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, CMS released the CY 2023 OPPS Proposed Rule and HHS issued reproductive health care guidance to both providers and pharmacists clarifying their legal obligations. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On July 11, 2022, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Supplemental Evidence and Data Request on Radiation Therapy for Bone Metastases. AHRQ is seeking scientific information submissions from the public to inform AHRQ’s review on Radiation Therapy for Bone Metastases, which is currently conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program.
- On July 13, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare Program; MIPS Payment Adjustment Exception Applicable for Enhancing Oncology Model Monthly Enhanced Oncology Services (MEOS) Payments. CMS is issuing a payment advisory to inform potential Enhancing Oncology Model (EOM) applicants and participants that the Merit-based Incentive Payment System (MIPS) payment adjustment factors will not apply to the Monthly Enhanced Oncology Services (MEOS) payments in EOM.
- On July 13, 2022, CMS issued a final rule timeline extension for a proposed rule entitled, Medicare and Medicaid Program; Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Efficiency, and Transparency Final Rule. Medicare final rules must be published no later than 3 years after the publication date of the proposed rule or interim final rule, as applicable, except under exceptional circumstances. Due to the COVID-19 pandemic, CMS is extending the timeline to finalize the provisions in the June 18, 2022 proposed rule for 1 year, until July 18, 2023. The proposed rule would revise the Medicare and Medicaid long-term care facility requirements that CMS had identified as unnecessary, obsolete, or excessively burdensome. The proposed rule also aims to increase the ability of health care professionals to apportion resources to improve resident care by eliminating or reducing requirements that could impede quality care or that divert resources away from providing high quality care.
- On July 14, 2022, the Food and Drug Administration (FDA) issued final guidance entitled, Instructions for Use--Patient Labeling for Human Prescription Drug and Biological Products-- Content and Format; Guidance for Industry; Availability. This guidance provides recommendations for developing the content and format of an Instructions for Use (IFU) document for human prescription drug and biological products, as well as drug-led or biologic-led combination products submitted under a new drug application (NDA) or a biologics license application (BLA). The IFU is written for patients (or their caregivers) who use drug products that have complicated or detailed patient-use instructions. The recommendations in this guidance are intended to help ensure that patients receive clear and concise information that is easily understood for the safe and effective use of such products.
- On July 14, 2022, FDA issued a notice entitled, Revocation of Methods of Analysis Regulation. FDA issued the notice to propose to revoke the Methods of Analysis regulation describing an FDA policy to use certain methods of analysis for FDA enforcement programs when the method of analysis is not prescribed in a regulation. FDA is proposing this action because the existing regulation is unnecessary. Absent specifying a method of analysis in a regulation, FDA believes it is more appropriate, flexible, and efficient to identify its preferred methods of analysis in documents such as the Office of Regulatory Affairs Laboratory Procedures Manual, FDA compliance programs, and other resources.
- On July 14, 2022, AHRQ issued a notice entitled, Supplemental Evidence and Data Request on ADHD Diagnosis and Treatment in Children and Adolescents. AHRQ is seeking scientific information submissions from the public. Scientific information is being solicited to inform AHRQ’s review on ADHD Diagnosis and Treatment in Children and Adolescents, which is currently being conducted by AHRQ’s EPC Program. AHRQ believes access to published and unpublished pertinent scientific information will improve the quality of this review. AHRQ is looking for studies that report on ADHD diagnosis and treatment in children and adolescents, including those that describe adverse events.
- On July 15, 2022, FDA issued a notice entitled, Data Standards; Requirement Begins for the Clinical Data Interchange Standards Consortium Versions 1.2 and 1.3 of the Analysis Data Model Implementation Guide. FDA’s Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) are announcing the date that support begins for versions 1.2 and 1.3 of the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model Implementation Guide (ADaMIG) and the date that this version update is required in certain submissions. The requirement for electronic submissions to be submitted using versions 1.2 and 1.3 of the CDISC ADaMIG begins March 15, 2024, for new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs).
- On July 15, 2022, CMS issued a proposed rule entitled, Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; Rural Emergency Hospitals: Payment Policies, Conditions of Participation, Provider Enrollment, Physician Self-Referral; New Service Category for Hospital Outpatient Department Prior Authorization Process; Overall Hospital Quality Star Rating. This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year (CY) 2023 based on CMS’ continuing experience with these systems. In this proposed rule, CMS describes the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program, the ASC Quality Reporting (ASCQR) Program, and the Rural Emergency Hospital Quality Reporting (REH) Program. CMS is also proposing updates to the requirements for Organ Acquisition, Rural Emergency Hospitals, Prior Authorization, and Overall Hospital Quality Star Rating. CMS is establishing a new provider type for rural emergency hospitals (REHs), and CMS has proposals regarding payment policy, quality measures, and enrollment policy for REHs. Finally, CMS is soliciting comments on the use of CMS data to drive competition in healthcare marketplaces, and an alternative methodology for counting organs.
