Payment for Physician and Other Health Care Professional Services Purchased by Indian Health Programs and Medical Charges Associated With…
Payment for Physician and Other Health Care Professional Services Purchased by Indian Health Programs and Medical Charges Associated With Non-Hospital-Based Care
Final rule with comment period.
CFR Part: "42 CFR Part 136"
RIN Number: "RIN 0917-AA12"
Citation: "81 FR 14977"
Page Number: "14977"
"Rules and Regulations"
SUMMARY: The Secretary of the
DATES: Effective date: These final regulations are effective
Comment date: IHS will consider comments on this final rule with comment period received at one of the addresses provided below, no later than
Compliance and applicability dates: A health program operated by the IHS or by an urban
ADDRESSES: You may submit comments in one of four ways (please choose only one of the ways listed):
* Electronically. You may submit electronic comments on this regulation to http://regulations.gov. Follow the "Submit a Comment" instructions.
* By regular mail. You may mail written comments to the following address ONLY:
* By express or overnight mail. You may send written comments to the above address.
* By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments before the close of the comment period to the address above.
If you intend to deliver your comments to the
Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
FOR FURTHER INFORMATION CONTACT: Ms.
SUPPLEMENTARY INFORMATION: The Consolidated Appropriation Act of 2014 signed by
I. Background
On
II. Provisions of the Proposed Regulations
a. The Proposed Rule
HHS proposed to amend the regulations at 42 CFR part 136 by adding a new Subpart I to describe the payment methodologies to all physician and health care professional services and all non-hospital-based services that are not covered currently under 42 CFR part 136 subpart D. The final rule would amend the regulation at 42 CFR part 136, by adding a new Subpart I to apply the
b. Summary of Changes in the Final Rule
IHS has added an applicability provision in
III. Analysis of and Responses to Public Comments
The Agency received 57 comments from Tribes, Tribal organizations, medical associations, and individuals. The Agency carefully reviewed the submissions by individuals, groups,
Comment: The majority of commenters support the rule as a positive step toward achieving the goal of expanding PRC rates to non-hospital-based providers and suppliers. Many commenters stated the rule's potential impact on individual providers would be diffuse and de minimus and that the proposed rule would provide an enormous benefit to the IHS and Tribal health care programs. Commenters noted that IHS and Tribal health programs often pay higher payment rates than private health insurers and other Federal programs, such as
Response: IHS agrees with the commenters that this rule is necessary and important towards achieving payment parity with other Federal health care programs.
Comment: There were a number of commenters that support the proposed rule, but with changes. Several commenters expressed the view, that as drafted, the proposed rule does not provide enough flexibility to ensure continued access to care through the PRC program. Specifically, many commenters felt that a rigid take-it-or-leave-it rate structure would result in many health care providers refusing to do business with I/T/Us. Many Tribal stakeholders recommended providing Tribal and urban
Response: IHS highlighted concerns about the impact the rule could have on access to care in the preamble to the NPRM and was pleased with the thoughtful responses received. IHS agrees with commenters that more flexibility must be built into the rule. IHS also agrees with Tribal stakeholders that Tribes should be provided more flexibility to negotiate rates that exceed
Comment: In addition to the ability to negotiate rates under the rule, several Tribal stakeholders also want an opt-out clause from the proposed rule for Tribal and urban
Response: IHS agrees with Tribal stakeholders that Tribal health programs should have the option to administer PRC programs outside of the rule. Rather than memorialize this option as an opt-out clause, IHS is finalizing the recommendation as an opt-in provision in section 136.201. The opt-in provision is intended to be consistent with 25 U.S.C. 458aaa-16(e), which provides, with certain exceptions, that Tribes are not subject to rules adopted by the IHS unless they are expressly agreed to by the Tribe in their compact, contract or funding agreement with IHS. Although 25 U.S.C. 458aaa-16(e) only expressly applies to Tribes compacted under Title V of the ISDEAA, IHS is extending opt-in flexibility to Tribes contracted under Title I of the ISDEAA too. IHS is not incorporating a comparable provision allowing urban
Comment: One commenter believes that reducing physician payments will provide a disincentive to participate in the PRC program and will result in less beneficiary access to care.
