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, HHS issued guidance on HIPAA compliance with audio-only telehealth and announced the distribution of $427 million in PRF Phase 4 payments. Read more about these actions and other news below.
I. Regulations, Notices & Guidance
- On June 14, 2022, the National Institutes of Health (NIH) issued a request for information entitled, Inviting comments and suggestions from stakeholders on Pediatric Medical Devices Public-Private Partnership. NIH is seeking comments and input focusing on challenges, gaps, clinical needs, and research opportunities related to Pediatric Medical Devices (PMD) to inform priorities for a Public Private Partnership (PPP) to catalyze the national ecosystem. Such ecosystem will focus on optimizing the translation of technological advancements into medical devices designed, evaluated, and approved for pediatric populations to improve quality of life in this population. These comments are requested from public and private stakeholders such as, but not limited to, innovators, researchers, academic and medical centers, small- and large-scale industries, non-profit organizations, patients, providers, advocacy groups, payors, and federal agencies.
- On June 14, 2022, the Department of Health and Human Services (HHS) issued a notice entitled, Announcement of Intent to Establish the 2025 Dietary Guidelines Advisory Committee and Solicitation of Nominations for Membership. HHS and the Department of Agriculture (USDA) are tasked with publishing the Dietary Guidelines for Americans jointly at least every five years. The guidelines contain nutritional and dietary information and guidelines for the general public. It is based on the preponderance of scientific and medical knowledge current at the time of publication and is required to be promoted by each federal agency in carrying out any federal food, nutrition, or health program. The Dietary Guidelines Advisory Committee is expected to begin meeting in early 2023 and the Committee will meet approximately five times during its operation. The Dietary Guidelines Advisory Committee will consist of 15 to 20 members, including the Chair and Vice Chairperson. Factors to be considered in selecting individuals to serve on the Committee include educational background, professional experience, and demonstrated scientific expertise in the issues to be examined by the Committee, as well as statutory obligations under the Federal Advisory Committee Act (FACA) and desire for a balanced and diverse membership.
- On June 14, 2022, the Food and Drug Administration (FDA) issued draft guidance entitled, Q9(R1) Quality Risk Management; International Council for Harmonisation; Draft Guidance for Industry; Availability. The current Q9 guideline published in 2006 provides a common, harmonized framework for Quality Risk Management (QRM) that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug products across the product lifecycle. This draft guidance is a targeted revision that addresses four areas for improvement, including high levels of subjectivity in risk assessments and in QRM outputs; product availability risks; lack of understanding as to what constitutes formality in QRM work; and lack of clarity on risk-based decision-making. The revisions are intended to update the original Q9 guideline based on implementation experience to promote improved lifecycle management of hazards and prevent defects, recalls, and shortages.
- On June 14, 2022, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Rescinding Requirement for Negative Pre-Departure COVID-19 Test Result or Documentation of Recovery from COVID-19 for All Airline or Other Aircraft Passengers Arriving Into the United States From Any Foreign Country. This notice rescinds the prior order that required all air passengers, two years or older, traveling to the United States from a foreign country to present a negative COVID-19 test result from a sample taken no more than one day before departure, or documentation of recovery from COVID-19 in the past 90 days, before boarding a flight. The rescission was implemented on June 12, 2022.
- On June 15, 2022, FDA issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The licensing availability is for beta globin mimetic peptides and their use. The technology could be used for novel peptides to treat vascular diseases characterized by vasoconstriction, excess alpha adrenergic signaling, or insufficient nitric oxide signaling. Applications could range from cerebral vasospasm to pulmonary hypertension to chronic kidney disease to transfusion medicine to erectile dysfunction to exercise physiology.
- On June 15, 2022, FDA issued a notice entitled, Government-Owned Inventions; Availability for Licensing. The licensing availability is for methods to use modulators of extracellular adenosine or an adenosine receptor to enhance immune response and inflammation. Potential commercial uses could include anti-tumor therapy, vaccine adjuvants for tumors, and immunotherapy.
- On June 15, 2022, FDA issued draft guidance entitled, Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request. The draft guidance describes a standards recognition program for regenerative medicine therapies (SRP-RMT) at FDA’s Center for Biologics Evaluation and Research (CBER) designed to identify Voluntary Consensus Standards (VCS) to facilitate the development and assessment of regenerative medicine therapy (RMT) products regulated by CBER when such standards are appropriate. The voluntary use of recognized VCS can assist stakeholders in more efficiently meeting regulatory requirements and increasing regulatory predictability for RMT products. The program is modeled after the formal standards and conformity assessment program (S-CAP) for medical devices.
