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 House of Representatives passed legislation that aims to modernize the Medicare Advantage (MA) program’s prior authorization process and President Biden issued an Executive Order on advancing biotechnology and biomanufacturing innovation. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On September 12, 2022, the Food and Drug Administration (FDA) issued final guidance entitled, Policy for Monkeypox Tests To Address the Public Health Emergency; Guidance for Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff; Availability. This guidance describes FDA’s review priorities of Emergency Use Authorization (EUA) requests for monkeypox diagnostic tests, describes FDA’s enforcement policies for certain diagnostic tests that are developed by and performed in a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) that meets the requirements to perform tests of high complexity, describes FDA’s enforcement policies for FDA-cleared or authorized monkeypox diagnostic tests that are modified, describes FDA’s enforcement policies for certain serology tests, and provides recommendations for diagnostic test validation.
- On September 12, 2022, FDA issued draft guidance entitled, Computer Software Assurance for Production and Quality System Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. FDA is issuing this draft guidance to provide recommendations on computer software assurance for computers and automated data processing systems used as part of medical device production or the quality system. FDA believes that these recommendations will help foster the adoption and use of innovative technologies that promote patient access to high-quality medical devices and help manufacturers to keep pace with the dynamic, rapidly changing technology landscape, while promoting compliance with laws and regulations implemented by FDA.
- On September 12, 2022, FDA issued a final rule entitled, Public Information. This rule amends FDA’s public information regulations. The final rule revises the current regulations to incorporate changes made to the Freedom of Information Act (FOIA) by the Openness Promotes Effectiveness in our National Government Act of 2007 (OPEN Government Act) and the FOIA Improvement Act of 2016 (FOIA Improvement Act). Additionally, the final rule updates the current regulations to reflect changes to the organizational structure of FDA, to make the FOIA process easier for the public to navigate, and to make provisions clearer.
- On September 13, 2022, the Department of Health and Human Services (HHS) issued a notice entitled, OWH Observance Champions. HHS’ Office on Women's Health (OWH) invites public and private sector organizations to apply to become a Women’s Health Champion during National Women’s Blood Pressure Awareness Week (NWBPAW), National Eating Disorder Awareness Week (NEDAW), National Women and Girls’ HIV/AIDS Awareness Day (NWGHAAD), National Women’s Health Week (NWHW), and/or other OWH observances. Letters of interest from stakeholders will be accepted starting September 15, 2022, and will be reviewed periodically.
- On September 13, 2022, FDA issued a final rule entitled, Annual Summary Reporting Requirements Under the Right to Try Act. FDA is issuing this final rule to specify the deadline and content for submission of an annual summary of investigational drugs supplied under the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Right to Try Act) and the uses for which the investigational drugs were supplied. This final rule implements a provision in the Right to Try Act that requires sponsors and manufacturers who provide an “eligible investigational drug” under the provisions of the Right to Try Act to submit to FDA an annual summary of such use and directs FDA to specify by regulation the deadline of submission.
- On September 14, 2022, FDA issued final guidance entitled, Q3D(R2)--Guideline for Elemental Impurities; International Council for Harmonisation; Guidance for Industry; Availability. This guidance revises the guidance for industry Q3D(R1) Elemental Impurities issued in March 2020 to provide Permissible Daily Exposures (PDEs) for the cutaneous and transcutaneous routes of administration. It also provides relevant risk assessment considerations to supplement previous guidance for the oral, parenteral, and inhalation routes of administration. This guidance is intended to provide recommendations for acceptable amounts of the listed elemental impurities for pharmaceutical products and for conducting risk assessments.
- On September 14, 2022, HHS, the Department of Personnel Management (OPM), the Department of Labor (DOL), and the Department of the Treasury issued a request for information (RFI) entitled, Request for Information; Advanced Explanation of Benefits and Good Faith Estimate for Covered Individuals. The RFI aims to inform the Departments rulemaking for advanced explanation of benefits (AEOB) and good faith estimate (GFE) requirements of the No Surprises Act, which was enacted as part of the Consolidated Appropriations Act, 2021 (CAA). This RFI seeks information and recommendations on transferring data from providers and facilities to plans, issuers, and carriers; other policy approaches; and the economic impacts of implementing these requirements. Comments close on November 15, 2022.
