National Association of Community Health Centers Issues Public Comment on HHS Proposed Rule

WASHINGTON, Dec. 15 -- Tom Van Coverden, president and CEO of the National Association of Community Health Centers, Bethesda, Maryland, 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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NACHC is the national membership organization for federally qualified health centers (also known as FQHCs or health centers). Health centers are federally-funded or federally-supported nonprofit, community-directed clinics that serve as the health home for over 29 million people, including 1 in 5 Medicaid beneficiaries and 1 in 3 people living in poverty nationwide. It is the collective mission and mandate of over 1,400 health centers around the country to provide access to high quality, cost effective primary and preventative care, as well as dental, behavioral health, and pharmacy services and critical "enabling" or support services that facilitate access to care to individuals and families located in medically underserved areas, regardless of insurance status or ability to pay.

Generally, NACHC encourages measures which increase transparency and accountability and foster stakeholder engagement through public notice and comment. As such, 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").

Comment on the Proposed Regulations Rule

As the association representing hundreds of health centers nationwide, NACHC strongly supports government accountability, including efforts to ensure that regulations governing the Health Center Program (HCP) remain current and up-to-date. However, it is equally important that regulations strive for consistency in implementation without interruptions that could adversely impact operations. Regulations play an important role in forming and establishing the framework for HHS safety net programs such as the HCP. With approximately 90 percent of health center patients earning annual incomes at or below 200 percent of the Federal Poverty Guidelines, reliability and stability of operations are critical for ensuring that our vulnerable populations retain access to the services on which they rely and that are crucial to their health and welfare.

Further, regulations are critical in implementing the government payor programs - including Medicaid, Medicare and Children's Health Insurance Programs - that combined provide coverage for nearly 60% of health center patients and represent a principal source of health center revenues. Just as consistency of operations is critical for the health of our patients, revenue stability is essential for maintaining the strength of health center organizations. A strong regulatory framework provides all stakeholders - including states, provider organizations, managed care plans, patients - with both the clarity and constancy they need to operate on a dayto day basis and the key guidance necessary to understand their various rights and obligations.

Insofar as the majority of health centers would be considered "small entities" as it pertains to this Rule, NACHC welcomes any effort to modernize and streamline the various regulatory approaches under which health centers operate and are reimbursed, thus minimizing the economic and administrative burdens that could adversely impact health centers' ability to serve their patients and their communities. In this regard, NACHC supports the overall goals of the Regulations Rule; however, NACHC believes that the process proposed by HHS to achieve these goals is misguided and unworkable.

As crafted, the proposed rule places a significant administrative burden on the agencies tasked with the required regulatory review, which would divert resources from critical ongoing work that includes efforts to address the COVID-19 pandemic, without providing additional resources. HHS itself estimates that the proposed rule would necessitate ninety (90) full-time staff positions to undertake the required review of some 12,400 regulations at a cost nearly $26 million dollars over ten years. Given these estimates, it is highly likely the Regulations Rule would adversely affect HHS's ability to focus on the administration of current programs, to issue new regulations and to revise those existing regulations that require immediate modification or amendment. We are concerned also that these reviews will divert resources from critical ongoing work that includes efforts to address the COVID-19 pandemic.

The establishment of a two (2) year deadline for the various agencies within HHS to review existing regulations that have been in place for more than ten (10) years is arbitrary and not warranted given that Congress has already established procedures for regulatory promulgation, review, and public comment through the Administrative Procedure Act (APA, 5 U.S.C. Secs. 551-559) and the Regulatory Flexibility Act (RFA, 5 U.S.C. Secs. 600-612). Since 1980, the RFA has required federal agencies to conduct reviews every ten (10) years of regulations that have a significant economic impact on a substantial number of small entities. HHS posted its final plan for retrospective review of existing regulations in 2011, with a stated purpose to "identify those rules that can be eliminated as obsolete, unnecessary, burdensome, or counterproductive or that can be modified to be more effective, efficient, flexible, and streamlined"./1

From 2012 to 2016, HHS provided semi-annual updates on its website listing the rules undergoing or scheduled for review./2

While the website has not been updated recently, we encourage the Department to continue to conduct retrospective reviews using its already established process and to provide regular updates to the public. For these reasons, we strongly object to the truncated 30-day comment period, which provides insufficient time to fully consider this complex proposal that has potentially far-reaching consequences.

From an operations perspective, implementation of the Regulations Rule would create legal uncertainty regarding the validity and enforceability of regulations throughout the review process. A substantial danger posed by the Regulations Rule is that important regulations may be arbitrarily rescinded because there are simply not enough HHS staff with subject matter expertise or other 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 that is critical for implementing important HHS programs and policies such as the HCP.

Such consequences would be devasting to the HCP, resulting in a lack of consistency and stability that, as discussed above, is crucial for health centers to appropriately serve the patients and communities who rely upon them. Effectively, the consequences of an agency failure would fall upon health centers that are not at fault for such failures but nonetheless will suffer the most. Ultimately, accountability for the investments made by the federal government in the national HCP could suffer. The parties that will likely suffer the most from these shortcomings will be the low-income patients of health centers who depend on them for critical primary care services.

Finally, given the importance of the Regulations Rule and the dire consequences if agencies fail to complete required reviews on a timely basis, NACHC opposes the Regulations Rule until a detailed analysis of the potential consequences can be conducted, and urges HHS to withdraw it immediately.

Conclusion

In general, NACHC strongly supports government accountability and welcomes any attempts to modernize, update and streamline the regulatory approaches under which health centers operate in order to minimize the economic and administrative burdens that could adversely impact health centers' ability to serve their patients.

However, for the reasons discussed in greater detail above, NACHC believes that the process outlined in the Regulations Rule is misguided and unworkable. The administrative burden placed on the various agencies to complete required reviews is substantial and the requirement to complete such reviews within a deadline of two (2) years is arbitrary and unfeasible. Of even greater importance, the consequences for failure to complete the reviews within the required deadline could be devastating for the HCP and the patients who have come to rely upon it at a time when health care choices for vulnerable populations is limited, or in many communities, non-existent.

Given the truncated 30-day comment period, NACHC opposes the Regulations Rule until a detailed analysis of the potential consequences can be conducted and urges HHS to withdraw it immediately. Alternatively, if HHS decides to proceed with the promulgation of the Regulations Rule, NACHC urges HHS to: (i) extend the two- (2) year review period for existing regulations to a period not less than five (5) years, and (ii) build in safeguards to ensure that regulations critical to the operation of safety net providers such as health centers will not automatically rescind due to the failure of HHS or one of its agencies to complete a timely review. For purposes of the latter, NACHC urges HHS to issue a second notice requesting appropriate stakeholder input.

We appreciate the opportunity to provide comment on this proposed rule. Should you have any questions about our comments, please feel free to contact Jeremy Crandall, Director of State Affairs at [email protected].

Sincerely,

Tom Van Coverden

National Association of Community Health Centers

www.nachc.org

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Footnotes:

1/ U.S. Department of health and Human Services (HHS). 2011. Plan for Retrospective Review of Existing Rules. Washington, DC: https://www.federalregister.gov/documents/2011/04/13/2011-8780/hhs-plan-forretrospective review-under-executive-order-13563

2/ U.S. Department of health and Human Services (HHS). 2016. Retrospective Review of Existing Rules. Washington, DC: HHS. https://www.hhs.gov/open/retrospective-review/index.html

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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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