data via the
Although we are proposing changes in this rule at section III.E that are expected to result in improvement to the timeliness of the CMS' reporting of the hospice election information, some time lag will remain in hospices filing their election information and plan sponsors' ability to access that information. One approach, recommended by hospice organizations, to address the time lag is to permit hospices to initiate communication with the beneficiary's Part D sponsor prior to a claim submission, such as at hospice election, to provide early notice of the election. When hospices provide this information, we are considering requiring Part D sponsors to accept it and use it to adjudicate requests for coverage until the official notice via the DTTR is received from CMS. We would expect sponsors to have processes in place to monitor receipt of the information from CMS and communicate with the hospice to resolve discrepancies between hospice-reported information and CMS-reported data.
We also are considering requiring that a Part D sponsor determine Part A versus Part D coverage at point-of-sale for any drugs for beneficiaries who have elected the hospice benefit as of the date the prescription is presented to be filled. By this we mean Part D sponsors would use HIPAA standard transactions to effectuate the Part D prior authorization requirement. The point of sale transaction related to Part A versus Part D coverage begins when a Part D sponsor receives a pharmacy claim for a beneficiary who has elected hospice, and rejects the claim with the following
The beneficiary, the beneficiary's appointed representative, or the prescriber must contact the sponsor to initiate a coverage determination request which would require the plan sponsor to obtain information from the hospice provider that the drug is unrelated to the terminal illness and related conditions. The standardized pharmacy notice instructs the enrollee on how to contact his or her plan and explains an enrollee's right to receive, upon request, a coverage determination (including a detailed written decision) from the Part D sponsor regarding his or her Part D prescription drug benefits. Part D sponsors must arrange with their network pharmacies (including mail-order and specialty pharmacies) to distribute the standardized notice.
After the Part D sponsor receives the coverage determination request and the PA process is initiated, the Part D sponsor would expect to receive either a verbal explanation or a completed PA form from the hospice within the timeframes proposed in this rule in
If the sponsor disagrees with the hospice's determination that the drug is unrelated to the terminal illness and related conditions, or determines that the documentation is insufficient to satisfy the beneficiary-level hospice PA, the Part D sponsor would initiate communication with the hospice and attempt to resolve the dispute. If the Part D sponsor and the hospice are unable to reach a resolution, the Part D sponsor may request a review by the independent review entity (IRE) we indicate in this rule we are considering.
Since the plan sponsor's decision about whether the PA is satisfied is a coverage determination, the Part D sponsor must notify the enrollee (and, if applicable, the prescriber) of its decision in accordance with the applicable adjudication timeframes and notice rules in Part 423, Subpart M. For example, if an enrollee, the enrollee's representative, or the prescriber's request is processed as an expedited coverage determination, the plan sponsor must provide notice of its decision as expeditiously as the enrollee's health condition requires, but no later than 24 hours after receiving the request or, for an exceptions request, the prescriber's supporting statement. If an appeal is requested following an adverse coverage determination decision, an expedited redetermination (plan level appeal) requires the plan to notify the enrollee (and prescriber, if appropriate) of the decision as expeditiously as the enrollee's health condition requires, but no later than 72 hours from receiving the request. The 72 hour expedited timeframe also applies to the IRE reconsideration level of review.
In those instances in which the Part D sponsor disagrees with the hospice's determination that the prescribed drug is unrelated to the terminal illness and related conditions, the denial notice would explain the Part D sponsor's intention to seek independent review of the hospice's determination, if applicable. Since Part D coverage of a drug depends on whether the drug is covered under the hospice benefit, if the hospice does not respond or refuses to provide the required explanation regarding why the drug is unrelated to the terminal illness and related conditions, Part A coverage cannot be ruled out and the PA would be unfulfilled.
In addition to providing early notice of a hospice election or termination/revocation, the hospice may identify any drugs determined to be coverable under Part D for a beneficiary and provide an explanation of why the drugs are unrelated to the terminal illness and related conditions. When the hospice furnishes the documentation to satisfy the PA, prior to a claim submission, we are considering requiring Part D sponsors to accept the information from the hospice either verbally or on the PA form. Once the information is received from the hospice provider, the Part D sponsor would determine whether it is sufficient to establish that the drug as prescribed and dispensed or administered is unrelated to the terminal illness and related conditions. If it does, the Part D sponsor would reflect that the PA is satisfied for this drug in their system. If the Part D sponsor determines that the explanation provided is unsatisfactory, the Part D sponsor would communicate this to the hospice. The Part D sponsor and hospice may attempt to resolve the coverage issue, but should they be unable to do so, the plan sponsor would be able to seek review by the IRE.
We also are considering requiring that a Part D sponsor process retrospective claims adjustments and issue requests for repayment and or refunds for drugs that are excluded from Part D by virtue of their being covered under the hospice benefit in accordance with the timeframes in
We believe that the definitions of "terminal illness" and "related conditions" in section III.B of this proposed rule would guide hospices, prescribers, and Part D sponsors by clarifying and strengthening the concepts of holistic and comprehensive hospice care. Thus, through a good faith effort, Part D sponsors and hospices would be able to resolve issues of payment responsibility for prescription drugs using the processes under consideration and outlined in this proposed rule.
While we expect the overwhelming preponderance of cases involving payment coverage responsibility to be resolved using the communication and coordination of benefits processes we are considering, we recognize that there may be some instances where the Part D sponsor and the hospice will be unable to agree on which entity is responsible for covering a prescription drug. Therefore, we are considering enabling the Part D sponsor to request review from the IRE that has contracted with CMS. As noted above, drugs available under Part A as prescribed and dispensed or administered are excluded by statute from coverage under Part D. We believe that the coverage exclusion set forth at section 1860D-2(e)(2)(B) of the Act provides CMS with the authority to implement a process whereby the Part D sponsor can request an independent review of a disagreement over payment responsibility with a Part A hospice. In addition, section 1860D-24 of the Act requires Part D sponsors to coordinate with other drug plans, including with other health benefit plans or programs that provide coverage or financial assistance for the purchase or provision of prescription drug coverage on behalf of Part D eligible individuals. We believe these statutory provisions support the coordination and independent review processes being considered, as these processes would help ensure that payment responsibility is properly determined and that drugs are not being inappropriately covered and paid for by the Part D program.
