Centers for Medicare & Medicaid Services Rule: Organ Procurement Organizations Conditions for Coverage – Revisions to Outcome Measure Requirements for Organ Procurement Organizations

WASHINGTON, Dec. 2 -- The Centers for Medicare & Medicaid Services has issued a rule (42 CFR Part 486), published in the Federal Register, entitled: "Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations".

The rule was issued by Seema Verma, Administrator, Centers for Medicare & Medicaid Services and Alex M. Azar II, Secretary, Department of Health and Human Services..

EFFECTIVE DATE: These regulations are effective on February 1, 2021, except for amendment number 3 (further amending Section 486.302), which is effective July 31, 2022. Implementation date: The regulations will be implemented on August 1, 2022.

FOR FURTHER INFORMATION CONTACT: Diane Corning, (410) 786-8486; Jesse Roach, (410) 786-1000; Kristin Shifflett, (410) 786-4133; CAPT James Cowher, (410) 786-1948; or Alpha-Banu Wilson, (410) 786-8687.

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This final rule revises the Organ Procurement Organizations (OPOs) Conditions for Coverage (CfCs) to increase donation rates and organ transplantation rates by replacing the current outcome measures with new transparent, reliable, and objective outcome measures and increasing competition for open donation service areas (DSAs).

SUPPLEMENTARY INFORMATION:

Table of Contents

To assist readers in referencing sections contained in this preamble, we are providing a Table of Contents.

I. Background

A. The Importance of Organ Procurement Organizations and the Need To Reform the Organ Procurement System

B. Statutory and Regulatory Provisions

C. HHS Initiatives Related to OPO Services and Executive Order (E.O.) 13879

II. Summary of the Proposed Provisions and Responses to Public Comments

A. General Comments

B. Proposed Changes to Definitions (Section 486.302) and Proposed Changes to Outcome Requirements (Section 486.318)

1. General Comments About the Outcome Measures

2. Donation Rate Section 486.318(d)(1)

3. Donor Definition Section 486.302 and the "Zero Organ Donors"

4. Organ Transplantation Rate Section 486.302 and Section 486.318(d)(2)

5. Organ Definition Section 486.302

6. Donor Potential (Section 486.302 and Section 486.318(d)(4))

a. Death That Is Consistent With Organ Donation Section 486.302

i. Death Certificate Data

ii. International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM)

