A&B Healthcare Week in Review, June 26, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On June 26, 2015, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled “Medicare Program; End-Stage Renal Disease Prospective Payment System, and Quality Incentive Program”, which will update payment policies and rates under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to beneficiaries on or after January 1, 2016. . This rule also proposes to set forth requirements for the ESRD Quality Incentive Program (QIP) for CY 2016. In an effort to incentivize ongoing quality improvement among eligible providers, the ESRD QIP proposes to establish and revise requirements for quality reporting and measurement, including the inclusion of new quality measures for payment year (PY) 2019 and beyond and updates to programmatic policies for the PY 2017 and PY 2018 ESRD QIP. Comments on the proposed rule are due August 25, 2015. A CMS Fact Sheet on the proposed rule may be found here.
• On June 22, 2015 the Department of Veterans Affairs (VA) announced that it is soliciting nominations for an appointment to the Genomic Medicine Program Advisory Committee. The Committee was established by the Secretary of the VA to advise the Secretary with respect to the development of a world-class genomic medicine program within the Department, including policies to collect and utilize both genetic and other medical information to promote optimal medical care and research that contribute to the knowledge of diseases prevalent in Veterans. The Committee will be guided by the goal of using genetic information to optimize clinical care of Veterans, and enhance the study and development of diagnostic tests and treatments for diseases of particular relevance to Veterans. Nominations of qualified candidates in the area of genomic medicine from healthcare, academia, and/or other government agencies are being sought to fill vacancies on the Committee. Nominations for membership on the Committee must be received no later than 5:00 p.m. EDT on July 15, 2015. More information may be found here.
• On June 25, 2015, the Food and Drug Administration (FDA) announced the availability of a guidance for industry entitled ‘‘Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.’’ It replaces the draft of the same name that was published on March 14, 2014. This guidance clarifies FDA requirements and regulations pertaining to allowable excess volume in injectable vials and reinforces the importance of appropriate fill volumes and labeled vial fill sizes for injectable drug and biological products.
• On June 23, 2015, the Centers for Disease Control and Prevention (CDC) released a notice of proposed rulemaking entitled “Medical Examination of Aliens— Revisions to Medical Screening Process” to amend its regulations governing medical examinations that aliens must undergo before they may be admitted to the United States. Specifically, the Department of Health and Human Services (HHS)/ CDC proposes to: revise the definition of communicable disease of public health significance by removing chancroid, granuloma inguinale, and lymphogranuloma venereum as inadmissible health-related conditions for aliens seeking admission to the United States; update the notification of the health-related grounds of inadmissibility to include proof of vaccinations to align with existing requirements established by the Immigration and Nationality Act (INA); revise the definitions and evaluation criteria for mental disorders, drug abuse and drug addiction; clarify and revise the evaluation requirements for tuberculosis; clarify and revise the process for the HHS/CDC-appointed medical review board that convenes to reexamine the determination of a Class A medical condition based on an appeal; and update the titles and designations of federal agencies within the text of the regulation. Written comments must be received on or before August 24, 2015.
• On June 23, 2015, HHS issued a notice entitled “Announcement of Revision to the Department of Health and Human Services Guidance on Procedures for the Provision of Marijuana for Medical Research as Published on May 21, 1999”. The notice is effective June 2015.
• On June 25, 2015, FDA announced an opportunity for the public to comment on research entitled “Hearing, Aging, and Direct-to-Consumer Television Advertisements’’. This study will examine how changes to hearing across the lifespan affect the comprehension of direct-to-consumer (DTC) television advertisements for prescription drugs. Comments are due August 24, 2015.
• On June 26, 2015, CMS announced the opportunity for the public to comment on CMS’ intention to collect information from the public. The information collection activities are entitled: 1) Medicaid State Plan Base Plan Pages; 2) Medicaid Program Eligibility Changes under the Affordable Care Act of 2010; and 3) Cooperative Agreement to Support Navigators in Federally-facilitated and State Partnership Exchanges. Comments are due July 27, 2015. More information may be found here.
