I. REGULATIONS, NOTICES, & GUIDANCE
- On October 16, 2014, the Food and Drug Administration (FDA) announced the availability of a guidance for industry ‘‘New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products.’’ This guidance sets forth a change in the Agency’s interpretation of the 5-year new chemical entity (NCE) exclusivity statutory and regulatory provisions as they apply to certain fixed-combination drug products (fixed combinations). As described in the guidance, a drug product will be eligible for 5-year NCE exclusivity if it contains a drug substance that meets the definition of ‘‘new chemical entity,’’ regardless of whether that drug substance is approved in a single-ingredient drug product or in certain fixed-combinations. This guidance finalizes the draft guidance issued in February 2014.
- On October 14, 2014, FDA announced the availability of draft guidance industry entitled ‘‘Flow Cytometric Devices.’’ This draft guidance addresses the current major review concerns regarding submissions for flow cytometric devices used as in vitro diagnostic devices for leukocyte immunophenotyping and provides suggestions on the content of submissions for these types of devices. Comments on the draft guidance must be submitted by January 12, 2014. More information may be found here.
- On October 15, 2014, FDA announced the availability of draft guidance for industry entitled ‘‘Distinguishing Medical Device Recalls From Medical Device Enhancements.’’ This guidance is intended to clarify when a potential change to a device is a medical device recall, distinguish those instances from product enhancements, and explain reporting requirements. More information may be found here.
- On October 14, 2014, the Department of Veterans Affairs (VA) released a proposed information collection for public comment entitled “Payment/Reimbursement for Emergency Services for Nonservice-Connected Conditions in Non-VA Facilities”. This notice solicits comments on the information needed for Veterans, Veteran Representatives and health care providers to request reimbursement from the federal government for emergency services at a private institution. 38 U.S.C. Chapter 17 authorizes VA to provide hospital care, medical services, domiciliary care and nursing home care to eligible veterans. Public Law 106–117, The Veterans Millennium Health Care and Benefits Act, amended 38 U.S.C. by adding § 1725 establishing reimbursement authority for an individual who is an active Department health-care participant who is personally liable for emergency treatment furnished in a non-Department facility provided that the veteran fit the limitations outlined in the statute. Comments are due December 15, 2014.
- On October 14, 2014, the VA released a proposed collection of information entitled “Locality Pay for Nurses and Other Health Care Professionals”. This notice solicits comments on information needed to obtain an accurate and comprehensive assessment of satisfaction of patients who receive mental health care services and on outcomes for Veterans who seek mental health treatment from VHA. Data will allow the program office to ensure that the target audience is being reached, effective treatments are being offered, and tangible, quantitative results are being measured and tracked for continual program improvement. Comments are due December 15, 2014.
- On October 16, 2014, FDA announced that a proposed information collection entitled “Medical Devices; Device Tracking—21 CFR part 821” had been submitted to the Office of Management and Budget (OMB) for review and clearance. Tracked device information is collected to facilitate identifying the current location of medical devices and patients possessing those devices, to the extent that patients permit the collection of identifying information. Manufacturers and FDA (where necessary) use the data to: (1) Expedite the recall of distributed medical devices that are dangerous or defective and (2) facilitate the timely notification of patients or licensed practitioners of the risks associated with the medical device. The annual hourly burden for respondents involved with medical device tracking is estimated to be 615,380 hours per year. Comments on the proposal are due November 17, 2014.
- On October 17, 2014, the Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) released an interim final rule entitled “Medicare Program; Final Waivers in Connection With the Shared Savings Program; Continuation of Effectiveness and Extension of Timeline for Publication of Final Rule”. The Shared Savings Program is one of the first initiatives implemented under the Affordable Care Act (ACA) aimed specifically at improving value in the Medicare program—that is, both higher quality and lower total expenditures for individual Medicare beneficiaries and the Medicare program the timeline. In connection with the Shared Savings Program, section 1899(f) of the Social Security Act authorizes the Secretary of the Department of Health and Human Services (HHS) to waive certain specified fraud and abuse laws. The Secretary determined that certain waivers were ‘‘necessary,’’ consistent with this statutory standard, and, CMS and OIG jointly published an interim final rule with comment period (‘‘Waiver IFC’’) (76 FR 67992; November 2, 2011) in conjunction with the issuance of the Shared Savings Program final rule. The Waiver IFC established waivers of the application of the Federal physician self-referral law (section 1877 of the Act), the Federal anti-kickback statute (section 1128B(b) of the Act), and certain civil monetary penalties (CMP) law provisions (sections 1128A(a)(5), (b)(1), and (b)(2) of the Act) to specified arrangements involving Accountable Care Organizations (ACOs) participating in the Shared Savings Program. Because the Waiver IFC was issued under the authority at section 1899(f) of the Act, it is considered a Medicare rule subject to the conditions of section 1871(a)(3)(C) of the Act. This document extends the timeline for publication of a final rule concerning Shared Savings Program waivers promulgated in the Waiver IFC. CMS and OIG contend that in the absence of this continuation notice, the Waiver IFC would expire, creating legal uncertainty for ACOs participating in the Shared Savings Program and potentially disrupting ongoing business plans or operations of some ACOs. CMS is currently developing a proposed rule regarding the Shared Savings Program. In light of the planned issuance of a proposed rule and the importance of final waiver regulations that align with the Shared Savings Program, the agency believes that the prudent course of action at this time is to extend the effectiveness of the Waiver IFC.
