A&B Healthcare Week in Review, May 1, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On April 30, 2015, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled “Medicare Program; FY 2016 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements” (CMS-1629-P). This proposed rule would update the hospice payment rates and the wage index for fiscal year (FY) 2016, including implementing the last year of the phase-out of the wage index budget neutrality adjustment factor (BNAF). This proposed rule also discusses recent hospice payment reform research and analyses and proposes to differentiate payments for routine home care (RHC) based on the beneficiary’s length of stay and to implement a service intensity add-on (SIA) payment for services provided in the last 7 days of a beneficiary’s life, if certain criteria are met. In addition, this rule would implement changes to the aggregate cap calculation mandated by the Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act), align the cap accounting year for both the inpatient cap and the hospice aggregate cap with the federal fiscal year starting in FY 2017, make changes to the hospice quality reporting program, and would include a clarification regarding diagnosis reporting on the hospice claim. Comments ON THE PROPOSED RULE are due June 29, 2015. More information on the proposed rule may be found here.
• On May 1, 2015, CMS released an interim final rule with comment period entitled “Medicare Program; Changes to the Requirements for Part D Prescribers”. This interim final rule with comment period revises requirements related to beneficiary access to covered Part D drugs. Under these revised requirements, pharmacy claims and beneficiary requests for reimbursement for Medicare Part D prescriptions, written by prescribers other than physicians and eligible professionals who are permitted by state or other applicable law to prescribe medications, will not be rejected at the point of sale or denied by the plan if all other requirements are met. In addition, a plan sponsor will not reject a claim or deny a beneficiary request for reimbursement for a drug when prescribed by a prescriber who does not meet the applicable enrollment or opt-out requirement without first providing provisional coverage of the drug and individualized written notice to the beneficiary. This interim final rule with comment period also revises certain terminology to be consistent with existing policy and to improve clarity. Prescribers should submit their Medicare enrollment applications as soon as possible. More information is available on the CMS website here.
• On April 28, 2015, the Food and Drug Administration (FDA) released three guidances regarding biosimilars:
  • Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: This guidance is intended to assist sponsors in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for purposes of the submission of a marketing application under section 351(k) of the Public Health Service Act (PHS Act). The guidance addresses a broad range of issues, including: 1) Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; 2) Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; 3) Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009; 4) Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants; and 5) Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product.
  • Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product: This guidance is intended to provide recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) section of a marketing application for a proposed product submitted under section 351(k) of the PHS Act.
  • Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009: This guidance provides 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). The questions and answers (Q&As) are grouped in the following categories: Biosimilarity or Interchangeability; Provisions Related to Requirement to Submit a BLA for a “Biological Product”; and Exclusivity.
• On April 27, 2015, the CMS Center for Consumer Information & Insurance Oversight (CCIIO) issued a notice entitled “EDGE Data Submission Grace Period”. In order to permit issuers to complete the loading and testing of the required data to the issuers’ EDGE servers, CMS is providing a grace period for issuers to submit and update EDGE server data for the 2014 benefit year financial transfers through Friday, May 15, 2015, 4:00 p.m. EDT. During the grace period, issuers may submit data that was not accepted by April 30, and correct data that has already been accepted on the EDGE servers. This grace period will not delay CMS’s transmission of risk adjustment and reinsurance results to issuers by June 30, 2015, but will permit CMS to further assist issuers in complying with the data submission requirements necessary to run a credible and effective risk adjustment and reinsurance program in each State. No data will be accepted on EDGE servers from any issuer for the 2014 benefit year financial transfers after 4:00 p.m. EDT on Friday, May 15, 2015.
• On April 27, 2015, CMS announced that it is requesting nominations for individuals to serve on the Advisory Panel on Outreach and Education (APOE). Nominations are due May 18, 2015. The APOE will advise the Department of Health and Human Services (HHS) and CMS on developing and implementing education programs for individuals with, or who are eligible for, the Health Insurance Marketplace, Medicare, Medicaid, and CHIP about options for selecting health care coverage under these and other programs intended to ensure improved access to quality care, including preventive services. The scope of this panel, convened under the Federal Advisory Committee Act (FACA), also includes advising on education of providers and stakeholders with respect to the Affordable Care Act and certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA). More information may be found here.
