A&B Healthcare Week in Review, August 22, 2014

I. REGULATIONS, NOTICES, & GUIDANCE

• On August 15, 2014, the Centers for Medicare and Medicaid Services (CMS) released a guidance document entitled, “Guidance Regarding Training, Certification, and Recertification for Navigator Grantees, Certified Application Counselors, and Non-Navigator Assistance Personnel in the Federally-facilitated Marketplaces.” Among other items discussed in the document, the CMS Center for Consumer Information and Insurance Oversight (CCIIO) notes that 2015 training for certain Health Insurance Exchange Navigators and other personnel will be available in early September 2014 through the Medicare Learning Network (MLN), and CCIIO will provide future updates to announce the exact date when the 2015 training will be available.
• On August 19, 2014, Food & Drug Administration (FDA) announced the availability of guidance entitled “FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations.” This guidance document was developed to promote the initiation of clinical investigations to evaluate medical devices under the FDA's IDE regulations. The guidance is intended to provide clarification regarding the regulatory implications of the decisions that the FDA may render based on review of an IDE and to provide a general explanation of the reasons for those decisions. More information may be found here.
• On August 19, 2014, the FDA issued guidance entitled, “Unique Device Identifier System: Frequently Asked Questions, Vol. 1 - Guidance for Industry and Food and Drug Administration Staff.” In this guidance, the FDA provides clarification of key provisions of its September 2013 final rule establishing a unique device identification system (“the UDI Rule”). Section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and section 614 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) amended the Federal Food, Drug, and Cosmetic Act to add section 519(f), which directs FDA to publish regulations establishing a unique device identification system for medical devices.
• On August 19, 2014, the FDA announced the availability of grant funds for the support of the FDA's Office of Orphan Products Development grant program. The goal of the FDA's Orphan Products Development (OPD) grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. The FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's Background and Significance section documentation to support the assertion that the product to be studied meets the statutory criteria to qualify for the grant and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development. The application due dates are February 4, 2015; February 3, 2016; February 1, 2017; and February 7, 2018.The resubmission due dates are October 15, 2015; October 14, 2016; October 16, 2017; and October 15, 2018.The anticipated start dates are November 2015; November 2016; November 2017; and November 2018. The opening date is December 4, 2014. More information may be found here.
• On August 20, 2014, the Centers for Disease Control and Prevention (CDC) announced the launch of the Million Hearts® Hypertension Control Challenge. The challenge will identify clinicians, clinical practices, and health systems that have exceptional rates of hypertension control and recognize them as Million Hearts® Hypertension Control Champions. To support improved quality of care delivered to patients with hypertension, Million Hearts® will document the systems, processes, and staffing that contribute to the exceptional blood pressure control rates achieved by Champions. Champions will receive a cash prize and local and national recognition. The contest begins on August 20th and ends on October 10th. More information may be found here.
• On August 20, 2014, the FDA issued a notice requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify the FDA in writing. The FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Letters of interest must be submitted by September 19, 2014. More information may be found here.
• On August 22, 2014, CMS published a notice entitled, “Medicare and Medicaid Programs; Application From the Accreditation Commission for Health Care, Inc., for Continued Approval of Its Home Health Agency Accreditation Program.” This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Health Care Inc., (ACHC) for continued recognition as a national accrediting organization for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, CMS publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period. Public comments on this notice are due September 22, 2014.
• On August 22, 2014, the FDA published a proposed rule entitled, “Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications.” In this proposed rule, the FDA is proposing to amend biologics regulations by removing the general safety test (GST) requirements for biological products. The FDA proposes this action because the existing codified GST regulations are duplicative of requirements that are also specified in biologics licenses, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. The FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation, in response to an Executive order.
