Health Care Week in Review: New House Speaker Elected; HRSA Issued a Notice on 340B Drug Pricing Program Requirements

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, members of the House of Representatives elected Representative Mike Johnson (R-LA-4) as the new Speaker and the Health Resources and Services Administration (HRSA) issued a notice of registration requirements for off-site, outpatient hospital facilities to participate in the 340B Drug Pricing Program.

I. Regulations, Notices & Guidance

• On October 23, 2023, the Health Resources and Services Administration (HRSA) issued a notice of request for public comment on a proposed update entitled, Proposed Update to the Bright Futures Periodicity Schedule as Part of the HRSA-Supported Preventive Services Guidelines for Infants, Children, and Adolescents. This notice seeks public comment on a proposed update to the Periodicity Schedule of the Bright Futures Recommendations for Pediatric Preventive Health Care (Bright Futures Periodicity Schedule), as part of the HRSA-supported preventive services guidelines for infants, children, and adolescents.
• On October 23, 2023, the Food and Drug Administration (FDA) issued draft guidance entitled, Communications From Firms to Health Care Providers Regarding Scientific Information. This revised draft guidance, when finalized, will provide FDA’s current thinking on common questions regarding certain communications by firms to health care providers of scientific information on unapproved use(s) of approved/cleared medical products. This revised guidance supersedes the revised draft guidance entitled Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices issued in 2014.
• On October 23, 2023, the Drug Enforcement Administration (DEA) issued a notice entitled, Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals. The Controlled Substances Act provides for civil penalties for the distribution of a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, if that distribution was made with reckless disregard for the illegal uses to which such laboratory supply will be put. The term laboratory supply is defined as a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals. DEA is hereby publishing a final notice to update the Special Surveillance List.
• On October 23, 2023, the Administration for Children and Families (ACF) issued a request for public comment entitled, Title IV-E Prevention Services Clearinghouse Handbook of Standards and Procedures, Draft Version 2.0. ACF oversees the Title IV-E Prevention Services Clearinghouse. ACF seeks comments on proposed changes and clarifications to existing standards and procedures in the Handbook of Standards and Procedures, Version 2.0.
• On October 25, 2023, FDA issued guidance entitled, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry. FDA is issuing this draft guidance to describe how FDA requests and conducts voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held, and at facilities covered under FDA’s bioresearch monitoring program. FDA may consider the use of a remote interactive evaluation for any of the inspection program areas described in the guidance. FDA is also announcing the withdrawal of the guidance entitled, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency.
• On October 25, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Medicare and Medicaid Programs; Quarterly Listing of Program Issuances— July through September 2023. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published in the 3-month period, relating to the Medicare and Medicaid programs and other programs administered by CMS.
• On October 26, 2023, HRSA issued a notice entitled, Registration Requirements in the 340B Drug Pricing Program. HRSA issued the notice to inform and remind stakeholders of the registration requirements for off-site, outpatient hospital facilities to participate in the 340B Drug Pricing Program (340B Program). This notice applies to all hospital types that participate in the 340B Program.
• On October 26, 2023, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a notice entitled, Reorganization of the Center for Mental Health Services, to announce it has modified its structure. This new organizational structure was approved by the Secretary of Health and Human Services (HHS) on October 11, 2023, and became effective on October 26, 2023.
• On October 27, 2023, HRSA issued a notice entitled, Charter Renewal for the National Advisory Committee on Rural Health and Human Services. In accordance with the Federal Advisory Committee Act, HHS is hereby giving notice that the National Advisory Committee on Rural Health and Human Services (NACRHHS) has been renewed. The effective date of the renewed charter is October 29, 2023.
• On October 27, 2023, CMS issued a final rule entitled, 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 final rule updates and revises the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year (CY) 2024. This rule also updates the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury (AKI). In addition, this final rule updates requirements for the ESRD Quality Incentive Program and the ESRD Treatment Choices Model.
• On October 27, 2023, HHS issued a proposed rule entitled, Federal Independent Dispute Resolution Process. This document sets forth proposed rules related to certain provisions of the No Surprises Act regarding the federal independent dispute resolution (IDR) process. These proposed rules would set forth new requirements relating to the disclosure of information that group health plans and health insurance issuers must include along with the initial payment or notice of denial of payment for certain items and services. These proposed rules would also require plans and issuers to communicate information by using claim adjustment reason codes (CARCs) and remittance advice remark codes (RARCs), when providing any paper or electronic remittance advice to an entity that does not have a contractual relationship with the plan or issuer. This document also proposes to amend certain requirements related to the open negotiation period preceding the federal IDR process, the initiation of the federal IDR process, the federal IDR dispute eligibility review, and the payment and collection of administrative fees and certified IDR entity fees. This document also proposes to define bundled payment arrangements, amend requirements related to batched items and services, and amend the rules for extensions of timeframes due to extenuating circumstances. Additionally, this document proposes to require plans and issuers to register in the Federal IDR portal.