• On April 28, 2015, CMS released an information collection activity for public comment, entitled “Initial Plan Data Collection to Support Qualified Health Plan (QHP) Certification and Other Financial Management and Exchange Operations”. Comments on the information collection activity are due May 28, 2015.
• On April 29, 2015, FDA announced an opportunity for the public to comment on a proposed information collection activity entitled “Financial Disclosure by Clinical Investigators”. Respondents to this collection are sponsors of marketing applications that contain clinical data from studies covered by the regulations. These sponsors represent pharmaceutical, biologic, and medical device firms. Respondents are also clinical investigators who provide financial information to the sponsors of marketing applications. Responses are due June 29, 2015.
• On April 29, 2015, FDA announced the availability of a draft guidance for industry entitled ‘‘Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity.’’ This guidance is intended to supplement CDER’s guidance for industry on ‘‘Environmental Assessment of Human Drug and Biologics Applications,’’ issued July 1998, by addressing specific considerations for drugs that have potential estrogenic, androgenic, or thyroid pathway activity (E, A, or T activity) in environmental organisms. It is intended to help sponsors of such drugs determine whether they should submit environmental assessments (EA) for new drug applications (NDAs) and certain NDA supplements, and to clarify what information such sponsors should include if they submit a claim of categorical exclusion instead of an EA. Comments should be submitted by June 29, 2015.
• On April 29, 2015, FDA issued a notice and request for comments entitled “Retrospective Review of Premarket Approval Application Devices; Striking the Balance Between Premarket and Postmarket Data Collection”. FDA is announcing the progress of the Center for Devices and Radiological Health (CDRH) on its 2014–2015 Strategic Priority ‘‘Strike the Right Balance Between Premarket and Postmarket Data Collection.’’ To achieve this priority, CDRH established a goal to assure the appropriate balance between premarket and postmarket data collection to facilitate and expedite the development and review of medical devices, in particular high-risk devices of public health importance, and established a target date of December 31, 2014, by which to review 50 percent of product codes subject to a premarket approval application (PMA) that are legally marketed to determine whether or not, based on our current understanding of the technology, to rely on postmarket controls to reduce premarket data collection, to shift some premarket data collection to the postmarket setting, or to pursue down classification. CDRH has taken such actions periodically in the past consistent with the medical device statutory framework but typically has done so on an ad hoc basis. CDRH also will require more data or up-classify a device, if warranted, based on the current state of the science; however, up-classification is not warranted for the devices subject to this retrospective review because they are already in the highest risk classification. In this document, CDRH is providing its current thinking on reviewed product types to solicit comments on the product codes that have been identified as candidates for reclassification, for reliance on postmarket controls to reduce premarket data collection, or a shift in premarket data collection to the postmarket setting. Comments should be submitted by June 29, 2015.
• On May 1, 2015, the Department of Veterans Affairs (VA) released a final rule entitled “Health Care for Homeless Veterans Program”. VA amends its medical regulations concerning eligibility for the Health Care for Homeless Veterans (HCHV) program. The HCHV program provides per diem payments to non-VA community-based facilities that provide housing, outreach services, case management services, and rehabilitative services, and may provide care and/or treatment to homeless veterans who are enrolled in or eligible for VA health care. The rule modifies VA’s HCHV regulations to conform to changes enacted in the Honoring America’s Veterans and Caring for Camp Lejeune Families Act of 2012. Specifically, the rule removes the requirement that homeless veterans be diagnosed with a serious mental illness or substance use disorder to qualify for the HCHV program. This change makes the program available to all homeless veterans who are enrolled in or eligible for VA health care. The rule also updates the definition of homeless to match in part the one used by the Department of Housing and Urban Development (HUD). The rule further clarifies that the services provided by the HCHV program through non-VA community-based providers must include case management services, including non-clinical case management, as appropriate. This final rule is effective June 1, 2015.
• On May 1, 2015, FDA released a proposed rule entitled “Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record.” FDA is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, FDA is proposing to establish conditions under which OTC antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are generally recognized as safe and effective. In the 1994 TFM, certain antiseptic active ingredients were proposed as being generally recognized as safe for use in health care settings based on safety data evaluated by FDA as part of its ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments, the Agency is now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for these uses. It is also proposing that all health care antiseptic active ingredients have in vitro data characterizing the ingredient’s antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient. Comments are due October 28, 2015.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On Tuesday April 28, 2015, the Senate Finance Committee convened hearing entitled “Medicare Audit and Appeals Issues”. Witnesses for the hearing included Nancy Griswold, chief administrative law judge, Office of Medicare Hearings and Appeals; Sandy Coston, CEO and president, Diversified Service Option, Inc.; and Thomas Naughton, senior vice president, MAXIMUS Federal Services, Inc. More information on the hearing may be found here. The hearing was originally scheduled for April 14th.