• On August 22, 2014, the FDA published a notice entitled, “Reopening of Docket and Request for Comments on the Food and Drug Administration Safety and Innovation Act Action Plan.” In this notice, the FDA announces the availability of the action plan regarding clinical trial participation by demographic subgroups, issued as required by section 907 of FDASIA and the reopening of a public docket for comments pertaining to the action plan. The accompanying report, entitled, “Reporting of Inclusion of Demographic Subgroups in Clinical Trials and Data Analysis in Applications for Drugs, Biologics, and Devices” is available at the FDA website, posted here.
• On August 22, 2014, the FDA published a notice entitled, “Evaluation of Sex-Specific Data in Medical Device Clinical Studies; Guidance for Industry and Food and Drug Administration Staff; Availability.” In this notice, the FDA announces the availability of the guidance entitled “Evaluation of Sex-Specific Data in Medical Device Clinical Studies.” This document provides guidance on the study and evaluation of sex-specific data in medical device clinical studies, and it outlines the Center for Devices and Radiological Health's (CDRH's) and Center for Biologics Evaluation and Research's (CBER's) expectations regarding sex-specific patient enrollment, data analysis, and reporting of device study information. The guidance is intended to improve the quality and consistency of available data regarding the performance of medical devices in both sexes by encouraging appropriate enrollment by sex in clinical studies of devices, and appropriate interpretation and assessment if data from such studies are analyzed by sex. Evaluation of sex-specific data in medical device clinical studies can benefit patients, their medical providers, clinical researchers, and others.
• On August 22, 2014, HHS, the Internal Revenue Service (IRS), and the Department of Labor (DOL) issued joint proposed and interim final rules entitled, “Coverage of Certain Preventive Services under the Affordable Care Act.” Together the proposed and interim final rules would propose (and, for the interim period of time during the public comment period on the proposal, finalize) a change to the definition of an eligible organization that can avail itself of an accommodation with respect to requirements for health insurance coverage of certain preventive services, namely contraceptive services, under section 2713 of the Public Health Service Act (PHS Act), added by the ACA. These rules propose and seek comments on potential changes to the definition of “eligible organization” in the existing HHS-IRS-DOL joint regulations in light of the Supreme Court’s decision in Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751 (2014), to ensure that participants and beneficiaries in group health plans (and enrollees and dependents in student health insurance coverage arranged by institutions of higher education) obtain, without additional cost, coverage of the full range of FDA approved contraceptive services, as prescribed by a health care provider, while respecting certain closely-held for profit entities’ religion-based objections for contraceptive coverage. Section 2713 of the PHS Act requires coverage without cost sharing of certain preventive health services by non-grandfathered group health plans and health insurance coverage. Among these services are women’s preventive health services, as specified in guidelines supported by the Health Resources and Services Administration (HRSA). In the Hobby Lobby decision, the Supreme Court invalidated existing HHS-IRS-DOL joint requirements for coverage of contraceptive services for certain closely-held for-profit entities with religious objections. Under these joint proposed and interim final rules, a qualifying closely held for-profit entity that has a religious objection to providing coverage for some or all of the contraceptive services otherwise required to be covered would not be required to contract, arrange, pay or refer for contraceptive coverage; instead, payments for contraceptive services provided to participants and beneficiaries in the eligible organization’s plan would be provided separately by an issuer (if the qualifying entity sponsors an insured group health plan, or if the qualifying entity is an institution of higher education that arranges student health insurance coverage) or arranged separately by a third party administrator (if the qualifying entity is self-insured). This proposed change would extend to participants and beneficiaries in group health plans established or maintained by certain closely held for-profit entities with religious objections to contraceptive coverage, and to enrollees and dependents enrolled in student health insurance coverage arranged by certain closely held for-profit entities that are institutions of higher education with religious objections to contraceptive coverage, the same, separate payments for contraceptive services provided to participants and beneficiaries of group health plans (and enrollees and dependents in student health insurance) established or maintained by certain nonprofit religious entities with such objections, while similarly respecting the religious objections of the closely held for-profit entities.