Event Notices

• October 31, 2023: The National Institutes of Health (NIH) announced a meeting of the National Advisory Child Health and Human Development Council Stillbirth Working Group. This is a virtual meeting open to the public.
• October 31 and November 1, 2023: CMS announced a meeting of the Ground Ambulance and Patient Billing (GAPB) Advisory Committee. The committee will make recommendations with respect to the disclosure of charges and fees for ground ambulance services and insurance coverage, consumer protection and enforcement authorities of the Department of Labor (DOL), HHS, the Department of the Treasury, and relevant states, and the prevention of balance billing to consumers. This is a virtual meeting that is open to the public.
• November 2 and 3, 2023: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Healthcare Infection Control Practices Advisory Committee. This is a virtual meeting open to the public.
• November 2 and 3, 2023: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a virtual meeting open to the public.
• November 7, 2023: FDA announced a meeting of the Radiological Devices Panel of the Medical Devices Advisory Committee. This is a virtual meeting open to the public.
• November 9, 2023: The Office of the National Coordinator for Health Information Technology (ONC) announced a meeting of the Health Information Technology Advisory Committee. This is a hybrid meeting open to the public.
• November 13 and 14, 2023: The Administration for Strategic Preparedness and Response (ASPR) announced its Biomedical Advanced Research and Development Authority (BARDA) Industry Day 2023. BARDA annually hosts a two-day conference with industry and government partners to share BARDA’s goals and objectives, increase awareness of U.S. government medical countermeasure (MCM) priorities, and facilitate collaboration between public and private sectors within the health security space. This year, BARDA plans to discuss implementation efforts for the 2022-2026 Strategic Plan. This is a hybrid event open to the public.
• November 14, 2023: CDC announced a meeting of the Advisory Committee to the CDC Director. This is a hybrid meeting that is open to the public. There will be an opportunity for public comment.
• November 16, 2023: NIH announced that the Diabetes Mellitus Interagency Coordinating Committee will hold a public online meeting entitled, The Application of Digital Health Technology to Type 2 Diabetes Management: Current Status, Research Gaps, and Opportunities.
• November 16, 2023: FDA announced a meeting of the Oncologic Drugs Advisory Committee. This is a virtual meeting that will be open to the public and the agency is establishing a docket for public comment on this document.
• November 17, 2023: NIH announced a meeting of the National Advisory Child Health and Human Development Council Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) Implementation Working Group. This is a virtual meeting open to the public.
• November 28, 29, 30, 2023: CMS announced a virtual public meeting entitled, New Revisions to the Healthcare Common Procedure Coding System (HCPCS) to discuss preliminary coding, Medicare benefit category, and payment determinations for new revisions to the HCPCS Level II code set for non-drug and nonbiological products.
• November 29, 2023: NIH announced the National Cancer Institute will hold a meeting of their Frederick National Laboratory Advisory Committee. This is a virtual meeting open to the public.
• November 30, 2023: CDC announced a meeting of the Board of Scientific Counselors, Deputy Director for Infectious Diseases. This is a virtual meeting open to the public.
• November 30, 2023: FDA announced a public workshop entitled, Advancing the Development of Pediatric Therapeutics on Drug Dosing in Pediatric Patients with Renal Impairment. The workshop will discuss the current landscape of drug dosing in pediatric patients with renal impairment, discuss the gaps in knowledge, and consider innovative approaches to improve the current paradigm for dosing in pediatric patients with renal impairment.
• December 4 and 5, 2023: NIH announced a meeting of the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The meeting will be videocast and is open to the public.
• December 5 and 6, 2023: HRSA announced a meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). This is a hybrid meeting open to the public.
• December 6, 2023: SAMHSA announced a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The meeting will include reports from the ISUDCC working groups and discussion of the ISUDCC’s recommendations to HHS on how the federal government can further integrate and coordinate harm reduction approaches and strategies across the continuum of prevention, treatment, and recovery policies, programs, and practices. This is a virtual meeting open to the public.
• December 7, 2023: NIH announced the National Heart, Lung, and Blood Institute will hold a meeting to update their Advisory Board and public stakeholders on research agendas across NIH for fiscal year (FY) 2024. This is a virtual public meeting that requires registration to attend.
• December 12 and 13, 2023: CDC announced a meeting of the Advisory Council for the Elimination of Tuberculosis (ACET). This is a virtual meeting open to the public.
• December 13 and December 14, 2023: HHS announced it will hold a virtual public town hall meeting to discuss FY 2025 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS).
• January 29, 2024: NIH announced the National Heart, Lung, and Blood Institute Sickle Cell Disease Advisory Committee will hold a virtual meeting open to the public.

