Health Care For All Issues Public Comment on HHS Proposed Rule
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On behalf of Health Care For All (HFCA), we appreciate the opportunity to provide comments on the
HCFA is a non-profit consumer health advocacy organization that advocates for health justice in
The proposed 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 Medicaid and Medicare to
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
Within the first two years, HHS estimates the need to assess at least 12,400 regulations that are over 10 years old./3
However, these estimates 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's 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 (ACA) 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, even if the regulations expire. Without the cost-sharing rule, states would not have clear guidance on how to implement cost-sharing amounts.
HCFA is also concerned about the impact of the proposed rule on the Mental Health Parity and Addiction Equity Act (MHPAEA), which requires that mental health and substance use disorder coverage be comparable to general medical coverage. While the original 2008 law applied to large group coverage with regulations promulgated through the Departments of Labor and
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
Further, regulations like the ACA Navigator rules establish clear program criteria, such as conflict of interest standards, and provide a structure for training and funding mechanisms. Enrollment assistance programs like HCFA's consumer HelpLine are critically important to ensure that people have access to local assisters in their communities who can assist with health coverage eligibility and enrollment. 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 consumer review process would summarily expire, potentially leaving vast, gaping holes in the regulatory framework implementing HHS programs and policies.
For example, multiple insurance affordability programs including Medicaid and CHIP rely on regulations at 42 C.F.R. Sec. 435.603 to determine financial eligibility using Modified Adjusted Gross Income (MAGI) methodologies. If this regulation were to simply disappear, programs would be free to redefine MAGI household and income counting rules, with no standards, consistency, or accountability. Arbitrarily rescinding large swaths of regulations would wreak havoc in HHS programs, leading to untold harm to the millions of people who rely on those programs.
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
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,
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 simply an attempt to sabotage and destroy duly promulgated regulations, by retroactively imposing an arbitrary end date to duly promulgated regulations. This rule is unnecessary, will wreak havoc in current HHS programs, and will tie the hands of the incoming Administration by detracting from critical issues like the COVID-19 pandemic, to undertake this time-consuming process. We strongly oppose this rule and urge HHS to withdraw it immediately. Thank you for the opportunity to comment on this important issue.
Sincerely,
Executive Director
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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 (
5/ CMS, Medicaid and
6/ CMS, Medicaid and
7/ CMS, Medicaid Program; Medicaid and
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
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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