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 Drug Enforcement Agency (DEA) issued two proposed rules that would establish post-pandemic requirements for the prescription of controlled substances via telemedicine. Read about this action and other news below.
I. Regulations, Notices & Guidance
- On February 27, 2023, the Drug Enforcement Administration (DEA) issued a proposed rule entitled, Expansion of Induction of Buprenorphine Via Telemedicine Encounter. DEA is proposing to amend its regulations, in concert with the Department of Health and Human Services (HHS), to expand the circumstances under which individual practitioners are authorized to prescribe schedule III-V narcotic drugs, or combinations of such drugs, that have been approved for use in continuous medical treatment (also referred to as maintenance) or withdrawal management treatment (also referred to as detoxification)—via a telemedicine encounter, including an audio-only telemedicine encounter.
- On February 27, 2023, DEA issued a proposed rule entitled, Telemedicine Prescribing of Controlled Substances when the Practitioner and the Patient have not had a Prior In-person Medical Evaluation. Under the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 (Ryan Haight Act) and DEA’s implementing regulations, after a patient and a practitioner have had an in-person medical evaluation, that practitioner may use telehealth to prescribe that patient any prescription for a controlled medication that the practitioner deems medically necessary. The Ryan Haight Act and DEA’s existing implementing regulations do not apply to other forms of telemedicine, telehealth, or telepsychiatry that are not otherwise addressed in the Controlled Substances Act (CSA). This proposed rule applies only in limited circumstances to allow a prescribing practitioner to prescribe controlled medications via telemedicine when that practitioner has not otherwise conducted an in-person medical evaluation prior to the issuance of the prescription.
- On February 28, 2023, the Food and Drug Administration (FDA) issued final guidance entitled, Q13 Continuous Manufacturing of Drug Substances and Drug Products; International Council for Harmonisation; Guidance for Industry; Availability. The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The guidance provides clarification on continuous manufacturing (CM) concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products. The guidance is intended to provide scientific and regulatory considerations for the development, implementation, operation, and life-cycle management of CM.
- On February 28, 2023, FDA issued a request for information (RFI) entitled, Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments. FDA announced the publication of a discussion paper providing information for stakeholders and soliciting public comments on a specific area of emerging and advanced manufacturing technologies. The discussion paper presents areas for consideration and policy development identified by the Center for Drug Evaluation and Research (CDER) scientific and policy experts associated with application of artificial intelligence (AI) to pharmaceutical manufacturing. The discussion paper includes a series of questions to stimulate feedback from the public, including from CDER and the Center for Biologics Evaluation and Research (CBER) stakeholders.
- On February 28, 2023, FDA issued a notice entitled, Request for Nominations for Individuals and Consumer Organizations for Advisory Committees. FDA is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to exist in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. This notice includes a table of advisory committees with vacancies and descriptions of each advisory committee. Nominations will be accepted for current vacancies and for those that will or may occur through December 31, 2023.
- On February 28, 2023, FDA issued a notice entitled, Request for Nominations for Voting Members for the Patient Engagement Advisory Committee. FDA is requesting nominations for voting members, excluding consumer and industry representatives, to serve on the Patient Engagement Advisory Committee (the Committee) in the Center for Devices and Radiological Health (CDRH). The Committee provides advice on complex scientific issues related to medical devices, the regulation of devices, and their use by patients. The Committee may consider topics related to FDA guidance and policies, clinical trial or registry design, patient preference study design, benefit-risk determinations, device labeling, unmet clinical needs, available alternatives, patient-reported outcomes, device-related quality of life measure, or health status issues.
- On March 1, 2023, FDA issued draft guidance entitled, Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens; Draft Guidance for Industry; Availability. The purpose of this draft guidance is to provide to sponsors recommendations that assist in the development of monoclonal antibodies (mAbs) and other therapeutic proteins that directly target viral proteins or host cell proteins mediating pathogenic mechanisms of infection. A critical quality control measure for these products is the development and implementation of a potency assay(s) adequate to ensure that each lot is produced consistently with the potency necessary to achieve clinical efficacy and that such potency is maintained over the shelf life of the product. This draft guidance provides detailed recommendations to drug developers with the goal of helping to ensure that drug developers provide adequate information to assess potency at each stage of a product’s life cycle.
- On March 2, 2023, the Centers for Disease Control and Prevention (CDC) issued a final rule entitled, Possession, Use, and Transfer of Select Agents and Toxins – Addition of SARS-CoV/SARS-CoV-2 Chimeric Viruses Resulting from Any Deliberate Manipulation of SARS-CoV-2 to Incorporate Nucleic Acids Coding for SARS-CoV Virulence Factors to the HHS List of Select Agents and Toxins. CDC has amended the select agents and toxins regulations to add SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins. With this final rule, regulated entities are required to obtain prior approval from CDC to conduct deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors because these chimeric viruses have the potential to pose a severe threat to public health and safety.