- On September 15, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued an RFI entitled, Request for Information on Person-Centered Care Planning for Multiple Chronic Conditions (MCC). AHRQ seeks public comment about comprehensive, longitudinal, person-centered care planning for individuals with Multiple Chronic Conditions (MCC). Specifically, the RFI seeks comment on the current state of comprehensive, longitudinal, person-centered care planning for individuals at risk for or living with MCC across settings of care (e.g., health systems, primary care, home, and other ambulatory practices), including existing models of person-centered care planning, their current scale, and barriers and facilitators to implementation. In addition, the RFI seeks comments about innovative models of care, approaches, promising strategies, and solutions in order for clinicians and practices to routinely engage in comprehensive, longitudinal, person-centered care planning to improve the care of people at risk for or living with MCC. This RFI will inform AHRQ’s work in improving care for people at risk for or living with MCC. Comments must be received by November 15, 2022.
- On September 16, 2022, FDA issued a notice entitled, Request for Applications for New Members of the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative. FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is requesting applications from patient advocates interested in participating in the Patient Engagement Collaborative (PEC). Through the PEC, the patient community and regulators are able to discuss an array of topics regarding increasing meaningful patient engagement with diverse populations in medical product development and regulatory discussions at FDA. The activities of the PEC may include, but are not limited to, providing diverse perspectives on topics such as systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patient and patient advocate perspectives are incorporated into general medical product development and regulatory processes.
- September 21, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Science Advisory Board for Biosecurity (NSABB). The meeting agenda will include a progress update from the NSABB Working Group to review and evaluate the Potential Pandemic Pathogen Care and Oversight (PC3O) Policy, and stakeholder engagement on topics related to the U.S. policies for the Oversight of Dual Use Research of Concern (DURC).
- September 22-23, 2022: HHS announced a public meeting of the National Vaccine Advisory Committee (NVAC). NVAC will hear presentations on COVID-19, monkeypox, influenza, and polio vaccination, as well as vaccine safety, innovation, and gaps in rural vaccination coverage.
- September 28, 2022: NIH announced a public meeting of the National Cancer Institute (NCI) Council of Research Advocates. The meeting agenda will include opening remarks, a report from the NCI acting director, NCI updates, and a legislative update.
- September 28, 2022: HHS announced a virtual listening session of the HHS OWH that will focus on the impact that COVID-19 has had on intimate partner violence (IPV). The purpose of the listening session is to exchange information about this topic and to seek input from stakeholders and subject matter experts on an individual basis.
- October 19, 2022: The Centers for Disease Control and Prevention (CDC) announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on influenza vaccines, the pneumococcal vaccine, meningococcal vaccines, the respiratory syncytial virus vaccine, the rotavirus vaccine, dengue vaccines, adult immunization schedules, child/adolescent immunization schedules, COVID-19 vaccines, and the Chikungunya vaccine. Recommendation votes on the pneumococcal vaccine, adult immunization schedules, child/adolescent immunization schedules, and COVID -19 vaccines are scheduled. A Vaccines for Children (VFC) vote on COVID-19 vaccine is scheduled.
- October 19, 2022: HHS announced a public summit hosted by HHS OWH. The Hypertension Summit will be focused on innovations and evidence to bridge practice gaps in the field of hypertension treatment and prevention.
- October 21, 2022: NIH announced a public meeting of the Clinical Center (CC) Research Hospital Board. The meeting agenda will include announcements from leadership, an update from the CC CEO on activities and organization priorities, and a status report on key CC Strategic Plan initiatives.
- October 25, 2022: HHS announced a public meeting of the Tick-Borne Disease Working Group (TBDWG). The TBDWG will review and vote upon the third and final Report to Congress and the HHS Secretary. The 2022 report will address a wide range of topics related to tick-borne diseases, such as, surveillance, prevention, diagnosis, diagnostics, and treatment; identify advances made in research, as well as overlap and gaps in tick-borne disease research; and provide recommendations regarding any appropriate changes or improvements to such activities and research.
- November 1, 2022: FDA announced a public meeting of the Anesthesiology and Respiratory Therapy Devices Panel (ARTDP) of the Medical Devices Advisory Committee (MDAC). The meeting agenda will include discussion of ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations. The committee will also discuss factors that may affect pulse oximeter accuracy and performance, the available evidence about the accuracy of pulse oximeters, recommendations for patients and healthcare providers, and the amount and type of data that should be provided by manufacturers to assess pulse oximeter accuracy and to guide other regulatory actions as needed.
- November 16, 2022: FDA announced a public meeting of the Cardiovascular and Renal Drugs Advisory Committee. The committee will discuss new drug application 213931, for tenapanor hydrochloride tablets, submitted by Ardelyx, Inc., for the control of serum phosphorus levels in adults with chronic kidney disease on dialysis. The committee will be asked to comment on whether the size of the treatment effect on serum phosphorus is clinically meaningful and whether tenapanor’s benefits outweigh its risks.