II. Hearings & Markups

U.S. House of Representatives

• On October 25, 2023, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Supporting Access to Long-Term Services and Supports: An Examination of the Impacts of Proposed Regulations on Workforce and Access to Care. Witnesses present included Sarah Schumann, Vice President of Operations, Brookside Inn; Mary Killough, Vice President of Operations and Government Relations, AccentCare; Shelly Hughes, Certified Nurse Aide; Lori Smetanka, Executive Director, The National Consumer Voice for Quality Long-Term Care; and, Patti Killingsworth, Former Chief of LTSS, TennCare; Chief Strategy Officer, CareBridge Health.

U.S. Senate

• On October 25, 2023, the Senate Health, Education, Labor, and Pension (HELP) Committee held an executive session to advance nominations for positions in multiple agencies. Dr. Monica Bertagnolli’s nomination for NIH Director was voted on favorable during this hearing and will advance to a full committee vote.
• On October 26, 2023, the Senate Special Committee on Aging held a hearing entitled, Unlocking Hope: Access to Therapies for People with Rare, Progressive, and Serious Diseases. Witnesses present included Brian Wallach, JD, Co-Founder, I AM ALS; Maureen Bell, Galactosemia Patient and Advocate; Margaret Plews-Ogan, MD, Brodie Professor of Medicine; Anish Bhatnagar, MD, Chief Executive Officer, Soleno Therapeutics; Holly Fernandez Lynch, JD, MBe, Assistant Professor of Medical Ethics and Law, University of Pennsylvania; and Keith Desserich, Chairman/Co-Founder, The Cure Starts Now Foundation, President, Pediatric Brain Tumor Consortium Foundation.
• On October 27, 2023, the Senate HELP Committee held a field hearing entitled, Overworked and Undervalued: Is the Severe Hospital Staffing Crisis Endangering the Well-Being of Patients and Nurses?. Witnesses present included Judith Danella, RN, Staff Nurse, RWJ Barnabas Health, President, United Steelworkers Local 4-200; Carol Tanzi, RN, BSN; Pediatric Recovery Room Nurse, RWJ Barnabas Health; Nancy Hagans, RN, President of National Nurses United, President of New York State Nurses Association; Debbie White, RN, President, Health Professionals and Allied Employees; and Patricia Pittman, PhD, Fitzhugh Mullan Professor of Health Workforce Equity and Director of the Mullan Institute for Health Workforce Equity, George Washington University.

