Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare 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:

On November 15, CMS announced its CY 2020 OPPS Price Transparency for Hospitals Final Rule and Transparency in Coverage Proposed Rule. Read more about the rules and other news below.

I. Regulations, Notices, & Guidance

• On November 12, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Medicaid Program: Medicaid Fiscal Accountability Regulation. This proposed rule would promote transparency by establishing new reporting requirements for states to provide CMS with certain information on supplemental payments to Medicaid providers, including supplemental payments approved under either Medicaid state plan or demonstration authority, and applicable upper payment limits. Additionally, the proposed rule would establish requirements to ensure that state plan amendments proposing new supplemental payments are consistent with the proper and efficient operation of the state plan and with efficiency, economy, and quality of care. This proposed rule addresses the financing of supplemental and base Medicaid payments through the non-federal share, including states' uses of health care-related taxes and bona fide provider-related donations, as well as the requirements on the non-federal share of any Medicaid payment.
• On November 13, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Process to Request a Review of Food and Drug Administration's Decision Not to Issue Certain Export Certificates for Devices. FDA is issuing this guidance to comply with changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Reauthorization Act of 2017 (FDARA), which specifies the process afforded to persons denied a Certificate to Foreign Government (CFG) for a device. This guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), in collaboration with the Office of Regulatory Affairs (ORA), will provide to a person whose request for a CFG for a device is denied, and the process for seeking review of such a denial.
• On November 15, 2019, FDA issued guidance entitled, Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention. The purpose of this guidance is to assist sponsors in the clinical development of drugs for treating or preventing smallpox (variola virus) infection. This guidance addresses nonclinical development, key study design considerations for animal efficacy studies to support potential new drug application (NDA) submissions under the Animal Rule, and considerations for obtaining a human safety database.
• On November 15, 2019, CMS issued a final rule entitled, CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates: Price Transparency Requirements for Hospitals to Make Standard Charges Public. This final rule establishes requirements for hospitals operating in the United States to establish, update, and make public a list of their standard charges for the items and services that they provide. CMS believes these actions are necessary to promote price transparency in health care and public access to hospital standard charges. By disclosing hospital standard charges, CMS believes the public (including patients, employers, clinicians, and other third parties) will have the information necessary to make more informed decisions about their care. These final policies are intended help to increase market competition, and ultimately drive down the cost of health care services, making them more affordable for all patients.
• On November 15, 2019, CMS issued a proposed rule entitled, Transparency in Coverage. This proposed rule sets forth requirements for group health plans and health insurance issuers in the individual and group markets to disclose cost-sharing information upon request, to a participant, beneficiary, or enrollee (or his or her authorized representative), including an estimate of such individual’s cost-sharing liability for covered items or services furnished by a particular provider. Under this proposed rule, plans and issuers would be required to make such information available on an internet website and, if requested, through non-internet means, thereby allowing a participant, beneficiary, or enrollee (or his or her authorized representative) to obtain an estimate and understanding of the individual’s out-of-pocket expenses and effectively shop for items and services. The rule also includes proposals to require plans and issuers to disclose in-network provider negotiated rates, and historical out-of-network allowed amounts through two machine-readable files posted on an internet website, thereby allowing the public to have access to health insurance coverage information that can be used to understand health care pricing and potentially dampen the rise in health care spending. The Department of Health and Human Services (HHS) also proposes amendments to its medical loss ratio program rules to allow issuers offering group or individual health insurance coverage to receive credit in their medical loss ratio calculations for savings they share with enrollees that result from the enrollee’s shopping for, and receiving care from, lower-cost, higher-value providers.