Response: IHS acknowledges the implementation of rates could impact access to care, and believe sufficient language has been incorporated to ensure that beneficiary access to care is not compromised.
Comment: One commenter believes the rule would magnify the existing disparity between the average ambulance provider's total costs and their reimbursement.
Response: The implementation of the rule is not intended to require a provider or supplier to incur a financial loss. To the extent the
Comment: The majority of commenters stated that IHS should also engage in provider outreach and monitoring to ensure the rule is effectively implemented. Further, once the final rule is issued, the IHS, in collaboration with Tribes, should develop and issue a "Dear provider letter" for all I/T/Us to educate their network of providers regarding this regulation. Commenters believe that education and outreach to providers will be a critical component in successfully implementing the rule.
Response: IHS agrees. IHS took similar steps when it promulgated the hospital-based rate under 42 CFR part 136 subpart D. IHS intends to work with Tribes to educate the providers that participate in IHS and Tribal PRC programs.
Comment: One commenter indicates that some IHS Area Offices utilize case management to better monitor the services that are being purchased through PRC. The commenter proposed that IHS Area Offices have a medical physician on staff for utilization review.
Response: IHS agrees with the commenter but the proposal offered is beyond the scope of this final rule.
Comment: One commenter is concerned that the amount a provider "bills the general public" for the same service is too vague. The term "general public" is subject to multiple interpretations. The commenter recommended limiting payment to the amount the provider "accepts as payment for the same service from nongovernmental entities, including insurance providers."
Response: IHS agrees with the commenter that the proposed language may be open to more than one interpretation. To avoid multiple interpretations and to align this subsection with others changes made to
Comment: The majority of commenters believe the rule should not imply that professional services are never covered by the existing PRC regulations. The current PRC rate regulations apply to "all
Response: The PRC rate regulations at part 136 subpart D apply to hospitals and critical access hospitals pursuant to section 1866(a)(1)(U) of the Social Security Act which requires providers to agree to provide services under the
Comment: The majority of commenters requested training for Tribes. Many commenters suggested IHS develop a training and technical assistance initiative to prepare I/T/U sites to implement the rule. Tribes expressed concern about the lack of training and technical assistance associated with the implementation of the regulation for Payment to
Response: IHS agrees that training is necessary to ensure that the rule is implemented properly and effectively. Many suggestions for training, however, are beyond the scope of this final rule and will be addressed through subsequent communication with Tribes.
Comment: Commenters indicated that IHS should also develop and implement a process in consultation with Tribes to monitor and report on the success of the rule once it is implemented.
Response: IHS agrees that monitoring the effectiveness of the rule is important. Obtaining data from programs that are implementing the rule is essential to determining its success; however, reporting requirements exceed the scope of this final rule.
Comment: The majority of commenters stated that the proposed rule would have significant Tribal implications and substantial direct effects on one or more Indian Tribes. As a result, pursuant to the HHS Tribal Consultation Policy, Tribal consultation is required. Tribes stated in their comments that they welcomed the opportunity to comment on the proposed rule through the notice and public comment process required by the Administrative Procedure Act, but they stated that the Director of the IHS must also engage in Tribal consultation on the proposed rule before any action is taken to finalize this rule.
Response: IHS consulted with Tribes, during listening sessions and other meetings, on whether Tribes thought IHS should pursue applying PRC rates for non-hospital-based services. It has been noted that while these interactions indicated that regulations may have been a good idea, the level of discussion did not get into the complexities of developing a regulation and how such regulations would impact Tribes given the variation in access to specialty care and the number of hospitals across the
Comment: One commenter recommended IHS pursue legislation, not a regulation.