- On October 17, 2014, FDA announced a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (‘‘FDA Recognized Consensus Standards’’). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 037’’ (‘‘Recognition List Number: 037’’), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. An electronic copy of Recognition List Number: 037 is available here.
- On October 17, 2014, the Office of Personnel Management (OPM) released a final rule entitled “Federal Employees Health Benefits Program Modification of Eligibility to Certain Employees on Temporary Appointments and Certain Employees on Seasonal and Intermittent Schedules”. OPM is issuing a final rule to modify eligibility for enrollment under the Federal Employees Health Benefits (FEHB) Program to certain temporary, seasonal, and intermittent employees who are identified as full-time employees. This final rule follows a notice of proposed rulemaking published July 29, 2014. This regulation will allow newly eligible Federal employees to enroll no later than January 2015. This final rule is effective November 17, 2014.
- November 5-6, 2014: FDA announced this week an educational conference co-sponsored with the Society of Clinical Research Associates (SoCRA). The public workshop regarding FDA’s clinical trial requirements is designed to aid the clinical research professional’s understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRB). Individual FDA representatives will discuss the informed consent process and informed consent documents; regulations relating to drugs, devices, and biologics; as well as inspections of clinical investigators, IRB, and research sponsors. The meeting will take place on November 5th and 6th from 8:00 AM to 5:00 PM in Lake Buena Vista, Florida. More information may be found here.
- November 6-7, 2014: FDA will host a meeting of the Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC) on November 6th and 7th. The committee is charged with advising the Secretary, Department of Health and Human Services, and the Director, CDC, regarding the early detection and control of breast and cervical cancer. The committee makes recommendations regarding national program goals and objectives; implementation strategies; and program priorities including surveillance, epidemiologic investigations, education and training, information, dissemination, professional interactions and collaborations, and policy. The agenda will include: (1) Discussing the impact of implementation of the Affordable Care Act on the National Breast and Cervical Cancer Early Detection Program (NBCCEDP); (2) assessing the needs of the public and impact to the NBCCEDP; (3) population-based activities to increase appropriate screening; (4) screening communication tools; (5) provider risk assessments. The meeting will take place at CDC headquarters in Atlanta, Georgia, and may be accessed via teleconference. More information may be found here.
- November 13, 2014: FDA announced a public workshop entitled ‘‘Regulatory Science Considerations for Software Used in Diabetes Management.’’ The goals of this public workshop are to foster greater stakeholder collaboration in the area of diabetes device interoperability and to seek input from the clinical community, academia, government, industry, and other stakeholders regarding usability considerations for appropriate information consumption (e.g., notifications, indicators, data, and displays) based on user skill and knowledge. The Agency also requests input regarding the technical considerations for insulin bolus calculator design and use. The meeting will be held at FDA’s White Oak Campus in Silver Spring, Maryland. More information may be found here.
- March 9-10, 2015: CMS announced that the Advisory Panel on Hospital Outpatient Payment will host a meeting on the clinical integrity of the Ambulatory Payment Classification (APC) groups
and their associated weights, and hospital outpatient therapeutic services supervision issues. The meetings will take place March 9th and 10th from 9:00 AM to 5:00 PM at the CMS Central Office in Woodlawn, Maryland. More information may be found here.
II. LEGISLATION & COMMITTEE ACTION
- The Senate is not in session. More information about the Senate schedule may be found here.
House of Representatives
- The House is not in session. More information about the House schedule may be found here.