• On June 26, 2015, CMS issued a notice announcing an opportunity for the public to comment on an information collection activity entitled “CMS–10575 Generic Clearance for the Heath Care Payment Learning and Action Network”. On January 26, 2015, HHS Secretary Burwell announced the ambitious goal to have 30% of Medicare Fee-For-Service payments tied to alternative payment models (such as Pioneer ACOs or bundled payment arrangements) by the end of 2016, and 50% of payments by the end of 2018. To reach this goal, CMS will continue to partner with stakeholders across the health care system to catalyze transformation through the use of alternative payment models. To this end, CMS launched the Health Care Payment Learning and Action Network, an effort to accelerate the transition to alternative payment models, identify best practices in their implementation, collaborate with payers, providers, consumers, purchasers, and other stakeholders, and monitor the adoption of value-based alternative payment models across the health care system. The information collected from LAN participants will be used by the CMS Innovation Center to potentially inform the design, selection, testing, modification, and expansion of innovative payment and service delivery models in accordance with the requirements of section 1115A, while monitoring progress towards the Secretary’s goal to increase the percentage of payments tied to alternative payment models across the U.S. health care system. In addition, the requested information will be made publically available so that LAN participants (payers, providers, consumers, employers, state agencies, and patients) can use the information to inform decision making and better understand market dynamics in relation to alternative payment models. Comments are due August 25, 2015.
• On June 26, 2015, FDA announced an opportunity for public comment on a proposed information collection activity entitled “Electronic User Fee Payment Request Forms—Form FDA 3913 and Form FDA 3914 (OMB Control Number (0910– NEW)”. The electronic user fee payment request forms will streamline the refund and transfer processes, facilitate processing, and improve the tracking of requests. The burden for this collection of information is the same for all customers (small and large organizations). The information being requested or required has been held to the absolute minimum required for the intended use of the data. Customers will be able to request a user fee payment refund and transfer online at http:// www.fda.gov/forindustry/userfees/default.htm.  This electronic submission is intended to reduce the burden for customers to submit a user fee payment refund and transfer request. Comments on this proposal are due August 25, 2015.
• On June 26, 2015, FDA announced that an information collection activity entitled “Emergency Shortages Data Collection System” had been submitted to the Office of Management and Budget (OMB) for review and clearance. Comments are due July 27, 2015.
• On June 26, 2015, FDA announced the availability of draft guidance entitled ‘‘Unique Device Identification: Direct Marking of Devices.’’ Direct marking is an important feature of FDA’s unique device identification system. This document is intended to assist industry and FDA staff to understand FDA’s requirements for direct marking of devices with a unique device identifier (UDI). In addition, FDA is seeking information on what processes should be considered to meet the definition of ‘‘reprocessing’’ for purposes of UDI direct marking requirements. Comments are due September 24, 2015.
• On June 26, 2015, FDA released a notice entitled “Source Data Capture From Electronic Health Records: Using Standardized Clinical Research Data”. The Center for Drug Evaluation and Research (CDER) is interested in supporting demonstration projects to test the capability and evaluate performance of using an end-to-end Electronic Health Record (EHR)- to-Electronic Data Capture (EDC) single-point data capture approach, using established data and implementation standards in a regulated clinical research environment. A demonstration project should ideally test the use of a standards-based technology solution to enable the collection of related healthcare and clinical research information within a single system and workflow. Stakeholders may include regulated industry, EHR and EDC vendors, academic medical centers, and other interested parties. DATES: Submit either electric or written requests for participation in the demonstration project by August 10, 2015.
• On June 23, 2015, FDA announced that a proposed information collection activity entitled “Post-marketing Adverse Drug Experience Reporting” had been submitted to OMB for review and clearance. The primary purpose of FDA’s adverse drug experience reporting system is to enable identification of signals for potentially serious safety problems with marketed drugs. Although premarket testing discloses a general safety profile of a new drug’s comparatively common adverse effects, the larger and more diverse patient populations exposed to the marketed drug provide the opportunity to collect information on rare, latent, and long-term effects. Signals are obtained from a variety of sources, including reports from patients, treating physicians, foreign regulatory agencies, and clinical investigators. In the notice, FDA estimates the total reporting burden as 839,768 hours.
• This week FDA released the Center for Biologic Evaluation and Research “List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity Interchangeability Evaluations to Date”; and Center for Drug Evaluation and Research “List of Licensed Biological Products with (1) Reference Product Exclusivity and (2) Biosimilarity or Interchangeability Evaluations to Date”.