Event Notices         

• November 21, 2019: FDA announced a public meeting entitled, Pediatric Stakeholder Meeting. The purpose of the meeting is to solicit input from patient/parent groups, consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA).
• November 22, 2019: HHS announced a public meeting entitled, National Clinical Care Commission. The Commission will evaluate and make recommendations to the HHS Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for complex metabolic or autoimmune diseases that result from issues related to insulin that represent a significant disease burden in the United States, which may include complications due to such diseases. During this fifth meeting, the Commission will hear from informants from selected federal agencies about programs related to diabetes prevention and treatment and discuss potential topics for the Commission’s final report.
• November 22, 2019: FDA announced a public meeting entitled, Blood Products Advisory Committee. The Committee will meet in open session to discuss scientific considerations for cold stored platelet products intended for transfusion, including product characterization, duration of storage and clinical indications for use. The committee will hear presentations on available characterization and functional studies of cold stored platelets, clinical studies, and the potential role of cold stored platelets in clinical care in military and civilian patient populations. The committee will also discuss the clinical studies needed to support the indications for use of cold stored platelet products stored beyond 3 days.
• December 5-6, 2019: The National Institute of Health (NIH) announced a public workshop entitled, National Center for Advancing Translational Sciences. This workshop is being held to discuss challenges around finding new uses for drugs that are already on the market but lack commercial and regulatory incentives for research and development.
• December 6, 2019: FDA announced a public meeting entitled, Patient-Focused Drug Development Guidance: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making. The purpose of this meeting is to discuss incorporating clinical outcome assessments into endpoints for regulatory decision making. This workshop will inform development of patient-focused drug development guidance as required by the 21st Century Cures Act (Cures Act) and as part of commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Amendments (PDUFA VI).
• December 16-17, 2019: CMS announced a town hall meeting entitled, Medicare Program; Town Hall Meeting on the FY 2021 Applications for New Medical Services and Technologies Add-On Payments. CMS is holding this meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss Fiscal Year (FY) 2021 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system. Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2021 new medical services and technologies applications meet the substantial clinical improvement criterion.

II. Congressional Hearings

House of Representatives

• On November 13, 2019, the House Energy and Commerce Subcommittee on Health held a markup of four health bills. Legislation included: H.R. 2339, Reversing the Youth Tobacco Epidemic Act of 2019; H.R. 4995, Maternal Health Quality Improvement Act of 2019; H.R. 4996, Helping Medicaid Offer Maternity Services (MOMS) Act of 2019; and H.R. 2387, Stop the Overuse of Petitions and Get Affordable Medicines to Enter Soon (STOP GAMES) Act of 2019. All four bills were favorably reported to the full Committee.
• On November 13, 2019, the House Committee on Small Business held a hearing entitled, Upskilling the Medical Workforce: Opportunities in Health Innovation. Witnesses present included: Dr. Matthew Conti, Orthopaedic Surgery Resident, Hospital for Special Surgery, American Academy of Orthopaedic Surgeons; Dr. Ingrid Zimmer-Galler, Associate Professor of Ophthalmology, Founding Clinical Director of the Office of Telemedicine, Johns Hopkins University School of Medicine, American Academy of Ophthalmology; Dr. Nancy Fahrenwald, Dean and Professor, Texas A&M University, College of Nursing, American Association of Colleges of Nursing; and Michael Hopkins, CEO and Founder, True Concepts Medical.
• On November 14, 2019, the House Committee on Ways and Means held a hearing entitled, Caring for Aging Americans. Witnesses present included: Kristina Brown, Caregiver, Medical Student; Robert Egge, Chief Public Policy Officer, Alzheimer’s Association; Dr. Joanne Lynn, Director, Program to Improve Eldercare, Altarum; Robert Blancato, National Coordinator, Elder Justice Coalition; Richard J. Mollot, Executive Director, The Long-Term Care Community Coalition (LTCCC); and Edo Banach, JD, President and CEO, National Hospice and Palliative Care Organization (NHPCO).
• On November 14, 2019, the House Committee on Oversight and Reform held a hearing entitled, Examining State Efforts to Undermine Access to Reproductive Health Care. Witnesses present included: Jennifer Box; Fatima Goss Graves, President and CEO, National Women’s Law Center; Marcela Howell, President and CEO, In Our Own Voice: National Black Women’s Reproductive Justice Agenda; Dr. Colleen McNicholas, OB/GYN, Chief Medical Officer, Planned Parenthood of the St. Louis Region and Southwest Missouri; and Alli Stuckey.