b. Age 75 and Younger

c. Inpatient Deaths

d. Waiver Hospitals

7. Risk-Adjustments Section 486.302 and Section 486.318(d)(2)

a. Chronic Diseases

b. Race

c. Gender and Age

d. Ventilator Status

8. OPO Performance on Outcome Measures Section 486.318(e) and Section 486.302

9. Non-Contiguous States, Commonwealths, Territories, or Possessions Section 486.318(e)(7)

10. Assessment and Data for the Outcome Measures Section 486.318(f)

11. Implementation Timeline

12. Definitions Section 486.302

C. Re-Certification and Competition Processes (Section 486.316)

1. Re-Certification of OPOs Section 486.316(a)

2. De-Certification and Competition Section 486.316(b)

3. Criteria to Compete Section 486.316(c)

4. Criteria for Selection Section 486.316(d)

5. Extension of the Agreement Cycle for Extraordinary Circumstances Section 486.316(f)

D. Reporting of Data Section 486.328

E. Proposed Change to the Quality Assessment and Performance Improvement Requirement (Section 486.348)

1. Death Record Review in QAPI

F. Response to Solicitation of Comments

1. Out of Scope

III. Provisions of the Final Rule

A. Proposed Changes to Definitions (Section 486.302) and Proposed Changes to Outcome Requirements (Section 486.318).

B. Re-Certification and Competition Processes (Section 486.316)

C. Proposed Change to the Quality Assessment and Performance Improvement Requirement (Section 486.348)

D. Solicitation of Comments (Including Changes to Re-Certification Cycle)

IV. Collection of Information Requirements

A. ICRs Regarding Re-Certification and Competition Processes (Section 486.316)

B. ICRs Regarding Condition: Reporting of Data (Section 486.328)

C. ICRs Regarding Quality Assessment and Performance Improvement (Section 486.348)

V. Regulatory Impact Analysis

A. Statement of Need

B. Scope of Review

C. Effects on OPO Performance

D. Anticipated Costs and Benefits

1. Effects on Medical Costs

2. Effects on Patients

3. Implementation and Continuing Costs

E. Effects on Medicare, Medicaid, and Private Payers

F. Effects on Small Entities, Effects on Small Rural Hospitals, Unfunded Mandates, and Federalism

1. Regulatory Flexibility Act

2. Small Rural Hospitals

3. Unfunded Mandates Reform Act

4. Federalism

G. Alternatives Considered

1. Changes to the Denominator

a. CALC as the Denominator

b. All Deaths, Age <= 75 as the Denominator

c. Total Population, Age <75

2. Changing the Confidence Interval

3. Changing the Threshold Rates

H. Accounting Statement and Table

I. Reducing Regulation and Controlling Regulatory Costs

J. Conclusion

Regulations Text

I. Background

A. The Importance of Organ Procurement Organizations and the Need To Reform the Organ Procurement System

Organ procurement organizations (OPOs) are vital partners in the procurement, distribution, and transplantation of human organs in a safe and equitable manner for all potential transplant recipients. The role of OPOs is critical to ensuring that the maximum possible number of transplantable human organs is available to individuals with organ failure who are on a waiting list for an organ transplant. There are currently 58 OPOs that are responsible for identifying eligible donors and recovering organs from deceased donors in the United States (U.S.), with no current statutory authority to add new OPOs. Therefore, the Centers for Medicare & Medicaid Services (CMS) views OPO performance as a critical element of the organ transplantation system in the United States (U.S.)

As of November 2020, a total of 108,725 people were on the waiting lists for a lifesaving organ transplant.[1] Many people face tremendous quality of life burdens or death while on the waiting list. An OPO that is efficient in procuring organs and delivering them to recipients will help more people on the waiting list receive lifesaving organ transplants, which could ultimately save more lives.

Based on public feedback and our own internal analysis of organ donation and transplantation rates, it is the agency's belief that the current OPO outcome measures are not sufficiently objective and transparent to ensure appropriate accountability in assessing OPO performance, nor do they properly incentivize the adoption of best practices and optimization of donation and organ placement rates.

Given OPOs' important role in the organ donation system in the U.S., some stakeholders have stated that underperformers have faced few consequences for poor performance, by noting "Performance varies across the OPO network, with many persistent underperformers failing to improve over the last decade."[2] They further note that there are serious negative impacts to both organ transplantation and donation when OPOs are underperforming, in that "[w]hen OPOs are inefficient or ineffective, donor hospitals are reluctant to refer potential donors, and transplant programs have fewer organ offers for patients on the waiting list. The end result is a bottleneck within the system that leads to avoidable deaths and increased national health care spending."[3]

Some stakeholders, including members of the OPO industry, have stated that the current OPO outcome measures should be reformed to incentivize improvements in OPO performance. Some of these stakeholders note that "[e]xisting regulations need dramatic improvement to remove perverse incentives to organ procurement (for example, OPOs are evaluated on the number of organs procured per donor, which leads to older single-organ donors being overlooked) and increase continuous performance accountability."2 Reforming the current outcome measures can be achieved, they indicated, through metrics that improve accountability and "by replacing current ineffective metrics for OPO performance with a simplified transparent metric that enables independent performance measurement."2

B. Statutory and Regulatory Provisions

To be an OPO, an entity must meet the applicable requirements of both the Social Security Act (the Act) and the Public Health Service Act (the PHS Act). Section 1138(b) of the Act provides the statutory qualifications and requirements that an OPO must meet in order for organ procurement costs to be paid under the Medicare program or the Medicaid program. Section 1138(b)(1)(A) of the Act specifies that payment may be made for organ procurement costs only if the agency is a qualified OPO operating under a grant made under section 371(a) of the PHS Act or has been certified or re-certified by the Secretary of the Department of Health and Human Services (the Secretary) as meeting the standards to be a qualified OPO within a certain time period. Section 1138(b)(1)(C) of the Act provides that payment may be made for organ procurement costs "only if" the OPO meets the performance-related standards prescribed by the Secretary. Section 1138(b)(1)(F) of the Act requires that to receive payment under the Medicare program or the Medicaid program for organ procurement costs, the entity must be designated by the Secretary. The requirements for such designation are set forth in 42 CFR 486.304 and include being certified as a qualified OPO by CMS.