- On March 3, 2023, the Health Resources and Services Administration (HRSA) issued a notice entitled, Solicitation of Nominations for Membership to serve on the Advisory Committee on Training in Primary Care Medicine and Dentistry. HRSA is seeking nominations of qualified candidates to consider for appointment as members of the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD). The ACTPCMD develops, publishes, and implements performance measures, develops and publishes guidelines for longitudinal evaluations, and recommends appropriation levels for programs under Part C of Title VII of the Public Health Service (PHS) Act. The ACTPCMD currently focuses on the following primary care professions and disciplines: Family Medicine, General Internal Medicine, General Pediatrics, Physician Assistants, General Dentistry, Pediatric Dentistry, Public Health Dentistry, and Dental Hygiene.
- March 22-23, 2023: HHS announced a public meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). The meeting will begin with an overview of the recently published Government Accountability Office (GAO) report #GAO-23-104721, Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness, followed by a panel of expert speakers who will discuss how to define stakeholders and evaluate institutional review board (IRB) quality and effectiveness.
- March 29-30: 2023: HHS announced a public meeting of the Presidential Advisory Council on HIV/AIDS (PACHA or the Council). The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective HIV diagnosis, treatment, prevention, and quality care services. The meeting agenda will include discussion of PACHA business.
- March 30, 2023: CDC announced a public meeting of the Board of Scientific Counselors, Center for Preparedness and Response (BSC, CPR). The agenda will include: (1) an organizational update; (2) an Office of Policy, Planning, and Evaluation update; (3) a CDC Ready Responder update; (4) health equity updates; (5) a data modernization update; and (6) liaison representative updates.
- April 4, 2023: The National Institutes of Health (NIH) announced a public meeting of the Interagency Autism Coordinating Committee (IACC). The meeting agenda will include discussion of IACC business, IACC updates, and issues related to autism spectrum disorder (ASD) research and services activities.
- April 12, 2023: NIH announced a public meeting of the Advisory Committee on Research on Women's Health (ACRWH). The meeting agenda will include a report from the Director of the NIH Office of Research on Women’s Health (ORWH), a presentation from the Director of the National Center for Advancing Translational Sciences (NCATS), a presentation on NIH inclusion data, and a presentation on the fiscal year (FY) 2024 – 2028 NIH-wide Strategic Plan on Research on the Health of Women.
- April 19-20, 2023: CDC announced a public meeting of the Community Preventive Services Task Force (CPSTF). The CPSTF was convened in 1996 by HHS to identify community preventive programs, services, and policies that increase health, longevity, save lives and dollars, and improve Americans’ quality of life. Topics for the April 2023 meeting will include mental health, substance use, preparedness and response, cancer, and oral health.
- April 20, 2023: The Centers for Medicare & Medicaid Services (CMS) announced a public meeting of the Advisory Panel on Outreach and Education (APOE). APOE advises and makes recommendations to HHS and CMS on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). The meeting agenda will include a recap of the previous APOE meeting; presentations on various CMS programs, initiatives, and priorities; and a discussion of APOE recommendations.
- April 26, 2023: FDA announced a public meeting of the Blood Products Advisory Committee (BPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues related to blood and products derived from blood. In this meeting, BPAC will meet in open session to hear an overview of the research programs in the Division of Hemostasis, the Office of Plasma Protein Therapeutics Chemistry, Manufacturing, and Controls, the Office of Therapeutic Products (OTP), and CBER.
- April 28, 2023: FDA announced a public meeting of the Oncologic Drugs Advisory Committee (ODAC). The committee will discuss supplemental new drug application (sNDA) 208558/S-025, for LYNPARZA (olaparib) tablets, submitted by AstraZeneca Pharmaceuticals LP. The proposed indication (use) for this product is in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).
- April 28, 2023: CDC and HRSA announced a public meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHAC). The agenda will include discussions on: (1) sexual health; (2) equitable scale-up of interventions; (3) mpox; and (4) youth and sexually-transmitted disease (STD) testing.
II. Hearings & Markups
U.S. House of Representatives
- On February 28, 2023, the House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a roundtable entitled, Preparing For the Future By Learning From the Past: Examining COVID Policy Decisions. Witnesses present included: Dr. Jay Bhattacharya, Professor of Medicine, Stanford University; Dr. Martin Kulldorff, Professor of Medicine (on leave), Harvard University; and Dr. Marty Makary, Chief, Islet Transplant Surgery & Professor of Surgery, Johns Hopkins University.