• On April 28, 2015, the Senate Health, Education, Labor and Pensions (HELP) Committee convened a hearing entitled “Medical Innovation for Patients”. Witnesses for the hearing included Roderic I. Pettigrew, director, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health; Christopher P. Austin, director, National Center for Advancing Translational Sciences, National Institutes of Health; Janet Woodcook, director, Center for Drug Evaluation and Research, Food and Drug Administration; and Jeffrey E. Shuren, director, Center for Devices and Radiological Health, Food and Drug Administration. More information on the hearing may be found here.
• On April 29, 2015, the Senate Committee on Small Business and Entrepreneurship hosted a hearing entitled “King vs. Burwell Supreme Court Case and Congressional Action that can be taken to Protect Small Businesses and Their Employees”. Witnesses for the hearing included Michael F. Cannon, Director of Health Policy Studies, Cato Institute; Jeffrey Anderson, Executive Director, The 2017 Project; and Linda Blumberg, Senior Fellow, the Urban Institute. More information on the hearing may be found here.
• On April 29, 2015, the Senate Veterans’ Affairs Committee convened a hearing entitled "GAO's (Government Accountability Office) High Risk List and the Veterans Health Administration." More information on the hearing may be found here.
• On April 29, 2015, Senate HELP Committee Chairman Lamar Alexander (R-TN) and Ranking Member Patty Murray (D-WA) announced a working group to identify ways to improve electronic health records. “After $28 billion in taxpayer dollars spent subsidizing electronic health records, ‎doctors don’t like these electronic medical record systems and say they disrupt workflow, interrupt the doctor-patient relationship and haven’t been worth the effort,” said Alexander. "The goal of this working group is to identify the five or six things we can do to help make the failed promise of electronic health records something that physicians and providers look forward to instead of something they endure.” The goals of this Senate health committee working group are to help identify ways that Congress and the administration can work together to: help doctors and hospitals improve quality of care and patient safety; facilitate information exchange between different electronic record vendors and different health professionals, referred to as “interoperability”; empower patients to engage in their own healthcare through convenient, user-friendly access to their personal health information; leverage health information technology capabilities to improve patient safety; and protect patient privacy and security of health information.
• On April 30, 2015, the Senate Appropriations Subcommittee on Labor and the Department of Health and Human Services (HHS) convened a hearing on the National Institutes of Health (NIH) budget for fiscal year (FY) 2016. Dr. Francis Collins, Director of NIH, provided witness testimony, and was accompanied by Anthony Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases (NIAID); Douglas Lowy, M.D., Acting Director, National Cancer Institute (NCI); Gary Gibbons, M.D., Director, National Heart, Lung, and Blood Institute (NHLBI); Jon Lorsch, Ph.D., Director, National Institute of General Medical Sciences (NIGMS); and Tom Insel, M.D., Director, National Institute of Mental Health. More information on the hearing may be found here.

House of Representatives

• On April 28, 2015, Representative Joe Courtney (D-CT) introduced H.R. 2050, a bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage. Also known as the “Cadillac tax,” the policy would apply a 40 percent tax on health insurance expenditures over $10,200 per person and $27,500 per family. “The excise tax is a poorly designed penalty that will put a dent in the pocketbooks of many families and businesses with health insurance plans that do not resemble the 'Cadillac' plans originally targeted when this policy was adopted—instead, the excise tax will punish people living in higher cost areas, with 'Ford Focus' level plans,” Courtney said in a press release. The measure currently has 71 cosponsors in the House.
• On April 30, 2015, the House Energy & Commerce Health Subcommittee convened a legislative hearing on the Committee’s “21st Century Cures” initiative. In January, the Committee launched the legislative phase of 21st Century Cures, and on April 29th, the Committee released an updated discussion draft for public review, which may be found here, and a section-by-section here. According to the Committee, the April draft includes provisions to:
  • Incorporate the patient perspective in the discovery, development, and delivery process.
