A&B Healthcare Week in Review, December 12, 2014

I. REGULATIONS, NOTICES, & GUIDANCE

• On December 12, 2014, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule entitled “Medicare and Medicaid Program; Revisions to Certain Patient’s Rights Conditions of Participation and Conditions for Coverage”. This proposed rule would revise the applicable conditions of participation (CoPs) for providers, conditions for coverage (CfCs) for suppliers, and requirements for long-term care facilities, to ensure that certain requirements are consistent with the Supreme Court decision in United States v. Windsor, 570 U.S.12, 133 S.Ct. 2675 (2013), and Department of Health and Human Services (HHS) policy. Specifically, CMS proposes to revise certain definitions and patient’s rights provisions, in order to ensure that same sex spouses in legally-valid marriages are recognized and afforded equal rights in Medicare and Medicaid participating facilities. Comments on the proposal are due February 10, 2015.
• On December 9, 2014, the Food and Drug Administration (FDA) announced the availability of a draft guidance document entitled “Bacterial Detection Testing by Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion”. The draft guidance document provides blood collection establishments and transfusion services with recommendations for initial testing (primary testing) for bacterial contamination of platelets intended for transfusion, and provides additional considerations for blood collection establishments and transfusion services for subsequent retesting (secondary testing) of platelets prior to transfusion. The recommendations for primary testing of platelets and the additional considerations for secondary testing of platelets described in this guidance are expected to enhance the detection of bacteria in platelet products and thus enhance transfusion safety. The draft guidance, when finalized, is intended to supersede the recommendation in section VII.A.2, in regard to bacterial contamination testing in the document entitled ‘‘Guidance for Industry and FDA Review Staff: Collection of Platelets by Automated Methods’’ dated December 2007. Comments are due March 9, 2015.
• On December 9, 2014, FDA announced the availability of a draft guidance document entitled “Draft Guidance for Industry on Drug Supply Chain Security Act Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers”. This draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The draft guidance describes FDA’s expectations for prescription drug wholesale distributors (wholesale distributors) and third-party logistics providers (3PLs) about reporting to FDA under the DSCSA. Comments are due February 9, 2015.
• On December 8, 2014, the Health Resources and Services Administration (HRSA) announced plans to submit an information collection request entitled “National Practitioner Data Bank for Adverse Information on Physicians and Other Health Care Practitioners” to the Office of Management and Budget (OMB) for review and clearance. This is a request for a revision of OMB approval of the information collection contained in regulations found at 45 CFR part 60 governing the National Practitioner Data Bank (NPDB) and the forms to be used in registering with, reporting information to, and requesting information from the NPDB. Comments on the proposal are due February 6, 2015.
• On December 8, 2014, CMS announced an opportunity for the public to comment on a proposed revision of a currently approved information collection entitled “CMS–10535 Employer Notification to HHS of Its Objection to Providing Coverage for Contraceptive Services”. The proposed rules entitled ‘‘Coverage of Certain Preventive Services Under the Affordable Care Act’’ (79 FR 51118) would continue to require each closely-held, for-profit corporation seeking to be treated as an eligible organization to provide notification that it will not act as the plan administrator or claims administrator with respect to, or contribute to the funding of, coverage of all or a subset of contraceptive services. Issuers and third party administrators providing payments for contraceptive services for participants and beneficiaries in plans of eligible organizations would be required to meet the notice requirements as set forth in the 2013 final regulations. The interim final regulations entitled ‘‘Coverage of Certain Preventive Services Under the Affordable Care Act’’ (79 FR 51092) continue to allow eligible organizations that have religious objections to providing contraceptive coverage to notify an issuer or third party administrator using EBSA Form 700, as set forth in the July 2013 final regulations. In addition, the interim final regulations permit an alternative process under which an eligible organization could notify the Secretary of HHS that it will not act as the plan administrator or claims administrator with respect to, or contribute to the funding of, coverage of all or a subset of contraceptive services. Comments on the proposal are due February 6, 2015.