The independent review process considered would be made part of the regulations at 42 CFR Part 423, Subpart J, given the nexus between the coordination of benefits processes considered for inclusion at
The changes we are considering at
We are considering requiring that the written request for independent review include relevant clinical documentation and the explanation provided by the hospice. The IRE would be responsible for obtaining any additional information it believes is necessary to determine whether the disputed drug is the payment responsibility of the hospice or the Part D sponsor. The IRE would notify the hospice (and prescriber, as appropriate), the Part D sponsor, and the enrollee of its decision in writing. The IRE's decision would be binding on the Part D sponsor and the hospice. Decisions made through this review would not be subject to appeal, but could be reviewed and revised at the discretion of CMS. We are considering a corresponding change at 418.305(b) specifying the hospice would be bound by the decision made by the IRE under the change being considered at 423.464(i). If the IRE review process we are considering were to be proposed and finalized through future rulemaking, additional guidance related to the IRE's review, such as adjudication timeframes and specific notice requirements, would be established in manual guidance or rulemaking.
The following chart summarizes the existing and new requirements under consideration for Part D sponsor coordination with hospices:
Process Timeframes Communication/Coordination: Part D sponsors would be required to A hospice would be able to furnish communicate and coordinate with a information to the Part D sponsor at hospice when: any time. . The hospice furnishes information This communication/coordination regarding a beneficiary's hospice process would begin when the election or plan of care; and beneficiary, the beneficiary's . The Part D coverage determination appointed representative or the process is initiated. prescriber requests a coverage determination. Prior Authorization: Part D sponsors would implement When a coverage determination is beneficiary-level hospice PAs and requested, sponsors would be required NCPDP reject coding at point-of-sale to comply with the existing timeframes (POS) for drugs for beneficiaries who of 72 hours for standard requests and have elected hospice 24 hours for expedited requests, as When a claim rejects at POS, the specified in Federal regulation at S. beneficiary would be provided with a 423.568 and S. 423.572 respectively. notice explaining the right to request a coverage determination from the plan Payment Recovery: When a Part D sponsor has paid for Once payment responsibility is drugs prior to receiving notification determined, the sponsor would be of the beneficiary's hospice election, required to process any adjustments the sponsor would be required to and issue refunds or recovery notices determine payment responsibility for within 45 days, as specified in the drugs, process retrospective Federal regulations at S. 423.466(a). claims adjustments, and issue refunds or recovery requests Independent Review: If a sponsor disagrees with a hospice Sponsors would be required to request determination that a drug is an IRE review within 5 business days unrelated, the sponsor would be able of receiving the hospice's explanation to request an IRE review. IRE of why a drug is unrelated and not decisions would be binding on the covered under the hospice benefit. sponsor and hospice
In formulating the requirements under consideration, we have become aware that the regulatory requirement for a Part D sponsor to coordinate with other health benefit plans or programs at
We solicit comments on the changes under consideration regarding the coordination of benefits process and appeals for Part D payment for drugs while beneficiaries are under a hospice election.
2. Hospice Coordination of Payment With Part D Sponsors and Other Payers
As specified in section 1861(dd) of the Act, and in regulation at 42 CFR Part 418, the hospice is responsible for covering all drugs and biologicals for the palliation and management of the terminal illness and related conditions. As noted in 418.202(f), drugs and biologicals for palliation of pain and symptom management are included in the Medicare Part A per-diem payment to a hospice. Therefore, such drugs and biologicals are excluded from coverage under Part D (see section III.I.1). Additionally, our payment regulations at
We have received anecdotal reports from
In addition, several hospices have stated that pre-existing, chronic and/or controlled conditions are not related to the prognosis of the hospice beneficiary and should not be the responsibility of the hospice--a concept which is contrary to the hospice philosophy of providing comprehensive coordinated care to patients at end of life as described in sections II and III.B of this proposed rule. One hospice illustrated the issue with an example, a patient that was admitted with a primary terminal diagnosis of COPD. In the example, the patient also has diabetes which pre-dates the COPD; the patient uses corticosteroids to manage the COPD. The diabetes is well managed with an oral hypoglycemic agent and the patient needs to continue the medication to manage the diabetes. The hospice argues that since the diabetes is unrelated to the COPD, the oral hypoglycemic agent medication should not be covered by hospice. However, increased glucose levels are a common manifestation of corticosteroid use. While the hospice states that the admission to hospice is a result of COPD, treatment for the COPD has the potential to affect glucose levels, and hence the hypoglycemic agent would be covered by the hospice and not through Part D. As we stated above, and as required by
As outlined in section III.A.4,
FOOTNOTE 42 MedPAC "Report to the
To safeguard the integrity of the Medicare Trust Funds and encourage hospices to coordinate with other providers and payers, and to ensure that beneficiaries have access to needed services and medications, we are considering how hospices can coordinate with Part D plan sponsors and comply with a standardized process for determining payment responsibility (prior authorization (PA) process), for recovering payment when the wrong party has paid, and for resolving disputes regarding payment responsibility. We are not proposing any requirements at this time, but are soliciting comments on approaches to these issues.
Currently, the CoPs at
The PA process described in Section III.I.1 would be a mechanism that would emphasize the recognition of the hospice and hospice physician as the clinical point of contact and enable the hospice and hospice physician to better maintain the professional and clinical responsibility for hospice patients. Hospices are health care leaders in coordinating care for beneficiaries at the end of life, and thus we believe this solicitation fits well within a hospice's usual care paradigm. The solicitations outlined, above in section III.I.1, could ensure that hospices and hospice physicians are notified of any beneficiary medications prescribed by a non-hospice provider, as well as non-hospice care the beneficiary has initiated without the hospice's knowledge.
We are also soliciting comments on the steps hospices should take to reconcile payment responsibility within a specified timeframe that could be similar to an established timeframe set forth in Part 423, Subpart M, which also requires that payment responsibility be resolved within 45 days. We are soliciting comments on whether the determination of payment responsibility should be resolved within 45 days from the date of receipt of a repayment request from either the Part D plan sponsor or the hospice. We are soliciting comments on whether the hospice would issue a request for a refund from the other payer or provider for the total amount paid for the item or service within a specific timeframe and refund to the beneficiary any associated cost-sharing.
As described in section III.I.1, we believe a majority of cases involving payment coverage responsibility could be resolved under the communication and coordination of benefits process. However, we recognize that there may be instances where the hospice and the Part D sponsor will be unable to agree on which entity is responsible for the prescription drug. We are soliciting comments on the impact to hospices regarding the potential independent review process described in section III.I.1.