- On June 15, 2022, FDA issued final guidance entitled, Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability. FDA is issuing this guidance to provide recommendations for manufacturers about the information that should be included in premarket submissions for radiological devices that include quantitative imaging functions. This guidance document is broadly applicable to a variety of premarket submission types (i.e., premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests) for these devices and should be used in conjunction with existing device- and submission-specific guidance documents.
- On June 16, 2022, the Health Resources and Services Administration (HRSA) issued a request for information entitled, Early Hearing Detection and Intervention Program. HRSA’s Early Hearing Detection and Intervention (EHDI) Program is requesting input from the public to inform future EHDI program development. HRSA’s EHDI Program seeks to enable states, jurisdictions, families, and clinical, educational, and social service providers to develop coordinated systems of care so that newborns, infants, and young children who are deaf or hard of hearing are identified as early as possible and receive the services they need. HRSA is seeking responses for a series of ten questions.
- On June 17, 2022, FDA issued a notice entitled, Improving 510(k) Submission Preparation and Review: Center for Biologics Evaluation and Research; Voluntary Electronic Submission Template and Resource Pilot Program; Request for Comments. CBER is announcing a pilot program for sponsors of CBER premarket notification (510(k)) submissions that wish to use the voluntary Electronic Submission Template and Resource (eSTAR) Pilot Program. CBER’s voluntary eSTAR Pilot Program is intended to improve consistency and efficiency in both industry’s preparation and FDA’s review of premarket notification (510(k)) submissions. During CBER’s voluntary eSTAR Pilot Program, participants will have the opportunity to provide input to FDA on the eSTAR Pilot Program for submissions to CBER.
- On June 17, 2022, FDA issued draft guidance entitled, Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures; Draft Guidance for Industry and Food and Drug Administration Staff; Availability. This draft guidance provides recommendations that may help manufacturers comply with the special controls related to non-clinical performance data for gynecologic and general laparoscopic power morcellation containment systems.
- On June 17, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program; Calendar Year (CY) 2023 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Program Requirements; Home Health Value-Based Purchasing Expanded Model Requirements; and Home Infusion Therapy Services Requirements. This proposed rule would set forth routine updates to the Medicare home health and home infusion therapy services payment rates for calendar year (CY) 2023 in accordance with existing statutory and regulatory requirements. This proposed rule discusses home health utilization; proposes a methodology for determining the difference between assumed versus actual behavior change on estimated aggregate expenditures for home health payments as result of the change in the unit of payment to 30 days and the implementation of the Patient Driven Groupings Model (PDGM) case-mix adjustment methodology; and proposes a temporary retrospective and permanent prospective adjustment to the CY 2023 home health payment rates. This rule proposes reassignment of certain diagnosis codes under the PDGM. and proposes to establish a permanent mitigation policy to smooth the impact of year-to-year changes in home health payments related to changes in the home health wage index. This rule also proposes recalibration of the PDGM case-mix weights and updates the low utilization payment adjustment (LUPA) thresholds, functional impairment levels, comorbidity adjustment subgroups for CY 2023 and the fixed-dollar loss ratio (FDL) used for outlier payments. Additionally, this rule discusses the future collection of data regarding the use of telecommunications technology during a 30-day home health period of care on home health claims. In addition, this rule proposes changes to the Home Health Quality Reporting Program (HH QRP) requirements; changes to the expanded Home Health Value-Based Purchasing (HHVBP) Model; and updates to the home infusion therapy services payment rates for CY 2023.
- June 24, 2022: CDC announced a public meeting regarding biosafety and laboratory instrumentation. The agenda will include presentations and discussions on four topic areas: 1) instrument design and incorporating biosafety; 2) perceived risks to laboratory personnel and impact on testing; 3) independent assessment of risks and instrument design; and 4) a discussion of potential areas of collaboration to address issues discussed during the meeting. There will be prepared presentations, discussions among presenters and panelists, and a period for questions and public comments.
II. Congressional Hearings
U.S. House of Representatives
- On June 14, 2022, the House Committee on Oversight and Reform Select Subcommittee on the Coronavirus Crisis held a hearing entitled, Examining Federal Efforts to Prevent, Detect, and Prosecute Pandemic Relief Fraud to Safeguard Funds for All Eligible Americans. Witnesses present included: Kevin Chambers, Director for COVID-19 Fraud Enforcement, Department of Justice; Roy D. Dotson Jr., Acting Special Agent in Charge, National Pandemic Fraud Recovery Coordinator, United States Secret Service; The Honorable Michael Horowitz, Chair, Pandemic Response Accountability Committee; and The Honorable Hannibal "Mike" Ware, Inspector General, Small Business Administration.