Response: Regulations (or rules) implement the public policy of enacted legislation and establish specific requirements. IHS bases its authority on 42 U.S.C. 2003 to establish the methodology and payment rates for the IHS PRC.
Comment: One commenter is concerned that there is nothing explicit in the regulation that prevents the provider from avoiding the
Response: IHS recognizes that the rule does require providers to accept payment from PRC programs and understands that this may on occasion result in patients incurring financial responsibility. IHS beneficiaries already incur financial responsibility for care that IHS cannot cover. In FY 2013, PRC denied an estimated
Comment: One commenter stated there needs to be some oversight by either
Response: No changes will be made as a result of this comment. IHS is promulgating this rule pursuant to its own rulemaking authority, under which there is no basis for another agency to enforce compliance.
Comment: The majority of commenters state that any changes made, or proposed in the PRC program, must be careful to not adversely impact the effectiveness of the PRC programs. Any change to improve the efficiency or financial operations of the PRC program must be carefully evaluated to ensure that they do not impose additional administrative or financial burdens on the PRC program and the patients they serve. A meaningful and well-intentioned change could actually restrict access and cost the program more resources than it would save.
Response: IHS believes these concerns have been addressed through the flexibilities which have been added to the final rule, the training IHS intends to offer to PRC administrators, and the outreach and education IHS intends to provide to PRC-participating providers and suppliers.
Comment: Some commenters expressed serious concern regarding the long delay between publication of the proposed rule and issuing the final rule on limiting charges for services furnished by
Response: IHS acknowledges the concern and provides that the rule will be effective 60 days from publication and applicable to services provided after the effective date. The rule will apply to outpatient services provided after the effective date of the rule. The rule will apply to inpatient services with an admission that falls on or after the effective date of the rule. However, IHS also recognizes programs may not be fully equipped to implement the rule when it becomes effective. In accordance with 42 CFR 136.201(c), Tribal health programs may choose to opt-in to the rule immediately, or whenever they are able to fully implement the rule. A health program operated by the IHS or by an urban
IV. Collection of Information Requirements
These regulations do not impose any new information collection requirements. Specifically, federal acquisition regulations already govern the collection of contractor pricing data and agency regulations and procedures already govern the collection of information necessary to process claims. The IHS will use the IHS purchase order form number IHS-843 for collection of information. OMB No. 0917-0002.
V. Regulatory Impact Statement
The IHS has examined the impact of this final rule as required by Executive Order 12866 (
Executive Order 12866 directs 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). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects (
The GAO formulated its estimate using actual IHS data, which it obtained from the IHS fiscal intermediary. The GAO narrowed those claims to payments for physician and other nonhospital services. These are the same services at issue in this final rule. Since IHS is the payer of last resort, the GAO excluded services where IHS would not have had primary responsibility, such as services covered by the patient's insurance or another third party payer. The GAO also excluded nonhospital services that were not covered by the Medicare Physician Fee Schedule, as well as anesthesiologists, based upon lack of information to determine comparable
Once the GAO had isolated the necessary IHS payment data, the GAO compared the IHS payments to the corresponding rate on the 2010 Medicare Physician Fee Schedule. The GAO adjusted the payment rates according to the physician's approximated geographic location and the service setting, based upon
The GAO evaluated the reliability of the data it had relied upon in its estimates, including the IHS claims data, the Medicare Physician Fee Schedule data, and the private insurance database. The GAO reviewed the documentation and discussed the database with officials it considered knowledgeable in this area. The GAO also performed data reliability checks to test the internal consistency and reliability of the data. The GAO determined that the data was sufficiently reliable for its purposes after taking these steps.
