Health Care Week in Review: IRA Guidance and ESRD PPS Rule

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 revised guidance on the IRA Medicare Drug Price Negotiation Program and issued the ESRD prospective payment proposed rule. Read more about these actions and other news below.

I. Regulations, Notices & Guidance

• On June 26, 2023, the Agency for Healthcare Research and Quality (AHRQ) issued a notice entitled, Supplemental Evidence and Data Request on Nonpharmacologic Treatment for Maternal Mental Health Conditions. AHRQ is seeking scientific information submissions from the public to inform its review on Nonpharmacologic Treatment for Maternal Mental Health Conditions, which is currently being conducted by the AHRQ’s Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information is intended to improve the quality of this review. Submissions must be received by July 27, 2023.
• On June 26, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program; End-Stage Renal Disease Prospective Payment System, Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, and End-Stage Renal Disease Treatment Choices Model. This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2024. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also includes requests for information regarding potential changes to the low-volume payment adjustment under the ESRD PPS. In addition, this proposed rule would update requirements for the ESRD Quality Incentive Program and the ESRD Treatment Choices Model.
• On June 27, 2023, the Food and Drug Administration (FDA) issued draft guidance entitled, Patient-Matched Guides to Orthopedic Implants. This draft guidance document provides recommendations regarding information that should be included in regulatory submissions for patient-matched guides to orthopedic implants. This draft guidance also provides recommendations that manufacturers should consider when developing their design process for these device types. This draft guidance is intended to promote clarity and transparency as to expectations regarding submission recommendations for orthopedic patient-matched guides. Following such recommendations may increase efficiency and consistency in review.
• On June 27, 2023, FDA issued final guidance entitled, Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements. This guidance provides recommendations for presenting quantitative efficacy and risk information in Direct-to-Consumer (DTC) promotional labeling and advertisements for prescription human drug and biological products and prescription animal drugs and in DTC promotional labeling for over-the-counter (OTC) animal drugs (collectively, “promotional communications”). FDA is issuing this guidance to detail its recommendations for how manufacturers, distributors, and packers that include quantitative efficacy or risk information about their drugs in DTC promotional communications can make the language and presentation more consumer-friendly. This guidance finalizes the draft guidance of the same title issued in October 2018.
• On June 27, 2023, FDA issued draft guidance entitled, Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act. This draft guidance describes FDA’s interpretation of, and policies concerning, the statutory prohibition on wholesaling for certain compounded drugs. This draft guidance also describes examples of how FDA intends to apply the statutory wholesaling provision.
• On June 29, 2023, FDA issued final guidance entitled, Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment. The purpose of this guidance is to assist sponsors in the development of drugs or biological products for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP). Specifically, this guidance addresses FDA’s current thinking regarding trial population and design, effectiveness, statistical analysis, and safety for drugs being developed for the treatment of CRSwNP. This guidance finalizes the draft guidance of the same title issued on December 10, 2021.
• On June 30, 2023, the Health Resources and Services Administration (HRSA) issued a notice entitled, Lists of Designated Primary Medical Care, Mental Health, and Dental Health Professional Shortage Areas. This is the first of two notices planned for the coming months informing the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, dental health, and mental health professional shortage areas (HPSAs). This notice includes the lists of HPSAs in a designated status as of April 28, 2023. The lists are available on the shortage area topic page on HRSA's website and includes HPSAs which are proposed for withdrawal but currently remain designated. HRSA is extending the transition time communicated in the notice published on July 7, 2022, for jurisdictions and facilities to prepare for potential loss of HPSA designations. HPSA designations that are currently proposed for withdrawal will remain in this status until they are re-evaluated in preparation for the publication of the January 2, 2024, HPSA Federal Register notice. If these HPSAs do not meet the requirements for designation by the data pull scheduled for November 15, 2023, they will be withdrawn with the publication of a second Federal Register notice planned for January 2, 2024.
• On June 30, 2023, HHS Office of the Inspector General (OIG) issued a final rule entitled, Grants, Contracts, and Other Agreements: Fraud and Abuse; Information Blocking; Office of Inspector General’s Civil Money Penalty Rules. This final rule amends the civil money penalty (CMP) regulations of HHS OIG to: incorporate new CMP authority for information blocking; incorporate new authorities for CMPs, assessments, and exclusions related to HHS grants, contracts, other agreements; and increase the maximum penalties for certain CMP violations.
• On June 30, 2023, CMS issued a proposed rule entitled, Medicare Program; Calendar Year (CY) 2024 Home Health (HH) Prospective Payment System Rate Update; HH Quality Reporting Program Requirements; HH Value-Based Purchasing Expanded Model Requirements; Home Intravenous Immune Globulin Items and Services; Hospice Informal Dispute Resolution and Special Focus Program Requirements, Certain Requirements for Durable Medical Equipment Prosthetics and Orthotics Supplies; and Provider and Supplier Enrollment Requirements. This proposed rule would set forth routine updates to the Medicare home health payment rates for calendar year (CY) 2024 in accordance with existing statutory and regulatory requirements. This rule would: (1) provide information on home health utilization trends and solicits comments regarding access to home health aide services; (2) implement home health payment-related changes; (3) rebase and revise the home health market basket and revise the labor-related share; (4) codify statutory requirements for disposable negative pressure wound therapy (dNPWT); and (5) implement the new items and services payment for the home intravenous immune globulin (IVIG) benefit. In addition, the rule proposes: (1) changes to the Home Health Quality Reporting Program (HH QRP) requirements and the expanded Home Health Value-Based Purchasing (HHVBP) Model; (2) to implement the new Part B benefit for lymphedema compression treatment items, codify the Medicare definition of brace, and make other codification changes based on recent legislation; (3) to add an informal dispute resolution (IDR) and special focus program (SFP) for hospice programs; (4) to codify Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) refill policy; and (5) to revise Medicare provider and supplier enrollment requirements.

