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 1, CMS issued final rules pertaining to the Medicare Physician Fee Schedule and the Hospital Outpatient Prospective Payment System. Read more about these two final rules below.

I. Regulations, Notices, & Guidance

• On October 28, 2019, the Food and Drug Administration (FDA) issued a rule entitled, Medical Devices: Clinical Chemistry and Clinical Toxicology Devices; Classification of the Continuous Glucose Monitor Data Management System. This rule classifies the continuous glucose monitor data management system into class I (general controls). FDA is taking this action because they have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. FDA believes this action will also enhance patients’ access to beneficial innovative devices, in part by reducing regulatory burdens.
• On October 28, 2019, FDA issued guidance entitled, Type V Drug Master Files for Center for Drug Evaluation and Research-Led Combination Products Using Device Constituent Parts with Electronics or Software. A drug master file (DMF) is a voluntary submission to FDA that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. This draft guidance explains when a Type V DMF may be used to submit information regarding a combination product for which the Center for Drug Evaluation and Research (CDER) has primary jurisdiction (i.e., a CDER-led combination product) and which features a device constituent part with electronics and/or software that is planned to be used as a platform, that is, may be used in multiple CDER-led combination products. The draft guidance also describes the administrative process and outlines the recommended content for these Type V DMF submissions and amendments.
• On October 29, 2019, FDA issued guidance entitled, Providing Regulatory Submissions in Electronic Format: Investigational New Drug Application Safety Reports. This draft guidance describes the electronic format sponsors will be required to use when they electronically submit to FDA investigational new drug (IND) safety reports to the CDER or the Center for Biologics Evaluation and Research (CBER) for serious and unexpected suspected adverse reactions that are required under the Agency’s regulations. FDA is establishing the electronic format requirements described in this guidance under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The draft guidance, once finalized and effective, will require sponsors submitting the specified IND safety reports electronically to submit the reports to FDA using the FDA Adverse Event Reporting System (FAERS) as structured data elements and will provide sponsors with a reporting format that is consistent with the International Council for Harmonisation (ICH) E2B(R2) format guidelines and reporting requirements to other regulatory agencies.
• On October 30, 2019, FDA issued guidance entitled, Electronic Submission of IND Safety Reports Technical Conformance Guide. This Technical Conformance Guide provides specifications, recommendations, and general considerations on how to submit electronic investigational new drug application (IND) safety reports to CDER or CBER.
• On October 30, 2019, FDA issued guidance entitled, Providing Regulatory Submissions in Electronic Format: IND Safety Reports. This draft guidance describes the electronic format sponsors will be required to use when they electronically submit to FDA IND safety reports for serious and unexpected suspected adverse reactions that are required under 21 CFR 21 CFR 312.32(c)(1)(i). This guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act for the electronic format of the content submitted for IND safety reports that are required under 21 CFR 312.32(c)(1)(i) for serious and unexpected suspected adverse reactions. This guidance applies to such IND safety reports that are submitted to CDER or CBER. This guidance changes the electronic submission requirements for this category of IND safety reports by requiring sponsors to submit the IND safety reports to the FDA Adverse Event Reporting System (FAERS) in accordance with this guidance.
• On October 31, 2019, CMS issued a final rule with comment period entitled, CY 2019 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements. This final rule with comment period updates the home health prospective payment system (HH PPS) payment rates and wage index for CY 2020; implements the Patient-Driven Groupings Model (PDGM), a revised case-mix adjustment methodology, for home health services beginning on or after January 1, 2020. This final rule with comment period also implements a change in the unit of payment from 60-day episodes of care to 30-day periods of care, as required by section 51001 of the Bipartisan Budget Act of 2018, hereinafter referred to the “BBA of 2018”, and finalizes a 30-day payment amount for CY 2020. Additionally, this final rule with comment period: modifies the payment regulations pertaining to the content