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:
This week, CMMI announced a new primary care model and CMS announced a list of 43 Part B drugs subject to lower coinsurance rates under the IRA. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On June 5, 2023, the Food and Drug Administration (FDA) issued final guidance entitled, Cover Letter Attachments for Controlled Correspondence and ANDA Submissions. This guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used when preparing cover letters that accompany controlled correspondence, original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA. This guidance finalizes the draft guidance of the same title issued on December 13, 2021.
- On June 6, 2023, FDA issued draft guidance entitled, E6(R3) Guideline for Good Clinical Practice. The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance outlines modernized Good Clinical Practice considerations to guide thoughtful design and responsible conduct of clinical trials in a manner that ensures participant safety and the reliability of trial results. This draft guidance encourages innovation, focuses on quality, and establishes proportionate and risk-based approaches for conducting clinical trials, while minimizing unnecessary complexities. The draft guidance is intended to provide flexible, modern, and clear Good Clinical Practice for conducting clinical trials.
- On June 7, 2023, FDA issued draft guidance entitled, Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry. This draft guidance describes an approach to satisfy the requirements for the completion of the Bioequivalence technical section for generic Type A medicated articles (TAMAs) containing poorly soluble, locally acting, active pharmaceutical ingredients (APIs) that have little to no systemic absorption, and for which blood level studies are not considered appropriate to demonstrate product bioequivalence. The suggested approach described in this draft guidance uses a combination of in vitro and in vivo data to support a determination of bioequivalence to address the unique challenges associated with demonstrating bioequivalence of TAMAs containing poorly soluble, locally acting APIs that have little to no systemic absorption.
- On June 7, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a rule entitled, Medicare Program; Treatment of Medicare Part C Days in the Calculation of a Hospital’s Medicare Disproportionate Patient Percentage. This final action establishes a policy concerning the treatment of patient days associated with persons enrolled in a Medicare Part C (also known as “Medicare Advantage”) plan for purposes of calculating a hospital’s disproportionate patient percentage for cost reporting periods starting before fiscal year (FY) 2014 in response to the Supreme Court’s ruling in Azar v. Allina Health Services, 139 S. Ct. 1804 (June 3, 2019).
- On June 8, 2023, FDA issued final guidance entitled, Clinical Drug Interaction Studies With Combined Oral Contraceptives. This guidance is intended to help sponsors of investigational new drug applications and new drug applications evaluate the need for drug-drug interaction (DDI) studies with combined oral contraceptives (COCs), design such studies, and determine how to communicate DDI study results and risk mitigation strategies to address potential risks associated with increased or decreased exposure of COCs in labeling. The guidance finalizes the draft guidance “Clinical Drug Interaction Studies With Combined Oral Contraceptives” issued on November 23, 2020.
- July 6-7, 2023: The Department of Health and Human Services (HHS) announced a public meeting of the President’s Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders (Commission) and the solicitation of written and oral comment regarding the advancement of equity, justice and opportunity for Asian American, Native Hawaiian, and Pacific Islander (AA and NHPI) communities. The meeting is the sixth in a series of federal advisory committee meetings regarding the development of recommendations to advance equity, justice, and opportunity for AA and NHPI communities. The Commission will discussed full and draft recommendations by the Commission’s six Subcommittees: Belonging, Inclusion, Anti-Asian Hate, Anti-Discrimination; Data Disaggregation; Language Access; Economic Equity; Health Equity; and Immigration and Citizenship Status.
- July 11, 2023: The National Institutes of Health (NIH) announced a public meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC will provide input to the NTP on programmatic activities and issues. The preliminary agenda topics include a presentation on needed research capabilities to support predictive toxicology and evidence evaluation, including the development and implementation of computational, alternative, literature-based, and quality assessment tools and methodologies.
- July 19, 2023: NIH’s National Cancer Institute (NCI) announced a hybrid public meeting of the NCI Clinical Trials and Translational Research Advisory Committee (CTAC). The agenda will include strategic discussion of NCI’s clinical and translational research programs.
