Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
The 2022 Midterm Elections were held this week, and while ballot counting continues, it is expected Republicans will narrowly secure the House majority, while Democrats maintain a path to keeping their Senate majority. Read more about this and other news below.
I. Regulations, Notices & Guidance
- On November 7, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Supplemental Evidence and Data Request on Respectful Maternity Care: Dissemination and Implementation of Perinatal Safety Culture to Improve Equitable Maternal Healthcare Delivery and Outcomes. AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform the agency’s review on Respectful Maternity Care: Dissemination and Implementation of Perinatal Safety Culture to Improve Equitable Maternal Healthcare Delivery and Outcomes, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. Submissions are due by December 8, 2022.
- On November 7, 2022, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Administrative Simplification: Modifications of Health Insurance Portability and Accountability Act of 1996 (HIPAA) National Council for Prescription Drug Programs (NCPDP) Retail Pharmacy Standards; and Adoption of Pharmacy Subrogation Standard. This proposed rule would adopt updated versions of the retail pharmacy standards for electronic transactions adopted under the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These updated versions would be modifications to the currently adopted standards for the following retail pharmacy transactions: health care claims or equivalent encounter information; eligibility for a health plan; referral certification and authorization; and coordination of benefits. The proposed rule would also broaden the applicability of the Medicaid pharmacy subrogation transaction to all health plans. To that end, the rule would rename and revise the definition of the transaction and adopt an updated standard, which would be a modification for state Medicaid agencies and an initial standard for all other health plans.
- On November 8, 2022, the Food and Drug Administration (FDA) issued draft guidance entitled, Sameness Evaluations in an Abbreviated New Drug Application--Active Ingredients; Draft Guidance for Industry; Availability. This guidance is intended to assist applicants preparing an abbreviated new drug applications (ANDAs) by providing recommendations on demonstrating sameness between the active ingredient in a proposed generic drug product and its reference listed drug (RLD).
- On November 10, 2022, FDA issued final guidance entitled, Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Guidance for Industry and Food and Drug Administration Staff; Availability. FDA is issuing this guidance to promote clarity regarding references to the terms “device” and “counterfeit device” in guidance, regulatory documents, communications, and other public documents. To minimize the potential for miscommunication, FDA also encourage stakeholders, to the extent practicable, to align with the conventions described in the guidance.
- On November 10, 2022, FDA issued draft guidance entitled, Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin; International Council for Harmonisation; Draft Guidance for Industry; Availability. The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance updates the ICH guidance for industry “Q5A Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin” issued in September 1998 to reflect advances in scientific knowledge and regulatory expectations. The draft guidance is intended to describe risk-based principles and mitigation strategies to assure the viral safety of biotechnology products, including the data necessary to submit in a marketing application.
- On November 10, 2022, FDA issued a notice of an extension of comment period entitled, Protection of Human Subjects and Institutional Review Boards, and Institutional Review Boards; Cooperative Research; Extension of Comment Period. FDA is extending the comment period for two proposed rules that appeared in the Federal Register of September 28, 2022. In the proposed rule entitled “Protection of Human Subjects and Institutional Review Boards,” FDA requested comments on proposed changes to its regulations regarding obtaining and documenting informed consent from research participants, and institutional review board membership and functions, including continuing review. In the proposed rule entitled “Institutional Review Boards; Cooperative Research,” FDA requested comment on a change to its regulations that would require any institution located in the U.S. participating in FDA-regulated cooperative research to rely on approval by a single institutional review board (IRB) for that portion of the research that is conducted in the U.S., with some exceptions. FDA is taking this action in response to requests for an extension to allow interested stakeholders additional time to submit comments. The comment period for both rules was extended until December 28, 2022.
- December 20, 2022: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The meeting will include information on establishing ISUDCC working groups, and their deliverables in support for the mission and work of the ISUDCC; federal advances to address challenges in substance use disorder (SUD); and non-federal advances to address challenges in SUD.
- February 9, 2023: The National Institutes of Health (NIH) announced a public meeting of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Advisory Council on Alcohol Abuse and Alcoholism (the Council). The meeting agenda will include presentations and other business of the Council.
II. Reports, Studies & Analyses
- On November 7, 2022, the Congressional Research Service (CRS) published a report entitled, Health Insurance Premium Tax Credit and Cost-Sharing Reductions. The Affordable Care Act (ACA) established the premium tax credit (PTC), as well as two types of cost-sharing reductions (CSRs). One type of CSR reduces annual cost-sharing limits; the other directly reduces cost-sharing requirements. The American Rescue Plan Act of 2021 (ARPA) made temporary changes to the PTC and to CSRs. The ARPA provision to expand eligibility for and the amount of the PTC applicable to certain exchange plans continues to be in effect. Overall, this report describes current law and applicable regulations and guidance, specifically with regard to how the PTC and CSR requirements applied to beneficiaries in 2022.