- On June 14, 2022, the House Committee on Energy and Commerce Subcommittee on Consumer Protection and Commerce held a hearing entitled, Protecting America's Consumers: Bipartisan Legislation to Strengthen Data Privacy and Security. Witnesses present included: Caitriona Fitzgerald, Deputy Director, Electronic Privacy Information Center; David Brody, Managing Attorney, Digital Justice Initiative, Lawyers' Committee for Civil Rights Under Law; Bertram Lee, Senior Policy Counsel, Data Decision Making, and Artificial Intelligence, Future of Privacy Forum; Jolina Cuaresma, Senior Counsel, Privacy & Technology Policy, Common Sense Media; John Miller, Senior Vice President of Policy and General Counsel, Information Technology Industry Council; Graham Dufault, Senior Director for Public Policy, ACT | The App Association; Doug Kantor, General Counsel, National Association of Convenience Stores; and Maureen K. Ohlhausen, Co-Chair, 21st Century Privacy Coalition.
- On June 14, 2022, the House Committee on the Budget held a hearing entitled, How the American Rescue Plan Saved Lives and the U.S. Economy. Witnesses present included: Dr. Julia Coronado, Founder and President, Macropolicy Perspectives; The Honorable Vince Williams, Mayor of Union City, Georgia, and President, National League of Cities; Sharon Parrott, President, Center on Budget and Policy Priorities; and Stephen Moore, Chair of the Save America Coalition, America First Policy Institute, and Distinguished Fellow in Economics, Heritage Foundation.
- On June 14, 2022, the Senate Committee on Health, Education, Labor, and Pensions (HELP) held an executive session entitled, 4348, S. 958, S. 4353, H.R. 1193, and S. 4052. The executive session included discussion of H.R. 1193, the Cardiovascular Advances in Research and Opportunities Legacy (CAROL) Act, S. 4052, the Early Hearing Detection and Intervention (EHDI) Act of 2022; S. 958, the Maximizing Outcomes through Better Investments in Lifesaving Equipment for (MOBILE) Health Care Act, S. 4353, the Retirement Improvement and Savings Enhancement to Supplement Healthy Investments for the Nest Egg (RISE & SHINE) Act, and S. 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act.
- On June 16, 2022, the Senate Committee on HELP held a hearing entitled, An Update on the Ongoing Federal Response to COVID-19: Current Status and Future Planning. Witnesses present included: Dr. Rochelle Walensky, Director, CDC; Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases, NIH; the Honorable Robert Califf, M.D., Commissioner, FDA; and Dawn O'Connell, Assistant Secretary for Preparedness and Response, HHS.
III. Reports, Studies & Analyses
- On June 13, 2022, the HHS Office of Inspector General (OIG) published a report entitled, Medicare and Beneficiaries Paid Substantially More to Provider-Based Facilities in Eight Selected States in Calendar Years 2010 Through 2017 Than They Paid to Freestanding Facilities in the Same States for the Same Type of Services. The report identifies the potential cost savings to both the Medicare program and its beneficiaries by comparing their payments made for certain evaluation and management (E&M) services performed at provider-based facilities in calendar years (CYs) 2010 through 2017 in eight selected States with what Medicare and beneficiaries would have paid for the same type of services performed at freestanding facilities in the same eight States. OIG found that both the Medicare program and its beneficiaries could have realized significant savings for E&M services if those services had been paid as if provided at freestanding facilities.
- On June 15, 2022, HHS OIG published a report entitled, Inaccuracies in Medicare’s Race and Ethnicity Data Hinder the Ability to Assess Health Disparities. OIG conducted this review of Medicare’s race and ethnicity data because assessing disparities and achieving health equity hinges on the quality of underlying race and ethnicity data. OIG found that Medicare’s enrollment race and ethnicity data are less accurate for some groups, particularly for beneficiaries identified as American Indian/Alaska Native, Asian/Pacific Islander, or Hispanic.
- On June 15, 2022, the Bipartisan Policy Center published a report entitled, Answering the Call: 988: A New Vision for Crisis Response. This report examines three areas critical regarding the implementation of 988, which is the new number for the National Suicide Prevention Lifeline. The essential areas assessed in the report are interagency collaboration, the behavioral health workforce, and financing. The recommendations outlined in the report focus on enhancing federal support for the effective and equitable buildout of 988 alongside existing crisis response infrastructure while primarily utilizing existing resources.