- August 3, 2023: NIH’s National Heart, Lung, And Blood Institute (NHLBI) announced a public meeting of the Sleep Disorders Research Advisory Board (SDRAB). The purpose of this meeting is to update SDRAB and stakeholders on the progress of sleep and circadian research activities across NIH.
II. Hearings & Markups
U.S. House of Representatives
- On June 6, 2023, the House Committee on Education and the Workforce held a markup entitled, Markup on Bills to Improve Health Care Options for Small Businesses and Student Outcomes. The committee considered the following bills: H. Res. 461, Condemning the use of elementary and secondary school facilities to provide shelter for aliens who are not admitted to the United States; H.R.1147, Whole Milk for Healthy Kids Act of 2023; H.R.2813, Self-Insurance Protection Act; H.R.2868, Association Health Plans Act; and H.R.824, Telehealth Benefit Expansion for Workers Act of 2023.
- On June 7, 2023, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Looking Back Before Moving Forward: Assessing CDC's Failures in Fulfilling its Mission. Witnesses present included: Charity Dean, M.D., M.P.H. & TM, Chief Executive Officer (CEO) & Founder, The Public Health Company; Mary Denigan-Macauley, Ph.D., Director, Health Care, U.S. Government Accountability Office (GAO); Tracy Beth Høeg, M.D., Ph.D., Epidemiologist, Department of Epidemiology & Biostatistics, University of California—San Francisco; and Georges C. Benjamin, M.D., Executive Director, American Public Health Association (APHA).
- On June 7, 2023, the House Committee on Ways and Means held a markup entitled, Markup of H.R. 3667, H.R. 3784, H.R. 3796, H.R. 1843, H.R. 3800, H.R. 3797, H.R. 3801, H.R. 3798, H.R. 3799. The committee considered the following bills: H.R. 3784, the Improving Social Security’s Service to Victims of Identity Theft Act; H.R. 3667, the Social Security Child Protection Act of 2023; H.R. 3796, To provide for the extension of taxes funding the Airport and Airway Trust Fund and to require the designation of certain airports as ports of entry; H.R. 1843, the Telehealth Expansion Act of 2023; H.R. 3800, the Chronic Disease Flexible Coverage Act; H.R. 3797, the Paperwork Burden Reduction Act; H.R. 3801, the Employer Reporting Improvement Act; H.R. 3798, the Small Business Flexibility Act; and H.R. 3799, the Custom Health Option and Individual Care Expense Arrangement Act.
- On June 9, 2023, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Addressing the Opioid Crisis: Examining the SUPPORT Act Five Years Later. Witnesses present included: Emily Keller, Special Secretary of Opioid Response, Opioid Operational Command Center, Office of Governor Wes Moore; Mike Straley, Founder, Leah’s Legacy Foundation; Mitchell Crawford, D.O., Medical Director, Specialized Treatment and Recovery, WellSpan Health, Director, Addiction Services, WellSpan Health; and Chief William Ceravola, Reading Township Police Department.
- On June 8, 2023, the Senate Committee on Finance held a hearing entitled, Consolidation and Corporate Ownership in Health Care: Trends and Impacts on Access, Quality, and Costs. Witnesses present included: Zack Cooper, Ph.D., Associate Professor Of Public Health And Associate Professor Of Economics, Yale University; R. Shawn Martin Vice President and CEO, American Academy of Family Physicians (AAFP); Karen Maddox, M.D., M.P.H., Associate Professor of Medicine, Washington University in St. Louis; Chris Thomas, FACHE, President and CEO, Community Hospital; Caroline Pearson, Executive Director, Peterson Center on Healthcare.
- On June 8, 2023, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, Why Are So Many American Youth in a Mental Health Crisis? Exploring Causes and Solutions. Witnesses present included: Vice Admiral Vivek H. Murthy, U.S. Surgeon General, HHS; Katherine Neas, Deputy Assistant Secretary, Office of Special Education and Rehabilitative Services, U.S. Department of Education (ED); Charlene M. Russell-Tucker, Commissioner, Connecticut State Department of Education; Joshua Garcia, ME.d., Ed.D., Superintendent, Tacoma Public Schools; and Joy Osofsky, Ph.D., Professor of Pediatrics, Psychiatry, and Public Health, Head of Division of Pediatric Mental Health, Louisiana State University Health Sciences Center.
