December 31, 2021

More Federal Regulations to Be Rescinded and More

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Biden HHS Seeks to Repeal Multiple Trump Era Regulations

The Department of Health and Human Services ("HHS") has proposed 86 FR 58042, which repeals two final rules promulgated by the Trump administration: "Department of Health and Human Services Good Guidance Practices," published on December 7, 2020; and "Department of Health and Human Services Transparency and Fairness in Civil Administrative Enforcement Actions," published on January 14, 2021. The Good Guidance Practices Rule required agencies to treat guidance documents as non-binding both in law and in practice, except as incorporated into a contract. It also required agencies to take public input on guidance documents into account and make all guidance documents available on a single website.  The Civil Administrative Enforcement Actions Rule imposed a number of procedural hurdles on agencies engaged in civil administrative enforcement or adjudication. According to the HHS, the rules "create unnecessary hurdles that hinder the Department's ability to issue guidance, bring enforcement actions, and take other appropriate actions that advance the Department's mission" and "are inconsistent with the policies and goals of the current Administration." Comments are due November 19, 2021.

Final Rule Impacting 340B Discounts Rescinded

In our prior update dated July 6, 2021, we noted that HHS proposed a rule to rescind the final rule entitled "Implementation of Executive Order on Access to Affordable Life-Saving Medications," first published in the December 23, 2020, Federal Register ("2020 Rule"). 86 FR 54390  finalizes the proposal to rescind the 2020 Rule. The 2020 Rule required community health centers to pass on the 340B discounts they get for insulin and Epi-Pens directly to patients. HHS is rescinding the 2020 Rule due to the excessive administrative costs and burdens that implementation would have imposed on health centers, especially in light of the COVID-19 pandemic. In particular, the 2020 Rule required health centers to create and maintain new practices necessary to determine patients' eligibility to receive certain drugs at or below the discounted price paid by the health center or subgrantees, plus a minimal administration fee. HHS found that the 2020 Rule's implementation would have resulted in reduced resources available to support critical services to health center patients—including those who use insulin and injectable epinephrine.

HHS Issues Final Rule Aimed at Strengthening Family Planning Services

HHS has issued 86 FR 56144, a final rule, "Ensuring Access to Equitable, Affordable, Client‑Centered, Quality Family Planning Services," which revises the regulations that govern the Title X family planning program. The final rule reverses the Title X rules promulgated in 2019, which, among other things, prohibited Title X funded sites and providers from providing patients with any information about abortion services, or offering abortion services at the same site, even though those services were not funded by Title X. The prohibition on the use of Title X funds to pay for abortions is maintained under the final rule, but Title X funded sites and providers are once again permitted to counsel and refer patients to abortion services, as well as permit family planning services to be co‑located with abortion services. The final rule is effective November 8, 2021.

2022 User Fee Rates for Issuers Offering Qualified Health Plans

HHS issued a final rule, 86 FR 53412, that sets the revised 2022 user fee rates for issuers offering qualified health plans ("QHPs") through federally-facilitated Exchanges and State-based Exchanges on the Federal platform. The final rule also repeals separate billing requirements related to the collection of separate payments for the portion of QHP premiums attributable to coverage for certain abortion services.

Rule on Amendment to Uniform Administration Requirements Delayed

The final rule, 86 FR 53562, postpones the effective date of 86 FR 2257, first promulgated on January 12, 2021, which makes amendments to the Uniform Administrative Requirements. Specifically, the rule amends paragraph (c), which previously stated, "It is a public policy requirement of HHS that no person otherwise eligible will be excluded from participation in, denied the benefits of, or subjected to discrimination in the administration of HHS programs and services based on non-merit factors such as age, disability, sex, race, color, national origin, religion, gender identity, or sexual orientation. Recipients must comply with this public policy requirement in the administration of programs supported by HHS awards." The rule amended paragraph (c) to state, "It is a public policy requirement of HHS that no person otherwise eligible will be excluded from participation in, denied the benefits of, or subjected to discrimination in the administration of HHS programs and services, to the extent doing so is prohibited by federal statute."

The postponement arises from an Order issued by the U.S. District Court for the District of Columbia in Facing Foster Care et al. v. HHS, No. 21-cv-00308 (D.D.C. Feb. 2, 2021). In that case, plaintiff seeks injunctive relief, alleging that the rule amendments detrimentally modify a rule that previously set forth clear and uniform nondiscrimination protections for beneficiaries of and participants in services funded by federal grants. On August 5, 2021, the Court granted plaintiff's emergency application for a temporary restraining order and motion for stay, postponing implementation of the final rule and its accompanying amendments until November 9, 2021.

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