of the home health plan of care; allows therapist assistants to furnish maintenance therapy; and changes the split percentage payment approach under the HH PPS. For the Home Health Value-Based Purchasing (HHVBP) model, CMS is finalizing provisions requiring the public reporting of the Total Performance Score (TPS) and the TPS Percentile Ranking from the Performance Year 5 (CY 2020) Annual TPS and Payment Adjustment Report for each home health agency in the nine Model states that qualified for a payment adjustment for CY 2020. This final rule with comment period also finalizes the following updates to the Home Health Quality Reporting Program (HH QRP): removal of a measure; adoption of two new measures; modification of an existing measure; and a requirement for HHA’s to report standardized patient assessment data beginning with the CY 2022 HH QRP. Additionally, CMS is finalizing the proposal to redesignate the current HH QRP regulations in a different section of the regulations and to codify other current policies in that new regulatory section with one substantive change as well as a few technical edits. CMS is not finalizing the proposal to remove question 10 from all of the HH Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys. Lastly, it sets forth routine updates to the home infusion therapy payment rates for CY 2020, payment provisions for home infusion therapy services for CY 2021 and subsequent years, and solicits comments on options to enhance future efforts to improve policies related to coverage of eligible drugs for home infusion therapy.
• On November 1, 2019, CMS issued a final methodology entitled, Federal Funding Methodology for Program Years 2019 and 2020. The document provides the methodology and data sources necessary to determine federal payment amounts for program years 2019 and 2020 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges.
• On November 1, 2019, CMS issued a final rule entitled, Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Revisions of Organ Procurement Organizations Conditions of Coverage; Prior Authorization Process and Requirements for Certain Covered Outpatient Department Services; Potential Changes to the Laboratory Date of Service Policy; Changes to Grandfathered Children’s Hospitals-Within-Hospitals; Notice of Closure of Two Teaching Hospitals and Opportunity to Apply for Available Slots. This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for Calendar Year 2020 based on CMS’ continuing experience with these systems. In this final rule with comment period, CMS describes the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. Also, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, this final rule with comment period establishes a process and requirements for prior authorization for certain covered outpatient department services; revise the conditions for coverage of organ procurement organizations; and revise the regulations to allow grandfathered children’s hospitals-within-hospitals to increase the number of beds without resulting in the loss of grandfathered status; and provides notice of the closure of two teaching hospitals and the opportunity to apply for available slots for purposes of indirect medical education (IME) and direct graduate medical education (DGME) payments.
• On November 1, 2019, CMS issued a final rule and interim entitled, CY 2020 Revisions to Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Establishment of an Ambulance Data Collection System; Updates to the Quality Payment Program; Medicare Enrollment of Opioid Treatment Programs and Enhancements to Provider Enrollment Regulations Concerning Improper Prescribing and Patient Harm; and Amendments to Physician Self-Referral Law Advisory Opinion Regulations Final Rule; and Coding and Payment for Evaluation and Management, Observation and Provision of Self-Administered Esketamine Interim Final Rule. This major final rule addresses: changes to the physician fee schedule (PFS); other changes to Medicare Part B payment policies to ensure that payment systems are updated to reflect changes in medical practice, relative value of services, and changes in the statute; Medicare Shared Savings Program quality reporting requirements; Medicaid Promoting Interoperability Program requirements for eligible professionals; the establishment of an ambulance data collection system; updates to the Quality Payment Program; Medicare enrollment of Opioid Treatment Programs and enhancements to provider enrollment regulations concerning improper prescribing and patient harm; and amendments to Physician Self-Referral Law advisory opinion regulations. In addition, CMS is issuing an interim final rule with comment period (IFC) to establish coding and payment for evaluation and management, observation and the provision of self-administered Esketamine to facilitate beneficiary access to care for treatment-resistant depression as efficiently as possible.