Event Notices

• July 22, 2015: The Health Insurance Marketplace, Medicare, Medicaid, and Children’s Health Insurance Programs; Meeting of the Advisory Panel on Outreach and Education (APOE) will convene a meeting on July 22nd. The meeting was originally scheduled for June 25th. Under the current charter, the APOE will advise the Secretary and the Administrator on optimal strategies for the following: Developing and implementing education and outreach programs for individuals enrolled in, or eligible for, Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP), or coverage available through the Health Insurance Marketplace; Enhancing the federal government’s effectiveness in informing Health Insurance Marketplace, Medicare, Medicaid, and CHIP consumers, issuers, providers, and stakeholders, through education and outreach programs, on issues regarding these programs, including the appropriate use of public private partnerships to leverage the resources of the private sector in educating beneficiaries, providers, and stakeholders; Expanding outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of Health Insurance Marketplace, Medicare, Medicaid, and CHIP education programs; Assembling and sharing an information base of ‘‘best practices’’ for helping consumers evaluate health coverage options; Building and leveraging existing community infrastructures for information, counseling, and assistance; Drawing the program link between outreach and education, promoting consumer understanding of health care coverage choices, and facilitating consumer selection/enrollment, which in turn support the overarching goal of improved access to quality care, including prevention services, envisioned under the Affordable Care Act.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On Wednesday June 24, 2015, the Senate Finance Committee convened an Open Executive Session to mark up 12 healthcare bills, covering a wide range of health issues. They are as follows:
  • S. 607 – The Rural Community Hospital Demonstration Extension Act of 2015
  • S. 1349 – The Notice of Observation, Treatment and Implication for Care Eligibility (NOTICE) Act of 2015
  • S. 1461 – A One Year Extension of the Enforcement Instructions on Supervision Requirements of Outpatient Therapeutic Services in Critical Access Hospitals (CAHs) and Small Rural Hospitals
  • S. 313 – Prevent Interruptions in Physical Therapy Act of 2015
  • S. 1253 – Patient Access to Disposable Medical Technology Act of 2015
  • S. 1347 – Electronic Health Fairness Act of 2015
  • S. 704 – The Community Based Independence for Seniors Act
  • S. 1362 – The PACE Innovation Act of 2015
  • S. 861 – Preventing and Reducing Improper Medicare and Medicaid Expenditures Act of 2015
  • S. 349 – Special Needs Trust Fairness Act of 2015
  • S. 466 – Quality Care for Moms and Babies Act
  • S. 599 – Improving Access to Emergency Psychiatric Care Act of 2015

The bills were unanimously approved by voice vote en bloc; staff are authorized to make conforming and technical changes. More information may be found here.

• On Tuesday June 23, 2015, the Senate Committee on Appropriations approved the FY2016 Labor, Health and Human Services, and Education and Related Agencies (Labor-HHS) Appropriations Bill, a $153.2 billion measure funding a range of priorities involving health, education, and workforce training and development. The measure, approved 16-14, recommends $153.2 billion in base discretionary spending for the Departments of Labor, Health and Human Services, and Education and related agencies. The bill is $3.6 billion below the FY2015 level and $14.5 billion below the President’s budget request. In addition, the bill includes $1.561 billion in cap adjustment funding for preventing waste, fraud, abuse, and improper payments in the Social Security, Medicare, and Medicaid programs. Appropriations Committee approval readies the measure for debate and consideration before the full Senate. Details on the bill may be found here.