Event Notices

• June 21-23, 2023: 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 mpox vaccines, influenza vaccines, pneumococcal vaccines, meningococcal vaccines, polio vaccine, respiratory syncytial virus vaccine pediatric/maternal, respiratory syncytial virus vaccine in adults, dengue vaccines, chikungunya vaccine, informational session by CDC Immunization Safety Office, and COVID-19 vaccines. Recommendation votes on influenza vaccines, pneumococcal vaccines, polio vaccines, and respiratory syncytial virus vaccine in adults are scheduled. Vaccines for Children votes on influenza and pneumococcal vaccines are scheduled.
• July 10, 2023: The National Institutes of Health (NIH) announced a meeting of the Frederick National Laboratory Advisory Committee (FNLAC) to the National Cancer Institute (NCI). The agenda will include discussion of ongoing and new activities at the Frederick National Laboratory for Cancer Research (FNLCR).
• July 19-20, 2023: HHS announced a public meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP). SACHRP was established to provide expert advice and recommendations to the Secretary of Health and Human Services through the Assistant Secretary for Health, on issues and topics pertaining to or associated with the protection of human research subjects. The agenda for day one will include: (1) opening remarks from Julie Kaneshiro, Acting Director of OHRP and Dr. Douglas Diekema, SACHRP Chair; (2) a discussion of internal review board (IRB) effectiveness, topic #4 of the recently published GAO report #GAO-23-104721, Institutional Review Boards: Actions Needed to Improve Federal Oversight and Examine Effectiveness; and (3) commentary on the FDA draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices, in addition to discussion of recommendations that address the ethical conduct of decentralized clinical trials in human subjects research more broadly. Discussions on IRB effectiveness and on decentralized clinical trials will continue on day two in addition to commentary on the recently released draft HHS guidance, Frequently Asked Questions: Limited Institutional Review Board Review and Related Exemptions.
• July 20, 2023: AHRQ announced a public meeting for software developers on the Common Formats for patient safety data collection. AHRQ coordinates the development of sets of standardized definitions and formats (Common Formats) that make it possible to collect, aggregate, and analyze uniformly structured information about health care quality and patient safety for local, regional, and national learning. The Common Formats include technical specifications to facilitate the collection of electronically comparable data by Patient Safety Organizations (PSOs) and other entities. This meeting is designed as an interactive forum where software developers can provide input on use of the formats. AHRQ especially requests participation by and input from those entities which have used AHRQ’s technical specifications and implemented, or plan to implement, the Common Formats electronically.
• August 9, 2023: HHS announced a public stakeholder listening session in preparation for the U.S. delegation to the Group of 20 (G20) Health Working Group Ministers’ Meeting. The Stakeholder Listening Session is designed to seek input from stakeholders and subject matter experts on priority areas expected to be covered at this meeting in order to help inform and prepare for U.S. government engagement with the G20 Health Ministers. The following have been identified as priorities for the G20 Health Working Group: (1) health emergency prevention, preparedness and response (including a focus on a One Health approach & antimicrobial resistance); (2) strengthening cooperation on availability of and access to safe, effective, quality and affordable medical countermeasures during health emergencies; and (3) digital health innovations and solutions to aid universal health coverage and improve health care service delivery.
• September 7, 2023: NIH announced a partially open meeting of the National Institute of General Medical Sciences (NIGMS) National Advisory General Medical Sciences Council (NAGMS Council). The open agenda will include discussion of program policies and issues; opening remarks; report of the Director of NIGMS; and other business of the NAGMS Council. The closed agenda will include review and evaluation of grant applications.
• September 12-13, 2023: NIH announced a partially open meeting of the Board of Regents of the National Library of Medicine (NLM). The open agenda will include program discussions. The closed agenda will include review and evaluation of grant applications.
• September 13, 2023: FDA announced a public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee (the Committee). The Committee will discuss supplemental new drug application (sNDA) 210922-s015, for ONPATTRO (patisiran) lipid complex for injection, submitted by Alnylam Pharmaceuticals, Inc., for the proposed treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults.
• September 28, 2023: NIH announced that the All of Us Research Program will be hosting a virtual Tribal Consultation with American Indian and Alaska Native (AI/AN) Federally Recognized Tribes. The All of Us program aims to accelerate health research and medical breakthroughs to enable an era of precision medicine for all and is committed to ensuring the program reflects the diversity of the U.S. This virtual consultation will include an update on NIH’s approach to Tribal engagement, discussion about integrating data from self-identified AI/AN participants in the program’s data platform, the All of Us Research Hub, and program planning.