Pursuant to section 371(b)(1)(D)(ii)(II) of the PHS Act, the Secretary is required to establish outcome and process performance measures for OPOs to meet based on empirical evidence, obtained through reasonable efforts, of organ donor potential and other related factors in each service area of the qualified OPO. Section 1138(b)(1)(D) of the Act requires an OPO to be a member of, and abide by the rules and requirements of, the Organ Procurement and Transplantation Network (OPTN). OPOs must also comply with the regulations governing the operation of the OPTN (42 CFR part 121). The Department of Health and Human Services (HHS) has explained that only those policies approved by the Secretary will be considered "rules and requirements" of the OPTN for purposes of section 1138 of the Act. The OPTN is a membership organization that links all professionals in the U.S. organ donation and transplantation system. Currently, the United Network for Organ Sharing (UNOS) serves as the contractor for the operation of the OPTN under contract with HHS. OPOs are required under the OPTN final rule (42 CFR 121.11(b)(2)) and 42 CFR 486.328 of the OPO CfCs to report information specified by the Secretary to the OPTN, including the data used to calculate the outcome measures for OPOs.

In addition, OPOs are required to comply with title VI of the Civil Rights Act of 1964, 42 U.S.C. 2000d (title VI), section 504 of the Rehabilitation Act of 1973, 29 U.S.C. 794 and section 1557 of the Patient Protection and Affordable Care Act, 42 U.S.C. 18116 (section 1557). Title VI and section 1557, protect individuals on the basis of race, color and national origin. Under these laws, OPOs are required to take reasonable steps to ensure meaningful access to their programs by individuals with limited English proficiency. Reasonable steps may include providing language assistance services at no cost, such as providing interpreters or translated material. Also, section 504 and section 1557 protect qualified individuals with a disability, including prospective organ recipients with a disability and prospective organ donors with a disability, from discrimination in the administration of organ transplant programs. Under these laws, OPOs must ensure that qualified individuals with a disability are afforded opportunities to participate in or benefit from the organ transplant programs that are equal to opportunities afforded others. Decisions to approve or deny organ transplants must be made based on objective facts related to the individual in question. "Individuals with disabilities are also entitled to reasonable accommodations needed to participate in and benefit from a program, and auxiliary aids and services needed for effective communication. These rights extend in some circumstances to family members of a prospective organ donor or recipient. For example, health care providers and organ donation programs are required to provide auxiliary aids and services (including sign language interpreters) when necessary for effective communication between a relative involved in a prospective donor or recipient's care and a health care provider or donation program." Additionally, if eligibility criteria for being a transplant recipient require an individual to be able to comply with post-transplant regimens, it would be a reasonable accommodation to allow an individual with a developmental or intellectual, or other disability to meet that requirement with the assistance of a relative, attendant, or other individual.

We established CfCs for OPOs at 42 CFR part 486, subpart G, and OPOs must meet these requirements in order to be able to receive payments from the Medicare and Medicaid programs. These regulations set forth the certification and re-certification processes, outcome requirements, and process performance measures for OPOs and became effective on July 31, 2006 (71 FR 30982), which we refer to as the "2006 OPO final rule". The current outcome measures, found under Section 486.318, are used to assess OPO performance for re-certification and competition purposes (see Section 486.316(a) and (d)).

Section 486.322 requires that an OPO must have a written agreement with 95 percent of the Medicare- and Medicaid-participating hospitals and critical access hospitals in its service area that have both a ventilator and an operating room, and have not been granted a waiver by CMS to work with another OPO. Meanwhile, 42 CFR 482.45 requires a hospital have written protocols that incorporate an agreement with an OPO under which it must notify, in a timely manner, the OPO or a third party designated by the OPO, of individuals whose death is imminent or who have died in the hospital. Potential organ donors may encounter Medicare- and Medicaid-certified providers prior to an emergency department visit or hospital admission to a critical care unit. Therefore, we expect that each OPO's responsibilities and work begins long before a hospital notifies the OPO of an impending death--through, but not limited to, extensive training and education of all Medicare and Medicaid-certified providers along the continuum of care and by fostering a collaborative relationship among them.

