Alston & Bird Health Care Week in Review, October 11, 2019

Below is Alston & Bird’s Health Care 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 October 10, 2019, the Department of Health and Human Services announced the publication of its long-awaited proposed rules intended to revise the Stark Law and Federal Anti-Kickback Statue. Read more about the two rules below.

I. Regulations, Notices, & Guidance

• On October 9, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Coronary, Peripheral, and Neurovascular Guidewires—Performance Tests and Recommended Labeling. This guidance provides recommendations for the information and testing that should be included in premarket submissions for guidewires intended for use in the coronary vasculature, peripheral vasculature, and neurovasculature.
• On October 9, 2019, FDA issued guidance entitled, Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations. This guidance addresses labeling considerations for devices containing lubricious coatings used in the vasculature. The purpose of this guidance is to provide recommendations for information to be included in the device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for Class III and Class II devices, to enhance the consistency of information across these product areas as well as to promote the safe use of these devices in the clinical setting.
• On October 9, 2019, FDA issued guidance entitled, Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination. This guidance, developed by the Oncology Center of Excellence at FDA, describes an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic in an oncology clinical trial is considered significant risk, nonsignificant risk, or exempt from investigational device exemption requirements. In the streamlined process, the sponsor submits all information about the oncology trial (including information about the investigational in vitro diagnostic) to the investigational new drug application (IND). As part of IND review, the Center for Biologics Evaluation and Research (CBER) works with the Center for Drug Evaluation and Research (CDER), or CDER or CBER works with the Center for Devices and Radiological Health (CDRH), as appropriate, to determine if the investigational in vitro diagnostic is significant risk, nonsignificant risk, or exempt.
• On October 10, 2019, the Federal Communications Commission (FCC) issued a final rule entitled, Promoting Telehealth in Rural America. The FCC promotes telehealth in rural areas through the Rural Health Care Program, which provides financial support to help rural health care providers obtain broadband and other communications services at discounted rates. These services are in turn used by health care providers to offer telehealth to patients living in and around the communities they serve. In this final rule, the FCC takes a variety of measures to promote transparency and predictability, and further the efficient allocation of limited Rural Health Care Program resources while guarding against waste, fraud and abuse.
• On October 10, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Modernizing and Clarifying the Physician Self-Referral Regulations. The proposed rule is intended to address any undue regulatory impact and burden under the physician self-referral law. It proposes exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. Additionally, it would create a new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician; create a new exception for donations of cybersecurity technology and related services; and amend the existing exception for electronic health records (EHR) items and services. Finally, the proposed rule also provides new guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations.
• On October 10, 2019, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a proposed rule entitled, Fraud and Abuse; Revisions to Safe Harbors Under the Anti-Kickback Statute, and Civil Monetary Penalty Rules Regarding Beneficiary Inducements. This proposed rule would add, on a prospective basis only after a final rule is issued, safe harbor protections under the Federal antikickback statute for certain coordinated care and associated value-based arrangements between or among clinicians, providers, suppliers, and others that squarely meet all safe harbor conditions. It also would add protections under the antikickback statute and civil monetary penalty (CMP) law that prohibits inducements offered to patients for certain patient engagement and support arrangements to improve quality of care, health outcomes, and efficiency of care delivery that squarely meet all safe harbor conditions. The proposed rule would add a new safe harbor for donations of cybersecurity technology and amend the existing safe harbors for EHR arrangements, warranties, local transportation, and personal services and management contracts. Further, the proposed rule would add a new safe harbor pursuant to a statutory change set forth in the Bipartisan Budget Act of 2018 related to beneficiary incentives under the Medicare Shared Savings Program and a new CMP exception for certain telehealth technologies offered to patients receiving in-home dialysis.

Event Notices         

• October 16-17, 2019: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Community Preventive Services Task Force (CPSTF). The CPSTF is an independent, nonfederal panel whose members are appointed by the CDC Director. CPSTF members represent a broad range of research, practice, and policy expertise in prevention, wellness, health promotion, and public health. Matters proposed for discussion during the upcoming meeting include: Cancer Prevention and Control; Obesity Prevention and Control; Pregnancy Health; and Tobacco Cessation.
• October 21, 2019: HHS announced a public meeting entitled, Advisory Council on Alzheimer’s Research, Care, and Services. During the meeting, the Advisory Council will welcome six new members, and discuss ways to increase access to long-term services and supports that support people with dementia and their caregivers in their homes and the community including innovative state programs. Federal workgroups will also provide updates on work completed in the last quarter, as well as an overview of the 2019 Update to the National Plan to Address Alzheimer’s Disease.
• October 31, 2019: FDA announced a public meeting entitled, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials. The purpose of the meeting is to provide information on the draft revised E8(R1) Guideline “General Considerations for Clinical Trials” (ICH E8 Guideline) following the closing of the FDA comment period and closing of the regional consultations conducted in other ICH regions. The ICH E8 Guideline is being revised to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources being employed to support regulatory and other health policy decisions, while retaining the underlying principles of human subject protection and data quality.
• November 5-6, 2019: 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: 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 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 16-17: 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

There were no Congressional hearings this week.

III. Reports, Studies, & Analyses

• On October 7, the Journal of the American Medical Association published a study entitled, Waste in the US Health Care System: Estimated Costs and Potential for Savings. This analysis was conducted to estimate current levels of waste in the U.S. health care system in six previously developed domains and to report estimates of potential savings for each domain. These domains include: failure of care delivery, failure of care coordination, overtreatment or low-value care, pricing failure, fraud and abuse, and administrative complexity. According to the study, approximately one-quarter of total U.S. health care spending—between $760 and $935 billion every year—is waste.
• On October 10, the Government Accountability Office (GAO) published a report entitled, Medicaid Demonstrations: Actions Needed to Address Weaknesses in Oversight of Costs to Administer Work Requirements. In 2018, CMS announced a new policy allowing states to test work requirements under demonstrations and soon after began approving such demonstrations. Implementing work requirements can involve various administrative activities, not all of which are eligible for federal funds. GAO examined the administrative costs of demonstrations with work requirements. Among other things, this report examines five states’ estimates of costs of administering work requirements in selected states, and CMS’s oversight of these costs.

IV. Other Health Policy News

• On October 7, CMS announced a major enhancement of the information available to nursing home residents, families, and caregivers on the Agency’s Nursing Home Compare website. Later this month, CMS will display a consumer alert icon next to nursing homes that have been cited for incidents of abuse, neglect, or exploitation. By making this information accessible and understandable, CMS is empowering consumers to make the right decisions for themselves and their loved ones. Read more about this update here.
• On October 10, HHS published guidance entitled, Guide for Clinicians on the Appropriate Dosage Reduction or Discontinuation of Long-Term Opioid Analgesics. Compiled from published guidelines and practices endorsed in peer-reviewed literature, the Guide covers important issues to consider when changing a patient’s chronic pain therapy. It lists issues to consider prior to making a change, which include shared decision-making with the patient; issues to consider when initiating the change; and issues to consider as a patient’s dosage is being tapered, including the need to treat symptoms of opioid withdrawal and provide behavioral health support. Read more about this guidance here.