National Family Planning & Reproductive Health Association Issues Public Comment on HHS Proposed Rule

WASHINGTON, Dec. 15 -- Clare Coleman, president and CEO of the National Family Planning and Reproductive Health Association, has issued a public comment on the Department of Health and Human Services proposed rule entitled "Securing Updated and Necessary Statutory Evaluations Timely". The comment was written on Dec. 4, 2020, and posted on Dec. 8, 2020:

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The National Family Planning & Reproductive Health Association (NFPRHA) appreciates the opportunity to provide comments on the Department of Health and Human Services (HHS) proposed rule, "Securing Updated and Necessary Statutory Evaluations Timely" (hereinafter referred to as the "Regulations Rule").

The National Family Planning & Reproductive Health Association (NFPRHA) is a non-partisan, nonprofit membership association whose mission is to advance and elevate the importance of family planning in the nation's health care system and promotes and supports the work of family planning providers and administrators, especially in the safety net. NFPRHA membership includes more than 1,000 members that operate or fund more than 3,500 health centers that deliver high-quality family planning education and preventive care to millions of people every year in the United States. NFPRHA represents the broad spectrum of publicly funded family planning providers including, state and local health departments, hospitals, family planning councils, federally qualified health centers, Planned Parenthood affiliates, and other private non-profit agencies. As a leading expert in publicly funded family planning, NFPRHA conducts and participates in research; provides educational subject matter expertise to policymakers, health care providers, and the public; and offers its members capacity-building support aimed at maximizing their effectiveness and financial sustainability as providers of essential health care.

The proposed Regulations Rule would retroactively impose an expiration provision on most HHS regulations and establish "assessment" and "review" procedures to determine which, if any, regulations should be retained or revised. The Regulations Rule is an ill-conceived proposal that would create tremendous administrative burden for HHS and would wreak havoc across a broad swath of Department programs and regulated entities from the Centers for Medicare & Medicaid Services (CMS) to the Centers for Disease Control and Prevention (CDC). NFPRHA strongly objects to the proposed rule. Additionally, the truncated 30-day comment period is insufficient for a rule of this broad scope and potentially harmful effects. We urge HHS to immediately withdraw this proposed rule.

The proposed rule would create tremendous administrative burden for HHS

HHS asserts that the Regulations Rule will promote "accountability, administrative simplification [and] transparency. . . ."/1

In fact, the proposed rule would create a significant administrative burden that would divert resources from critical work, including efforts to address the COVID-19 pandemic. HHS itself estimates that the proposed rule would cost nearly $26 million over 10 years, needing 90 full-time staff positions to undertake the required reviews./2

Within the first two years, HHS estimates the need to assess at least 12,400 regulations that are more than 10 years old./3

However, these figures likely underestimate the time and money involved in the review process, and do not accurately account for complications that may arise.

The Regulations Rule would adversely affect HHS' ability to focus on the administration of current programs, to issue new regulations, and appropriately review current regulations that need modification. In addition, several regulations implementing important parts of the Affordable Care Act are approaching their ten-year anniversary, like the Medicaid cost-sharing rule. Regulations like these would need to be reviewed within the next two years, or they would expire. However, the underlying law still exists, and thus, expirations of these regulations would result in significant uncertainty and confusion for all involved stakeholders, including NFPRHA's member organizations and the patients they serve.

The network of providers of publicly funded family planning and sexual health services represented in NFPRHA's membership rely on or participate in a patchwork of federal programs and funding streams, including the Title X family planning program, Medicaid, the section 330 federally qualified health center program, the 340B drug pricing program, and the CDC 318 sexually transmitted disease program, to name just a few. These programs are governed by hundreds of regulations with which NFPRHA members must comply. These providers also must understand the complexities of how all of these regulations interact. The Regulations Rule would stoke enormous and sustained disruption of the interaction of federal programs and rules.

The current rule would wreak havoc across all HHS programs Regulations play an important role in implementing HHS policies and programs including safety net programs such as Medicaid and the Children's Health Insurance Program (CHIP), which provide health coverage for over 75.5 million people. A strong regulatory framework provides states the clarity they need to run these programs on a day-to-day basis, gives providers and managed care plans guidance as to their obligations, and explains to beneficiaries what their entitlement means. The Regulations Rule would create legal uncertainty regarding the validity and enforceability of regulations throughout the review process.

The bigger danger posed by the Regulations Rule is that important regulations may be arbitrarily rescinded because there are simply not enough HHS staff or resources to undertake such a sweeping review process. Regulations that do not complete the complicated and time-intensive consumer review process would summarily expire, potentially leaving vast, gaping holes in the regulatory framework implementing HHS programs and policies.

For example, there are several regulations governing eligibility for and coverage of family planning and family planning-related services for Medicaid beneficiaries, both in traditional Medicaid populations as well as in those states that have established family planning expansion programs through either Sec. 1115 waivers or state plan amendments. Medicaid is the largest payor for publicly funded family planning services, accounting for approximately 75% of the services provided, and ensures coverage for critical family planning and preventive health services for tens of millions of people who are poor or who have low incomes. Should some or all of the regulations governing this coverage expire, state Medicaid agencies would be left with no guidance on how to implement the many facets of this program. This disruption in federal rulemaking would undoubtedly lead to confusion among providers, and ultimately to Medicaid beneficiaries themselves, a population of individuals who already experience significant systemic barriers to care.

The proposed rule is unnecessary, and HHS does not have the authority to propose automatic expiration dates on almost all regulations.