- November 18, 2022: FDA announced a joint public meeting of the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive and Urologic Drugs Advisory Committee. The meeting agenda will include a discussion of the supplemental new drug application 017031/S-041 for OPILL (norgestrel) Tablet, 0.075 mg, submitted by Laboratoire HRA Pharma. OPILL is proposed for nonprescription use as a once-daily oral contraceptive to prevent pregnancy.
- December 7, 2022: HHS announced a public meeting of the TBDWG. The meeting agenda will include a review of the progress of the TBDWG and further discussion of Working Group activities.
II. Congressional Hearings
U.S. House of Representatives
- On September 14, 2022, the House Committee on Energy and Commerce Subcommittee on Health held a markup of five health-related bills. The bills under consideration included: R. 3173, theImproving Seniors' Timely Access to Care Act of 2021; H.R. 3655, the Vaccine Injury Compensation Modernization Act of 2021; H.R. 5141, the Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act; H.R. 8163, the Improving Trauma Systems and Emergency Care Act; and H.R. 6737, the Flint Registry Reauthorization Act.
- On September 15, 2022, the House Committee on Science, Space, & Technology Subcommittee on Investigations and Oversight held a hearing entitled, The Fountain of Youth? The Quest for Aging Therapies. Witnesses present included: Dr. Jay Olshansky, Professor of Public Health, University of Illinois at Chicago; Dr. Laura Niedernhofer, Director, Institute on the Biology of Aging and Metabolism; Medical Discovery Team on the Biology of Aging; and Dr. Steve Horvath, Principal Investigator, Altos Labs.
- On September 15, 2022, the House Committee on Ways and Means held a hearing entitled, Preparing America’s Health Care Infrastructure for the Climate Crisis. Witnesses present included: Dr. Jodi Sherman, Founding Director of the Yale Program on Healthcare Environmental Sustainability, Yale Center on Climate Change and Health; Dr. Paul Biddinger, Chief Preparedness and Continuity Officer, Mass General Brigham and Director of the Center for Disaster Medicine at Mass General; Dr. Parinda Khatri, Chief Executive Officer, Cherokee Health Systems; Dr. Elizabeth Schenk, Executive Director of Environmental Stewardship for Providence; and Rich Powell, Chief Executive Officer, ClearPath Inc.
- On September 14, 2022, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing entitled, Stopping the Spread of Monkeypox: Examining the Federal Response. Witnesses present included: Dr. Rochelle Walensky, Director, CDC; Dr. Anthony Fauci, National Institute of Allergy and Infectious Diseases (NIAID), NIH; Dr. Robert Califf, Commissioner, FDA; and Dawn O’Connell, Assistant Secretary for Preparedness and Response, Administration for Strategic Preparedness and Response (ASPR).
- On September 14, 2022, the Senate Committee on the Judiciary Subcommittee on Immigration, Citizenship, and Border Safety held a hearing entitled, Flatlining Care: Why Immigrants Are Crucial to Bolstering Our Health Care Workforce. Witnesses present included: Sarah Peterson, Principal Attorney, SPS Immigration PLLC; Dr. Ram Sanjeev Alur, Hospitalist Physician, Marion Veterans Affairs Medical Center; and Urbino Martinez, Brooks County Sheriff.
III. Reports, Studies & Analyses
- On September 14, 2022, the Government Accountability Office (GAO) published a report entitled, COVID-19 in Nursing Homes: CMS Needs to Continue to Strengthen Oversight of Infection Prevention and Control. This report (1) describes what data reveal about any changes in resident health before and during the pandemic and (2) examines infection prevention and control actions the Centers for Medicare & Medicaid Services (CMS) and CDC have taken in nursing homes before and during the pandemic. GAO’s analysis of CMS data reported by nursing homes shows that seven of the eight key indicators of nursing home resident mental and physical health decreased in the first year of the pandemic (2020), compared to the years prior to the pandemic.
- On September 15, 2022, the HHS Office of the Inspector General (OIG) published a report entitled, Opioid Overdoses and the Limited Treatment of Opioid Use Disorder Continue To Be Concerns for Medicare Beneficiaries. OIG issued this report to monitor trends in opioid use and access to treatment for beneficiaries with opioid use disorder as well as access to the opioid overdose-reversal drug naloxone. OIG found that about 50,400 Part D beneficiaries experienced an opioid overdose— from prescription opioids, illicit opioids, or both—during 2021. Additionally, OIG found that the number of Medicare Part D beneficiaries who received opioids in 2021 decreased to almost a quarter of beneficiaries, which continued a downward trend of beneficiaries receiving opioids from prior years. OIG found that over 1 million Medicare beneficiaries had a diagnosis of opioid use disorder in 2021, but fewer than 1 in 5 of them received medication to treat their disorder.