III. Reports, Studies, & Analyses

• On October 20, 2023, the Office of the Inspector General (OIG) released a report entitled, States Face Ongoing Challenges in Meeting Third-Party Liability Requirements for Ensuring That Medicaid Functions as the Payer of Last Resort. In this report, OIG sought to identify challenges to states in their efforts to meet third-party liability (TPL) requirements and actions they have taken to address those challenges. Additionally, OIG determined whether states reported Medicaid TPL amounts on the CMS-64 statement in accordance with federal requirements. The report found that states reported experiencing several challenges in their efforts to meet TPL requirements, including: 1) difficulties obtaining complete, accurate, and up-to-date coverage information from Medicaid enrollees and providers; 2) difficulties obtaining timely and reliable coverage information from third parties; 3) difficulties coordinating TPL with out-of-state third parties; 4) technical issues related to third-party coverage information received and electronic billing of Medicaid claims with third parties; 5) a lack of federal prompt payment requirements and penalties for third parties that do not cooperate with states’ efforts to meet TPL requirements; 6) difficulties coordinating TPL with Tricare health insurance, the U.S. military’s health care program; and 7) difficulties coordinating TPL with Medicare. The report also showed some states did not have laws addressing all Deficit Reduction Act of 2005 provisions, as required by federal law. According to the report, states did not always report TPL amounts according to federal requirements. Specifically, 27 states either did not report or did not correctly report TPL amounts during at least one fiscal quarter of our audit period.
• On October 26, 2023, OIG released a report entitled, CDC's Internal Control Weaknesses Led to Its Initial COVID-19 Test Kit Failure, but CDC Ultimately Created a Working Test Kit. OIG investigated CDC’s process for developing the COVID-19 test kits and determine factors that contributed to the initial COVID-19 test kit failure. OIG identified weaknesses in CDC’s COVID-19 test kit development processes and the agencywide laboratory quality processes that may have contributed to the failure of the initial COVID-19 test kits. The report found that without effective internal controls, CDC may: 1) experience delays in the development of test kits when responding to future public health emergencies; 2) not identify problems in a timely manner when developing test kits; and 3) risk damaging public trust, which could undermine its ability to accomplish its mission. OIG also offered recommendations to CDC, including the following: 1) create policies and procedures for developing test kits; 2) ensure that the recently finalized Graduated Response Framework addresses OIG’s report findings; 3) develop and implement documented processes to ensure that adequate staffing and laboratory space can be obtained for future responses; 4) re-evaluate the Incident Management System structure at all levels of CDC’s response framework; 5) implement a CDC-wide laboratory document control system; and 6) ensure that all infectious disease laboratories implement and periodically evaluate a laboratory quality management system.
• On October 27, 2023, Alston & Bird published an advisory entitled, Is Medicare Physician Fee Schedule Reform on the Horizon?. Alston & Bird’s Brian Lee, Mark Rayder, James Paluskiewicz, and Timothy Cordova explained how draft legislation from the House Republican Doctors Caucus entitled, the Provider Reimbursement Stability Act of 2023 (PRSA) aims to reform the Medicare Physician Fee Schedule (PFS). The draft legislation aims to stabilize the PFS in the following ways: 1) raising the budget neutrality threshold from $20 million to $53 million in 2025 and increasing the threshold every five years using the cumulative increase in the Medicare Economic Index starting in 2030; 2) requiring CMS to analyze its utilization estimates compared to actual utilization by September 1^st of a given year and if there is a difference between the estimate and the actual utilization, and that difference implicates budget neutrality, adjust payments made to providers to account for the actual utilization data; 3) requiring CMS to update, at least every five years, the direct cost inputs for practice expense (PE) relative value units (RVU) of clinical staff wage rates, medical supplies, and equipment; and 4) limiting the increases or decreases to the conversion factor to no more than 2.5 percent each year to provide greater PFS payment stability should there be budget neutrality adjustments. The advisory noted an additional proposed PFS reform being considered by Congress is the Strengthening Medicare for Patients and Providers Act, which provides for an annual update to PFS payments that is tied to inflation. This proposal was not included in PRSA.