3. Beneficiary Rights and Appeals
Sometimes a beneficiary requests a certain medication that a hospice cannot or will not provide because the hospice has deemed that the specific medication is not reasonable and necessary for the palliation and management of the terminal illness and related conditions. Coverage of such medication would not be permissible under Part D coverage since the medication is not for any condition completely separate and distinct from the terminal illness and related conditions, nor is it covered under Part A since it is not reasonable and necessary for the palliation and management of the terminal illness and related conditions. If the hospice does not provide the medication, the hospice is not obligated to provide any notice of non-coverage (including the Advance Beneficiary Notice of Non-coverage or ABN). If the hospice provides medication it believes is not reasonable and necessary for the palliation and management of the terminal illness and related conditions, the hospice must first issue an ABN in order to charge the beneficiary for the cost of such medication. Regardless of whether or not the hospice furnishes the drug, if the beneficiary independently obtains the drug, but believes that the
Beneficiaries who disagree with such medication coverage determinations may use the
There may also be instances where a beneficiary prefers a non-formulary drug because, for example, he or she believes it to be more efficacious than the formulary drug prescribed by the hospice. In such instances, the hospice may have determined that the formulary drug prescribed is reasonable and necessary for the palliation and management of the terminal illness and related conditions; however, the beneficiary may prefer another brand of such drug that is off formulary, which the hospice believes is not reasonable and necessary, or more expensive but no more effective than the drug in the formulary. In those cases, the beneficiary may submit quality of care complaints to a
J. Update on the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) and Coding Guidelines for Hospice Claims Reporting
3. International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM)
On
In the HIPAA regulations at 45 CFR 162.1002, the Secretary adopted the ICD-9-CM code set, including the Official ICD-9-CM Guidelines for Coding and Reporting. The current ICD-9-CM Coding Guidelines use the International Classification of Diseases, 9th Revision, Clinical Modification (ICD-9-CM) and are available through the CMS Web site at: http://www.cms.gov/Medicare/Coding/ICD9ProviderDiagnosticCodes/index.html or on the CDC's Web site at http://www.cdc.gov/nchs/icd/icd9cm.htm.
4. Coding Guidelines for Hospice Claims Reporting
In the FY 2014 Hospice Wage Index and Payment Rate Update, we reiterated that diagnosis reporting on hospice claims should include the appropriate selection of principal diagnoses as well as the other, additional and coexisting diagnoses related to the terminal illness and related conditions (78 FR 48254). Additionally, in the
In the FY 2014 Hospice Wage Index and Payment Rate Update final rule, we stated that beginning on
Also in the FY 2014 Hospice Wage Index and Payment Rate Update final rule, we advised hospice providers to pay particular attention to dementia diagnoses which are found under two separate ICD-9-CM classifications: "Mental, Behavioral, and Neurodevelopmental Disorders" and "Diseases of the Nervous System and Sense Organs"(78 FR48252-48253). Many of the codes relating to dementia manifestations found under the ICD-9-CM classification, "Mental, Behavioral, and Neurodevelopmental Disorders", are not appropriate as principal diagnoses because of etiology/manifestation guidelines or sequencing conventions under the ICD-9-CM Coding Guidelines. ICD-9-CM Coding Guidelines for this classification state that dementia is most commonly a secondary manifestation of an underlying causal condition. Codes found under this classification identify the common behavioral disturbances of dementia manifestations. Many of the dementia codes under the ICD-9-CM classification, "Mental, Behavioral and Neurodevelopmental Disorders" have coding conventions that require to code first the associated neurological condition. Many of the associated neurological conditions can be found under the classification, "Diseases of the Nervous System", including such conditions as "Alzheimer's disease" and "Senile Degeneration of the Brain". We advise hospices to pay close attention to the various coding and sequencing conventions found within The Official ICD-9-CM Guidelines for Coding and Reporting when reporting diagnoses on hospice claims.
To ensure additional compliance with ICD-9-CM Coding Guidelines we will implement certain edits from Medicare Code Editor (MCE), which detect and report errors in the coding of claims data, for all hospice claims effective
We will implement edits related to etiology/manifestation code pairs from the MCE; therefore, it is important for hospice providers to follow the ICD-9-CM Coding Guidelines regarding codes that fall under this coding convention. The etiology/manifestation coding convention states that there are certain conditions which have both an underlying cause (etiology) and subsequent multiple body system manifestations. For such conditions, ICD-9-CM coding convention requires the underlying condition be sequenced first, followed by the manifestation. Whenever such a combination exists, there is a "use additional code" note at the etiology code and a "code first" note at the manifestation code. These instructional notes indicate the proper sequencing order of the codes. In most cases, the manifestation codes will have in the code title, "in diseases classified elsewhere." "In diseases classified elsewhere" codes are never permitted to be used as first-listed or principal diagnosis codes. They must be used in conjunction with an underlying condition code and they must be listed following the underlying condition. An example of this can be found under the category 294, "Persistent mental disorders due to conditions classified elsewhere." However, there are manifestation codes that do not have "in diseases classified elsewhere" in the title. For such codes, there is "use an additional code" note at the etiology code and a "code first" note at the manifestation code and the rules for sequencing apply.
There are sequencing conventions under ICD-9-CM coding guidelines that are not accounted for in the MCE edits. There are several dementia codes under the classification, "Mental Behavioral and Neurodevelopmental Disorders" that have a sequencing convention that require the underlying physiological condition to be coded first, but for which there is no edit in the MCE. We will be issuing technical guidance through a Change Request to include these codes for edits in the MCE to be consistent for claims processing under ICD-9-CM Coding Guidelines. We are reminding providers to utilize the ICD-9-CM coding guidelines when submitting hospice claims to ensure they are following the appropriate guidelines for coding so that claims are not returned to providers as a result of MCE edits. Following the ICD-9-CM coding guidelines will help hospice providers with appropriate code selection for hospice claims processing. This is not to say that hospice beneficiaries with various dementia conditions are not appropriate for hospice services, rather, this is merely a clarification regarding the ICD-9-CM coding guidelines for claims processing. We expect hospice providers to follow ICD-9-CM coding guidelines to ensure that the most accurate information is provided regarding the patients for whom hospices are providing services.
Additional details describing the specific MCE edits that will be applied will be announced through a change request, an accompanying Medicare Learning Network article, and other CMS communication channels, such as the
We have clarified in previous rules that hospice providers are expected to report on hospice claims all ICD-9-CM codes to provide an accurate description of the patients' conditions. In the Hospice Wage Index for Fiscal Year 2013 (77FR 44247) and again in the Hospice Wage Index for Fiscal Year 2014 (78 FR 48240), we reminded providers to follow ICD-9-CM Coding Guidelines for reporting diagnoses on hospice claims. HIPAA, federal regulations, and the
In the FY 2014 Hospice Wage Index and Payment Rate Update final rule, we reported that for the first quarter of FY 2013 (
Analysis conducted on FY 2013 hospice claims shows that 67 percent of hospice claims still only report a single, principal hospice diagnosis. /43/ Though this is a trend in the right direction, there still appears to be some confusion by the majority of hospice providers as to the requirements for diagnosis reporting on hospice claims. We are reminding providers to follow the ICD-9-CM Coding Guidelines, per longstanding policy, in regard to diagnosis reporting on claims.
