New Jersey Primary Care Association Issues Public Comment on HHS Proposed Rule

WASHINGTON, Dec. 15 -- Selina Haq, president and CEO of the New Jersey Primary Care Association, Hamilton, 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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The New Jersey Primary Care Association proudly represents our State's Federally Qualified Health Centers who serve over 584,000 medically underserved patients. New Jersey FQHCs deliver primary and preventive care services through a network of 23 Health Centers and 136 satellite sites located throughout all 21 counties of the State. As the backbone of the primary care "safety net," in New Jersey and across the nation, FQHCs are united by a shared mission to ensure access to high-quality health care for all individuals, regardless of a patient's ability to pay. They provide a full range of primary, preventive, behavioral, and oral health care services and no one is ever turned away. Our vulnerable patient population includes people who are experiencing homelessness, those who are living with HIV, migrant and seasonal farmworkers, and residents of public housing.

Generally, NJPCA encourages measures that 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 FQHCs throughout the State, NJPCA 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 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 60% of health center patients and represent a principal source of health center revenues. Just as the 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 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, NJPCA 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, NJPCA supports the overall goals of the Regulations Rule; however, NJPCA 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 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 has 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, the 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 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 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.

Finally, given the importance of the Regulations Rule and the dire consequences if agencies fail to complete required reviews on a timely basis, NJPCA 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, NJPCA 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, NJPCA 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, NJPCA 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, NJPCA 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, NJPCA urges HHS to issue a second notice requesting appropriate stakeholder input.

We appreciate the opportunity to provide comments on this proposed rule. Should you have any questions about our comments, please feel free to contact me at 609-689-9930.

Very truly yours,

Selina Haq, Ph.D.

President and CEO

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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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