IHS agrees with the methodology utilized by the GAO in its report to select, verify, and compare the necessary elements of the GAO estimate. While the GAO study did not consider the additional flexibility added to this final rule at the request of Tribes or payments made to anesthesiologists, IHS anticipates that most PRC programs and PRC payments under this final rule will closely follow the policy that the GAO considered when developing its study. For this reason, the GAO estimate from the
In 2014, IHS performed an analysis similar to the GAO study with claims data from the IHS fiscal intermediary for fiscal year (FY) 2012. Instead of analyzing the entire IHS system, as GAO had done with data from 2010, IHS focused on the potential impact to IHS PRC programs in the states of North and
Overall, IHS estimated that in FY2012, it could have saved
Both the GAO study and the IHS analysis note the possible consequences of this policy change. The GAO study determined that providers overall would receive less if the payments for professional services and non-hospital-based care are capped at the applicable
Although the GAO study and the IHS analysis did not include other types of non-hospital services or funding that goes to Tribal PRC programs, particular Tribes and tribal organizations may decide not to opt-in to this final rule. Even if all of the Tribally-operated PRC programs choose to participate, IHS estimates that the increase in purchasing power brought about by this final rule would be unlikely to exceed
The Secretary has determined this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the RFA, 5 U.S.C. 601-612. The final rule will not cause significant economic impact on health care providers, suppliers, or entities since only a small portion of the business of such entities concern IHS beneficiaries. The
Section 202 of the Unfunded Mandates Reform Act of 1995 requires that agencies assess anticipated costs and benefits before issuing any rule whose requirements mandate expenditure in any one year by State, local, or Tribal governments, in the aggregate, or by the private sector, of
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by OMB.
List of Subjects in 42 CFR Part 136
American
Dated:
Principal Deputy Director,
Dated:
Secretary.
For the reasons set forth in the preamble, the
PART 136--
1. The authority citation for part 136 continues to read as follows:
Authority: 25 U.S.C. 13; sec. 3, 68 Stat. 674 (42 U.S.C., 2001, 2003); Sec. 1, 42 Stat. 208 (25 U.S.C. 13); 42 U.S.C. 2001, unless otherwise noted.
2. Add subpart I, consisting of SUBSEC 136.201 through 136.204, to read as follows:
Subpart I--Limitation on Charges for Health Care Professional Services and Non-Hospital-Based Care
Sec.
136.201 Applicability.
136.202 Definitions.
136.203 Payment for provider and supplier services purchased by
136.204 Authorization by urban
Subpart I--Limitation on Charges for Health Care Professional Services and Non-Hospital-Based Care
The requirements of this Subpart shall apply to:
(a) Health programs operated by the
(b) Health programs operated by an urban
(c) Health programs operated by an
For purposes of this subpart, the following definitions apply.
Notification of a claim means, for the purposes of part 136, and also 25 U.S.C. 1621s and 1646, the submission of a claim that meets the requirements of 42 CFR 136.24.
(1) Such claims must be submitted within the applicable time frame specified by 42 CFR 136.24, or if applicable, 25 U.S.C. 1646, and include information necessary to determine the relative medical need for the services and the individual's eligibility.
(2) The information submitted with the claim must be sufficient to:
(i) Identify the patient as eligible for IHS services (e.g., name, address, home or referring service unit, Tribal affiliation),
(ii) Identify the medical care provided (e.g., the date(s) of service, description of services), and
(iii) Verify prior authorization by the IHS for services provided (e.g., IHS purchase order number or medical referral form) or exemption from prior authorization (e.g., copies of pertinent clinical information for emergency care that was not prior-authorized).
(3) To be considered sufficient notification of a claim, claims submitted by providers and suppliers for payment must be in a format that complies with the format required for submission of claims under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) or recognized under section 1175 of such Act (42 U.S.C. 1320d-4).
Provider, as used in this subpart only, means a provider of services not governed by or subject to 42 CFR part 136 subpart D, and may include, but not limited to, a skilled nursing facility, comprehensive outpatient rehabilitation facility, home health agency, or hospice program.