FOOTNOTE 43 FY 2013 hospice claims data from the
The ICD-9-CM Official Guidelines for Coding and Reporting state that for accurate reporting of ICD-9-CM diagnosis codes, "The documentation should describe the patient's condition, using terminology which includes specific diagnoses, as well as symptoms, problems, and reasons for the encounter. List first the ICD-9-CM code for the diagnosis, condition, problem, or other reason for the encounter/visit shown in the medical record to be chiefly responsible for services provided." The coding guidelines also state to code all documented conditions that coexist at the time of the encounter/visit and require or affect patient care treatment or management. Therefore, this is a reminder that all diagnoses should be reported on the hospice claim for the terminal illness and related conditions, including those that can affect the care and management of the beneficiary. We will condition to monitor hospice claims to see if all conditions are being reported as required by ICD-9-CM Coding Guidelines.
K. Technical Regulatory Text Change
We propose to make at technical correction in
We invite comments on this technical correction and associated change in the regulations at
IV. Collection of Information Requirements
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
* The need for the information collection and its usefulness in carrying out the proper functions of our agency.
* The accuracy of our estimate of the information collection burden.
* The quality, utility, and clarity of the information to be collected.
* Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comment on each of these issues for this section of this document that contains information collection requirements (ICRs). This section includes ICR information on data collection A) related to hospice payment policy, including proposed changes to the election statement and proposed changes to inpatient and aggregate cap determination reporting; and B) related to the CAHPS(R) Hospice Survey.
A. Proposed Changes Related to Hospice Payment Policy
Sections A.1, A.2, and A.3 are associated with the information collection request (ICR) previously approved under OMB control number as 0938-1067. We are currently seeking to have the ICR reinstated under notice and comment periods separate from those associated with this notice of proposed rulemaking. The following assumptions were used in estimating the burden for the proposed changes related to hospice payment policy:
Table 10--Hospice Payment Policy Burden Estimate Assumptions # ofMedicare -participating hospices 3,897 nationwide, CY 2012 # ofMedicare -billing hospices, from 3,727 CY 2012 claims # of Part D prescriptions per hospice, 481 from CY 2012 claims Hourly rate of registered nurse$41 Hourly rate of accountant$40 Hourly rate of office employee$17 Hourly rate of administrator$63 Note: CY = Calendar year.
All salary information is from the
1. Proposed Changes to the Election Statement (
Section 1812(d) of the Act requires that patients elect hospice care in order for
We estimated that the burden for this requirement is the one-time burden to modify the election statement to include a place for identifying the attending physician and acknowledging that he or she was chosen by the patient or representative. Hospices are currently required to explain these processes to patients, so we do not believe there is any additional burden for discussing that part of the election statement with patients or their representatives. We estimate that it would take a hospice clerical staff person 20 minutes (20/60 = 0.33333 hours) to modify the election form, and the hospice administrator 15 minutes (15/60 = 0.25 hours) to review the revised form. The clerical time plus administrator time equals a one-time burden of 35 minutes or (35/60) = 0.58333 hours per hospice; for all 3,897 hospices, the total time required would be (0.58333 x 3,897) = 2,273 hours. At
Because of concerns related to the potential inappropriate changing of attending physicians by hospices, we also proposed to add paragraph (f) to our regulations at
2. Proposed Changes to Inpatient and Aggregate Cap Determination Reporting (
Congress mandated two caps on hospice payments: an inpatient cap and an aggregate cap. The hospice cap year is
We expect that it would take a hospice about 1.5 hours to complete its cap determination. All information needed to file the cap determination is available in the Provider Statistical and Reimbursement (PS&R) system. For all 3,727 hospices that bill
C. CAHPS(R) Hospice Survey
This section is associated with a new information collection request that is required to start in
Here are the estimates for the approximate annual cost of the CAHPS(R) Survey (Table 11).
Table 11--Assumptions and Estimates for CAHPS(R) Hospice Survey Approximate # of hospices required to do the CAHPS(R) 2,600. Survey annually Approximate Cost to each hospice annually for the$3,300 . CAHPS(R) Survey Approximate Cost for all CAHPS(R) Hospices annually$8.5 million . for the CAHPS(R) Survey Respondent Cost burden$3.8 million . Approximate Total Cost of CAHPS(R) Survey annually$12.3 million .
In implementing the HQRP, we seek to collect measure information with as little burden to the providers as possible, but which reflects the full spectrum of quality performance. As such, we are moving forward toward the implementation of the CAHPS(R) Hospice Survey to provide data to the public about the patients' families' and friends' perspectives of care of their loved ones who passed way while in hospices.
The CAHPS(R) Hospice Survey data will provide the peoples' voices to hospice care in
The survey contains 47 items and is estimated to require an average administration time of 10.4 minutes in English, and 12.5 minutes in Spanish, for an average response time of 10.505 minutes or 0.175 hours, assuming that 5 percent of the survey respondents complete the survey in Spanish. These burden estimates are based on CMS' experiences with surveys of similar lengths that were fielded with
Table 12 below provides a summary of the burden and cost estimates associated with both the hospice payment policy changes and the CAHPS(R) Hospice Survey requirements.
Table 12--Burden and Cost Estimates Associated With All Information Collection Requirements Regulation OMB Number of Number of Burden per section(s) Control No. respondents responses response (hours) 418.24(b) 0938-1067 3,897 3,897 0.583333 418.24(f) 0938-1067 3,897 3,897 0.583333 418.308(c) 0938-1067 3,727 3,727 1.500000 418.312 0938--New 1,100,000 550,000 0.175 Totals 1,107,624 561,521
Table 12--Burden and Cost Estimates Associated With All Information Collection Requirements Regulation Total annual Hourly labor Total labor Total cost section(s) burden cost of cost of ( ] (hours) reporting reporting ( ] ( ] 418.24(b) 2,273$21.41 $83,435 $83,435 418.24(f) 2,273 21.41 83,435 83,435 418.308(c) 5,591 71.50 266,481 266,481 418.312 95,029.55 22.77 2,163,823 2,163,823 Totals 105,167 2,597,174 2,597,174
There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associated column from Table 13.
If you comment on these information collection and recordkeeping requirements, please submit your comments electronically as specified in the ADDRESSES section of this proposed rule.
