March of Dimes Issues Public Comment on HHS Proposed Rule

WASHINGTON, Dec. 16 -- Ariel Gonzalez, senior vice president for public policy and federal affairs at March of Dimes, 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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As an organization committed to promoting maternal and infant health, we appreciate this opportunity to comment on the proposed rule, "Securing Updated and Necessary Statutory Evaluations Timely" as published on November 4, 20202 (Docket No. HHS-OS-2020-0012). We respectfully ask that Health and Human Services (HHS) to immediately withdraw the proposed rule, which would create tremendous administrative burden for HHS and undermine critical programs such as Medicaid, Medicare, and the Affordable Care Act (ACA) health insurance marketplaces, as well as other core functions of government, such as Food and Drug Administration (FDA) operations.

March of Dimes is the leading non-profit organization fighting for the health of all moms and babies. We promote the health of women, children and families, across the life course, from birth through adolescence and the childbearing years, with an emphasis on preconception, prenatal, interconception, and infant health. Ensuring that women, infants, and families have access to quality care is essential to achieving our goals and thus this rule would cause confusion and wreak havoc on the services that many of these individuals rely on.

March of Dimes calls into question the fundamental fairness principles underlying the Administrative Procedure Act, which allows for a reasonable opportunity to review and comment on new government actions./1

This rule has the ability to drastically impact a number of regulations and therefore it is prudent to allow for more time to more thoroughly analyze the full breadth, scope, and impact of this proposed rule, and the potential harms it will have on moms, babies, and families.

The Rule would be overly Burdensome and Require Significant Resources

The proposed rule states that HHS regulations will automatically expire at the later of: two years after the SUNSET proposal takes effect; ten years after the regulation was originally promulgated; or ten years after HHS assesses and, if necessary, reviews the regulation. This would be a costly endeavor with HHS estimating that the new review procedures would cost up to $19 million to implement in the first two years and $26 million over the next ten years./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. Not only would the rule be a costly endeavor, but it would affect HHS's ability to focus on the administration of current programs, to issue new regulations, and appropriately review current regulations that need modification.

Finalizing this proposed rule now could not be more irresponsible. Currently, the country is facing an unprecedented moment in time as COVID-19 has killed over 200,000 individuals and the death toll keeps rising. The pandemic has impacted pregnant women as they are at a higher risk of contracting COVID-19 than nonpregnant women./4

Promulgating a rule that would upend many regulations, if not reviewed within a two year period that support public health services, during a pandemic is woefully irresponsible. During this crisis situation, it is critically important that HHS have the flexibility and bandwidth to shift focus and respond quickly to immediate needs instead of going through this time consuming and costly process.

The Rule would Wreak Havoc on Safety Net Programs Women, Children, and Families Rely on Regulations play an important role in implementing HHS policies and programs that support women, children, and families. 75.5 million individuals, including 36.6 million children rely on Medicaid and the Children's Health Insurance Programs (CHIP) for healthcare - and those numbers have only increased during the pandemic./5

Medicaid plays a key role in providing maternity-related services for pregnant women and paid for 43% of all births in 2018./6

Over two-thirds of women who have Medicaid started prenatal care during the first trimester and more than three quarters received nine or more prenatal visits over the course of their pregnancy./7

Additionally, Medicaid has covered a greater share of births in rural areas and among minority women./8

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 the terms of their eligibility for these essential programs. The rule would create legal uncertainty regarding the validity and enforceability of regulations throughout the review process.

The bigger danger posed by the 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. With this sweeping review process, Section 1115 waivers that were approved by Centers for Medicaid and Medicaid Services (CMS), which included demonstration projects that allowed for continuous coverage of healthcare for postpartum individuals could expire leaving many pregnant individuals without coverage during a time when it is essential.

Furthermore, the Affordable Care Act (ACA), which has been implemented for the last 10 years, has provided protections for individuals with preexisting conditions and essential health benefits that include maternity care. If the Department does not "assess" and, if necessary "review" these regulations within the two year period, the regulations will expire and leave millions of women without health insurance coverage or underinsured during a period of time that is critical. Therefore, arbitrarily rescinding large swaths of regulations would wreak havoc in HHS programs, leading to untold harm to the millions of women, babies, and families who rely on these programs.

Conclusion

The proposed rule would restrict our public health agencies and would leave millions of women, babies, and families without access to crucial public health and healthcare programs. It is entirely foreseeable that this hasty proposal will divert the focus of the agencies and would prevent meaningful review or implementation of new regulations. The result will be significant, unnecessary, and harmful to the health and wellbeing of women, children, and families. For all the above reasons, March of Dimes urges the Department to immediately withdraw this harmful rule that would be destructive to maternal and infant health.

Once again, the March of Dimes appreciates the opportunity to comment. If we can provide and further information or otherwise be of assistance, please contact our Deputy Director of Federal Affairs for Public Health, Deema Tarazi at [email protected].

Sincerely,

Ariel Gonzalez

Senior Vice President, Public Policy and Federal Affairs

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Footnotes:

1/ Administrative Procedure Act, 5 U.S. C. Subchapter II

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/ https://www.cdc.gov/mmwr/volumes/69/wr/mm6944e3.htm?s_cid=mm6944e3_w

5/ https://www.kff.org/coronavirus-covid-19/issue-brief/analysis-of-recent-national-trends-in-medicaid-and-chip-enrollment/

6/ https://www.macpac.gov/wp-content/uploads/2020/01/Medicaid%E2%80%99s-Role-in-Financing-Maternity-Care.pdf

7/ Id.

8/ Id.

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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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