- On June 16, 2022, the Kaiser Family Foundation (KFF) published a report entitled, Health Care Debt in the U.S.: The Broad Consequences Of Medical And Dental Bills. This report includes analysis from the KFF Health Care Debt Survey and is part of a broad investigative project on health care debt. This Report contains findings from the survey as well as the topline and methodology. The KFF Health Care Debt Survey provides a broad measure of health care debt, including medical and dental bills people are unable to pay as well as different forms of debt accruing from health care bills such as payment plans, credit cards, bank loans, and borrowing from family and friends. It also explores the effects of health care debt on individuals and the financial and personal sacrifices they make due to their debt.
- On June 16, 2022, the Government Accountability Office (GAO) published a report entitled, Public Health Preparedness: Medical Countermeasure Development for Certain Serious or Life-threatening Conditions. In this report GAO describes (1) FDA efforts to support medical countermeasure developers under the Animal Rule, and (2) the extent of animal model qualification under FDA’s Animal Model Qualification Program, and (3) the effect of qualified models on medical countermeasure development. GAO found that FDA has undertaken efforts to provide information and feedback to developers to support medical countermeasure development under the Animal Rule.
IV. Other Health Policy News
- On June 13, 2022, HHS issued guidance on how covered health care providers and health plans can use remote communication technologies to provide audio-only telehealth services when such communications are conducted in a manner that is consistent with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach Notification Rules. This guidance will clarify how covered entities can provide audio-only telehealth services compliance with the HIPAA Rules and by improving public confidence that covered entities are protecting the privacy and security of their health information. More information on this guidance can be found here.
- On June 15, 2022, President Biden issued an Executive Order on advancing equality for lesbian, gay, bisexual, transgender, queer, and intersex individuals. The Executive Order addresses discriminatory legislative attacks against LGBTQI+ children and families and directs federal agencies to protect LGBTQI+ children and families. It also prevents “conversion therapy” by directing HHS to explore guidance to clarify that federally-funded programs cannot offer so-called “conversion therapy.” HHS will also increase public awareness about the harms of “conversion therapy”, provide training and technical assistance to health care providers, and expand support for services to help survivors. Additionally, the Executive Order addresses discrimination and barriers faced by LGBTQI+ youth, parents, caretakers, and families in foster care, while also offering increased support through family counseling for families with LGBTQI+ youth. More information on this Executive Order can be found here.
- On June 16, 2022, HRSA announced the distribution of more than $427 million in Provider Relief Fund (PRF) Phase 4 General Distribution payments to over 1,400 providers across the country. With these payments, more than $14.3 billion in PRF Phase 4 funding has now been distributed to over 89,000 providers in all 50 states, Washington D.C., and five territories. This is in addition to HRSA’s distribution of American Rescue Plan Rural payments totaling $7.9 billion in funding so far to more than 46,000 providers since November 2021. More information on this funding can be found here.
- On June 16, 2022, HHS announced it had awarded nearly $115 million to 60 recipients to help implement the Ending the HIV Epidemic in the U.S. (EHE) initiative, which is part of the Biden Administration’s ongoing efforts to reduce the number of new HIV infections in the U.S. by at least 90 percent by 2030. Awards will support innovative strategies that help people with HIV access care, support, and treatment services to live longer, healthier lives. Awards include nearly $103 million to 39 metropolitan areas and eight states (Mississippi, Kentucky, Missouri, South Carolina, Alabama, Arkansas, Oklahoma, and Ohio) to implement strategies and interventions to provide core medical and support services to reduce new HIV infections in the U.S. Also, $4 million was awarded to provide workforce capacity development and technical assistance to 11 Ryan White HIV/AIDS Program (RWHAP) AIDS Education and Training Centers Programs across the country. More information on this funding can be found here.
- On June 17, 2022, HHS announced the availability of $10 million in substance misuse grant funding through the HRSA Rural Communities Opioid Response Program. This funding will help rural communities establish new treatment access points to connect individuals to medication to treat opioid use. Medication-assisted treatment (MAT) includes medications, ideally combined with counseling and behavioral therapies, to provide a “whole-patient” approach to the treatment of substance misuse. The $10 million in funding builds on the $15 million announced last week for rural communities to address psychostimulant misuse and related overdose deaths. These investments reflect HHS’ commitment to evidence-based programs addressing opioid and stimulant misuse, as reflected in President Biden’s Fiscal Year (FY) 2023 proposed budget for HHS on drug-related programs and initiatives that totaled $21.1 billion across HHS. More information on this funding can be found here.
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