Please identify which Collection of Information requirement you are commenting on by indicating whether it is from subsection:
* A.1. Proposed Changes to the Election Statement (
* A.2. Proposed Changes to Inpatient and Aggregate Cap Determination Reporting (
* B. CAHPS(R) Hospice Survey (
V. Regulatory Impact Analysis
A. Statement of Need
This proposed rule follows
This proposed rule also proposes that, in accordance with section 1814(i)(2)(A) through (C), that providers complete their hospice aggregate cap determination within 5 months after the cap year ends and remit any overpayments at that time. Furthermore, in accordance with section 1860D-24 of the Act, drugs and biologicals that may be covered under the Medicare Part A per-diem payment to a hospice program are excluded from coverage under Part D. Section 1861(dd) of the Act states the hospice is responsible for covering all drugs or biologicals for the palliation and management of the terminal illness and related conditions. This proposed rule, in accordance with sections 1860D-24 and 1861(dd) of the Act, solicits comments on a coordination of benefits process and appeals for Part D payment for drugs and biologicals while beneficiaries are under a hospice election. At this time, we are not making any proposals on the coordination of benefits process and appeals for Part D payment for drugs and biologicals while beneficiaries are under a hospice election.
Finally, section 3004 of the Affordable Care Act amended the Act to authorize a quality reporting program for hospices and this rule discusses changes in the requirements for the hospice quality reporting program in accordance with section 1814(i)(5) of the Act.
B. Introduction
We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects (
C. Overall Impact
The overall impact of this proposed rule is an estimated net increase in Federal payments to hospices of
1. Detailed Economic Analysis
Column 4 of Table 13 shows the combined effects of the updated wage data (the 2013 pre-floor, pre-reclassified hospital wage index) and of the additional 15 percent reduction in the BNAF (for a total BNAF reduction of 85 percent), comparing estimated payments for FY 2014 to estimated payments for FY 2015. The FY 2014 payments used for comparison have a 70 percent reduced BNAF applied. We estimate that the total hospice payments for FY 2015 would decrease by 0.7 percent. This 0.7 percent is the result of a 0.1 percent reduction due to the use of updated wage data (
Column 5 of Table 13 shows the combined effects of the updated wage data (the 2013 pre-floor, pre-reclassified hospital wage index), the additional 15 percent reduction in the BNAF (for a total BNAF reduction of 85 percent), and the proposed hospice payment update percentage of 2.0 percent. The proposed 2.0 percent hospice payment update percentage is based on a 2.7 percent estimated inpatient hospital market basket update for FY 2015 reduced by a 0.4 percentage point productivity adjustment and by 0.3 percentage point as mandated by the Affordable Care Act. The estimated effect of the 2.0 percent proposed hospice payment update percentage is an increase in payments to hospices of approximately
a. Effects on Hospices
This section discusses the impact of the projected effects of the hospice wage index and the effects of a proposed 2.0 percent hospice payment update percentage for FY 2015. This proposed rule continues to use the
For the purposes of our impacts, our baseline is estimated FY 2014 payments with a 70 percent BNAF reduction, using the FY 2012 pre-floor, pre-reclassified hospital wage index. Our first comparison (column 3 of Table 13) compares our baseline to estimated FY 2015 payments (holding payment rates constant) using the updated wage data (FY 2013 pre-floor, pre-reclassified hospital wage index). Consequently, the estimated effects illustrated in column 3 of Table 13 show the distributional effects of the updated wage data only. The effects of using the updated wage data combined with the additional 15 percent reduction in the BNAF are illustrated in column 4 of Table 13.
We have included a comparison of the combined effects of the additional 15 percent BNAF reduction, the updated wage data, and the proposed 2.0 percent hospice payment update percentage for FY 2015 (Table 13, column 5). Presenting these data gives the hospice industry a more complete picture of the effects on their total revenue based on changes to the hospice wage index and the BNAF phase-out as discussed in this proposed rule and the proposed FY 2015 hospice payment update percentage. Certain events may limit the scope or accuracy of our impact analysis, because such an analysis is susceptible to forecasting errors due to other changes in the forecasted impact time period. The nature of the
Table 13--Anticipated Impact on Medicare Hospice Payments of Updating the Pre- Floor, Pre-Reclassified Hospital Wage Index Data, Reducing the Budget Neutrality Adjustment Factor (BNAF) by an Additional 15 Percent (for a Total BNAF Reduction of 85 Percent) and Applying a 2.0 Percent Hospice Payment Update Percentage, Compared to the FY 2014 Hospice Wage Index With a 70 Percent BNAF Reduction Number of Number of Percent Percent Percent hospices routine home change in change in change in care days in hospice hospice hospice thousands payments payments payments due to due to wage due to wage FY2014 wage index index index change change, change, additional additional 15 15 reduction in reduction in budget budget neutrality neutrality adjustment adjustment and market basket update (1) (2) (3) (4) (5) ALL HOSPICES 3,702 87,456 -0.1 -0.7 1.3 URBAN 2,736 76,784 -0.1 -0.7 1.3 HOSPICES RURAL 966 10,672 -0.2 -0.5 1.5 HOSPICES BY REGION-- URBAN: NEW ENGLAND 128 2,771 0.0 -0.7 1.3 MIDDLE 252 7,880 0.5 -0.1 1.9 ATLANTIC SOUTH 388 16,778 -0.6 -1.2 0.8 ATLANTIC EAST NORTH 358 11,949 -0.1 -0.8 1.2 CENTRAL EAST SOUTH 156 4,467 -0.3 -0.7 1.2 CENTRAL WEST NORTH 209 4,775 -0.8 -1.4 0.5 CENTRAL WEST SOUTH 545 10,402 -0.2 -0.8 1.2 CENTRAL MOUNTAIN 276 6,596 -0.3 -0.9 1.1 PACIFIC 389 9,964 0.9 0.2 2.2 OUTLYING 35 1,201 0.7 0.7 2.7 BY REGION-- RURAL: NEW ENGLAND 24 236 -0.1 -0.7 1.3 MIDDLE 44 567 0.3 -0.3 1.7 ATLANTIC SOUTH 136 2,308 -0.6 -1.0 1.0 ATLANTIC EAST NORTH 137 1,763 -0.7 -1.3 0.7 CENTRAL EAST SOUTH 131 1,888 0.0 0.0 2.0 CENTRAL WEST NORTH 180 1,190 0.4 -0.1 1.9 CENTRAL WEST SOUTH 172 1,526 -0.3 -0.3 1.7 CENTRAL MOUNTAIN 94 681 0.5 0.1 2.1 PACIFIC 47 500 0.8 0.1 2.1 OUTLYING 1 13 0.0 0.0 2.0 BY SIZE/DAYS: 0-3499 DAYS 631 1,113 0.1 -0.4 1.6 (small) 3500-19,999 1795 18,345 0.0 -0.5 1.5 DAYS (medium) 20,000+ DAYS 1276 67,998 -0.1 -0.7 1.3 (large) TYPE OF OWNERSHIP: VOLUNTARY 1042 29,537 0.0 -0.6 