- July 19, 2022: CDC announced a public meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on the use of COVID-19 adult vaccines. A recommendation vote is also scheduled.
- August 9, 2022: CDC announced a public meeting of the Advisory Committee to the Director (ACD). The agenda will include discussions regarding CDC’s current and future work in the following topic areas: (1) data modernization; (2) laboratory quality; and (3) health equity. ACD will hear reports from its working groups on these three topics. In addition, ACD will hear an update on climate change and health.
- September 7-8, 2022: The National Institutes of Health (NIH) announced a public meeting of the National Institute of Neurological Disorders and Stroke (NINDS), National Advisory Neurological Disorders and Stroke Council (NANDSC). The agenda will include a report from NINDS’ director, and a report on administrative and program developments.
- September 8-9, 2022: NIH announced a public meeting of the National Deafness and Other Communication Disorders (NDCD) Advisory Council. The agenda will include staff reports on divisional, programmatic, and special activities.
- October 28, 2022: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The agenda will include a discussion of federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED).
II. Congressional Hearings
U.S. House of Representatives
- On July 13, 2022, the House Committee on Oversight and Reform held a hearing entitled, The Impact of the Supreme Court’s Dobbs Decision on Abortion Rights and Access Across the United States. Witnesses present included: Fatima Goss Graves, President and CEO, National Women’s Law Center; The Honorable Mallory McMorrow, Michigan State Senator; The Honorable Renitta Shannon, Member, Georgia State House of Representatives; Michelle Bratcher Goodwin, Chancellor’s Professor of Law, University of California (UC), Irvine; Sarah Lopez, Abortion Storyteller, We Testify; Youth Program Manager, Jane’s Due Process; and Erin Morrow Hawley, Senior Counsel, Alliance Defending Freedom (ADF).
- On July 14, 2022, the House Committee on the Judiciary held a hearing entitled, What's Next: The Threat to Individual Freedoms in a Post-Roe World. Witnesses present included: Catherine Glenn Foster, President and CEO, Americans United for Life; Melissa Murray, Frederick I. and Grace Stokes Professor of Law; Faculty Director, Birnbaum Women’s Leadership Network, New York University School of Law; Jim Obergefell, Plaintiff in Obergefell v. Hodges; and Sarah Warbelow, Legal Director, Human Rights Campaign.
- On July 12, 2022, the Senate Committee on the Judiciary held a hearing entitled, A Post-Roe America: The Legal Consequences of the Dobbs Decision. Witnesses present included: The Honorable Juliana Stratton, Lieutenant Governor, State of Illinois; Dr. Khiara M. Bridges, Professor of Law, UC Berkeley School of Law; Dr. Colleen P. McNicholas, Chief Medical Officer, Planned Parenthood of the St. Louis Region and Southwest Missouri; Denise Harle, Senior Counsel and Director of The Center for Life, Alliance Defending Freedom; and Heidi Matzke, Executive Director, Alternatives Pregnancy Center.
- On July 13, 2022, the Senate Committee on Health, Education, Labor and Pensions (HELP) held a hearing entitled, Reproductive Care in a Post-Roe America: Barriers, Challenges, and Threats to Women's Health. Witnesses present included: Kristyn Brandi, Board Chair, Physicians for Reproductive Health (PRH); Samie Detzer, Planned Parenthood Patient Advocate, Planned Parenthood Federation of America (PPFA); Dr. Jamila Taylor, Director of Health Care Reform and Senior Fellow, The Century Foundation (TCF); and Brandi Swindell, Founder and CEO, Stanton Healthcare.
III. Reports, Studies & Analyses
- On July 11, 2022, the Government Accountability Office (GAO) published a report entitled, Contact Tracing for Air Travel: CDC’s Data System Needs Substantial Improvement. GAO was asked to examine CDC’s process for collecting and managing air passengers’ contact information to facilitate contact tracing. This report addresses: (1) the factors that affect CDC’s ability to collect this information, (2) recent actions CDC has taken to improve the quality of the information it collects, and (3) how effectively it collects and manages this information. GAO found that while CDC plays a key role in contact tracing for air travel, its outdated data management system means CDC is not positioned to efficiently analyze and disseminate data to inform public health policies and respond to disease threats. GAO also found CDC is also not positioned to evaluate its performance in collecting and sharing quality passenger information.
- On July 14, 2022, the Kaiser Family Foundation (KFF) published a report entitled, Medicaid Enrollment Patterns During the Postpartum Year. This report examines Medicaid enrollment patterns in the 12 months after delivery. KFF also estimates the number of enrollees who would benefit from the 12-month continuous eligibility policy for postpartum people if adopted by all states. KFF found that among Medicaid enrollees with a live birth in 2018, 31 percent were disenrolled from Medicaid coverage within six months and 40 percent disenrolled within a year after delivery. KFF also found that in the states that had not implemented the Affordable Care Act’s (ACA) Medicaid expansion as of 2018, 61 percent of postpartum enrollees were disenrolled within a year after delivery, double the rate of 29 percent found in Medicaid expansion states.
- On July 15, 2022, the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) published a report entitled, CDC Found Ways to Use Data to Understand and Address COVID-19 Health Disparities, Despite Challenges with Existing Data. This report examines how CDC staff responsible for collecting and analyzing COVID-19 data; collaborating with State, local, and Territorial entities and with Tribal Epidemiology Centers (TECs); and developing initiatives to address disparities, worked to use data to identify and address disparities, as well as provide support to jurisdictions and TECs throughout the pandemic. In its report, OIG recommends that CDC (1) expand efforts both to improve racial and ethnic data associated with COVID-19 and to supplement them with additional data sources and (2) ensure that TECs have timely access to all public health data to which they are entitled.
IV. Other Health Policy News
- On July 11, 2022, HHS announced that it has secured 3.2 million doses of Novavax’s COVID-19 vaccine. The protein-based, adjuvanted vaccine will be made available for free to states, jurisdictions, federal pharmacy partners, and federally qualified health centers (FQHCs) if it receives FDA Emergency Use Authorization (EUA), and a recommendation from CDC. HHS stated that Novavax is expected to complete all necessary quality testing in the next few weeks, which would support final release of the vaccine. The Novavax COVID-19 vaccine is designed and manufactured differently than the mRNA COVID-19 vaccines. The Novavax vaccine contains a very small amount of the SARS-CoV-2 spike protein, which elicits an immune response, in combination with an adjuvant, which boosts the immune system response to vaccine. FDA-approved protein-based vaccines have been used widely for decades. The Novavax COVID-19 vaccine offers an option to individuals who may have an allergic reaction to mRNA vaccines or who have a personal preference for receiving a vaccine other than a mRNA-based vaccine. More information on this action can be found here.
- On July 11, 2022, HHS announced new guidance and communication to ensure all patients, including pregnant women and others experiencing pregnancy loss, have access to the full rights and protections for emergency medical care afforded under the law. HHS issued clarifying guidance on the Emergency Medical Treatment and Active Labor Act (EMTALA) and reaffirmed that it protects providers when offering legally-mandated, life- or health-saving abortion services in emergency situations. The EMTALA statute requires that Medicare hospitals provide all patients an appropriate medical screening, examination, stabilizing treatment, and transfer, if necessary, irrespective of any state laws or mandates that apply to specific procedures. Stabilizing treatment could include medical and/or surgical interventions, including abortion. If a state law prohibits abortion and does not include an exception for the health or life of the pregnant person — or draws the exception more narrowly than EMTALA’s emergency medical condition definition — that state law is preempted. More information on this action can be found here.
- On July 13, 2022, HHS issued guidance to roughly 60,000 U.S. retail pharmacies, reminding them of their obligations under federal civil rights laws. The guidance makes clear that as recipients of federal financial assistance, including Medicare and Medicaid payments, pharmacies are prohibited under law from discriminating based on race, color, national origin, sex, age, and disability in their programs and activities. This includes supplying prescribed medications; making determinations regarding the suitability of prescribed medications for a patient; and advising a patient about prescribed medications and how to take them. The action is the latest step in HHS’ response to protect reproductive health care. More information on this action can be found here.
- On July 15, 2022, HHS issued a news release to tout the transition of the 10-digit National Suicide Prevention Lifeline to 988 on July 16, 2022. The lifeline, which also links to the Veterans Crisis Line, follows a three-year joint effort by HHS, the Federal Communications Commission (FCC), and the U.S. Department of Veterans Affairs (VA) to put crisis care more in reach for people in need. Since 2021, the Biden Administration has invested $432 million to scale crisis center capacity and ensure all Americans have access to help during mental health crises. The National Suicide Hotline Designation Act, signed into law after the passage of bipartisan legislation in 2020, authorized 988 as a new three-digit number for suicide and mental health crisis. All telephone service and text providers in the United States and the five major U.S. territories are required by the FCC to activate 988 no later than July 16, 2022. In 2021, the Lifeline received 3.6 million calls, chats, and texts. That number is expected to at least double within the first full year after the 988 transition. More information on this action can be found here.
- On July 15, HHS Secretary Xavier Becerra announced the renewal of determination that a public health emergency (PHE) exists, which extended the ongoing COVID-19 PHE for another 90 days. The PHE was originally enacted under the Trump Administration on January 31, 2022. More information on this action can be found here.
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