The Regulations Rule claims that automatic expiration dates give HHS the incentive necessary to conduct regular assessments of existing regulations and comply with the Regulatory Flexibility Act (RFA). First, HHS agencies already commonly update regulations when needed. For example, in 2002 the Centers for Medicare & Medicaid Services (CMS) promulgated new regulations implementing statutory changes to Medicaid managed care./4

In 2015, CMS published a Notice of Proposed Rulemaking to update and modernize Medicaid managed care regulations./5

CMS took nearly a year to review and consider the 875 comments submitted, publishing the final rulemaking in May 2016./6

This administration undertook further rulemaking to revise Medicaid managed care regulations, to "relieve regulatory burdens; support state flexibility and local leadership; and promote transparency, flexibility, and innovation in the delivery of care."/7

HHS' contention that it needs to "incentivize" regulation review by imposing a mandatory rescission is simply not supported by the facts./8

Further, the RFA requires each agency to publish "a plan for the periodic review of the rules issued by the agency which have or will have a significant economic impact upon a substantial number of small entities."/9

However, nothing in this forty year-old law authorizes agencies to retroactively impose a blanket expiration date to rescind duly promulgated regulations.

In fact, this proposal is contrary to the Administrative Procedure Act's (APA) requirements for rulemaking. In the APA, Congress established clear procedures and standards for agencies seeking to modify or rescind a rule. The APA requires agencies to go through the same rulemaking process to revise or rescind a rule as they would for a new rule, with public notice and the opportunity to comment./10

HHS states it has authority under the APA to add end dates, or conditions whereby a previously promulgated rule would expire./11

We do not dispute that federal agencies can later amend existing regulations. However, the Regulations Rule would modify thousands of separate, distinct rules across HHS in a single stroke, in violation of the APA. HHS' attempt to apply a blanket amendment to 18,000 regulations violates the APA's requirements that review of an existing rule take place on an individual basis, requiring specific fact-finding relevant to the individual rule that the agency wants to amend.

Conclusion

The Regulations Rule is an attempt to sabotage duly promulgated regulations, by retroactively imposing an arbitrary end date to such regulations. This rule is unnecessary, will wreak havoc in current HHS programs, and will tie the incoming Administration up in an unnecessary and time-consuming process. Especially during crisis situations like COVID-19, it is critically important that HHS have the flexibility and bandwidth to shift focus and respond quickly to immediate needs.

NFPRHA strongly opposes this rule and urges HHS to withdraw it immediately. Thank you for the opportunity to comment on this important issue. If you have further questions, please contact Mindy McGrath, NFPRHA's Senior Director, Advocacy & Communications, at [email protected].

Sincerely,

Clare Coleman

President & CEO

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Footnotes:

1/ 85 Fed. Reg. 70104.

2/ 85 Fed. Reg. 70116.

3/ 85 Fed. Reg. 70112. To be specific, HHS states that "because the Department estimates that roughly five regulations on average are part of the same rulemaking, the number of Assessments to perform in the first two years is estimated to be roughly 2,480." Id.

4/ CMS, Medicaid Program; Medicaid Managed Care: New Provisions, RIN 0938-AK96, 67 Fed. Reg. 40989 - 41116 (June 14, 2002), https://www.cms.gov/Regulations-and-Guidance/Regulations-and-Policies/QuarterlyProviderUpdates/downloads/cms2104f.pdf.

5/ CMS, Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Proposed Rules, RIN 0938-AS25, 80 Fed. Reg. 31098-31296 (June 1, 2015), https://www.federalregister.gov/documents/2015/06/01/2015-12965/medicaid-and-childrens-health-insurance-program-chip-programs-medicaid-managed-care-chip-delivered.

6/ CMS, Medicaid and Children's Health Insurance Program (CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care, Medicaid and CHIP Comprehensive Quality Strategies, and Revisions Related to Third Party Liability; Final Rule, RIN 0938-AS25, 80 Fed. Reg. 27498-27901 (May 6, 2016), https://www.federalregister.gov/documents/2016/05/06/2016-09581/medicaid-and-childrens-health-insurance-program-chip-programs-medicaid-managed-care-chip-delivered.

7/ CMS, Medicaid Program; Medicaid and Children's Health Insurance Program (CHIP) Managed Care (Final Rule), RIN 0938-AT40, 85 Fed. Reg. 72754-72844, 72754 (Nov. 13, 2020), https://www.govinfo.gov/content/pkg/FR-2020-11-13/pdf/2020-24758.pdf.

8/ 85 Fed. Reg. 70099, 70106.

9/ 5 U.S.C. 610(a) (In the case of the RFA, periodically is defined as 10 years, unless such review is not feasible, in which case the review can be extended another 5 years).

10/ 5 U.S.C. Sec. 551(5);see also Maeve P. Carey, Specialist in Government Organization and Management, Can a New Administration Undo a Previous Administration's Regulations?, Congressional Research Service (Nov. 21, 2016), https://fas.org/sgp/crs/misc/IN10611.pdf ("In short, once a rule has been finalized, a new administration would be required to undergo the rulemaking process to change or repeal all or part of the rule."); Office of Information and Regulatory Affairs, Office of Management and Budget, The Reg Map 5 (2020) (noting that "agencies seeking to modify or repeal a rule" must follow the same rulemaking process they would under the APA).

11/ 85 Fed. Reg. 70104, fn 85 & 86, citing to separate, specific rulemakings modifying interim final rules implementing mental health parity and foreign quarantine provisions, respectively.

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The proposed rule can be viewed at: https://www.regulations.gov/document?D=HHS-OS-2020-0012-0001

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