III. Reports, Studies & Analyses
- On June 5, 2023, the Bipartisan Policy Center (BPC) published a report entitled, PEPFAR: 20 Years of Progress, Partnership, and Impact. BPC analyzed the impact of the President’s Emergency Plan for AIDS Relief (PEPFAR), which invested billions of dollars into a global public health campaign to address and mitigate HIV/AIDS in communities around the world. Presidents and Congress have reauthorized PEPFAR three times with strong bipartisan support since the founding of the program in 2003. As a result of funding and investment in PEPFAR, HIV incidence rates fell by nearly 61 percent in countries with medium/high PEPFAR investment and by 40 percent in countries with no/low PEPFAR investment between 2004 and 2020. In 2021 alone, 18.96 million people received life-saving antiretroviral treatments, 63.4 million people received HIV testing services, 300,000 new health care workers were trained, and 2.8 million babies were born HIV-free due to PEPFAR funding. The authors recognize that PEPFAR’s investments will help a country not only be healthier, but also have a more productive workforce and a stronger economy. The report notes that PEPFAR efforts have also strengthened U.S. diplomatic relationships and improved foreign perceptions of U.S. leadership. The authors conclude by urging Congress and the U.S. to continue reauthorizing PEPFAR to continue addressing the HIV pandemic and to foster more goodwill for the U.S.
- On June 6, 2023, the Kaiser Family Foundation (KFF) published an issue brief entitled, Medicaid Waiver Tracker: Approved and Pending Section 1115 Waivers by State. The authors track approved and pending Section 1115 Medicaid demonstration waivers (Section 1115 Waivers), which allow to test new approaches (e.g., benefit expansions, flexible and expanded eligibility groups, and provisions related to social determinants of health (SDOH)) in Medicaid that differ from what is required by federal statute. Section 1115 Waivers reflect both the state and federal governments’ changing priorities over time. For example, the Biden Administration has granted many waivers that expand access to Medicaid coverage such as by encouraging states to take steps to reduce health disparities and to remove work requirements. This issue brief outlines current waivers that provide Medicaid eligibility changes, benefit changes, and SDOH changes as well as waivers pending approval.
- On June 7, 2023, the Government Accountability Office (GAO) published a report entitled, Public Health: Leading Practices Could Help Guide HHS Reform Efforts to Address Risk and Improve Preparedness. This report discusses GAO’s work in examining HHS’ leadership and coordination of public health emergencies as well as recommendations for successful agency reform. GAO has placed HHS leadership and coordination of public health emergencies on its “High Risk List,” a list of programs and operations that are most vulnerable to waste, fraud, abuse, mismanagement, and in need of reform. Since 2007, GAO has issued several recommendations to address HHS vulnerabilities. Specifically, GAO found that HHS falls short in five key areas of effective national response to public health emergencies: (1) clear roles and responsibilities, (2) complete and consistent data, (3) clear and consistent communication, (4) transparency and accountability, and (5) understanding of key partners’ capabilities and limitations. As such, GAO has made 155 recommendations to HHS to help address these deficiencies since 2007, but as of April 2023, 91 of these recommendations remain unimplemented.
IV. Other Health Policy News
- On June 6, 2023, HHS, through the Substance Abuse and Mental Health Services Administration (SAMHSA), published the National Model Standards for Peer Worker Certification for substance use, mental health, and family peer workers. These national model standards were created to improve and accelerate the adoption, recognition, and integration of the peer workforce across the health care system. SAMHSA collaborated closely with stakeholders and partners to develop these standards and to develop the national certification program. SAMHSA officials recognize the important role peer workers can play in overdose prevention, crisis intervention, and in the promotion of recovery, and established these standards to help address the national mental health crisis by building and officially recognizing this critical part of the workforce. Although these standards will not replace state certifications, SAMHSA noted that the national model can help guide alignment across state peer support certification programs. More information on this publication can be found here.