Event Notices   

• November 4, 2019: FDA announced a public meeting entitled, Health Canada and United States Food and Drug Administration Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The purpose of the public meeting is to provide information and solicit public input on the current activities of the ICH, as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Singapore scheduled for November 16 through November 20, 2019.
• November 5-6, 2019: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the National Advisory Council on Nurse Education and Practice. During meeting, NACNEP will welcome new members to the Council and discuss strategic priorities for nursing education and practice in preparation for the development of the Council’s 17th Report to Congress.
• November 12, 2019: FDA announced a public workshop entitled, Advancing the Development of Pediatric Therapeutics: Pediatric Clinical Trial Endpoints for Rare Diseases with a Focus on Pediatric Patient Perspectives. The purpose of this workshop is to discuss pediatric patient-specific engagement in the development of clinical trial endpoints for rare diseases. In this workshop, FDA will obtain the pediatric patient perspective on their disease/condition and what is most important to consider when designing rare disease trials. There will also be discussion regarding patients’ thoughts on clinical endpoints that are currently being used in clinical trials, potential areas of innovation, and how to create processes that might include pediatric patients and their caregivers as collaborators in endpoint development in early stages of medical product development (e.g., protocol design).
• November 13-14, 2019: FDA announced a public meeting entitled, Immunology Devices Panel of the Medical Devices Advisory Committee. The committee will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam.
• November 6-7, 2019: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Clinical Laboratory Improvement Advisory Committee. The agenda will include agency updates from CDC, CMS, and FDA. Presentations and discussions will focus on a follow up on CLIAC recommendations; an update on the clinical laboratory workforce; improving integration of laboratory information systems with electronic health records; and future CLIAC topics. There will be an extended public comment session focusing on emerging technologies and the clinical laboratory. Agenda items are subject to change as priorities dictate.
• November 7, 2019: FDA announced a public meeting entitled, Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs. The purpose of the meeting is to solicit specific, actionable policy suggestions that could be implemented in the near-term by the review staff of the Center for Drug Evaluation and Research's Office of New Drugs to promote effective drug development programs without compromising FDA regulatory standards for the assessment of safety and effectiveness.
• November 13, 2019: FDA announced a public meeting entitled, Endocrinologic and Metabolic Drugs Advisory Committee. The committee will discuss supplemental new drug application (sNDA) 204629/S-020 for empagliflozin oral tablet, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the following proposed indication: as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.
• November 13-14, 2019: HHS announced a public meeting entitled, Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. The purpose of the meeting is to discuss issues related to the President’s initiative on “Ending the HIV Epidemic: A Plan for America,” building community capacity, strategies for engaging people with HIV who are out of care, models of clinical care, workforce issues, pre-exposure prophylaxis services in community health centers, and pending committee reports.
• 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: 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 16-17, 2019: The Centers for Medicare and Medicaid Services (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 October 30, 2019, the House Energy and Commerce Subcommittee on Health held a hearing entitled, Safeguarding Pharmaceutical Supply Chains in a Global Economy. Witnesses present included: Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, FDA; Michael Wessel, Commissioner, U.S.-China Economic Security Review Commission; David Gaugh, R.Ph., Senior Vice President, Science and Regulatory Affairs, Association for Accessible Medicines; Rosemary Gibson, Senior Advisor, The Hastings Center; and Ed Price, President and CEO, Seqens CDMO.
• On October 30, 2019, the House Oversight and Reform Subcommittee on Civil Rights and Civil Liberties held a hearing entitled, The Administration's Decision to Deport Critically Ill Children and Their Families. Witnesses present included: Ken Cuccinelli, Acting Director, U.S. Citizenship and Immigration Services, U.S. Department of Homeland Security (DHS); and Matthew T. Albence, Acting Director, U.S. Immigration and Customs Enforcement, DHS.

Senate

• On October 31, 2019, the Senate Committee on Health, Education, Labor, and Pensions held a markup of eight health bills. Legislation included: S. 1657, Ticks: Identify, Control, and Knockout Act; S. 2619, Healthy Start Reauthorization Act of 2019; S. 1399, Title VIII Nursing Workforce Reauthorization Act of 2019; S. 995, Lifespan Respite Care Reauthorization Act of 2019; S. 1130, Scarlett’s Sunshine on Sudden Unexpected Death Act; S. 1608, Promoting Physical Activity for Americans Act; S. 2629, United States Public Health Service Modernization Act of 2019; and S. __, Over-the-Counter Drug Safety, Innovation, and Reform Act of 2019.
• On October 31, 2019, the Senate Finance Committee held a hearing entitled, Medicaid: Compliance with Eligibility Requirements. Witnesses present included: Brian P. Ritchie, Assistant Inspector General for Audit Services, Office of Inspector General, HHS; Carolyn Yocom, Director, Health Care, U.S. Government Accountability Office; Daryl G. Purpera, CPA, CFE, Legislative Auditor, Louisiana Legislative Auditor; and Judith Solomon, Senior Fellow, Center on Budget and Policy Priorities.

III. Reports, Studies, & Analyses

• On October 28, the White House Council of Economic Advisers (CEA) published a new estimate of the cost of the opioid crisis. Overall, the CEA estimates the opioid crisis cost more than $2.5 trillion for the four-year period from 2015 to 2018.
• On October 29, FDA published a report entitled, Drug Shortages: Root Causes and Potential Solutions. The report attempts to identify root causes and offer recommendations for government and industry based on insights gleaned from stakeholders in the private and public sectors. These recommendations are intended to help prevent and mitigate future drug shortages. The report focuses on human drugs and can be found here.

IV. Other Health Policy News

• On Monday, October 28, the House passed H.R. 2115, the Public Disclosure of Drug Discounts Act, which would require the Department of Health and Human Services (HHS) to publish pharmacy benefit managers’ (PBMs) aggregate rebates, discounts, and price concessions and require plans to include real-time benefit information on drug costs in Medicare Part D; H.R. 3415, the Real-Time Beneficiary Drug Cost Bill, which would ensure congressional advisers have access to drug pricing and rebate data; and H.R. 1781, the Payment Commission Data Act of 2019, which would provide the Medicare Payment Advisory Commission and the Medicaid and CHIP Payment and Access Commission with rebate and drug pricing data from Medicare Parts B and D and Medicaid. All three bills have counterparts in the Senate Finance Committee’s bipartisan drug pricing package.

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