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, the COVID-19 PHE expired, and DEA issued a final rule that provides a six-month extension of PHE flexibilities that allow the prescription of controlled substances via telemedicine.
I. Regulations, Notices & Guidance
- On May 9, 2023, the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) issued a final rule entitled, Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. On March 1, 2023, DEA and HHS promulgated two notices of proposed rulemakings (NPRMs) soliciting comments on proposals to allow for the prescribing of controlled medications pursuant to the practice of telemedicine in instances where the prescribing practitioner has never conducted an in-person medical evaluation of the patient. Those NPRMs resulted in 38,369 public comments, which are being closely reviewed. DEA, in concert with HHS, is considering revisions to the proposed rules set forth in the NPRMs. In the meantime, and following initial review of the comments received, DEA, jointly with the Substance Abuse and Mental Health Services Administration (SAMHSA), is issuing this temporary rule to extend certain exceptions granted to existing DEA regulations in March 2020 as a result of the COVID-19 public health emergency (COVID-19 PHE), in order to avoid lapses in care for patients. Ultimately, there will be a final set of regulations permitting the practice of telemedicine under circumstances that are consistent with public health, safety, and effective controls against diversion.
- On May 9, 2023, the Food and Drug Administration (FDA) issued final guidance entitled, Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol; Guidance for Industry; Availability. This guidance provides updated recommendations on testing and other activities that will help pharmaceutical manufacturers, re-packers, other suppliers, and compounders prevent the use of high-risk drug components, including glycerin, propylene glycol, maltitol solution, hydrogenated starch hydrolysate, and sorbitol solution, that are contaminated with diethylene glycol (DEG) and ethylene glycol (EG). These and other appropriate measures under current good manufacturing practice (CGMP) are vital to prevent incidents of consumer poisoning.
- On May 10, 2023, FDA issued a notice entitled, Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products; Availability. FDA is announcing the publication of a discussion paper entitled, Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products. To fulfill its mission of protecting, promoting, and advancing public health, FDA’s Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER) and Center for Devices and Radiological Health (CDRH), including the Digital Health Center of Excellence (DHCoE), is issuing this document to facilitate a discussion with stakeholders on the use of artificial intelligence (AI) and machine learning (ML) in drug development to help inform the regulatory landscape in this area.
- On May 10, 2023, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Notice of End to Requirement for Air Passengers to Provide Proof of COVID-19 Vaccination Before Boarding a Flight to the United States. CDC announced that its amended order, Implementing Presidential Proclamation on Safe Resumption of Global Travel During the COVID-19 Pandemic, will no longer be in effect starting on May 12, 2023. Consequently, noncitizen, nonimmigrant air passengers will no longer be required to show proof of being fully vaccinated with an accepted COVID-19 vaccine before boarding a flight to the U.S.
- On May 11, 2023, FDA issued final guidance entitled, Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions To Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry; Availability. The guidance document provides blood establishments that collect blood or blood components, including source plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. FDA is also recommending that these blood establishments make corresponding revisions to donor educational materials, donor history questionnaires and accompanying materials, along with revisions to donor requalification and product management procedures. The guidance announced in this notice finalizes the draft guidance of the same title issued January 2023.
- June 6, 2023: The National Institutes of Health (NIH) announced a public meeting of the National Heart, Lung, and Blood Institute (NHLBI) National Heart, Lung, and Blood Advisory Council (NHLBAC). The meeting agenda will include discussion of NHLBI program policies and issues.
- June 6, 2023: NIH announced a public meeting of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Arthritis and Musculoskeletal and Skin Diseases Advisory Council (NAMSAC). The meeting agenda will include a discussion of NIAMS program policies and issues.
- June 13-14, 2023: The Health Resources and Services Administration (HRSA) announced a public meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). ACIMM advises HHS on department activities, partnerships, policies, and programs directed at reducing infant mortality, maternal mortality and severe maternal morbidity, and improving the health status of infants and women before, during, and after pregnancy. The meeting agenda will include: an update on the recommendations submitted to HHS on improving birth outcomes among American Indian and Alaska Native (AI/AN) mothers and infants; further discussion to determine new and continuing priority areas for the ACIMM, including data and information related to social determinants of health (SDOH) and infant health equity; federal updates; and discussion of ACIMM operations.