1.4 PROPRIETARY 2142 48,415 -0.1 -0.7 1.3 GOVERNMENT 518 9,505 -0.2 -0.7 1.3 HOSPICE BASE: FREESTANDING 2734 72,437 -0.1 -0.7 1.3 HOME HEALTH 502 9,435 0.1 -0.5 1.5 AGENCY HOSPITAL 445 5,345 0.2 -0.4 1.6 SKILLED 21 238 0.2 -0.4 1.6 NURSING FACILITY Source: FY 2013 Hospice claims data from the Standard Analytic Files for CY 2012 (as ofJune 30, 2013 ) and CY 2013 (as ofDecember 31, 2013 ). Note: The proposed 2.0 percent hospice payment update percentage for FY 2015 is based on an estimated 2.7 percent inpatient hospital market basket update, reduced by a 0.4 percentage point productivity adjustment and by 0.3 percentage point. Starting with FY 2013 (and in subsequent fiscal years), the market basket percentage update under the hospice payment system as described in section 1814(i)(1)(C)(ii)(VII) or section 1814(i)(1)(C)(iii) of the Act will be annually reduced by changes in economy-wide productivity as set out at section 1886(b)(3)(B)(xi)(II) of the Act. In FY 2013 through FY 2019, the market basket percentage update under the hospice payment system will be reduced by an additional 0.3 percentage point (although for FY 2014 to FY 2019, the potential 0.3 percentage point reduction is subject to suspension under conditions set out under section 1814(i)(1)(C)(v) of the Act). REGION KEY:New England =Connecticut ,Maine ,Massachusetts ,New Hampshire ,Rhode Island ,Vermont ; Middle Atlantic=Pennsylvania ,New Jersey ,New York ; South Atlantic=Delaware ,District of Columbia , Florida,Georgia ,Maryland ,North Carolina ,South Carolina ,Virginia ,West Virginia ; East North Central=Illinois ,Indiana ,Michigan ,Ohio ,Wisconsin ; East South Central=Alabama ,Kentucky ,Mississippi ,Tennessee ; West North Central=Iowa ,Kansas ,Minnesota ,Missouri ,Nebraska ,North Dakota ,South Dakota ; West South Central=Arkansas ,Louisiana ,Oklahoma ,Texas ; Mountain=Arizona ,Colorado ,Idaho ,Montana ,Nevada ,New Mexico ,Utah ,Wyoming ; Pacific=Alaska ,California ,Hawaii ,Oregon ,Washington ; Outlying=Guam ,Puerto Rico ,Virgin Islands .
Table 13 shows the results of our analysis. In column 1, we indicate the number of hospices included in our analysis as of
The impact of changes in this proposed rule has been analyzed according to the type of hospice, geographic location, type of ownership, hospice base, and size. Table 13 categorizes hospices by various geographic and hospice characteristics. The first row of data displays the aggregate result of the impact for all
As indicated in column 1 of Table 13, there are 3,702 hospices included in the regulatory impact analysis. Approximately 42.1 percent of
b. Hospice Size
Under the
c. Geographic Location
Column 3 of Table 13 shows the estimated impact of using updated wage data without the BNAF reduction. Urban hospices are anticipated to experience a decrease of 0.1 percent and rural hospices are anticipated to experience a decrease of 0.2 percent in payments. Urban hospices can anticipate an increase in payments in Middle Atlantic of 0.5 percent, in the Pacific of 0.9 percent and in the Outlying area of 0.7 percent. Urban hospices can anticipate a decrease in payments ranging from 0.8 percent in the West North Central region to 0.1 percent in the East North Central region. Urban hospices in New England are not anticipated to be affected by the updated wage data.
Rural hospices are estimated to see a decrease in payments in four regions, ranging from 0.7 percent in the East North Central region to 0.1 percent in the New England region. Rural hospices can anticipate an increase in payments in four regions ranging from 0.3 percent in the Middle Atlantic region to 0.8 percent in the Pacific region. There is no anticipated change in payments for Outlying regions due to the use of updated wage data.
Column 4 shows the combined effect of the updated wage data and the additional 15 percent BNAF reduction on estimated payments, as compared to the FY 2014 estimated payments using a BNAF with a 70 percent reduction. Overall, hospices are anticipated to experience a 0.7 percent decrease in payments, with urban hospices experiencing an estimated decrease of 0.7 percent and rural hospices experiencing an estimated decrease of 0.5 percent. All urban areas other than Outlying and Pacific are estimated to see decreases in payments, ranging from 1.4 percent in the West North Central region to 0.7 percent in the New England and East South Central region. Rural hospices are estimated to experience a decrease in payments in six regions, ranging from 1.3 percent in the East North Central region to 0.1 percent in the West North Central region. Payments in the Outlying and East South Central regions are anticipated to stay relatively stable.
Column 5 shows the combined effects of the updated wage data, the additional 15 percent BNAF reduction, and the proposed 2.0 percent hospice payment update percentage on estimated FY 2015 payments as compared to estimated FY 2014 payments. Overall, hospices are anticipated to experience a 1.3 percent increase in payments, with urban hospices anticipated to experience a 1.3 percent increase in payments, and rural hospices anticipated to experience a 1.5 percent increase in payments. Urban hospices are anticipated to experience an increase in estimated payments in every region, ranging from 0.5 percent in the West North Central region to 2.2 percent in Outlying area. Rural hospices in every region are estimated to see an increase in payments ranging from 0.7 percent in East North Central to 2.1 percent in the Mountain and Pacific regions.
d. Type of Ownership
Column 3 demonstrates the effect of the updated wage data on FY 2015 estimated payments, versus FY 2014 estimated payments. We anticipate that using the updated wage data would decrease estimated payments to proprietary (for-profit) and Government hospices by 0.1 percent and 0.2 percent, respectively. Voluntary (non-profit) hospices are expected to have no change in payments. Column 4 demonstrates the combined effects of the updated wage data and of the additional 15 percent BNAF reduction. Estimated payments to voluntary (non-profit), proprietary (for-profit) and government hospices are anticipated to decrease by 0.6 percent, 0.7 percent and 0.7 percent, respectively. Column 5 shows the combined effects of the updated wage data, the additional 15 percent BNAF reduction (for a total BNAF reduction of 85 percent), and the proposed 2.0 percent hospice payment update percentage on estimated payments, comparing FY 2015 to FY 2014. Estimated FY 2015 payments are anticipated to increase for voluntary (non-profit) hospices by 1.4 percent, for proprietary (for-profit) hospices by 1.3 percent, and government hospices by 1.3 percent.