II. Reports, Studies & Analyses

• On June 26, 2023, the Kaiser Family Foundation (KFF) published an issue brief entitled, Climate-Related Health Risks Among Workers: Who is at Increased Risk? Research has found that climate change is increasingly contributing to adverse health outcomes (e.g., due to extreme heat, poor air quality, increased risk of infectious disease transmission, etc.) and that risk of climate-related health impacts varies across occupations. In this issue brief, the authors assessed occupations that are at increased risk of climate-related health impacts and the characteristics of workers in these jobs. The authors noted that some occupations are more at-risk to climate-related health impacts than others, such as agricultural workers, construction workers, firefighters, water sanitation workers, food preparation workers, and health care workers, among others. An estimated 65.7 million nonelderly adults work in these occupations. Among them, people of color and noncitizen immigrants as well as people with lower education and income levels are more likely to be in jobs with increased climate-related health risks. Further, nonelderly workers in higher-risk occupations are less likely to have health insurance. The authors concluded that climate-related health impacts exacerbate and compound existing disparities for vulnerable and underserved populations. They emphasized that as the threat of climate change continues to grow, actions to address climate-related health risks must also address social and economic inequities that lead to disparate occupational exposures.
• On June 26, 2023, the Congressional Budget Office (CBO) published a report entitled, CBO’s Macroeconomic Analysis of Legislation, Health Care Modeling, and Support for the Legislative Process. In response to a request from Chairman Jodey Arrington (R-TX-19) of the House Committee on the Budget, CBO provided information about the office’s ongoing work in macroeconomic analysis of legislation, health care modeling, and supporting the legislative process. The agency described its dynamic approach to understand how legislation may affect the total output of the economy and how macroeconomic changes affect federal revenues and spending. Specifically, to understand the budgetary effects of federal spending on health care, CBO made extended baseline projections using not only its current understanding but also its capacity to analyze overall trends related to access and availability of preventive health care, the health status of the population, the development and adoption of innovative technologies, and the effects of market forces on health care costs. CBO also supports House and Senate committees throughout the legislative process by providing technical assistance, cost estimates, and background information. CBO reports its findings along with explanations for its methods and is continually taking action to ensure its processes and analyses remain transparent. For example, CBO is currently undertaking efforts to: (1) explain how it analyzes policies that expand access to treatments; and (2) describe how it assesses the implications of legislation on the availability of products (e.g., legislation regulating prescription drugs or increasing competition) in the market.
• On June 27, 2023, Better Medicare Alliance (BMA) and Avalere Health released a report entitled, Analysis of Medicare Advantage Enrollee Demographics, Utilization, Spending, and Quality Compared to Fee-for-Service Medicare Among Enrollees with Chronic Conditions. The report examined health outcomes, characteristics, and utilization trends of Medicare Advantage (MA) and Fee-for-Service (FFS) Medicare beneficiaries with certain chronic conditions, including hypertension, hyperlipidemia, and diabetes. The report also assessed spending on and quality of care received for these two populations. The report found that MA population had