- June 16, 2023: FDA announced a public meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (ODAC). The subcommittee will discuss considerations related to dosage optimization of new drug and biological products for pediatric patients with cancer. Representatives from the European Medicines Agency (EMA), the pediatric oncology investigator community, and the pharmaceutical industry have also been invited to present.
- June 21, 2023: NIH announced a public meeting of the National Cancer Institute (NCI) Council of Research Advocates (NCRA). The meeting agenda will include opening remarks, an update from the NCI Director, and an NCI legislative update.
- July 12, 2023: The Agency for Healthcare Research and Quality (AHRQ) announced a public meeting of the National Advisory Council (NAC) for Healthcare Research and Quality. The meeting agenda will include an update from the AHRQ Director, an update on AHRQ’s aging initiatives, and a discussion of consumer experience measurements.
- July 12, 2023: CDC and the Agency for Toxic Substances and Disease Registry (ATSDR) announced a public meeting with AI/AN Federally Recognized Tribes. CDC and ATSDR are hosting this meeting to consult with federally recognized AI/AN tribes to receive input and guidance to inform sexual violence prevention activities and strategies in developing Notices of Funding Opportunity (NOFOs).
II. Hearings & Markups
U.S. House of Representatives
- On May 10, 2023, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Closing the Digital Divide: Overseeing Federal Funds for Broadband Deployment. Witnesses present included: Andrew Von Ah, Director, Physical Infrastructure, Government Accountability Office (GAO); Dr. George Ford, Chief Economist, Phoenix Center for Advanced Legal & Economic Public Policy Studies (the Phoenix Center); and Angela Siefer, Executive Director, National Digital Inclusion Alliance (NDIA).
- On May 10, 2023, the House Committee on Ways and Means Subcommittee on Health held a hearing entitled, Examining Policies that Inhibit Innovation and Patient Access. Witnesses present included: Tony Gonzales, National Early-Stage Advisor, Alzheimer’s Association; Ted Okon, Executive Director, Community Oncology Alliance (COA); Dr. Darius Lakdawalla, Professor of Pharmaceutical Economics and Public Policy, USC Schaffer Center for Health Policy & Economics; Dr. Joshua Makower, Director of the Stanford Byers Center for Biodesign, Stanford University; and Dr. Aaron Kesselheim, Professor of Medicine, Harvard Medical School.
- On May 11, 2023, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Preparing for and Responding to Future Public Health Security Threats. Witnesses present included: The Honorable Dawn O’Connell, Assistant Secretary, Administration for Strategic Preparedness and Response (ASPR); Dr. Rochelle Walensky, Director, CDC; Dr. Robert Califf, Commissioner, FDA; Dr. Tom Inglesby, Director, Johns Hopkins Center for Health Security, Bloomberg School of Public Health; Dr. Randall Lutter, Senior Fellow, Manhattan Institute; Erik Decker, Chair, Cybersecurity Working Group, Health Sector Coordinating Council; and Dr. Mary Denigan-Macauley, Director, Health Care and Public Health & Private Markets, GAO.
- On May 11, 2023, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Examining the Root Causes of Drug Shortages: Challenges in Pharmaceutical Drug Supply Chains. The witnesses present included: Dr. Alex Oshmyansky, CEO/Founder, Mark Cuban Cost Plus Drug Company; Anthony Sardella, Chair, API Innovation Center, Adjunct Lecturer & Senior Research Advisor, Center for Analytics & Business Insights, Washington University in St. Louis; Laura Bray, Founder, Angels for Change; and Dr. Fernando Muzzio, Distinguished Professor of Chemical & Biochemical Engineering, Rutgers University.
