A&B Healthcare Week in Review, May 15, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On May 11, 2015, the Departments of Health and Human Services (HHS), Labor, and Treasury released guidance regarding coverage of preventive services under the Affordable Care Act (ACA). Among the issues addressed by the guidance are: coverage of BRCA and other genetic testing; coverage of Food and Drug Administration (FDA)-approved contraceptives; coverage of sex-specific recommended preventive services; coverage of well-woman preventive care for dependents; and coverage of colonoscopies pursuant to United States Preventive Task Force (USPSTF) recommendations.
• On May 13, 2015, FDA announced the availability of a revised draft guidance for industry entitled ‘‘Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.’’ This draft guidance is intended to provide answers to common questions from sponsors interested in developing proposed biosimilar products, biologics license application (BLA) holders, and other interested parties regarding FDA’s interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This guidance revises the draft guidance entitled ‘‘Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009,’’ issued February 15, 2012, to provide new and revised questions and answers (Q&As). Comments are due July 13, 2015. More information may be found here.
• On May 15, 2015, FDA announced the availability of a draft guidance for industry entitled ‘‘Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators.’’ The purpose of this guidance is to assist sponsor-investigators in preparing and submitting complete investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) at FDA. Although not an exhaustive step-by-step instruction manual, this guidance highlights certain elements of this process to facilitate a sponsor-investigator’s successful submission of an IND. This guidance also discusses the IND review process and general responsibilities of sponsor-investigators related to clinical investigations. Details of the informational content of an IND as well as information needed to complete required forms also are provided throughout this guidance. Comments are due July 14, 2015. More information may be found here.
• On May 11, 2015, FDA issued a request for nominations on the Vaccines and Related Biological Products Advisory Committee. FDA is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Vaccines and Related Biological Products Advisory Committee for the Center for Biologics Evaluation and Research (CBER) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Vaccines and Related Biological Products Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations should be submitted by June 10, 2015.
• On May 14, 2015, FDA announced that a proposed information collection entitled “Survey of Pharmacists and Patients; Variations in the Physical Characteristics of Generic Drug Pills and Patients’ Perceptions” has been submitted to the Office of Management and Budget (OMB) for approval. To provide additional information that may help guide regulatory policy or pharmacy business practices, the Agency intends to conduct surveys of pharmacists and patients about their perceptions about and experiences with generic drug product pill appearance change. The Federal Register notice, available here, summarizes public comments on the information collection, as well as FDA responses.

Event Notices

• May 18-19, 2015: FDA, in co-sponsorship with the American Association for Cancer Research (AACR), is announcing a public workshop entitled ‘‘Dose Finding of Small Molecule Oncology Drugs.’’ The purpose of this 2-day workshop is to provide an interdisciplinary forum to discuss the best practices of dose finding and dose selection for small molecule kinase inhibitors developed for oncology indications. The goal is to foster robust scientific discussion to promote a movement away from the conventional 3+3 dose escalation trial design and move toward innovative designs that can potentially incorporate key clinical, pharmacologic, and pharmacometric data and, when appropriate, nonclinical information to guide dose selection. Ideally, this workshop will propel a movement toward integrating dose finding into the entire life cycle of product development as opposed to confining it to the Phase 1, first-in-human trial based on short-term safety measures. The public workshop will be held on May 18 and 19, 2015, from 8 a.m. to 5 p.m. at the Washington Court Hotel, 525 New Jersey Ave. NW., Washington, DC 20001. More information may be found here.
• July 15, 2015: FDA has announced a public meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2018 through 2022. PDUFA authorizes FDA to collect user fees for the process for the review of human drugs. The current legislative authority for PDUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA begin the PDUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2018–2022. The public meeting will be held on July 15, 2015, from 9 a.m. to 2 p.m. Registration to attend the meeting must be received by June 30, 2015. More information may be found here.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On Thursday May 14th the Senate Finance Committee convened a hearing entitled “A Pathway to Improving Care for Medicare Patients with Chronic Conditions”. Witnesses for the hearing included Dr. Patrick Conway, Acting Principal Deputy Administrator, Deputy Administrator for Innovation and Quality, and Chief Medical Officer, CMS, and Mark E. Miller, Ph.D., Executive Director, Medicare Payment Advisory Commission (MedPAC). During the hearing Chairman Orrin Hatch (R-UT) announced that the Committee has established a chronic care reform working group, which will be chaired by Committee Members Isakson and Warner. The group is tasked with producing an in-depth analysis of potential legislative solutions, which will “serve as a foundation to develop bipartisan chronic care legislation”. He also noted that the Senators will issue a formal invitation requesting all interested public and private sector stakeholder submit ideas for ways to improve outcomes for Medicare patients with chronic conditions. More information on the hearing may be here.
• On Tuesday May 12th, the Senate Veterans’ Affairs Committee convened a hearing entitled "Exploring the Implementation and Future of the Veterans Choice Program." Witnesses for the hearing included Sloan Gibson, deputy secretary of Veterans Affairs; James Tuchschmidt, acting principal deputy under secretary of Veterans Affairs for Health; David J. McIntyre, president and CEO, TriWest Healthcare Alliance; Donna Hoffmeier, vice president, VA Services and PCCC Program Manager, HealthNet Federal Services; Roscoe Butler, deputy director, Health Care, The American Legion; Darin Selnick, senior veterans affairs advisor, Concerned Veterans for America; Joseph Violante, national legislative director, Disabled American Veterans; Bill Rauch, political director, Iraq and Afghanistan Veterans of America; and Carlos Fuentes, senior legislative associate, Veterans of Foreign Wars. More information on the hearing may be found here.