higher proportions of beneficiaries with clinical and social risk factors, who identify as racial or ethnic minorities, and who had hypertension and hyperlipidemia. On the other hand, rates of diabetes were equal between the MA and FFS populations. Authors also found that compared to the FFS population, the MA population, including those with the three chronic conditions studied, had lower overall annual spending on health care, as well as lower utilization rates of high-cost services (e.g., inpatient stays and emergency room visits) and higher utilization rates of physician office visits. Additionally, quality of care was similar between the MA and FFS populations based on several measures, although MA beneficiaries did report higher rates of comprehensive diabetes care. The authors concluded that the demographic differences and spending differences between MA and FFS populations warrant further study.
• On June 28, 2023, GAO published a report entitled, Medicaid: CMS Oversight and Guidance Could Improve Recovery Audit Contractor Program. GAO reviewed states’ use of the Medicaid Recovery Audit Contractor (RAC) program and CMS’ oversight of these programs. The RAC program was established by the Patient Protection and Affordable Care Act (ACA) as an optional program to help state Medicaid agencies identify and recoup overpayments and identify underpayments. GAO's review found that 34 states and the District of Columbia (D.C.) did not participate in the RAC program during fiscal year (FY) 2021, mostly because they had other Medicaid program-integrity initiatives in place. GAO also found that CMS does not have written procedures for documenting and monitoring their approvals for exempting states from the Medicaid RAC program. This means that if a state’s exemptions expired but CMS did not track it, the Agency may miss opportunities to collect overpayments. As such, GAO recommended that CMS establish written policies to document and communicate an expiration date for a state’s exemption from the Medicaid RAC program. Additionally, GAO noted that the Medicaid RAC program may benefit from including payments to managed care organizations (MCOs) because states regularly use recovery audit contracts to collect overpayments effectively from MCOs. Thus, GAO recommended CMS conduct a cost-effectiveness study to determine whether states should include payments to managed care organizations as part of the RAC program.
• On June 29, 2023, KFF published an issue brief entitled, What Does the Recent Literature Say About Medicaid Expansion?: Impacts on Sexual and Reproductive Health. The authors summarized 40 studies published between April 2021 and June 2023 to assess the impact of Medicaid expansion on a range of sexual and reproductive health outcomes, including: (1) health insurance coverage before, during, and after pregnancy; (2) maternal and infant health access, utilization, and outcomes; (3) family planning; and (4) HIV care and prevention. Since the ACA offered to provide states with an enhanced Federal Medical Assistance Percentage (FMAP) for expanding Medicaid coverage to nearly all adults with incomes up to 138 percent of the Federal Poverty Level (FPL), all but 10 states have done so. The authors found that generally, Medicaid expansion is associated with increased health insurance coverage prior to and after pregnancy; access to and utilization of prenatal and postpartum care; birth and postpartum outcomes; use of contraception, and access to HIV care and prevention. However, some studies found that Medicaid expansion had little to no effect on certain maternal health outcomes or contraception use in certain populations. The authors concluded that these findings warrant further study, especially to understand the effect of Medicaid expansion against the evolving landscape in states’ Medicaid eligibility processes, abortion policies, and policies related to LGBTQ+ populations.