Event Notices

• September 2-3, 2014: The National Advisory Council on Drug Abuse will hold a public meeting on September 2nd and 3rd to discuss announcements and reports of administrative, legislative, and program developments in the drug abuse field. The meeting will take place at the National Institutes of Health (NIH) Neuroscience Center in Rockville, Maryland. More information may be found here.
• September 12, 2014: This week CMS announced a meeting of the Advisory Panel on Outreach and Education (APOE), which advises and makes recommendations to the Secretary of the Department of Health and Human Services (HHS) and the Administrator of CMS on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). The meeting will take place on September 12th from 8:30 AM to 4:00 PM at the Federal Hubert H. Humphrey Building in Washington, DC. Registration, presentations, and comments are due August 29, 2014. More information may be found here.
• September 12, 2014: The FDA announced a public workshop entitled, “Revamping Microbiological Test Methods for Contact Lenses, Products, and Accessories,” which will take place on September 12th from 8:00 a.m. to 5:00 p.m. at the at FDA's White Oak Campus, 10903 New Hampshire Ave., Silver Spring, MD 20993. The workshop will be co-sponsored by the American Academy of Ophthalmology (AAO), the American Academy of Optometry (AAOpt), the American Optometric Association (AOA), and the Contact Lens Association of Ophthalmologists, Inc. (CLAO). The purpose of this workshop is to discuss adequate testing of contact lens care products for disinfection efficacy against emerging pathogens as well as common infectious etiologies. Participants will explore the pros and cons of the various proposals for disinfection efficacy testing and aid in developing general recommendations. The workshop will assist in informing the regulatory science for evaluating contact lenses and disinfection efficacy of associated care products as well as improving test methods to mitigate potential infections. More information about this event may be found here.
• September 16, 2014: The National Institute of Nursing Research will hold a public meeting on September 16th from 1:00 PM to 5:00 PM at the NIH building in Bethesda, Maryland. More information on the meeting may be found here.
• September 17, 2014: On August 19, 2014, the FDA announced a public hearing to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA), and the GDUFA Commitment Letter that accompanies the legislation. The public hearing also will provide an opportunity for public input on future policy priorities. The FDA is seeking participation in the public hearing and written comments from all interested parties, including, but not limited to, regulated industry, consumers, patients, caregivers, health care professionals, and patient groups. The public hearing will be held on September 17th from 9:00 AM to 5:00 PM in Hyattsville, Maryland. Submit electronic or written requests to make oral presentations at the hearing by September 3, 2014. Electronic or written comments will be accepted after the hearing until October 13, 2014.
• September 29-30, 2014: The NIH announced a public workshop entitled, “Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain,” which will be held on September 29-30th beginning at 8:30 a.m. on both days at the NIH Natcher Conference Center, 45 Center Drive, Bethesda, Maryland 20892. At the workshop, participants will seek to clarify: (1) the long-term effectiveness of opioids for treating chronic pain; (2) the potential risks of opioid treatment in various patient populations; (3) the effects of different opioid management strategies on outcomes related to addiction, abuse, misuse, pain, and quality of life; (4) the effectiveness of risk mitigation strategies for opioid treatment; and (5) the future research needs and priorities to improve the treatment of pain with opioids. More information about this event may be found here.
• November 6, 2014: On August 22, 2014, the FDA announced that a meeting of its Cellular, Tissue and Gene Therapies Advisory Committee will take place on November 6, 2014 from 9:00 a.m. to 4:30 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31, Silver Spring, MD 20993. At the meeting, the committee will discuss the draft guidance for industry entitled “Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products” and the Dear Gene Therapy IND or Master File Sponsor Letter. More information about this meeting may be found here.

II. LEGISLATION & COMMITTEE ACTION

U.S. Senate

• The Senate is in recess for the remainder of the month and will reconvene on Monday September 8th. More information about the Senate Floor Schedule may be found here.

House of Representatives

• The House is in recess for the remainder of the month and will reconvene on Monday September 8th. More information about the House Floor Schedule may be found here.