- On November 7, 2022, the Government Accountability Office (GAO) published a report entitled, Private Health Insurance: Markets Remained Concentrated through 2020, with Increases in the Individual and Small Group Markets. The ACA included a provision directing GAO to periodically study health insurance market concentration. This report describes changes in the concentration of enrollment among issuers in the overall individual, small group, and large group health insurance markets and in the individual market exchanges. GAO considered a market concentrated if three or fewer issuers held at least 80 percent of that market in a state. Using enrollment data from 2019 and 2020, GAO found that in 2020, individual, small group, and large group health insurance markets were all concentrated in at least 42 states (including the District of Columbia). GAO also found that individual and small group markets generally became more concentrated in recent years, with the median market share of the top three issuers in each market increasing by 12 and 10 percentage points, respectively, from 2011 through 2020.
- On November 10, 2022, the Kaiser Family Foundation (KFF) published an annual report entitled, Medicare Advantage 2023 Spotlight: First Look. KFF reported that in 2022, more than 28 million Medicare beneficiaries enrolled in a Medicare Advantage (MA) plan, nearly half of the total Medicare population. This report also provides an overview of the MA plans that are available for 2023 and key MA trends over time. The report states that in 2023, there will be an average of 43 MA plans available to typical beneficiary, which is more than double the average amount in 2018. Further, KFF found that of the 43 MA plans available on average to Medicare beneficiaries, 35 include Medicare Part D coverage. The report details that there are eight new MA organizations entering the marketplace for the first time in 2023, which accounts about 6 percent of the growth in the number of plans available for general enrollment and about 5 percent of the growth in special needs plans (SNPs).
III. Other Health Policy News
- On November 10, 2022, an HHS delegation to the United Nations Climate Conference (COP27) announced that more than 100 health care organizations have signed the White House/HHS Health Sector Climate Pledge to meet targets for emissions reduction and climate resilience. The White House/HHS Health Sector Climate Pledge is a voluntary commitment to climate resilience and emissions reduction that includes cutting greenhouse gas emissions by 50 percent by 2030 and achieving net zero emissions by 2050. Since announcing the pledge in 2021, 102 organizations representing 837 hospitals have signed onto the commitment. HHS also announced plans to collaborate with the National Health Service (NHS) of England to develop proposals for aligned procurement requirements as part of a larger update on climate progress and future plans. More information on this announcement can be found here.
- As of November 10, 2022, control of the House and the Senate for the 118th Congress remains uncertain following the 2022 Midterm Elections, with a number of races yet to be called or headed to a runoff. However, at the moment, Republicans appear likely to secure a narrow majority in the House, and Democrats have a path to holding onto their majority in the Senate. A number of states will likely continue counting ballots through the weekend, namely Arizona and Nevada. In Georgia, the Senate race between incumbent Senator Raphael Warnock (D-GA) and his Republican challenger Herschel Walker, will go to a December 6 runoff after neither candidate secured 50 percent of the vote as required for victory under Georgia law. From a leadership perspective, Senate Majority Leader Chuck Schumer (D-NY) and Senate Republican Leader Mitch McConnell (R-KY) are expected to remain in their positions. On the House side, there is heavy speculation that Speaker Nancy Pelosi (D-CA) will step aside from her leadership position, while it appears, at least for now, that Representative Kevin McCarthy (R-CA) will not be challenged in becoming Speaker of the House if Republicans secure the majority. 2022 Midterm Election results can be monitored here.
- On November 10, 2022, Senate Finance Committee Chair Ron Wyden (D-OR), Ranking Member Mike Crapo (R-ID), Senator Catherine Cortez Masto (D-NV), and Senator John Cornyn (R-TX) released a discussion draft of legislation designed to improve the integration of mental and physical health care services. The discussion draft also outlines policies aimed at expanding Americans’ access to crisis care and follow up services. Included in the discussion is a provision that would increase payment rates to support providers in integrating behavioral health and primary care, as well as a provision to create a standardized payment under Medicare for mobile crisis response team services. Additionally, the Senators propose to ensure peer support specialists can be reimbursed for behavioral health integration services under Medicare, while also proposing to make mobile crisis intervention services permanently available to states as a benefit eligible for federal matching. The discussion draft also includes provisions requiring the Centers for Medicare & Medicaid Services (CMS) to provide technical assistance and best practices to providers for integrating behavioral health care. It also directs the Agency to issue guidance to stakeholders for partnering with states and community-based organizations (CBOs) to address health-related social needs. More information on this action can be found here.
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