e. Hospice Base
Column 3 demonstrates the effect of using the updated wage data, comparing estimated payments for FY 2015 to FY 2014. Estimated payments are anticipated to decrease for freestanding hospices by 0.1 percent. Estimated payments are anticipated to increase for
f. Effects on Other Providers
This proposed rule would only affect Medicare hospices, and therefore has no effect on other provider types. We note that our suggested approaches with respect to Part D coordination with hospice payments may ultimately have an effect on Part D spending, if proposed and adopted.
g. Effects on the Medicare and Medicaid Programs
This proposed rule only affects Medicare hospices, and therefore has no effect on Medicaid programs. As described previously, estimated Medicare payments to hospices in FY 2015 are anticipated to decrease by
h. Alternatives Considered
In continuing the reduction to the BNAF by an additional 15 percent, for a total BNAF reduction of 85 percent (10 percent in FY 2010, and 15 percent per year for FY 2011 through FY 2015), and implementing the hospice payment update percentage and the updated wage index, the aggregate impact will be a net increase of
Since the hospice payment update percentage is determined based on statutory requirements, we did not consider not updating hospice payment rates by the payment update percentage. The proposed 2.0 percent hospice payment update percentage for FY 2015 is based on a proposed 2.7 percent inpatient hospital market basket update for FY 2015, reduced by a 0.4 percentage point productivity adjustment and by an additional 0.3 percentage point. Payment rates for FYs since 2002 have been updated according to section 1814(i)(1)(C)(ii)(VII) of the Act, which states that the update to the payment rates for subsequent FYs must be the market basket percentage for that FY. The Act requires us to use the inpatient hospital market basket to determine the hospice payment rate update. In addition, section 3401(g) of the Affordable Care Act mandates that, starting with FY 2013 (and in subsequent FYs), the hospice payment update percentage will be annually reduced by changes in economy-wide productivity as specified in section 1886(b)(3)(B)(xi)(II) of the Act. In addition, section 3401(g) of the Affordable Care Act also mandates that in FY 2013 through FY 2019, the hospice payment update percentage will be reduced by an additional 0.3 percentage point (although for FY 2014 to FY 2019, the potential 0.3 percentage point reduction is subject to suspension under conditions specified in section 1814(i)(1)(C)(v) of the Act).
We also considered proposing a waiver of the consequences for not filing the NOE within 3 calendar days after the effective date of election, to account for exceptional circumstances. However, since hospices are to operate 24 hours a day, 7 days a week, and should have back-up systems in place so that they can care for their patients without interruption, we did not believe that this would be necessary.
To ensure the attending physician of record is properly documented in the patient's medical record, we proposed, in section III.F, to amend the regulations at SEC 418.24(b)(1) and require the election statement to include the patient's choice of attending physician. We considered limiting the number of times that a beneficiary can change his/her attending to once per election period (similar to the current regulations at SEC 418.30(a) that only allows a beneficiary to change a hospice provider once during an election period). However, we first want to conduct additional analyses of hospice Part A billing for physician services provided by nurse practitioners and Part B attending physician billing to determine how frequently beneficiaries change attending physicians.
i. Accounting Statement
As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Table 14 below, we have prepared an accounting statement showing the classification of the expenditures associated with this proposed rule. Table 14 provides our best estimate of the increase in Medicare payments under the hospice benefit as a result of the changes presented in this proposed rule for 3,702 hospices in our impact analysis file constructed using FY 2013 claims as of
Table 14--Accounting Statement: Classification of Estimated Transfers, From FY 2014 to FY 2015 [In $millions] Category Transfers FY 2015 Hospice Wage Index and Payment Rate Update Annualized Monetized Transfers$230 . From Whom to Whom? Federal Government to Hospices. Category Costs Annualized Monetized Costs for Hospice$8.77 . Providers n1 *1 Costs associated with hospice cap reporting and with the CAHPS(R) Hospice Survey.
j. Conclusion
In conclusion, the overall effect of this proposed rule is an estimated
2. Regulatory Flexibility Act Analysis
The RFA requires agencies to analyze options for regulatory relief of small businesses if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate that almost all hospices are small entities as that term is used in the RFA. The great majority of hospitals and most other health care providers and suppliers are small entities by meeting the
HHS's practice in interpreting the RFA is to consider effects economically "significant" only if they reach a threshold of 3 to 5 percent or more of total revenue or total costs. As noted above, the combined effect of the updated wage data, the additional 15 percent BNAF reduction, and the proposed FY 2015 hospice payment update percentage of 2.0 percent results in an increase in estimated hospice payments of 1.3 percent for FY 2015. For small and medium hospices (as defined by routine home care days), the estimated effects on revenue when accounting for the updated wage data, the additional 15 percent BNAF reduction, and the proposed FY 2015 hospice payment update percentage reflect increases in payments of 1.6 percent and 1.5 percent, respectively. Therefore, the Secretary has determined that this proposed rule will not create a significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. This proposed rule only affects hospices. Therefore, the Secretary has determined that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals.
3. Unfunded Mandates Reform Act Analysis
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of
VI. Federalism Analysis and Regulations Text
Executive Order 13132 on Federalism (
List of Subjects
42 CFR Part 405
Administrative practice and procedure, Health facilities, Medicare, Reporting and recordkeeping requirements.
42 CFR Part 418
Health facilities, Hospice care, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the
PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
1. The authority citation for part 405, subpart C continues to read:
Authority: Secs. 1102, 1815, 1833, 1842, 1862, 1866, 1870, 1871, 1879 and 1892 of the Social Security Act (42 U.S.C. 1302, 1395g, 1395l, 1395u, 1395y, 1395cc, 1395gg, 1395hh, 1395pp and 1395ccc) and 31 U.S.C. 3711.
2. Section 405.371 is amended by revising paragraph (c)(1) and adding paragraph (e) to read as follows:
SEC 405.371 Suspension, offset, and recoupment of Medicare payments to providers and suppliers of services.
* * * * *
(c) * * *
(1) Except as provided in paragraphs (d) and (e) of this section, CMS or the Medicare contractor suspends payments only after it has complied with the procedural requirements set forth at SEC 405.372.
* * * * *
(e) Suspension of payment in the case of unfiled hospice cap determination reports.
(1) If a provider has failed to timely file an acceptable hospice cap determination report, payment to the provider is immediately suspended in whole or in part until a cap determination report is filed and determined by the Medicare contractor to be acceptable.
(2) In the case of an unfiled hospice cap determination report, the provisions of SEC 405.372 do not apply. (See SEC 405.372(a)(2) concerning failure to furnish other information.)