Senate

• On November 13, 2019, the Senate Committee on Health, Education, Labor, and Pensions held a hearing entitled, Examining the Response to Lung Illnesses and Rising Youth Electronic Cigarette Use. Witnesses present included: Mitch Zeller, Director, Center for Tobacco Products, FDA; and Dr. Anne Schuchat, Principal Deputy Director, Centers for Disease Control and Prevention.

III. Reports, Studies, & Analyses

• On November 14, 2019, the U.S. Government Accountability Office (GAO) published a report entitled, Drug Development: Stakeholders' Views of Risk Evaluation and Mitigation Strategies Differ. To manage the risks posed by some drugs, FDA requires drug companies to establish risk evaluation and mitigation strategies (REMS). Companies developing generic drugs generally need samples of the reference standard drug to conduct bioequivalence testing. Generic companies may also have to negotiate a shared system with the reference drug company, when that company’s drug is subject to certain REMS requirements. Some drug companies have used certain practices that prevent or delay the development of generic drugs, including limiting access to samples of reference standard drugs with and without REMS and delaying negotiations for creating required shared systems. GAO was asked to review drugs subject to REMS and drug companies’ experience with these practices. This report describes the drugs subject to REMS, and FDA and FTC’s efforts to address these practices, as well as stakeholders’ views on agencies’ efforts.
• On November 14, 2019, the Kaiser Family Foundation published an issue brief entitled, Medicare Part D: A First Look at Prescription Drug Plans in 2020. During the Medicare open enrollment period from October 15 to December 7 each year, beneficiaries can enroll in a plan that provides Part D drug coverage, either a stand-alone prescription drug plan (PDP) as a supplement to traditional Medicare, or a Medicare Advantage prescription drug plan (MA-PD), which covers all Medicare benefits, including drugs. Among the 45 million Part D enrollees in 2019, 20.6 million (46 percent) are in PDPs (excluding employer-only group PDPs). This issue brief provides an overview of PDPs that will be available in 2020 and highlights key changes from prior years.
• On November 15, 2019, the Alston & Bird Health Group released their summary of the CMS final rule entitled, CY 2020 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates: Price Transparency Requirements for Hospitals to Make Standard Charges Public; and the CMS proposed rule entitled, Transparency in Coverage. This summary analyzes the long-awaited Trump Administration transparency rules intended to increase price transparency to empower patients and increase competition among all hospitals, group health plans, and health insurance issuers in the individual and group markets. The summary is available here.

IV. Other Health Policy News

• On November 14, 2019, HHS announced that it is providing advanced development support for a new diagnostics technology that reads gene expression patterns in the immune system to distinguish bacterial infections from viral infections and determines the severity within minutes. The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will support the advanced development of the new testing technology, known as host-response testing, under a 14-month, $6 million contract with Inflammatix Inc. Read more about this collaboration here.
• On November 15, 2019, House Committee on Ways and Means Chairman Richard E. Neal (D-MA) and Ranking Member Kevin Brady (R-TX) announced a Request for Information (RFI) soliciting input that will inform the Rural and Underserved Communities Health Task Force as it works to develop bipartisan legislation to improve health care outcomes within underserved communities. The RFI can be found here.
• On November 15, 2019, Senators Bernie Sanders and Cory Booker introduced a bill entitled The Prescription Drug Affordability and Access Act. This bill would establish an independent federal agency known as the Bureau of Prescription Drug Affordability and Access. The new agency would be given authority to control prices of prescription drugs and could abolish patent protections for manufacturing companies that don't comply. More information about this legislation can be found here.

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