- On October 16, 2014, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled “Examining the US Public Health Response to the Ebola Outbreak”. Dr. Tom Frieden, Director of the Centers for Disease Control and Prevention; Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Disease at the National Institutes of Health; Dr. Luciana Borio, Assistant Commissioner Counterterrorism Policy, U.S. Food and Drug Administration; Dr. Robin Robinson, Director Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services; Mr. John P. Wagner, Acting Assistant Commissioner Office of Field Operations, Customs and Border Protection, U.S. Department of Homeland Security; Dr. Daniel Varga, Chief Clinical Officer and Senior Vice President, Texas Health Resources More information on the hearing may be found here.
III. REPORTS, STUDIES, & ANALYSES
- On October 14, 2014, the Kaiser Family Foundation released the results of a study of Medicaid spending and enrollment growth with a focus on state fiscal years 2014 and 2015. Findings are based on interviews and data provided by state Medicaid directors as part of the 14th annual survey of Medicaid directors in all 50 states and the District of Columbia conducted by the Kaiser Commission on Medicaid and the Uninsured (KCMU) with Health Management Associates (HMA). The survey finds that across all states, implementation of coverage expansions under the ACA are resulting in higher enrollment and total overall spending growth in Medicaid in FY 2014 and FY 2015. However, with full federal government financing of the Medicaid expansion population, state Medicaid spending is growing more slowly than total spending. Across all states implementing the ACA Medicaid expansion in FY 2014 and FY 2015, enrollment growth averaged 12.2 percent and 18.0 percent, respectively, well above national averages. Expansion states also reported higher total spending growth relative to the national average in both years. In FY 2014, across all states not implementing the ACA Medicaid expansion, enrollment growth averaged 2.8 percent. States reported that this relatively low rate of enrollment growth reflected an improving economy as well as processing backlogs due to problems with enrollment systems and account transfers. For FY 2015, enrollment growth is projected to average 5.2 percent across non-expansion states, as system issues are resolved and these states (like expansion states) experience increased participation among individuals eligible under pre-ACA rules.
- On October 16, 2014, the CMS Medicare Parts C&D Oversight and Enforcement Group (MOEG) released the “2013 Part C and Part D Program Annual Audit and Enforcement Report”. This is the second annual report produced by MOEG, in which the Group provides a brief overview of the Part C and Part D program audit and enforcement processes, a current and projected snapshot of the program audit landscape, a summary of the program audit and enforcement activities in 2013, and other highlights and noteworthy developments in MOEG’s operations since the issuance of its 2012 annual report.
- The journal Health Affairs released its October 2014 issue featuring a number of articles on Specialty Pharmaceutical Spending and Policy issues. Featured studies include: 1) The Impact of Specialty Pharmaceuticals As Drivers Of Health Care Costs; 2) Specialty Medications: Traditional And Novel Tools Can Address Rising Spending On These Costly Drugs; 3) Specialty Drug Coupons Lower Out-Of-Pocket Costs And May Improve Adherence At The Risk Of Increasing Premiums; and 4) Existing FDA Pathways Have Potential To Ensure Early Access To, And Appropriate Use Of, Specialty Drugs.
IV. OTHER HEALTH POLICY NEWS
- On October 15, 2014, CMS announced the availability of a new initiative for Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program, the “ACO Investment Model”. The ACO Investment Model is a model of pre-paid shared savings that builds on the experience with the Advance Payment Model to encourage new ACOs to form in rural and underserved areas and current Medicare Shared Savings Program ACOs to transition to arrangements with greater financial risk. The ACO Investment Model was developed in response to stakeholder concerns and available research suggesting that some providers lack adequate access to the capital needed to invest in infrastructure necessary to successfully implement population care management. More information on the model may be found here.
- On October 15, 2014, CMS announced a series of initiatives underway to “help Marketplace enrollees stay covered” in the coming open enrollment period for Health Insurance Exchanges. The agency noted that when consumers return to HealthCare.gov (the plan compare and enrollment website for Federally-Facilitated Exchanges, or FFEs) to begin their 2015 application, 90 percent of their online application will already be filled out or pre-populated. In addition, CMS announced that it is staffing up an additional 1,000 call center representatives this year over last year that will be available to answer questions and walk consumers through the coverage process. CMS also indicated that this week consumers began to receive notices from the FFEs in the mail and in their HealthCare.gov accounts, explaining how they can renew their coverage during Open Enrollment. The full announcement may be accessed here.
This advisory is published by Alston & Bird LLP’s Health Care practice area to provide a summary of significant developments to our clients and friends. It is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions.