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 outlined a new coverage pathway designed to ensure timely and predictable access to new medical technologies for Medicare beneficiaries and SAMHSA issued an advisory outlining mental health symptoms associated with Long COVID. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On June 20, 2023, the Food and Drug Administration (FDA) issued final guidance entitled, Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program; Guidance for Industry, Clinical Laboratories, and Food and Drug Administration Staff; Availability. FDA is issuing this guidance to announce and describe FDA’s voluntary pilot program for certain oncology drug products regulated by FDA’s Center for Drug Evaluation and Research (CDER) used with certain in vitro diagnostic tests. FDA intends to pilot a new approach to provide greater transparency regarding performance characteristics that certain tests for oncology biomarkers should meet. Through this transparency, FDA seeks to support better and more consistent performance of certain laboratory-developed tests (LDTs) used to identify patients for treatment with certain oncology drug products, resulting in better drug selection and improved care for patients with cancer. The guidance has been implemented without prior comment, but remains subject to comment in accordance with FDA’s good guidance practices.
• On June 20, 2023, the National Institutes of Health (NIH) issued a notice entitled, National Institute of Biomedical Imaging and Bioengineering Notice of Proposed Reorganization. NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB) will be making available a public forum between June 26, 2023 and June 30, 2023, for stakeholders to publicly discuss NIBIB’s proposal to establish the Section on Mechanics and Tissue Remodeling Integrating Computational & Experimental Systems (MATRICES). NIBIB believes the proposed reorganization will more accurately reflect the current structure by which the Intramural Research Program (IRP) is functioning and improve the coordination of the scientific activities within the institute. The online forum will allow members of the public to review the reorganization proposal and submit comments. A public hearing will also be held on July 6, 2023 to discuss the proposal.
• On June 22, 2023, NIH issued a request for information (RFI) entitled, Request for Information (RFI) on NIDCD’s Research Directions to Support Communication in Minimally Verbal/Non-Speaking People. The National Institute on Deafness and Other Communication Disorders (NIDCD) is seeking comment on research directions to support communication in minimally verbal/non-speaking people. NIDCD invites anyone with interests in communication in minimally verbal/non-speaking people to provide input from a personal, service delivery, or research viewpoint. Responses to this RFI will be used by NIDCD for planning purposes and are due on August 1, 2023.
• On June 22, 2023, FDA announced draft guidance entitled, Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability. This draft guidance provides recommendations for industry and review staff on the formal dispute resolution and administrative hearings procedures for resolving scientific and/or medical disputes between CDER, requestors, and sponsors of drugs that will be subject to a final administrative order (final order) under section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
• On June 22, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a notice with comment period entitled, Medicare Program; Transitional Coverage for Emerging Technologies. The notice provides information to the public on the process CMS will use to provide transitional coverage for emerging technologies (TCET) through the national coverage determination (NCD) process under the Social Security Act. It also solicits public comment on the proposed TCET pathway. The TCET pathway is designed to deliver transparent, predictable, and expedited national coverage for certain eligible breakthrough devices that are FDA-authorized. The TCET pathway described in this notice is intended to balance multiple considerations when making coverage determinations. Specifically, the TCET pathway will help: (1) facilitate early, predictable and safe beneficiary access to new technologies; (2) reduce uncertainty about coverage by evaluating early the potential benefits and harms of technologies with innovators; and (3) encourage evidence development if notable evidence gaps exist for coverage purposes. Further, the TCET pathway aims to coordinate benefit category determination, coding, and payment reviews and to allow any evidence gaps to be addressed through fit-for-purpose studies.
• On June 23, 2023, FDA issued final guidance with immediate effect entitled, Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical; Guidance for Industry; Availability. FDA is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in biologics regulations regarding blood and blood components. This notice is being issued to respond to a public health need and to address the urgent and immediate need for platelets to treat active bleeding when conventional platelets are not available, or their use is not practical. In addition, the guidance document provides recommendations to blood establishments for the manufacture and labeling of cold-stored platelets (CSP).
• On June 23, 2023, FDA issued draft guidance entitled, Psychedelic Drugs: Considerations for Clinical Investigations; Draft Guidance for Industry; Availability. Because interest in the therapeutic potential of psychedelic drugs has been increasing and designing clinical trials to evaluate these compounds presents unique challenges, FDA has developed this draft guidance to present foundational aspects for sponsors to consider. This draft guidance provides general considerations for sponsors developing psychedelic drugs for treatment of medical conditions (e.g., psychiatric disorders, substance use disorders (SUDs)) and discusses considerations for clinical investigations using psychedelic drugs.

Event Notices

• July 17 & 21, 2023: NIH announced two public forums to discuss a potential reorganization of the National Institute of General Medical Sciences (NIGMS) Division for Capacity Research Building (DRCB) and Division of Pharmacology, Physiology, and Biological Chemistry (PPBC). The proposals being considered would create a new branch in both DRCB and PPBC.
• August 22-23, 2023: FDA announced a public meeting of the Circulatory System Devices Panel (CSDP) of the Medical Devices Advisory Committee (MDAC). The general function of MDAC is to provide advice to FDA on regulatory issues. On both days, the committee will discuss, make recommendations, and vote on devices designed to reduce blood pressure in patients with hypertension.
• September 1, 2023: NIH announced a public meeting of the National Advisory Council on Minority Health and Health Disparities (NACMHD). The meeting agenda will include opening remarks, discussion of administrative matters, presentations, and other NACMHD business.

II. Hearings & Markups

U.S. House of Representatives

• On June 21, 2023, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Responding to America's Overdose Crisis: An Examination of Legislation to Build Upon the SUPPORT Act. The hearing is being held to discuss the ongoing opioid crisis and to examine 28 bills related to the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act). Witnesses present included: Dr. Christopher Jones, Director of the National Center for Injury Prevention and Control (NCIPC), Centers for Disease Control and Prevention (CDC); Tom Coderre, Acting Deputy Assistant Secretary for Mental Health and Substance Use, Substance Abuse and Mental Health Services Administration (SAMHSA); Diana Espinosa, Principal Deputy Administrator, Health Resources and Services Administration (HRSA); and Jonathan Blum, Principal Deputy Administrator and Chief Operating Officer (COO), CMS.
• On June 21, 2023, the House Committee on Education & the Workforce Subcommittee on Health, Employment, Labor and Pensions (HELP) held a hearing entitled, Competition and Transparency: The Pathway Forward for a Stronger Health Care Market. Witnesses present included: Dr. Gloria Sachdev, President and Chief Executive Officer (CEO), Employers' Forum of Indiana; Christine Monahan, Assistant Research Professor, Georgetown University Center on Health Insurance Reforms; Sophia Tripoli, Director of Health Care Innovation, Families USA; JC Scott, President and CEO, Pharmaceutical Care Management Association (PCMA); and Greg Baker, CEO, Affirmed Rx.
• On June 22, 2023, the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, MACRA Checkup: Assessing Implementation and Challenges that Remain for Patients and Doctors. Witnesses present included: Joe Albanese, Policy Analyst, Paragon Institute; Aisha Pittman, Senior Vice President, National Association of ACOs (NAACOS); Dr. Anas Daghestan, Chair of the Board of America’s Physician Groups, CEO of the Austin Regional Clinic in Texas; and Dr. J Michael McWilliams, Warren Alpert Foundation Professor of Health Care Policy Professor of Medicine Dept. of Health Care Policy, Harvard Medical School.

U.S. Senate

• On June 21, 2023, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held an executive session entitled, 728, S. 1664, and S. 567. The bills under consideration included: S. 728, the Paycheck Fairness Act; S. 1664, the Healthy Families Act; and S. 567, the Richard L. Trumka Protecting the Right to Organize Act of 2023.

III. Reports, Studies & Analyses

• On June 22, 2023, the Department of Health and Human Services (HHS) published a study in the Journal of the American Medical Association (JAMA) entitled, Trends in Maternal Mortality and Severe Maternal Morbidity During Delivery-Related Hospitalizations in the United States, 2008 to 2021. The report found that in-hospital delivery-related maternal mortality rates improved by 57 percent between 2008 and 2021, despite identified increases in severe maternal morbidity (SMM). HHS attributed the decline in deaths during delivery to national and local strategies that aimed to improve the quality of care provided by hospitals during delivery-related hospitalizations. Specifically, HHS highlighted state Perinatal Quality Collaboratives’ (PQCs) and the Alliance for Innovation on Maternal Health’s (AIMH) efforts to reduce maternal mortality during birth. Additionally, the report also found that delivery-related mortality for American Indian women decreased by 92 percent, for Asian women by 73 percent, Black women by 76 percent, Hispanic women by 60 percent, Pacific Islander women by 79 percent, and White women by 40 percent during the study period. HHS emphasized that while mortality decreased, rates of SMM increased for all racial and ethnic groups between 2008 and 2021. HHS called the study an important step in better understanding the root causes of poor maternal health outcomes and in understanding how to direct resources in order to drive future improvements.
• On June 22, 2023, the Government Accountability Office (GAO) published a report entitled, Critical Access Hospitals: Views on How Medicare Payment and Other Factors Affect Behavioral Health Services. GAO conducted this study to assess whether Medicare fee-for-service (FFS) payment policy makes it difficult for critical access hospitals (CAHs) to meet the behavioral health needs of their patient populations. The CAHs interviewed by GAO said they provided behavioral health services through their emergency departments, as well as in both inpatient and outpatient settings. GAO found that CAHs had mixed views on whether FFS Medicare payment policies affected their ability to provide behavioral health services. For example, officials from multiple CAHs shared that they were able to operate a psychiatric unit in their hospitals in a fiscally sustainable way. However, on the other hand, some CAH officials acknowledged that Medicare payment limits for behavioral health services can make it difficult to open new rural health clinics that provide such services.
• On June 22, 2023, GAO published a report entitled, Data Science: NIH Needs to Implement Key Workforce Planning Activities. NIH has experienced a persistent shortage of employees with data science expertise needed to, among other things, analyze and extract insights from increasingly large and complex sets of data. In response, NIH released a Strategic Plan for Data Science in 2018, which in part outlined strategies to increase its data science workforce. GAO conducted this study to assess whether: (1) NIH has conducted data science workforce strategic planning in accordance with key practices; and (2) NIH’s data management and sharing policy and guidance are consistent with federal guidance. GAO found that while NIH has developed and implemented plans to enhance its data science workforce, it has not yet translated those plans to practice in order to fill priority data science vacancies. In terms of NIH’s data management and sharing policy, GAO found that while NIH’s policies were in line with federal guidance, NIH had not yet completed internal guidance needed to implement the relevant data management and sharing policies.
• On June 23, 2023, the HHS Office of the Inspector General (OIG) published a report entitled, CMS's Oversight of Medicare Payments for the Highest Paid Molecular Pathology Genetic Test Was Not Adequate To Reduce the Risk of up to $888 Million in Improper Payments. This report is part of ongoing OIG work to examine increased, and in some cases fraudulent, billing related to genetic testing under Medicare Part B. Prior OIG analyses found that between 2016 and 2019, Current Procedural Terminology (CPT) code 81408 was the genetic-testing procedure code with the second highest total of Medicare Part B payments and was the molecular pathology procedure (a type of genetic test) with the highest Medicare payment amount ($2,000/test). OIG identified CPT code 81408 as being at high risk for improper billing and therefore conducted this report to determine whether CMS’s oversight of Medicare payments was adequate to reduce the risk of improper payments. OIG found that CMS’s oversight of Medicare payments for CPT code 81408 did not: (1) ensure that all Medicare enrollees had established relationships with ordering providers; (2) ensure that Medicare payments for CPT code 81408 were related to diseases associated with genes that would generally be tested and billed under that CPT code; and (3) include adequate monitoring of the number of tests billed under CPT code 81408. Overall, OIG found that up to $888 million in Medicare claims for CPT code 81408 were at risk of improper payment during the audit period. OIG recommended that CMS and its contractors review all payments and recover all funds deemed to have been allocated improperly.

IV. Other Health Policy News

• On June 21, 2023, 230 House members and 61 Senators sent companion letters to CMS urging the agency to finalize proposed rules developed to modernize and streamline the prior authorization process. The Members urged CMS to expand on the proposed rules by including policies requiring Medicare Advantage (MA) plans to implement real-time electronic decision-making for routinely approved health care services, provide responses to emergency procedure requests within 24 hours instead of 72 hours, and implement enhanced transparency standards. The letter also highlighted the importance of streamlining the prior authorization process in order reduce administrative burden on providers. The provisions in the proposed rules are aligned with the bipartisan, bicameral Improving Seniors’ Timely Access to Care Act, which passed the House during the 117^th Congress and will likely be reintroduced during this Congress. More information on these letters can be found here.
• On June 21, 2023, SAMHSA issued an advisory entitled, Identification and Management of Mental Health Symptoms and Conditions Associated with Long COVID. The advisory identified fatigue, sleep disturbances, depression, anxiety, psychosis, cognitive impairment, obsessive compulsive disorder (OCD), and post-traumatic stress disorder (PTSD) as potential mental health symptoms associated with Long COVID. Further, the advisory highlighted that social determinants of health (SDOH) can worsen the effects of Long COVID for certain groups such as those with preexisting conditions and limited access to health care. Further, the advisory recommends that primary care providers screen for Long COVID symptoms and then consider referring patients to a range of therapeutic interventions if necessary. The mental health interventions for Long COVID recommended by SAMHSA include: individual and group psychotherapy; peer support; physical medicine and rehabilitation; occupational therapy; neurorehabilitation; pharmacotherapy; and substance use disorder (SUD) services. The advisory lists a number of tips for primary care providers working with Long COVID patients, such as conducting full face-to-face examinations when possible; sharing the uncertainties of a Long COVID diagnosis with patients; and entering the correct billing code (U09.9 post-COVID-19 condition, unspecified) for Long COVID patients on their medical record. Finally, SAMHSA provided a variety of resources that primary care providers can share with their patients experiencing Long COVID. More information on this announcement can be found here.
• On June 22, 2023, CMS released new details about how Medicare will provide coverage for drugs designed to slow the progression of Alzheimer’s disease. CMS clarified that it will cover FDA-approved Alzheimer’s drugs when a physician and clinical team participates in a registry, which collects evidence about how such drugs work in the real world. CMS is billing the registry’s data submission portal as having an easy-to-use format, and indicated that the agency will soon provide more details on the estimated length of time it will take physicians to enter data. The announcement also identified the information that will be required for submission in the registry, including demographic information for the data submitter/physician; patient demographic information; and patient clinical information (e.g., diagnosis, medications, test results). More information on this announcement can be found here.

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