- On May 10, 2023, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, The Need to Make Insulin Affordable for All Americans. Witnesses present included: David Ricks, Chair and Chief Executive Officer (CEO), Eli Lilly and Company; Lars Fruergaard Jørgensen, President and CEO, Novo Nordisk; Paul Hudson, CEO, Sanofi; David Joyner, Executive Vice President and President of Pharmacy Services, CVS Health; Adam Kautzner, President, Express Scripts; and Heather Cianfrocco, CEO, OptumRx.
- On May 11, 2023, the Senate Committee on HELP held an executive session entitled, Continuation: S. 1067, S. 1114, S. 1214, and S. 1339. The Committee considered the following bills: S. 1067, the Ensuring Timely Access to Generics Act of 2023; S. 1114, the Expanding Access to Low-Cost Generics Act of 2023; S. 1214, the RARE Act; and S. 1339, the Pharmacy Benefit Manager (PBM) Reform Act.
- On May 11, 2023, the Senate Committee on Finance held a hearing entitled, Cross-border Rx: Pharmaceutical Manufacturers and U.S. International Tax Policy. Witnesses present included: Brad Setser, Senior Fellow, Council on Foreign Relations (CFR); Diane Ring, Professor, Boston College Law School; William Morris, Deputy Global Tax Policy Leader, PricewaterhouseCoopers (PwC); and Daniel Bunn, President and CEO, Tax Foundation.
III. Reports, Studies & Analyses
- On May 8, 2023, the Kaiser Family Foundation (KFF) and the Peterson Center on Healthcare published a report entitled, Prices for COVID-19 testing. The federal requirement that private health plans cover COVID-19 tests ordered or administered by a clinician at no out-of-pocket charge to consumers ended on May 11, 2023. In this report, KFF analyzed prices for COVID-19 tests performed in an outpatient clinical setting and at home. The report found that COVID-19 test prices vary significantly in outpatient clinical settings, with the median price being about $45 in 2021 for people in large employer-based private health plans. The report also assessed self-pay cash prices among hospitals whose hospital price transparency data were aggregated. They found that prices varied state-by-state and were generally cheaper than in-office tests. Overall, KFF highlighted that with the end of the no out-of-pocket cost requirements for private health plans, consumers may see costs of up to $130-150 for office visit COVID-19 tests and will likely not have coverage from their insurers for at-home COVID-19 tests.
- On May 10, 2023, Alston & Bird (A&B) published another episode in its Healthy Byte series entitled, Healthy Byte: DEA Temporary Rule Extends Telemedicine Flexibilities. In the episode, A&B’s Sean Sullivan, Anthony Fanucci, and Sofia Molodanof discuss DEA’s recent temporary rule to allow the prescription of controlled substances via telehealth while it reviews and considers nearly 38,000 public comments on its previously proposed rules. The rule will extend the waiver that allows the prescription of controlled substances via telemedicine for six months (through November 11, 2023), and allows providers and patients that establish relationships prior to November 11 to continue that prescribing relationship for a year in addition to the six-month extension. DEA, in coordination with SAMHSA, issued these extensions in order to avoid lapses in care for patients following the end of the COVID-19 PHE.
- On May 11, 2023, GAO published a report entitled, 340B Drug Discount Program: Information about Hospitals That Received an Eligibility Exception as a Result of COVID-19. The report covers a variety of topics related to hospitals that requested a 340B Drug Pricing Program (340B Program) disproportionate share hospital (DSH) percentage eligibility exception from HRSA as of May 31, 2022, and that were subsequently approved. The topics explored include: (1) HRSA’s administration of the 340B DSH percentage eligibility exception process; (2) characteristics of excepted hospitals; (3) the amount of 340B drug purchases and discounts that excepted hospitals indicated they had in 2020 and 2021; (4) the extent to which excepted hospitals indicated they provided discounts on 340B drugs to low-income, uninsured patients in 2022; and (5) results of HRSA’s previous audits and other oversight activities to assess 340B Program compliance by excepted hospitals. GAO found that of the 53 hospitals that had their exception request approved, 35 were located in rural areas and 31 had fewer than 100 beds. The report also found that excepted hospitals had varying explanations for why they requested an exception for the DSH percentage requirement, with many highlighting the impact of COVID-19 their operations.