III. REPORTS, STUDIES, & ANALYSES

• On August 18, 2014, Enroll America released a report which suggests that almost 7 million adults ages 18 to 64 are likely to experience a qualifying life event that could make them eligible to enroll in qualified health plan (QHP) coverage through the Affordable Care Act (ACA)-established Health Insurance Marketplaces during a Special Enrollment Period (SEP). Using data from the US Census Bureau’s 2010-2012 American Community Survey and previous research, authors estimate that 2.7 million of the 7 million individuals are currently uninsured, and 4 million more have health insurance coverage but could lose it over the course of the year. Among the uninsured, the report finds that approximately 6.5 percent will likely experience one or more qualifying events between open enrollment periods. The document includes both national and state-level estimates of the percent of currently-uninsured individuals who are likely to have experienced at least one of these qualifying events during the seven months between open enrollment periods and are therefore eligible for an SEP.
• On August 19, 2014, the Bipartisan Policy Center (BPC) released a white paper entitled “Transitioning from Volume to Value: Opportunities and Challenges for Health Care Delivery System Reform”. The report indicates that in the coming months, BPC plans to issue a series of white papers that will offer legislative and regulatory policy recommendations on the implementation and acceleration of delivery system and payment reforms, targeted specifically at accountable care organization (ACO) models, bundled payments for episodes for care, and the patient-centered medical home (PCMH) model. As the first in this series, this paper identifies opportunities and challenges in the transition to organized systems of care through the lens of the current legislative and regulatory environment. This includes pending Medicare physician payment legislation as well as a discussion of the primary alternative models of health care delivery. Referring to BPC’s 2013 publication “A Bipartisan Rx for Patient-Centered Care and System-Wide Cost Containment”, the white paper acknowledges, “…the [2013] report was conceived in an environment of impending budget sequestration and the possibility of bipartisan compromise on deficit reduction, or a so-called ‘grand bargain.’ Since that time, the political environment has shifted, and prospects for comprehensive changes in the near-term are dim.”
• On August 19, 2014, the Treasury Inspector General for Tax Administration (TIGTA) released a report entitled “The Affordable Care Act: An Improved Strategy Is Needed to Ensure Accurate Reporting and Payment of the Medical Device Excise Tax”. The ACA established an excise tax equal to 2.3 percent of sales revenue for medical devices sold beginning January 1, 2013. Manufacturers, producers, and importers are responsible for collecting the medical device excise tax and must file a Form 720, Quarterly Federal Excise Tax Return. The Joint Committee on Taxation (JCT) estimated that revenues from the medical device excise tax would total $20 billion for Fiscal Years 2013 through 2019. TIGTA’s review found that both the number of Forms 720 filed reporting the medical device excise tax and the amount of the associated revenue reported are lower than estimated. In addition, the report indicated that processing controls do not ensure the accuracy of medical device excise tax figures reported on paper-filed Forms 720. TIGTA recommended that the Internal Revenue Service (IRS) continue refining its compliance strategy to include actions that can be taken to identify noncompliant manufacturers.
• The Center for Healthcare Quality and Payment Reform (CHQPR) recently released a study entitled “Measuring and Assigning Accountability for Healthcare Spending: Fair and Effective Ways to Analyze the Drivers of Healthcare Costs and Transition to Value-Based Payment”. The report notes that although most payers use similar methodologies for attribution, episode definition, and risk adjustment, the details of the methodologies differ from payer to payer. CHQPR finds that there are six fundamental problems with most current methodologies for assigning accountability for health spending. Specifically, the report indicates that: (1) many patients and the spending on their care are not assigned to any provider; (2) providers cannot control the services and spending assigned to them; (3) providers are not attributed the spending for many services they provide; (4) spending measures do not distinguish appropriateness of services; (5) risk adjustment systems do not adequately adjust for patient needs; and (6) inadequate adjustments are made for structural differences in costs.

IV. OTHER HEALTH POLICY NEWS

• On August 15, 2014, the Medicare Payment Advisory Commission (MedPAC) issued a comment letter regarding CMS’ proposed notice entitled “Medicare Program; End-Stage Renal Disease (ESRD)Prospective Payment System, Quality Incentive Program (QIP), and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS),” published in the Federal Register, vol. 79, no. 133, pages 40208 to 40315. In the letter, MedPAC expresses concern that CMS intends to establish the Dialysis Star Ratings System beginning October 2014 without addressing public comments. The Commission urges CMS to delay the Star Ratings System implementation in order for the agency to issue a proposal to establish the system, in which CMS should “…describe why the agency believes a second quality measurement system for dialysis facilities…is needed and address the comments they receive.” Furthermore, the letter indicates that the Commission generally believes that the measurement of quality performance should be based on absolute standards rather than one calculated from the performance distribution. MedPAC also expresses concern about the overall number of measures used in the ESRD QIP, urging CMS to “…remain vigilant in maintaining a reasonable number of outcomes-based performance measures”.

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.