III. Other Health Policy News

• On June 26, 2023, HHS hosted the HHS Pride Summit, which brought together advocates and leaders from the LGBTQI+ community. At the summit, attendees and presenters highlighted efforts by the Biden Administration to improve access to health care services, health equity, support for identity affirmation, and civil rights for the LGBTQI+ community. For example, HHS recently launched a federal website, FindSupport.Gov, which will have resources for LGBTQI+ individuals seeking access to mental health care. In addition to efforts already undertaken to increase access to mental health services in schools, HHS will soon release the Behavioral Health Care Advisory on Transgender and Gender Diverse Youth to provide evidence-based practices for mental health providers. Further, the Department is also taking steps to codify health care insurance and treatment protections for LGBTQI+ individuals as well as releasing guidance to states to make clear that the state child welfare agencies should take steps to advance the safety of and support for LGBTQI+ youth. More information on this announcement and other actions can be found here.
• On June 27, 2023, HHS announced the publication of its report, the Physical Activity Guidelines for Americans Midcourse Report: Implementation Strategies for Older Adults. This report explores evidence-based interventions to support physical activity among older adults 65 years of age and older. This report builds upon the Physical Activity Guidelines for Americans (federal guidance on physical activity and fitness for all Americans) by specifically focusing on how to help older adults achieve the recommended 150 minutes or more of moderate-intensity aerobic physical activity and 2 days of muscle-strengthening physical activity each week. This report also describes strategies policymakers, exercise and health professionals, providers, and built-environment professionals can use to encourage and increase physical activity among older adults. More information on this announcement and the report can be found here.
• On June 27, 2023, CMS issued guidance to state Medicaid and Children's Health Insurance Program (CHIP) agencies on section 11405 of the IRA, which describes new mandatory coverage requirements for approved adult vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) without cost sharing. Specifically, beginning October 1, 2023, the IRA requires state Medicaid and CHIP agencies to cover and pay for both the procurement and administration of adult vaccines recommended by ACIP. CMS notes that by expanding coverage of ACIP-recommended vaccines for adults, the U.S. will see improved health and lower overall costs of care due to reduced rates of serious illness and hospitalizations. This guidance also outlines the requirements that states must meet in order to claim a one percentage point FMAP increase for these services. More information on this guidance can be found here.
• On June 28, 2023, HHS, through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced the distribution of $31.5 million through three behavioral health grants for children and young adults. Specifically, $10.5 million was awarded to 13 communities through the Linking Action for Unmet Needs in Children’s Health (Project LAUNCH) grant program, which aims to address the social, emotional, cognitive, physical and behavioral aspects of children from birth to 8 years of age. $2.3 million was awarded to recipients through the Community Programs for Outreach and Intervention with Youth and Young Adults at Clinical High Risk for Psychosis, which will help recipients use evidence-based interventions to support youth and young adults at clinical high risk for psychosis. $18.9 million was awarded to 35 community organizations through the Enhancement and Expansion of Treatment and Recovery Services for Adolescents, Transitional Aged Youth, and their Families (Youth and Family TREE) program, which aims to support adolescents and transitional-aged youth with substance use disorders (SUDs) and/or co-occurring mental health disorders. These three programs will help support children and young people with mental health illnesses and their families. More information on this announcement can be found here.
• On June 29, 2023, HHS released a draft framework designed to support and accelerate smoking cessation and deliver equitable outcomes for all Americans. Cigarette smoking is the single largest driver of cancer deaths in the U.S., resulting in more than 480,000 deaths each year. This draft framework was delivered by expert stakeholders to increase collaboration across HHS and nonfederal stakeholders to increase access to and availability of smoking cessation resources and to reduce smoking-related health disparities. Specifically, the draft framework identifies six goals: (1) eliminate smoking-related and cessation-related disparities; (2) increase awareness of smoking and cessation; (3) strengthen cessation services; (4) increase access to and coverage of cessation treatment; (5) expand public health surveillance, measurement, and evaluation of smoking and cessation behaviors; and (6) promote innovative research to accelerate smoking cessation. The draft framework will also be open for public comment through July 30, 2023. More information on this announcement can be found here.
• On June 30, 2023, HHS released revised guidance from CMS on the Medicare Drug Price Negotiation Program established by the IRA. Through this program, Medicare will be able to negotiate directly with drug manufacturers to bring down the price of covered high-cost prescription drugs beginning in 2023. This guidance details the first round of negotiations which will occur during 2023 and 2024 and result in prices that will be effective beginning in 2026. For example, the guidance explains how CMS will negotiate to reach agreement on a maximum fair price for a selected drug with participating manufacturers, including by assessing: (1) a drug’s clinical benefit, (2) the extent to which it fulfills an unmet medical need, (3) its impact on Medicare beneficiaries, (4) costs associated with research and development of the drug, and (5) costs associated with production and distribution of the drug, among others. This guidance also clarifies additional opportunities for drug companies and members of the public to engage with CMS during the negotiation process on the selected drugs. CMS is expected to announce the first 10 drugs selected for negotiation by September 1, 2023. More information on this announcement can be found here and here.

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