- On May 11, 2023, GAO published a report entitled, Public Health Preparedness: Critical Need to Address Deficiencies in HHS's Leadership and Coordination of Emergencies. GAO assessed HHS’ ability to lead and coordinate the nation’s preparedness for, and response to, PHEs. GAO concluded that HHS fell short in the following five areas: (1) establishing clear roles and responsibilities; (2) collecting and analyzing complete and consistent data; (3) providing clear and consistent communication; (4) establishing transparency and accountability; and (5) understanding key partners’ capabilities and limitations. Specifically, GAO found that HHS has not developed an interoperable network of systems for near real-time public health situational awareness, which has been required in statute since 2006. Further, GAO concluded that HHS has not been transparent when relaying information to the public during an emergency, specifically citing the Department’s failure to explain the scientific reasoning for changes to the COVID-19 testing guidelines. Overall, GAO made 155 recommendations to HHS in regard to improving its leadership and coordination of PHE preparedness and response efforts.
- On May 12, 2023, the Congressional Budget Office (CBO) issued a report entitled, An Update to the Budget Outlook: 2023 to 2033. This report is an update to budget projections released by CBO in February 2023. CBO’s current projections show a federal budget deficit of $1.5 trillion for 2023—which is $0.1 trillion more than what was estimated in February. CBO warned that the updated projection for this year is still uncertain, noting that lower than anticipated revenue collections in April could impact total federal revenues for 2023. Additionally, in CBO’s updated 10-year projections, annual deficits nearly double over the next decade, reaching $2.7 trillion in 2033. The projected cumulative deficit over the 2024–2033 period, $20.2 trillion, is about the same as the shortfall CBO projected in February. When measured in relation to the size of the U.S. economy, deficits grow from 6 percent of gross domestic product (GDP) in 2024 to 6.9 percent in 2033. Based on its projections, CBO concluded that in 2033, debt measured as a share of GDP would reach the highest level ever recorded in the U.S., and would be on track to rise even further afterwards.
IV. Other Health Policy News
- On May 9, 2023, the U.S. Preventive Services Task Force (USPSTF) issued a draft recommendation on breast cancer screening. USPSTF is now recommending that all women get screened for breast cancer every other year starting at age 40. This represents a change from standing USPSTF guidance, which recommended women receive breast cancer screening starting at age 50 and encouraged women over 40 to make a personal decision based on health history whether to screen or not. The new recommendation is aimed at women with an average risk for breast cancer, as well as women with a family history of breast cancer and those with other risk factors, such as having dense breasts. USPSTF estimates that lowering the recommended screening age to 40 could result in 19 percent more lives being saved. Additionally, USPSTF highlighted that Black women are 40 percent more likely to die from breast cancer than White women and is calling for additional research to be conducted into the underlying causes of racial and ethnic disparities in breast cancer incidence and ways to eliminate the existing inequity. More information on this action can be found here.
- May 11, 2023 marked the expiration of the COVID-19 PHE, which was officially declared on January 31, 2020. To coincide with the end of the PHE, HHS released a fact sheet detailing which pandemic-era policies will and will not change with the end of the PHE. For example, HHS clarified that access to COVID-19 vaccinations and treatments will largely remain the same, with most insurance plans continuing to offer coverage to their beneficiaries and the newly-established HHS Bridge Access Program For COVID-19 Vaccines and Treatments maintaining access for uninsured Americans. Additionally, HHS noted that the FDA’s Emergency Use Authorizations (EUAs) for COVID-19 products will not be impacted, nor will any major telehealth provisions that were extended by the Consolidated Appropriations Act, 2023 (CAA, 2023). HHS also highlighted the policies that will change and end with the PHE, including a number of Medicare and Medicaid waivers and flexibilities originally designed to help expand health care facility capacity. Further, HHS detailed how CDC’s data reporting and surveillance operations will be scaled back due to expiring authorities. Finally, HHS added that FDA’s ability to detect shortages of critical devices related to COVID-19 will be more limited once the PHE expires. More information on this action can be found here.
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