House of Representatives

• On May 14, 2015, the House Energy and Commerce Health Subcommittee convened a markup to consider the 21st Century Cures Discussion Draft. Members largely expressed support for the bill, citing provisions of particular importance to them. Several Members noted that some sections of the draft still need to be improved (e.g., interoperability was repeatedly cited as one such provision). The amendment in the nature of the substitute was agreed to by voice vote. No additional amendments were offered and the draft legislation was passed out of Subcommittee by voice vote. The full Committee will hold a markup of the draft next week. More information on the markup may be found here.
• On May 13, 2015, the House passed H.R. 36, the Pain-Capable Unborn Child Protection Act, which would ban most abortions after 20 weeks of pregnancy. The vote was originally scheduled for January, but was cancelled when a number of Republican lawmakers (the majority women) opposed a provision which held that rape and incest exceptions could only be used if the crime had been reported. H.R.36 passed the House by a vote of 242 – 184.
• On May 13, 2015, the House Veterans’ Affairs Committee convened a hearing entitled “Assessing the Promise and Progress of the Veterans’ Choice Program”. More information on the hearing may be found here.

III. REPORTS, STUDIES, & ANALYSES

• A small percentage of Medicaid-only enrollees—that is, those who were not also eligible for Medicare—consistently accounted for a large percentage of total Medicaid expenditures for Medicaid-only enrollees, according to a report from the Government Accountability Office (GAO). In each fiscal year from 2009 through 2011, the most expensive 5 percent of Medicaid-only enrollees accounted for almost half of the expenditures for all Medicaid-only enrollees. In contrast, the least expensive 50 percent of Medicaid-only enrollees accounted for less than 8 percent of the expenditures for these enrollees. Of the Medicaid-only enrollees who were among the 5 percent with the highest expenditures within each state, the nationwide proportions of these enrollees in different eligibility groups (such as the disabled or children) and with certain conditions (such as asthma) or services (such as childbirth or delivery) were also consistent from fiscal years 2009 through 2011. The distribution of high-expenditure Medicaid-only enrollees’ expenditures among categories of service in fiscal year 2011 varied widely across states. Expenditures for managed care and premium assistance varied most widely (from 0 to 75 percent).
• On May 13, 2015, Express Scripts released the results of an analysis entitled “Super Spending: U.S. Trends in High-Cost Medication Use”, which examines prescription drug use among patients with exceedingly high annual medication costs under the pharmacy benefit. According to the study, more than half a million Americans filled at least $50,000 worth of prescription drugs last year. The estimated number of U.S. patients with annual medication costs greater than $50,000 increased 63% in 2014, from 352,000 to 576,000 Americans. And the population of patients estimated to be taking at least $100,000 worth of medication nearly tripled, increasing 193%, from 47,000 to 139,000 Americans.
• This week the HHS Office of Inspector General (OIG) released a report entitled “Home Health Agencies [HHAs] Conducted Background Checks of Varying Types”. OIG requested data from a sample of Medicare-certified HHAs regarding all individuals they employed on January 1, 2014, and compared the employee data with criminal history records from the Federal Bureau of Investigation (FBI) to identify individuals with criminal convictions who were employed by the sampled HHAs. OIG found that all HHAs conducted background checks of varying types on prospective employees; approximately half also conducted periodic checks after the date of hire. Four percent of HHA employees had at least one criminal conviction. OIG recommended that CMS promote minimum standards in background check procedures, and CMS concurred.
• On May 11, 2015, GAO published a study entitled “CMS Oversight of Provider Payments Is Hampered by Limited Data and Unclear Policy”. GAO was asked to review state Medicaid payments to government providers compared to private, that is, for-profit and non-profit providers. GAO examined (1) in selected states (IL, NY and CA), how state Medicaid payments to government hospitals compare to those made to private hospitals, and, for selected hospitals, to their Medicaid costs and total hospital operating costs; and (2) CMS oversight. GAO assessed hospital payments by ownership for three states selected in part based on size and geographic diversity, reviewed laws, regulations, guidance, and other documents, and interviewed CMS and state officials. The report finds that oversight of Medicaid payments to individual hospitals and other institutional providers, which is CMS’ responsibility, is limited in part by insufficient information on payments and also by the lack of a policy and process for assessing payments to individual providers. CMS does not, GAO found, collect provider-specific payment and ownership information. CMS also lacks a policy and standard process for determining whether Medicaid payments to individual providers are economical and efficient. In addition, excessive state payments to individual providers may not be identified or examined by CMS.

IV. OTHER HEALTH POLICY NEWS

• On May 14th and 15th, the Medicaid and CHIP Payment and Access Commission (MACPAC) convened its final series of meetings before adjourning for the summer. (The Commission’s next meeting is scheduled for September 2015). This week’s meeting covered a number of topics, including updates on the CMS Financial Alignment Demonstration; an update on trends in Medicaid spending and state budgets; and issues in Medicaid managed care rate setting. More information, including transcripts and presentations as they become available, may be found here.