House of Representatives

• On June 24, 2015, the House Energy & Commerce Health Subcommittee convened a hearing entitled “Examining the Administration’s Approval of Medicaid Demonstration Projects”. The sole witness for Panel I was Katherine Iritani, Director, Health Care, Government Accountability Office (GAO). Witnesses for Panel II included Haley Barbour, former Governor of Mississippi and Founding Partner, BGR Group; Matt Salo, Executive Director, National Association of Medicaid Directors (NAMD); and Joan Alker, Executive Director, Georgetown University Center for Children and Families. During the hearing witnesses and Members discussed Section 1115 Medicaid waivers, through which the HHS Secretary may waive certain federal Medicaid requirements and allow costs that would otherwise not be eligible for federal matching funds for experimental, pilot, or demonstration projects that are likely to assist in promoting Medicaid objectives. Iritani discussed the results of a recently-released GAO report entitled “Medicaid Demonstrations: More Transparency and Accountability for Approved Spending are Needed”. According to Iritani, in April 2015, GAO found that under Medicaid section 1115 demonstrations HHS had authorized expenditures not otherwise allowed under Medicaid for a broad range of purposes beyond expanding coverage. How these expenditure authorities promoted Medicaid objectives was not always apparent, she said. In his opening statements, Subcommittee Chairman Joe Pitts (R-PA) said that, “When CMS has a process that is not transparent nor predictable, a process in which CMS often approves a demonstration for one state but denies a similar demo for another state—that process is, understandably, perceived by states and other stakeholders as inconsistent, unfair, and unaccountable.” More information on the hearing may be found here.
• On June 24, 2015, the House Ways and Means Subcommittee on Oversight convened a hearing entitled, “Rising Health Insurance Premiums Under Obamacare”. Witnesses for the hearing included Seth Chandler, Insurance Law Professor at the University of Houston; Julie McPeak, Commissioner of the Tennessee Department of Commerce & Insurance; Al Redmer Jr., Commissioner of the Maryland Insurance Administration; and Mike Kreidler, Washington State Insurance Commissioner. More information on the hearing may be found here.
• On June 24, 2015, the House Appropriations Committee held a markup of the FY 2016 Labor, Health and Human Services, and Education Appropriations bill (Labor-HHS). The legislation as amended was passed out of Committee by a vote of 30-21. More information on the markup may be found here.
• On Thursday June 25, 2015, the House Energy & Commerce Subcommittee on Health convened a hearing to consider public health legislation:
  • HR 1344 — A bill to amend the Public Health Service Act to reauthorize a program for early detection, diagnosis, and treatment regarding deaf and hard-of-hearing newborns, infants, and young children.
  • HR 1462 — Protecting Our Infants Act
  • HR 2820 — A bill to reauthorize the Stem Cell Therapeutic and Research Act of 2005.

More information may be found here.

