Caring Health Center Issues Public Comment on HHS Proposed Rule

WASHINGTON, Dec. 16 -- Tania M. Barber, president and CEO of the Caring Health Center, Springfield, Massachusetts, 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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Caring Health Center (CHC) is one of the premier health centers in Western Massachusetts, and for 25 years it has served as an essential source of health care for residents of the greater Springfield area. CHC is the most culturally diverse and linguistically leading institution in the region. It is the leader in modeling employment equity based on being both women-led and having majority representation of people of color in our executive and overall leadership team. As an innovator, CHC has participated in federally funded research for over 21 years

In 1995, the time of its inception, CHC employed 20 and provided health care to 5,000 patients at a single site. Today, CHC employs over 250 and serves about 20,000 patients annually, providing affordable, quality, comprehensive medical care at three sites. In addition, the organization operates a state-of-the art pharmacy and WIC Nutrition Program, and serves as the largest Refugee Health Assessment provider in Massachusetts. CHC's on-site Wellness Center provides nutrition education, group physical exercise, and other services to support healthy and productive lives among patients.

Generally, Caring Health Center 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

Caring Health Center 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% of health center patients nationwide earning annual incomes at or below 200% 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 74% of our health center patients and represent a principal source of our health centers revenue. Just as consistency of operations is critical for the health of our patients, revenue stability is essential for maintaining the strength of our health center. 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 day-to-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, Caring Health Center 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 our health centers' ability to serve patients and our communities. In this regard, Caring Health Center supports the overall goals of the Regulations Rule; however, Caring Health Center believes that the process proposed by HHS to achieve these goals is misguided and unworkable.

As crafted, the proposed rule would create 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. HHS itself estimates that the proposed rule would cost nearly $26 million dollars over ten (10) years and necessitate ninety (90) full-time staff positions to undertake the required reviews. 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.

Further, 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 unfeasible. Within the first two (2) years, HHS estimates the need to assess at least 12,400 regulations that are more than ten (10) years old. It is important to consider that these estimates likely underestimate the time and resources involved in the review process and do not accurately account for complications that may arise. 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. 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 is 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 that is critical for implementing important HHS programs and policies such as the HCP.

Such consequences would be devastating to the HCP, resulting in a lack of consistency and stability that, as discussed above, is crucial for our ability to appropriately serve the patients and communities who rely upon us. 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.

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

Conclusion

In general, Caring Health Center 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, Caring Health Center 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, Caring Health Center 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, Caring Health Center 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 letter, Caring Health Center 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 me directly.

Tania M. Barber

President/CEO

Caring Health Center

1049 Main St.

Springfield, MA 01103

413(693)1026

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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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