• On December 8, 2014, the Presidential Commission for the Study of Bioethical Issues released a notice entitled “Request for Comments on Ethical Considerations and Implications of Public Health Emergency Response With a Focus on the Current Ebola Virus Disease Epidemic”. The Commission is considering three areas of ethical concern raised by public health emergency response with a focus on the current Ebola virus disease (EVD) epidemic. The first area concerns U.S. public policies that restrict association or movement (such as quarantine), which have recently been proposed and/or employed for health care workers and military personnel returning from countries affected by EVD in western Africa. The second area concerns the ethics of placebo-controlled trials in the context of public health emergencies, and the EVD epidemic specifically, where the drug undergoing testing might be effective against the disease causing the emergency. The third area of concern is the ethical considerations relevant to collecting and storing bio specimens during a public health emergency, such as the EVD epidemic, and sharing these specimens and associated data internationally for future research. Commission is interested in receiving comments from individuals, groups, and professional communities regarding the three areas of ethical concern outlined above. To this end, the Commission is inviting interested parties to provide input and advice through written comments. Comments will be publicly available, including any personally identifiable or confidential business information that they contain. Trade secrets should not be submitted. Comments are due February 6, 2015.
• On December 8, 2014, the HHS Office of the National Coordinator for Health Information Technology (ONC) issued the Federal Health IT Strategic Plan 2015-2020. The Strategic Plan represents a coordinated and focused effort to appropriately collect, share, and use interoperable health information to improve health care, individual, community and public health, and advance research across the federal government and in collaboration with private industry. The Strategic Plan, which is open for comments, serves as the broad federal strategy setting the context and framing the Nationwide Interoperability Roadmap that will be released in early 2015. The Nationwide Interoperability Roadmap will help to define the implementation of how the federal government and private sector will approach sharing health information. Comments on the Strategic Plan are due February 6, 2015.
• On December 9, 2014, FDA extended the comment period for a notice of availability of draft guidance for industry (GFI #227) entitled "Two-Phased Chemistry, Manufacturing, and Controls Technical Sections" that appeared in the Federal Register of October 20, 2014. In that notice, FDA made available for comment the draft guidance, which provides recommendations to sponsors submitting chemistry, manufacturing, and controls (CMC) data submissions. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
• On December 10, 2014, FDA released a guidance for industry entitled ‘‘Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products—Content and Format.’’ The recommendations in this guidance are intended to assist applicants in developing the ‘‘Patient Counseling Information’’ section of labeling and to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format. This guidance finalizes the draft guidance issued on September 18, 2013.
• On December 11, 2014, FDA announced an opportunity for the public to comment on a proposed collection of information entitled “MedWatch: The Food and Drug Administration Medical Products Reporting Program”. This notice solicits comments on revisions to Forms FDA 3500, 3500A, and 3500B used in the FDA Medical Products Reporting Program. Comments are due February 9, 2015.
• On December 11, 2014, FDA announced the availability of a draft guidance for industry entitled ‘‘Bioequivalence Recommendations for Budesonide Extended-Release Tablets.’’ The guidance provides specific recommendations on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for budesonide extended release tablets. Comments are due February 9, 2015.
• On December 12, 2014, CMS released a notice announcing an opportunity for the public to comment on CMS’ intention to collect information from the public. This notice sets out a summary of the use and burden associated with the following information collections: 1) CMS–10341 Affordable Care Act Information and Collection Requirements for Section 1115 Demonstration Projects; 2) CMS–R–246 Medicare Advantage, Medicare Part D, and Medicare Fee-For-Service Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey; and 3) CMS–10531 Transcatheter Mitral Valve Repair (TMVR) National Coverage Decision (NCD). More information may be found here.

II. LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On December 10, 214, the Senate Subcommittee on African Affairs convened a hearing entitled “The Ebola Epidemic: The Keys To Success For The International Response”. More information on the hearing may be found here.

House of Representatives

• On December 11, 2014, the House passed a $1.014 trillion spending measure (often referred to as a “Cromnibus” because it combines the scope of an omnibus spending bill with a shorter-term continuing resolution, or CR, for the Department of Homeland Security) to fund the federal government through September 2015. The package also contains emergency Overseas Contingency Operations funding to combat the Islamic State of Iraq and the Levant (ISIL), and emergency funding to address the domestic and international Ebola crisis. A summary of the bill may be found here. The Consolidated and Further Continuing Appropriations Act passed by a vote of 219-206 and heads to the Senate for consideration. The Senate has until Wednesday night to complete work on the measure.
• On December 8, 2014, bipartisan House Energy and Commerce leaders released a request for public feedback on graduate medical education (GME) financing. The letter was signed by Health Subcommittee Chairman Joe Pitts (R-PA), Health Subcommittee Ranking Member Frank Pallone (D-NJ), Rep. Gene Green (D-TX), Rep. Diana DeGette (D-CO), Republican Conference Chair Rep. Cathy McMorris Rodgers (R-WA), Rep. Peter Welch (D-VT), Rep. Morgan Griffith (R-VA), and Rep. Kathy Castor (D-FL). The leaders write, “Given the importance of graduate medical education, we would like your thoughts on GME financing, federal program governance and structure, and how it might be improved or restructured to better meet the country’s health professional needs in both the short and long terms.”
• On December 9, 2014, the House Oversight and Government Reform Committee convened a hearing entitled “Examining ObamaCare Transparency Failures”. Witnesses for the hearing included Marilyn Tavenner, CMS Administrator; Jonathan Gruber, Professor at the Massachusetts Institute of Technology (MIT); and Ari Goldman, independent contractor. More information on the hearing may be found here.
• On December 9, 2014, the House Energy and Commerce Subcommittee on Health convened a hearing entitled “Setting Fiscal Priorities: Reforming Health Spending and Strengthening Our Future”. Witnesses for the hearing included Mark Miller, PhD, Executive Director the Medicare Payment Advisory Commission (MedPAC); Chris Holt, Director of Health Care Policy at the American Action Forum; Marc Goldwein, Senior Policy Director at the Committee for a Responsible Federal Budget; and Judy Feder, PhD, Professor of Public Policy at the Georgetown Public Policy Institute. More information on the hearing may be found here.
• On December 9, 2014, the House passed HR 5185, the Young Women’s Breast Health Education and Awareness Program (EARLY Act). The legislation amends the Public Health Service Act to reauthorize through FY2019 the Young Women's Breast Health Education and Awareness Requires Learning Young Act of 2009, which supports: (1) campaigns to educate the public and health care professionals about young women's breast health, (2) research into prevention of breast cancer in young women, and (3) support for young women with breast cancer. The legislation was received in the senate on December 10th.
• On December 9, 2014, the House Energy and Commerce Committee released a white paper and request for public feedback entitled “A Modernized Framework for Innovative Diagnostic Tests”. The document requests stakeholder feedback on a variety of regulatory issues related to the regulation of diagnostics, including the proposed regulation of laboratory developed tests (LDTs) as medical devices. Feedback is requested by January 5, 2015.

III. REPORTS, STUDIES, & ANALYSES

• On December 8, the HHS Office of Inspector General (OIG) released a report entitled “Access to Care: Provider Availability in Medicaid Managed Care”. OIG analysts examined the extent to which providers offer appointments to enrollees, as well as the timeliness of these appointments, by making calls to a stratified random sample of 1,800 primary care providers and specialists. OIG found that slightly more than half of providers could not offer appointments to enrollees. Notably, 35 percent could not be found at the location listed by the plan, and another 8 percent were at the location but said that they were not participating in the plan. An additional 8 percent were not accepting new patients. Among the providers who offered appointments, the median wait time was 2 weeks. However, over a quarter had wait times of more than 1 month, and 10 percent had wait times longer than 2 months. Finally, the report finds that primary care providers were less likely to offer an appointment than specialists; however, specialists tended to have longer wait times. OIG recommended that CMS work with states to 1) assess the number of providers offering appointments and improve the accuracy of plan information; 2) ensure that plans' networks are adequate and meet the needs of their Medicaid managed care enrollees; and 3) ensure that plans are complying with existing State standards and assess whether additional standards are needed. CMS concurred with all three recommendations.
• On December 10, 2014, the Kaiser Family Foundation released an issue brief entitled “Medicare Advantage 2015 Data Spotlight: Overview of Plan Changes”. Kaiser’s research suggests that the average beneficiary who remains in the same Medicare Advantage plan in 2014 and 2015 will pay $41 per month, an increase of $7 per month, or 20 percent, on average. All Medicare Advantage plans will include a limit on enrollees’ out-of-pocket expenses for services covered under Medicare Parts A and B, but the plans’ limits will be about $240 higher, on average, in 2015 than in 2014. Deductibles for Part D drug coverage will also increase, on average. These changes are consistent with historical trends, Kaiser reports, and indicate that Medicare Advantage plans can be expected to provide somewhat less financial protection in 2015 than they have historically.

IV. OTHER HEALTH POLICY NEWS

• This week the Medicaid and CHIP Payment and Access Commission (MACPAC) convened a series of public meetings in Washington, DC on December 11th and 12th. The Commission discussed a variety of topics including the future of CHIP, Medicaid premium assistance programs; policy options for improving access to care and reducing out-of-pocket costs for dually eligible beneficiaries; and an update on Medicaid managed care. More information on the meeting may be found here.
• On December 11, 2014, CMS announced proposed to subject home health agencies (HHAs) to the agency’s five-star rating program. CMS’ current plans are to begin with a single star rating summarizing HHAs’ performance across a 10-measure subset of the process, outcome, and utilization quality measures that are already displayed on the Home Health Compare (HHC) website. CMS says it plans to solicit stakeholder feedback on the proposed star rating methodology, including the measures proposed for inclusion. More information on CMS’ proposed methodology may be found here.