C. HHS Initiatives Related to OPO Services and Executive Order (E.O.) 13879

In 2000, the Secretary's Advisory Committee on Organ Transplantation (ACOT) was established under the general authority of section 222 of the PHS Act, as amended. See 42 CFR 121.12. ACOT is charged to: (1) Advise the Secretary, acting through the Administrator, Health Resources and Services Administration (HRSA) on all aspects of organ donation, procurement, allocation, and transplantation, and on such other matters that the Secretary determines; (2) advise the Secretary on federal efforts to maximize the number of deceased donor organs made available for transplantation and to support the safety of living organ donation; (3) at the request of the Secretary, review significant proposed OPTN policies submitted for the Secretary's approval to recommend whether they should be made enforceable; and (4) provide expert input to the Secretary on the latest advances in the science of transplantation, the OPTN's system of collecting, disseminating and ensuring the validity, accuracy, timeliness and usefulness of data, and additional medical, public health, patient safety, ethical, legal, financial coverage, social science, and socioeconomic issues that are relevant to transplantation.[4]

A 2012 recommendation by ACOT stated: "The ACOT recognizes that the current CMS and HRSA/OPTN structure creates unnecessary burdens and inconsistent requirements on transplant centers (TCs) and OPOs and that the current system lacks responsiveness to advances in TCs and OPO performance metrics. The ACOT recommends that the Secretary direct CMS and HRSA to confer with the OPTN, Scientific Registry of Transplant Recipients (SRTR), the OPO community, and TCs representatives to conduct a comprehensive review of regulatory and other requirements, and to promulgate regulatory and policy changes to requirements for OPOs and TCs that unify mutual goals of increasing organ donation, improving recipient outcomes, and reducing organ wastage and administrative burden on TCs and OPOs. These revisions should include, but not be limited to, improved risk adjustment methodologies for TCs and a statistically sound method for yield measures for OPOs . . . ."[5]

On July 10, 2019, President Trump issued Executive Order (E.O.) 13879 titled "Advancing American Kidney Health." The E.O. 13879 states that it is the policy of the U.S. to "prevent kidney failure whenever possible through better diagnosis, treatment, and incentives for preventive care; increase patient choice through affordable alternative treatments for end-stage renal disease (ESRD) by encouraging higher value care, educating patients on treatment alternatives, and encouraging the development of artificial kidneys; and increase access to kidney transplants by modernizing the organ recovery and transplantation systems and updating outmoded and counterproductive regulations."

Further, the E.O. 13879 aims to increase the utilization of available organs by ordering that, within 90 days of the date of the order, the Secretary propose a regulation to enhance the procurement and utilization of organs available through deceased donation by revising OPO rules and evaluation metrics to establish more transparent, reliable, and enforceable objective outcome measures for evaluating an OPO's performance. In conjunction with the E.O. 13879, HHS set a goal to deliver more organs for transplantation and aims to double the number of kidneys available for transplant by 2030.[6]

In accordance with the E.O. 13879, we published a proposed rule in the Federal Register on December 23, 2019 entitled, "Medicare and Medicaid Programs; Organ Procurement Organizations Conditions for Coverage: Revisions to the Outcome Measure Requirements for Organ Procurement Organizations" (84 FR 70628 through 70710), (referred to as the "December 2019 OPO proposed rule"), which proposed to revise the current OPO outcome and process measures to be more transparent, reliable, and provide enforceable objective outcome measures of OPO performance. The December 2019 OPO proposed rule would improve upon the current measures by using objective and reliable data, incentivize OPOs to ensure all viable organs are transplanted, hold OPOs to greater oversight while driving higher performance, and as a result, save more lives.

Dated: November 19, 2020.

Seema Verma,

Administrator, Centers for Medicare & Medicaid Services.

Dated: November 20, 2020.

Alex M. Azar II,

Secretary, Department of Health and Human Services.

[FR Doc. 2020-26329 Filed 11-24-20; 4:15 pm]

BILLING CODE 4120-01-P

The document is published in the Federal Register: https://www.federalregister.gov/documents/2020/12/02/2020-26329/medicare-and-medicaid-programs-organ-procurement-organizations-conditions-for-coverage-revisions-to

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