- On March 1, 2023, the House Committee on Energy and Commerce Subcommittee on Innovation, Data, And Commerce held a hearing entitled, Promoting U.S. Innovation and Individual Liberty through a National Standard for Data Privacy. Witnesses present included: Alexandra Reeve Givens, President and Chief Executive Officer (CEO), Center for Democracy & Technology; Graham Mudd, Founder and Chief Product Officer (CPO), Anonym; and Jessica Rich, Of Counsel and Senior Policy Advisor for Consumer Protection, Kelley Drye & Warren, LLP.
- On March 1, 2023, the House Committee on the Judiciary Subcommittee on Crime and Federal Government Surveillance held a hearing entitled, The Fentanyl Crisis in America: Inaction is No Longer an Option. Witnesses present included: Derek Maltz, Special Agent in Charge, DEA’s Special Operations Division, Retired; Erin Rachwal, Founder, Love, Logan Foundation; Dr. Timothy Westlake, Emergency Physician; and Dr. Jeffrey A. Singer, Senior Fellow in Health Policy Studies, CATO Institute.
- On March 2, 2023, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held a hearing entitled, Community Health Centers: Saving Lives, Saving Money. Witnesses present included: Amanda Pears Kelly, CEO, Advocates for Community Health, Executive Director, Association of Clinicians for the Underserved; Ben Harvey, CEO, Indiana Primary Health Care Association; Dr. Robert Nocon, Assistant Professor, Kaiser Permanente Bernard J. Tyson School of Medicine; Sue Veer, President and CEO, Carolina Health Centers; and Jessica Farb, Managing Director, Government Accountability Office (GAO).
III. Reports, Studies & Analyses
- On March 1, 2023, the HHS Office of the Inspector General (OIG) published a report entitled, Medicare Could Have Saved up to $216 Million Over 5 Years if Program Safeguards Had Prevented At-Risk Payments for Definitive Drug Testing Services. OIG’s objective was to identify Medicare Part B payments for definitive drug testing services that were at risk for noncompliance with Medicare requirements. OIG found that during the five-year audit period, Medicare paid $704.2 million for definitive drug testing services, primarily with the highest reimbursement amount (procedure code G0483), that was at risk for noncompliance with Medicare requirements. These payments were made to 1,062 at-risk providers that routinely billed this procedure code and may not have been reasonable and necessary. OIG concluded that these at-risk providers may have been able to bill for definitive drug testing services using procedure codes with lower reimbursement amounts, as the other providers were found to have done. OIG also found that if CMS’ programmatic safeguards had focused on at-risk payments to at-risk providers for procedure code G0483, Medicare could have saved up to $215.8 million over the five-year audit period. OIG recommended that CMS: (1) expand program safeguards to prevent and detect at-risk payments to at-risk providers for procedure code G0483; (2) review at-risk payments made to at-risk providers during and after the audit period and recover any overpayments; (3) notify appropriate providers to exercise reasonable diligence to identify, report, and return any overpayments; and (4) educate providers that received payments that did not comply with Medicare requirements.
- On March 2, 2023, HHS OIG published an issue brief entitled, The Inability To Identify Denied Claims in Medicare Advantage Hinders Fraud Oversight. OIG evaluated Medicare Advantage (MA) encounter data and examined whether the lack of an indicator to identify payment denials in the data hinders CMS’ efforts to combat fraud, waste, and abuse. Currently, CMS does not require MA plans to include an indicator that identifies denied claims in their MA encounter data. Instead, MA plans must submit claim adjustment reason codes to CMS in instances when the MA plan does not pay the actual amount billed by the provider. OIG found that adjustment codes are not a definitive method for identifying denied claims in the MA encounter data. Through interviews with CMS program integrity staff; OIG investigators and analysts; and DOJ health care fraud staff, OIG heard feedback that a denied-claim indicator in the MA encounter data would improve the efficiency, scope, and accuracy of their efforts to combat fraud, waste, and abuse. OIG recommended that CMS require MA plans to definitively indicate on MA encounter data records when they have denied payment for a service on a claim.
- On March 2, 2023, GAO published testimony entitled, Health Centers: Trends in Revenue and Grants Supported by the Community Health Center Fund. The testimony was prepared for the Senate HELP Committee hearing entitled, Community Health Centers: Saving Lives, Saving Money. In order to provide services, community health centers (CHCs) rely on multiple different revenue sources, including funding through HRSA’s Community Health Center Fund (CHCF). GAO examined trends in revenue and grants supported by the CHCF and found that CHCs’ revenue more than doubled from calendar years (CY) 2010 through 2017, from about $12.7 billion to $26.3 billion. Over the same time period, the number of CHCs increased from 1,124 centers in 2010 to 1,373 centers in 2017. Revenue from federal and state grants decreased from 38.0 percent of total revenue in 2010 to about 30.2 percent of total revenue in 2017, while reimbursements from Medicaid, Medicare, and private insurance increased. GAO concluded that the Agency will examine trends in CHC funding since its last review, particularly focusing on how additional funding provided in response to the COVID-19 pandemic has been used.
