Colorado Consumer Health Initiative Issues Public Comment on HHS Proposed Rule

WASHINGTON, Dec. 15 -- Adam Fox, deputy director of the Colorado Consumer Health Initiative, Denver, 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. 3, 2020, and posted on Dec. 8, 2020:

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The Colorado Consumer Health Initiative (CCHI) is a statewide, non-partisan, non-profit membership organization working so all Coloradans have equitable access to affordable, high-quality health care. We appreciate 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 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 Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). We also strongly object to the truncated 30-day comment period which is insufficient for a rule of this broad scope with 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 dollars 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 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 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.

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.

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, including 36.6 million children. Since the 2010 passage of the Affordable Care Act, CCHI and our members have been actively engaged in Colorado's efforts to expand access to coverage. Colorado expanded Medicaid and established a state-based marketplace, Connect for Health Colorado, where consumers can shop for coverage. As a result of these efforts, the state's uninsured rate is now at a record low. A strong regulatory framework is essential to protecting the collaborative efforts Colorado has made in reforming its private insurance market. It provides the state the clarity we 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. That uncertainty will ultimately lead to higher costs in our health systems and higher costs for consumers.

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 consuming review process would summarily expire, potentially leaving vast, gaping holes in the regulatory framework implementing HHS programs and policies.

There are countless rules and regulations that would be disrupted by the Regulations Rule. This includes the Final Rule implementing the prohibition of discrimination under Section 1557 of the Affordable Care Act, Nondiscrimination in Health Programs and Activities, which helps to ensure expanded access to health care for all people regardless of race, color, national origin, age, sex, or disability. Title X is the only federal grant program providing comprehensive family planning services to low income patients. The absence and/or delay of regulations around Title X funding that this rule would create, would result in disproportionate and negative health impacts for low-income women, women of color, young women, and the LGBTQ+ community, thereby increasing health disparities. If these regulations were to disappear, it would be a step back in the fight to advance equity and reduce health disparities in our health care system by protecting populations that have been most vulnerable to discrimination in the health care context or who are struggling economically. The Regulations Rule would also substantially disrupt Market Stabilization Rules and Benefits and Payment Parameters which protect consumers by increasing competition, lowering premiums, and stabilizing individual and small group markets to increase choice.

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 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 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. If you have further questions, please feel free to contact me.

Sincerely,

Adam Fox

Deputy Director

Colorado Consumer Health Initiative

[email protected]

303-839-1261

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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/dow nloads/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://beta.regulations.gov/document/HHS-OS-2020-0012-0001

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