Referral means an authorization for medical care by the appropriate ordering official in accordance with 42 CFR part 136 subpart C.
Repricing agent means an entity that offers an IHS, Tribe or Tribal organization, or urban
Supplier, as used in this subpart only, means a physician or other practitioner, a facility, or other entity (other than a provider) not already governed by or subject to 42 CFR part 136 subpart D, that furnishes items or services under this Subpart.
(a) Payment to providers and suppliers not covered by 42 CFR part 136 subpart D, for any level of care authorized under part 136, subpart C by a Purchased/Referred Care (PRC) program of the IHS; or authorized by a Tribe or Tribal organization carrying out a PRC program of the IHS under the Indian Self-Determination and Education Assistance Act, as amended, Public Law 93-638, 25 U.S.C.
(1) If a specific amount has been negotiated with a specific provider or supplier or its agent by the I/T/U, the I/T/U will pay that amount, provided that such amount is equal to or better than the provider or supplier's Most Favored Customer (MFC) rate, as evidenced by commercial price lists or paid invoices and other related pricing and discount data to ensure that the I/T/U is receiving a fair and reasonable price. The MFC rate limitation shall not apply if:
(i) The prices offered to the I/T/U are fair and reasonable, as determined by the I/T/U, even though comparable discounts were not negotiated; and
(ii) The award is otherwise in the best interest of the I/T/U, as determined by the I/T/U.
(2) If an amount has not been negotiated in accordance with paragraph (a)(1) of this section, the I/T/U will pay the lowest of the following amounts:
(i) The applicable
(ii) An amount negotiated by a repricing agent if the provider or supplier is participating within the repricing agent's network and the I/T/U has a pricing arrangement or contract with that repricing agent.
(iii) An amount not to exceed the provider or supplier's MFC rate, as evidenced by commercial price lists or paid invoices and other related pricing and discount data to ensure that the I/T/U is receiving a fair and reasonable price, but only to the extent such evidence is reasonably accessible and available to the I/T/U.
(3) In the event that a
(b) Coordination of benefits and limitation on recovery: If an I/T/U has authorized payment for items and services provided to an individual who is eligible for benefits under
(1) The I/T/U is the payer of last resort under 25 U.S.C. 1623(b);
(2) If there are any third party payers, the I/T/U will pay the amount for which the patient is being held responsible after the provider or supplier of services has coordinated benefits and all other alternate resources have been considered and paid, including applicable co-payments, deductibles, and coinsurance that are owed by the patient;
(3) The maximum payment by the I/T/U will be only that portion of the payment amount determined under this section not covered by any other payer;
(4) The I/T/U payment will not exceed the rate calculated in accordance with paragraph (a) of this section (plus applicable cost sharing); and
(5) When payment is made by
(c) Authorized services: Payment shall be made only for those items and services authorized by an I/T/U consistent with this part 136 or section 503(a) of the IHCIA, Public Law 94-437, as amended, 25 U.S.C. 1653(a).
(d) No additional charges:
(1) If an amount has not been negotiated under paragraph (a)(1) of this section, the health care provider or supplier shall be deemed to have accepted the applicable payment amount under paragraph (a)(2) of this section as payment in full if:
(i) The services were provided based on a Referral, as defined in
(ii) The health care provider or supplier submits a Notification of a Claim for payment to the I/T/U; or
(iii) The health care provider or supplier accepts payment for the provision of services from the I/T/U.
(2) A payment made and accepted in accordance with this section shall constitute payment in full and the provider or its agent, or supplier or its agent, may not impose any additional charge--
(i) On the individual for I/T/U authorized items and services; or
(ii) For information requested by the I/T/U or its agent or fiscal intermediary for the purposes of payment determinations or quality assurance.
(e) IHS will not adjudicate a notification of a claim that does not contain the information required by
(f) No service shall be authorized and no payment shall be issued in excess of the rate authorized by this section.
An urban
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