  • Increase funding for the National Institutes of Health, both through reauthorization and $10 billion over five years in mandatory funding, starting in FY 2016.
  • Foster development of treatments for patients facing serious or life-threatening diseases.
  • Repurpose drugs for serious or life-threatening diseases and conditions.
  • Modernize clinical trials.
  • Break down barriers to increased collaboration and data sharing among patients, researchers, providers, and innovators.
  • Help the development of personalized and precision medicines so the right patient can receive the right treatment at the right time.
  • Provide for continued work in the telehealth space.
  • Advance interoperable health care.
  • Provide clarity for developers of software products used in health management and medical care.
• Witnesses for the hearing included Kathy Hudson, deputy director, Science, Outreach, and Policy, National Institutes of Health; Janet Woodcock, director, Center for Drug Evaluation and Research, Food and Drug Administration; and Jeff Shuren, director, Center for Devices and Radiological Health, FDA. More information on the hearing may be found here.
• On May 1, 2015, the House Energy and Commerce Subcommittee on Oversight and Investigations convened a hearing entitled “What is the Federal Government Doing to Combat the Opioid Abuse Epidemic?” The purpose of this hearing was to confer with the relevant Federal agencies regarding their ongoing efforts to combat the opioid abuse epidemic and explore how Federal policies can most effectively incentivize the development and broaden use of evidence-based practices and treatments. Witnesses for the hearing included Michael Botticelli, Director, Office of National Drug Control Policy (ONDCP); Richard Frank, Ph.D., Assistant Secretary for Planning and Evaluation (ASPE), Department of Health and Human Services (HHS); Nora Volkow, M.D., Director, National Institute of Drug Abuse (NIDA), National Institute of Health (NIH); Douglas Throckmorton, M.D., Deputy Director, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA); Debra Houry, M.D., M.P.H., Director of the National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC); Pamela Hyde, J.D., Administrator, Substance Abuse and Mental Health Services Administration (SAMHSA); and Patrick Conway, M.D., M.Sc., Deputy Administrator for Innovation and Quality & CMS Chief Medical Officer, Centers for Medicare and Medicaid Services (CMS). More information on the hearing may be found here.
• On May 1, 2015, the House adopted the final Republican budget plan for FY 2016 by a vote of 226-197. In a statement, House Budget Committee Chairman Tom Price (R-GA) said, “With today’s passage of a joint House and Senate balanced budget – the first of its kind in over a decade – we have provided a positive vision for how we can achieve those goals. The credible solutions we are championing will build a brighter future for all Americans”. Of note, the agreement would repeal the Affordable Care Act and replace the measure with “real, patient-centered health care reform”.

III. REPORTS, STUDIES, & ANALYSES

• On April 27, 2015, the HHS Office of Inspector General (OIG) released a report entitled “Early Alert: Without Clearer Guidance, Marketplaces Might Use Federal Funding Assistance for Operational Costs When Prohibited by Law”. The Patient Protection and Affordable Care Act (ACA) establishes a clear prohibition that marketplaces cannot use grant funds to support ongoing operations after January 1, 2015. OIG’s report expresses concerns that, without more detailed guidance from CMS, State-based marketplaces (SBMs) might have used, and might continue to use, establishment grant funds for operating expenses after January 1, 2015, contrary to law. In the report OIG encourages CMS to consider developing and publishing clear guidance on what constitutes (1) operational costs and (2) design, development, and implementation costs to minimize the marketplaces' improper use of establishment grant funding for operational expenses after January 1, 2015.
• The National Women’s Law Center this week issued a report entitled “State of Women’s Coverage: Health Plan Violations of the Affordable Care Act,” This report assesses coverage of women’s health services by analyzing coverage offered on health insurance Marketplaces by more than 100 insurance companies in 15 states during 2014 and 2015 and found that more than half of the issuers were violating the ACA. The report exposes violations related to maternity care, birth control, breast-feeding support and supplies, genetic testing, well-woman visits, prescription drug coverage, care related to gender transition for transgender individuals, chronic pain treatment, and certain pre-existing conditions. The report also highlights examples of discriminatory practices, such as denying maternity coverage to daughters of subscribers.