- On March 2, 2023, the Kaiser Family Foundation (KFF) published a report entitled, Medicaid Enrollment Growth: Estimates by State and Eligibility Group Show Who may be at Risk as Continuous Enrollment Ends. The Consolidated Appropriations Act, 2023 (CAA, 2023) included a provision that set an end to the Medicaid continuous enrollment provision on March 31, 2023, and phased down the enhanced federal Medicaid matching funds (i.e., Federal Medical Assistance Percentages or FMAP) through December 2023. The Families First Coronavirus Response Act (FFCRA) required states to keep individuals enrolled in Medicaid in return for increased funding, which has led to substantial growth in Medicaid and CHIP enrollment. It is estimated that millions of people could lose coverage once the continuous enrollment provision ends. KFF conducted its analysis to assess the overall number and composition of enrollees who may lose their Medicaid/CHIP coverage loss when the continuous enrollment provision ends. KFF estimated that Medicaid and CHIP enrollment will reach nearly 95 million in March 2023, with enrollment growth since February 2020 accounting for one in four enrollees. Further, the report indicated that the groups that experienced the most growth due to the continuous enrollment provision—Affordable Care Act (ACA) expansion adults, other adults, and children—will experience the largest enrollment declines. KFF concluded by suggesting that states implement policies that smooth the transition out of Medicaid coverage and into alternate plan options.
IV. Other Health Policy News
- On February 27, 2023, CMS released a fact sheet detailing the Agency’s COVID-19 public health emergency (PHE) waivers and flexibilities, specifically focusing on the transition following the expected end of the PHE on May 11, 2023. The fact sheet discusses end-of-PHE scenarios for the following: (1) COVID-19 vaccines, testing, and treatments; (2) telehealth services; (3) health care access, including continuing flexibilities for health care providers; and (4) inpatient hospital-at-home care. CMS noted that Medicare beneficiaries will continue to have access to COVID-19 vaccinations after the end of the PHE without cost-sharing. The Agency also stated that most individuals in private plans will maintain access to COVID-19 vaccines with no cost-sharing. They added that while individuals enrolled in Medicaid and CHIP will have coverage of COVID-19 vaccines with no cost-sharing until September 30, 2024, coverage afterwards may vary by state. The fact sheet further provided an overview of some of the provisions in CAA, 2023 which extended the Acute Hospital Care at Home program, and many telehealth flexibilities, through December 31, 2024. The fact sheet also included information on nursing aide training emergency waivers, which were implemented to address staffing shortages, but will be ended at the expiration of the PHE. More information on this fact sheet can be found here.
- On February 27, 2023, HHS announced a new Enforcement Division, Policy Division, and Strategic Planning Division within its Office for Civil Rights (OCR). OCR: (1) enforces 55 civil rights, conscience and privacy statutes, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009; (2) investigates complaints; (3) conducts compliance reviews; (4) develops policy, promulgates regulations; (5) provides technical assistance; and (6) educates the public about federal civil rights, privacy, and conscience laws. OCR will also rename the Health Information Privacy Division (HIP) to the Health Information Privacy, Data, and Cybersecurity Division (HIPDC) to be more reflective of its work and role in cybersecurity. The Enforcement Division, Policy Division, and Strategic Planning Division have been established with the goal of providing a more integrated operational structure for civil rights, conscience protections and privacy protections, as well as cybersecurity protections. More information about this announcement can be found here.
- On March 2, 2023, HELP Committee Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy (R-LA) released a request for information (RFI) seeking public input on ways to address the country’s health care workforce shortage. The RFI is the byproduct of a February 16th hearing entitled, Examining Health Care Workforce Shortages: Where Do We Go From Here? The hearing examined the current and anticipated workforce shortages among health care personnel and addressed potential ways to mitigate the shortages. Members on both sides of the aisle focused on how to increase educational opportunities and supports for health care professionals, how to improve access to care in rural and underserved areas, how to improve diversity in the workforce to advance health equity, and how to alleviate provider burnout. Both Chair Sanders and Ranking Member Cassidy have indicated that they will work together to introduce bipartisan legislation designed to address the health care workforce shortage. Responses to the RFI are due by March 20, 2023. More information on the RFI can be found here.
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