PART 418--HOSPICE CARE
3. The authority citation for part 418 is revised to read as follows:
Authority: Secs. 1102, 1812(a)(5), 1812(d), 1813(a)(4), 1814(a)(7), 1814(i), and 1861(dd) of the Social Security Act (42 U.S.C. 1302 and 1395hh).
SEC 418.3 [Amended]
4. Section 418.3 is amended by removing the definition of "social worker."
5. Section 418.24 is amended by--
A. Revising paragraph (a).
B. Revising paragraph (b)(1).
C. Adding a new paragraph (f).
The addition and revisions read as follows:
SEC 418.24 Election of hospice care.
(a) Filing an election statement. (1) An individual who meets the eligibility requirement of SEC 418.20 may file an election statement with a particular hospice. If the individual is physically or mentally incapacitated, his or her representative (as defined in SEC 418.3) may file the election statement.
(2) The hospice chosen by the eligible individual (or his or her representative) must file the Notice of Election with its Medicare claims processing contractor within 3 calendar days after the effective date of the election statement.
(3) Consequences of failure to submit a timely Notice of Election. When a hospice does not file the required Notice of Election for its Medicare patients within 3 calendar days after the effective date of election, Medicare will not cover and pay for days of hospice care from the effective date of election to the date of filing of the NOE. These days are a provider liability, and the provider may not bill the beneficiary for them.
(b) * * *
(1) Identification of the particular hospice and of the attending physician that will provide care to the individual. The individual or representative must acknowledge that the identified attending physician was his or her choice.
* * * * *
(f) Changing the attending physician. To change the designated attending physician, the individual (or representative) must file a signed statement with the hospice that states that he or she is changing his or her attending physician.
(1) The statement must identify the new attending physician, and include the date the change is to be effective and the date signed by the individual (or representative).
(2) The individual (or representative) must acknowledge that the change in the attending physician is due to his or her choice.
(3) The effective date of the change in attending physician cannot be prior to the date the statement is signed.
6. Section 418.26 is amended by adding a new paragraph (e) to read as follows:
SEC 418.26 Discharge from hospice care.
* * * * *
(e) Filing a Notice of Termination of Election. When the hospice election is ended due to discharge, the hospice must file a notice of termination/revocation of election with its Medicare claims processing contractor within 3 calendar days after the effective date of the discharge, unless it has already filed a final claim for that beneficiary.
7. Section 418.28 is amended by adding a new paragraph (d) to read as follows:
SEC 418.28 Revoking the election of hospice care.
* * * * *
(d) Filing a Notice of Revocation of Election. When the hospice election is ended due to revocation, the hospice must file a notice of termination/revocation of election with its Medicare claims processing contractor within 3 calendar days after the effective date of the revocation, unless it has already filed a final claim for that beneficiary.
8. Section 418.306 is amended by adding paragraph (b)(6) to read as follows:
SEC 418.306 Determination of payment rates.
* * * * *
(b) * * *
(6) For FY 2014 and subsequent fiscal years, in the case of a Medicare-certified hospice that does not submit hospice quality data, as specified by the Secretary, the payment rates are equal to the rates for the previous fiscal year increased by the applicable market basket percentage increase, minus 2 percentage points. Any reduction of the percentage change will apply only to the fiscal year involved and will not be taken into account in computing the payment amounts for a subsequent fiscal year.
* * * * *
9. Section 418.308 is amended by revising paragraph (c) to read as follows:
SEC 418.308 Limitation on the amount of hospice payments.
* * * * *
(c) The hospice must file its cap determination notice with its Medicare contractor no later than 5 months after the end of the cap year (that is, by
* * * * *
10. Subpart G is amended by adding a new SEC 418.312 to read as follows:
SEC 418.312 Data Submission Requirements Under the Hospice Quality Reporting Program.
General rule. Except as provided in paragraph (f) of this section, Medicare-certified hospices must submit to CMS data on measures selected under section 1814(i)(5)(C)of the Act in a form and manner, and at a time, specified by the Secretary.
(a) Submission of Hospice Quality Reporting Program data. Hospices are required to complete and submit an admission Hospice Item Set (HIS) and a discharge HIS for each patient admission to hospice, regardless of payer or patient age. The HIS is a standardized set of items intended to capture patient-level data.
(b) A hospice that receives notice of its CMS certification number before
(c) Medicare-certified hospices must contract with CMS-approved vendors to collect the CAHPS(R) Hospice Survey data on their behalf and submit the data to the Hospice CAHPS(R) Data Center.
(d) If the hospice's total, annual, unique, survey-eligible, deceased patient count for the prior calendar year is less than 50 patients, the hospice is eligible to be exempt from the CAHPS(R) Hospice Survey reporting requirements in the current calendar year. In order to qualify for this exemption the hospice must submit to CMS its total, annual, unique, survey-eligible, deceased patient count for the prior calendar year.
(e) Vendors that want to become CMS-approved CAHPS(R) Hospice Survey vendors must meet the minimum business requirements. Survey vendors must have been in business for a minimum of 4 years, have conducted surveys in the approved survey mode for a minimum of 3 years, and have conducted surveys of individual patients for a minimum of 2 years. For Hospice CAHPS(R), a "survey of individual patients" is defined as the collection of data from at least 600 individual patients selected by statistical sampling methods, and the data collected are used for statistical purposes. Vendors may not use home-based or virtual interviewers to conduct the CAHPS(R) Hospice Survey, nor may they conduct any survey administration processes (e.g. mailings) from a residence.
(f) No organization, firm, or business that owns, operates, or provides staffing for a hospice is permitted to administer its own Hospice CAHPS(R) survey or administer the survey on behalf of any other hospice in the capacity as a Hospice CAHPS(R) survey vendor. Such organizations will not be approved by CMS as CAHPS(R) Hospice Survey vendors.
(g) Reconsiderations and appeals of Hospice Quality Reporting Program decisions.
(1) A hospice may request reconsideration of a decision by CMS that the hospice has not met the requirements of the Hospice Quality Reporting Program for a particular reporting period. A hospice must submit a reconsideration request to CMS no later than 30 days from the date identified on the annual payment update notification provided to the hospice.
(2) Reconsideration request submission requirements are available on the CMS Hospice Quality Reporting Web site on CMS.gov.
(3) A hospice that is dissatisfied with a decision made by CMS on its reconsideration request may file an appeal with the
Dated:
Marilyn Tavenner,
Administrator,
Approved:
Kathleen Sebelius,
Secretary,
[FR Doc. 2014-10505 Filed 5-2-14;
BILLING CODE 4120-01-P
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