• On April 28, 2015, the Institute of Medicine (IOM) released a report entitled “VITAL SIGNS: Core Metrics for Health and Health Care Progress.” The report proposes a streamlined set of 15 standardized mea¬sures to assess health and health care in the United States, with recommendations for their application at every level and across sec¬tors. Ultimately, the report concludes that this streamlined set of measures could provide consistent benchmarks for health progress across the nation and improve system performance in the highest-priority areas.
• On April 30, 2015, the Kaiser Family Foundation released a report entitled “How Are Hospitals Faring Under the Affordable Care Act? Early Experiences from Ascension Health”. This report examines the early experiences with the ACA by Ascension Health, the delivery subsidiary of the nation’s largest not-for-profit health system, Ascension, which includes 131 acute-care hospitals and more than 30 senior care facilities in 23 states and the District of Columbia. The analysis examines changes in discharge volumes, hospital finances, and other outcomes between the last three quarters of 2013 – just before implementation of the ACA coverage expansions – and the first three quarters of 2014 (through September 30, 2014). In addition, the analysis compares changes among hospitals in states that expanded Medicaid with hospitals in states that did not expand Medicaid. Key findings include: Compared to hospitals in states that did not expand Medicaid, Ascension Health hospitals in states that expanded Medicaid experienced larger increases in Medicaid discharge volumes and decreases in uninsured/self-pay volume from 2013 to 2014. In addition, looking at total revenue, Ascension hospitals in expansion states saw an increase (8.2 percent) in Medicaid revenue from 2013 to 2014 and a 63.2 percent decrease in revenue from self-pay.
• On April 29, 2015, The Leapfrog Group released updated and enhanced data for the Hospital Safety Score, which assigns A, B, C, D and F grades to more than 2,500 U.S. hospitals based on their ability to prevent errors, injuries, accidents, and infections. For the first time, the Hospital Safety Score website offers an enhanced feature, allowing users to view a hospital’s current score alongside its previous scores over the past three years. The findings from the Spring 2015 update to the Hospital Safety Score show that while hospitals have made statistically significant improvements since Fall 2014 on several pre- and post-surgery safety processes, as well as the implementation of computerized medication prescribing systems, their performance on safety outcomes—including preventing errors, accidents and infections—has not significantly improved.

IV. OTHER HEALTH POLICY NEWS

• On April 30, 2015, CMS announced the availability of a public data set the Medicare Provider Utilization and Payment Data: Part D Prescriber Public Use File (PUF), with information on the prescription drugs that individual physicians and other health care providers prescribed in 2013 under the Medicare Part D Prescription Drug Program. The Part D Prescriber PUF is based on information from CMS’s Prescription Drug Event Standard Analytic File, which has final-action claims that are submitted by Medicare Advantage Prescription Drug (MAPD) plans and by stand-alone Prescription Drug Plans (PDP). The new dataset identifies providers using their National Provider Identifier (NPI) and the specific prescriptions that were dispensed on their behalf, listed by brand name (if applicable) and generic name. For each prescriber and drug, the dataset includes the total number of prescriptions that were dispensed, which include original prescriptions and any refills, and the total drug cost. The total drug cost includes the ingredient cost of the medication, dispensing fees, sales tax, and any applicable administration fees and is based on the amount paid by the Part D plan, Medicare beneficiary, government subsidies, and any other third-party payors.
• This week Florida Governor Rick Scott filed a lawsuit against the Obama Administration, claiming that the federal government has coerced states into “dramatically expanding their Medicaid programs by threatening to cut off federal funding for unrelated programs unless they ‘agree’ to do so”. “President Obama’s sudden end to the Low Income Pool (LIP) health care program to leverage us for Obamacare is illegal and a blatant overreach of executive power,” Scott said in a statement.
  • On May 1, 2015, CMS released updated Medicaid and CHIP eligibility determinations and enrollment numbers, which are current through February 2015. According to the document, the total number of individuals enrolled in Medicaid and CHIP in all states reporting data in February was 70,515,716. 561,609 additional people were enrolled in February 2015 as compared to January 2015 in the 51 states that reported comparable February and January 2015 data. Among states that had implemented the Medicaid expansion and were covering newly eligible adults in February 2015, Medicaid and CHIP enrollment rose by almost 27 percent compared to the July-September 2013 baseline period, while states that have not, to date, expanded Medicaid reported an increase of over 8 percent over the same period.