- On June 7, 2023, Representatives Diana Harshbarger (R-TN-1) and Mikie Sherrill (D-NJ-11) introduced H.R. 3875, the Expanded Telehealth Access Act. Since the end of the COVID-19 public health emergency (PHE) on May 12, 2023, there has been uncertainty over CMS would continue to cover telehealth visits for certain therapy services. CMS initially indicated they would no longer cover telehealth visits for such services, but then reversed course saying they would cover telehealth services provided by physical therapists, occupational therapists, speech language pathologists, and audiologists through 2024. The Expanded Telehealth Access Act would allow the aforementioned therapy providers to offer telehealth services permanently under Medicare Part B. More information on the bill can be found here.
- On June 8, 2023, CMS announced a new primary care model that the Center for Medicare and Medicaid Innovation (CMMI) will test in eight states entitled, the Making Care Primary (MCP) Model. The MCP Model seeks to strengthen the primary care infrastructure in the U.S. by: (1) providing patients access to integrate, coordinated, and person-centered primary care; (2) creating a pathway for primary care organizations to enter into value-based care arrangements; and (3) improving the quality of care and health outcomes of patients while decreasing overall costs. Specially, the 10.5-year-long MCP Model will provide a pathway for primary care providers to gradually adopt prospective, population-based payments to deliver value-based care while building their infrastructure to improve behavioral health and specialty integration. This model will also provide funds for participants to make primary care more accessible and to better coordinate care with specialists. The MCP Model utilizes a flexible multi-payer alignment strategy to ensure more patients have access to the model’s benefits. More information on this announcement can be found here.
- On June 8, 2023, HHS released its STI Federal Implementation Plan to detail how federal agencies are taking a comprehensive approach to addressing the growing threat of sexually transmitted infections (STIs). The rates of STIs have grown significantly in the U.S. between 2020 and 2021, with now more than 2.5 million cases of chlamydia, gonorrhea, and syphilis reported. When left untreated, STIs can lead to long-term and irreversible health issues, such as infertility and cancer. As such, the STI Federal Implementation Plan describes the federal government’s five goals in addressing STIs: (1) prevent new STIs; (2) reduce adverse outcomes of STIs; (3) accelerate progress in STI research, technology, and innovation; (4) reduce STI-related health disparities and inequities; and (5) achieve integrated and coordinated efforts to address the STI epidemic. More information on this announcement can be found here.
- On June 9, 2023, CMS announced the list of 43 prescription drugs for which Part B beneficiary coinsurances may be lower between July 1 and September 30, 2023 as a result of provisions included in the Inflation Reduction Act (IRA) to lower out-of-pocket prescription drug costs. Specifically, the IRA established the Medicare Prescription Drug Inflation Rebate Program to reduce coinsurance for some people with Part B coverage and to discourage drug companies from increasing prices faster than inflation. For drugs whose prices do increase faster than the rate of inflation, the beneficiary coinsurance will be 20 percent of the inflation-adjusted payment amount, which will be less than what the beneficiary would pay in coinsurance otherwise. The lower Part B coinsurance on the 43 listed drugs announced will be in effect from July 1, 2023 to September 30, 2023. More information on this announcement can be found here.
- On June 9, 2023, HHS launched the new Pediatric Specialty Loan Repayment Program. This $15 million loan repayment program aims to support recruitment and retainment of pediatric clinicians. In exchange for three years of service working in a health professional shortage area (HPSA), medically underserved area (MUA), or providing care to a medically underserved population, the Pediatric Specialty Loan Repayment Program provides up to $100,000 to eligible pediatric clinicians. Specifically, the following disciplines are eligible to apply for loan repayment: pediatric medical subspecialty, pediatric surgical specialty, or child and adolescent behavioral health care, including substance use prevention and treatment services. Clinicians must submit applications by July 20, 2023. More information on this announcement can be found here.
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