- On September 16, 2022, the Kaiser Family Foundation (KFF) published a report entitled, Beneficiary Experience, Affordability, Utilization, and Quality in Medicare Advantage and Traditional Medicare: A Review of the Literature. In this report, KFF examined 62 studies published since 2016 that compare Medicare Advantage (MA) and traditional Medicare based on measures of beneficiary experience, affordability, service utilization, and quality. KFF found that both MA and traditional Medicare beneficiaries reported similar rates of satisfaction with their care and overall measures of care coordination. Also, KFF found MA outperformed traditional Medicare on some measures, such as use of preventive services, having a usual source of care, and lower hospital readmission rates. However, traditional Medicare outperformed MA on other measures, such as receiving care in the highest-rated hospitals for cancer care or in the highest-quality skilled nursing facilities and home health agencies.
- On September 16, 2022, KFF published a report entitled, Assessing Monkeypox (MPX) Vaccine Eligibility Across the United States. KFF conducted this study to assess vaccine eligibility criteria across the country, focusing on state and local jurisdictions that receive direct vaccine allocations from the federal government. KFF also compared local eligibility criteria to the approach recommended by CDC, and identified which groups and/or situations are being prioritized for vaccination. KFF found that almost all jurisdictions had adopted post-exposure prophylaxis, or PEP (vaccination after a known exposure) as well as expanded post-exposure prophylaxis and PEP++ (vaccination for those with actual or presumed exposure due to their risk factors or recent experiences) informed strategies. KFF also noted that several jurisdictions lack clear criteria or information about who is eligible or where to get vaccinated.
IV. Other Health Policy News
- On September 12, 2022, CMS announced its approval of the Oregon Health Authority’s proposal to cover community-based mobile crisis intervention services in Medicaid. Utilizing funds from the American Rescue Plan (ARP) Act, Oregon will be the first state in the country to implement the new mobile crisis intervention services Medicaid option that was made available by HHS in March 2022. Oregon will be able to provide community-based stabilization services to individuals experiencing mental health and/or substance use crises throughout the state by connecting them to a behavioral health specialist 24 hours per day, every day of the year. More information on this announcement can be found here.
- On September 12, 2022, President Biden issued an Executive Order (EO) entitled, Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy. The EO will launch a National Biotechnology and Biomanufacturing Initiative (NBBI), which will aim to drive research and development, improve access to quality federal data, grow domestic manufacturing capacity, expand market opportunities for biobased products, train a diverse and skilled workforce, streamline regulatory processes for products of biotechnology, advance biosafety and biosecurity to reduce risk, protect the U.S. biotechnology ecosystem, and build a secure global bioeconomy with partners and allies. More information on this announcement can be found here.
- On September 14, 2022, the House of Representatives passed, by a voice vote, the Improving Seniors' Timely Access to Care Act of 2021 (H.R. 3173). The bill aims to modernize the MA program’s prior authorization process in order to improve access and wait times for seniors to access health care services. Specifically, the bill would require MA plans to establish an electronic prior authorization program that meets specified standards, including the capability to provide real-time prior authorization decisions in response to requests for items and services that are routinely approved. Additionally, MA plans would be required to publish an annual accounting of specified prior authorization information, including the percentage of requests approved and the average response time. The House bill was introduced by Representative Suzan DelBene (D-WA), while a Senate version of the bill, S. 3018, was introduced by Senator Roger Marshall (R-KS). More information on this action can be found here.
- On September 16, 2022, HHS released the HHS Roadmap for Behavioral Health Integration. The Roadmap details policy solutions that would help to better integrate mental health and substance use care into the larger health care system and other systems. The Roadmap is based on feedback gathered from patients and providers during more than two dozen stops on HHS Secretary Becerra’s National Tour to Strengthen Mental Health. HHS identified strengthening system capacity, connecting individuals to care, and creating healthy environments as key priorities for addressing the nation’s mental and behavioral health crisis. More information on the roadmap can be found here.
- On September 16, 2022, HHS announced it awarded more than $3.6 million in competitive grants to seven organizations working to bolster support for individuals experiencing substance use disorder (SUD) during pregnancy and postpartum. Five of the recipients also will use the funds to address the intersection of SUD and intimate partner violence (IPV). The grants were awarded across two grant programs, one being the Reducing Maternal Deaths Due to Substance Use Disorder grant program, which aims to strengthen perinatal and postnatal support structures for patients with SUD and reduce deaths during the perinatal and postpartum periods. The other is the Violence Against Women and Substance Use Prevention Initiative, which will train SUD providers in IPV and address the intersection of IPV and SUD during the pregnancy and postpartum period. More information on this funding can be found here.
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