IV. Other Health Policy News

• On October 19, 2023, Representatives Yadira Caraveo (D-CO-8), John Moolenaar (R-MI-2), Andrea Salinas (D-OR-6), and Delegate James Moylan (R-Guam) introduced H.R. 5989, the Rural Health Care Facilities Revitalization Act. This bill is intended to help rural hospitals with infrastructure costs through the Community Facilities Program at the U.S. Department of Agriculture (USDA). The legislation would expand funding for rural health facilities to upgrade equipment and strengthen operations to help adapt to new telehealth and digital capabilities. The Office of Rural Development within USDA would provide loans and loan guarantees for the following purposes: 1) refinancing debt; 2) updating telehealth services, medical equipment, online databases, and other digital technology; and 3) supporting ancillary needs including operating expenses and reserve funds. Additionally, the bill would allow the Secretary of Agriculture to waive credit requirements for facilities in financially distressed or vulnerable areas. A press release announcing the introduction of the bill is available here.
• On October 24, 2023, Senator Bob Casey (D-PA), Chairman of the U.S. Senate Special Committee on Aging, introduced the Home and Community-Based Services (HCBS) Relief Act of 2023. The legislation would provide dedicated Medicaid funds to states for two years to stabilize their HCBS service delivery networks, recruit and retain HCBS direct care workers, and meet the long-term service and support needs of people eligible for Medicaid home and community-based services. Under the HCBS Relief Act, States would receive a 10-point increase in the federal match (FMAP) for Medicaid for two fiscal years to enhance HCBS. Funds could be used to increase direct care worker pay, provide benefits such as paid family leave or sick leave, and pay for transportation expenses to and from the homes of those being served. The additional funds also can be used to support family caregivers, pay for recruitment and training of additional direct care workers, and pay for technology to facilitate services. Chairman Casey introduced this bill along with 17 other democratic colleagues including Senators Tammy Duckworth (D-IL), Elizabeth Warren (D-MA), and Bernie Sanders (I-VT). A press release with more information is available here. The full text of the bill is available here.
• On October 25, 2023, Representative Mike Johnson (R-LA-4) was elected as Speaker of the U.S. House of Representatives. All 220 Republicans voted in favor of his Speakership and 209 Democrats voted against him. The successful vote follows three weeks of turmoil on the selection of a new Speaker. On October 23, 2023, Speaker Johnson sent a letter to his GOP colleagues outlining legislative priorities as well as short-term and long-term timelines for his agenda if elected. The current short-term government funding patch, or continuing resolution (CR), expires on November 17, 2023. Speaker Johnson has proposed a plan to pass another CR that would last until early 2024, which would provide additional time to pass necessary legislation. The Speaker plans to advance each of the 12 appropriations bills required to fund the government individually over the next several months. Notably, Speaker Johnson has announced plans to bring up the fiscal year (FY) 2025 Labor- Health and Human Services-Education appropriations bill for a floor vote during the week of November 13, 2023. Speaker Johnson laid out in his letter a number of other legislative and policy priorities that he would like to accomplish over the next several months, including voting on a resolution to condemn Hamas and beginning negotiations on several authorization bills. In addition, Speaker Johnson proposed keeping the House in session for its annual August recess in 2024 if the House has not passed all 12 FY 2025 appropriations bills by that time. The letter from Speaker Johnson to his colleagues is available here.
• On October 25, 2023, the Senate HELP Committee voted to advance the nomination of Dr. Monica Bertagnolli for Director for NIH by a vote of 15 to 6. All Democrats on the Committee voted in favor of advancing Dr. Bertagnolli’s nomination, except Chairman Bernie Sanders (I-VT). Ranking Member Bill Cassidy (R-LA) and Republican members including Senators Susan Collins (R-ME), Mitt Romney (R-UT), and Roger Marshall (R-KS) supported the nomination as well. The vote comes after Chairman Sanders delayed Dr. Bertagnolli’s confirmation hearing for several months because he believes that NIH should be taking more aggressive action to lower drug costs. Despite his objections, Dr. Bertagnolli received bipartisan support from HELP Committee members and her nomination will now move to the Senate floor for a full vote, which has not yet been scheduled. If confirmed, Dr. Bertagnolli will be the first permanent director of the NIH in nearly two years.
• On October 26, 2023, Representatives Doris Matsui (D-CA-7), Neal Dunn (R-FL-2), Mike Thompson (D-CA-04), and Mike Kelly (R-PA-16) introduced the Providing Realistic Opportunity to Equal and Comparable Treatment for Rare (PROTECT Rare) Act. This legislation aims to support patients with rare and ultra-rare diseases in getting evidence-based, medically necessary care covered by their health insurance by allowing Medicare and Medicaid to use additional sources, including peer-reviewed literature, when considering whether rare disease therapies meet the standard for “medically accepted indications” to provide coverage. It will also require private payers to create an expedited review pathway for formulary exception, reconsideration, and/or appeal of any denial of coverage for a drug or biological prescribed for a patient with a rare disorder. The bill was introduced during a hearing held by the Senate Special Committee on Aging entitled, Unlocking Hope: Access to Therapies for People with Rare, Progressive, and Serious Diseases. The full text of the bill is available here.
• On October 26, 2023, the Cybersecurity and Infrastructure Security Agency (CISA) and HHS released a cybersecurity tool kit that includes resources tailored for the healthcare and public health sector. The toolkit consolidates resources from CISA, including: 1) CISA’s Cyber Hygiene Services, which uses vulnerability scanning to help secure against known vulnerabilities, reduces the risk of cyberattacks and encourages the adoption of best practices; 2) HHS’s Health Industry Cybersecurity Practices, which outlines effective cybersecurity practices healthcare organizations of all sizes can adopt to become more cyber resilient; 3) HHS and the Health Sector Coordinating Council’s (HSCC’s) Healthcare and Public Health (HPH) Sector Cybersecurity Framework Implementation Guide. The guide was created to help organizations assess and improve their level of cyber resiliency and provide suggestions on how to link cybersecurity with their overall information security and privacy risk management activities. The toolkit was released ahead of a roundtable discussion co-hosted by CISA and HHS on the cybersecurity challenges that the U.S. HPH sector system faces, and how government and industry can work together to close the gaps in resources and cyber capabilities.

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