III. REPORTS, STUDIES, & ANALYSES

• On June 23, 2015, the Congressional Budget Office (CBO) released a cost estimate of H.R. 6, the “21st Century Cures Act”. H.R. 6 would authorize appropriations for the National Institutes of Health (NIH), the FDA, and other agencies within HHS for programs aimed at promoting the discovery and development of drugs and other technologies that prevent, diagnose, and treat disease or to support activities authorized by the legislation. CBO estimates that implementing the legislation would cost $106.4 billion over the 2016-2020 period, assuming the appropriation of the authorized and necessary amounts. CBO estimates that enacting H.R. 6 would reduce direct spending, on net, by $11.9 billion over the 2016-2025 period. (Of that amount, CBO estimates that off-budget costs for the U.S. Postal Service would total $6 million over the 2016-2025 period.) Pay-as-you-go procedures apply because enacting the legislation would affect direct spending. Enacting H.R. 6 would not affect revenues. H.R. 6 contains no intergovernmental mandates as defined in the Unfunded Mandates Reform Act (UMRA). However, because the bill would delay entry into the market of some generic drugs and limit Medicaid payments to states for DME, the bill could increase state Medicaid costs by $2.6 billion over the 2016-2025 period, CBO estimates. States have flexibility in that program to adjust their financial and programmatic responsibilities, so those costs would not result from an intergovernmental mandate. The bill would impose private-sector mandates, as defined in UMRA, on drug manufacturers. CBO estimates that the aggregate cost of the mandates would fall below the annual threshold established in UMRA ($154 million in 2015, adjusted annually for inflation) in each of the first five years that the mandates are in effect.
• The Office of Inspector General (OIG) released a study entitled “Ensuring the Integrity of Medicare Part D”. In the report, OIG summarized the results of numerous OIG investigations, audits, evaluations, and legal guidance related to Part D program integrity. The program integrity vulnerabilities that OIG has identified relate to the three key players charged with safeguarding the program: Part D plan sponsors, the Medicare Drug Integrity Contractor (MEDIC), and CMS. The underlying vulnerabilities in Part D center on two main issues: (1) the need to more effectively collect and analyze program data to proactively identify and resolve program vulnerabilities, and prevent fraud, waste, and abuse before it occurs; and (2) the need to more fully implement robust oversight to ensure appropriate payments, prevent fraud, and protect beneficiaries. Furthermore, OIG reports that Part D remains vulnerable to fraud, as evidenced by ongoing investigations. These investigations have uncovered cases that resulted in financial harm to Part D and serious medical and financial harm to individuals. OIG recommends that, to fully protect Part D from fraud, waste, and abuse, CMS should take further action and implement OIG's unimplemented recommendations. Specifically, CMS should: (1) require plan sponsors to report all potential fraud and abuse to CMS and/or the MEDIC; (2) require plan sponsors to report data on the inquiries and corrective actions they take in response to fraud and abuse; (3) expand drug utilization review programs to include additional drugs susceptible to fraud, waste, and abuse; (4) implement an edit to reject prescriptions written by excluded providers; (5) exclude Schedule II drug refills when calculating final payments to plan sponsors at the end of each year; (6) seek authority to restrict certain beneficiaries to a limited number of pharmacies or prescribers; (7) develop and implement a mechanism to recover payments from plan sponsors when law enforcement agencies do not accept case referrals; (8) determine the effectiveness of plan sponsors' fraud and abuse detection programs; and (9) ensure that plan sponsors' compliance plans address all regulatory requirements and CMS guidance.
• On June 22, 2015, in tandem with the study described above, OIG published a data brief entitled “Questionable Billing and Geographic Hotspots Point to Potential Fraud and Abuse in Medicare Part D”. OIG based this data brief on an analysis of prescription drug event (PDE) records from 2006 to 2014. Authors described trends in spending for Part D drugs and identified pharmacies with questionable billing. Each of these pharmacies billed extremely high amounts for at least one measure that could indicate potentially fraudulent activity. They also identified geographic hotspots for specific non-controlled drugs that are vulnerable to fraud and abuse. OIG found that, since 2006, Medicare spending for commonly abused opioids has grown faster than spending for all Part D drugs; pharmacies with questionable billing raise concerns about pharmacy-related fraud schemes; and geographic hotspots for certain non-controlled drugs point to possible fraud and abuse.

IV. OTHER HEALTH POLICY NEWS

• On June 25, 2015, the Supreme Court issued a decision in King v. Burwell (Slip Op. No. 14-114). At issue in this case was whether a regulation issued by the Internal Revenue Service (IRS) providing for premium tax subsidies in both State-based and Federally Facilitated Exchanges (the “IRS Rule”) was a permissible interpretation of the underlying statute, the Patient Protection and Affordable Care Act (ACA). By a vote of 6 - 3, the Supreme Court upheld the IRS Rule, maintaining access to subsidies for otherwise eligible individuals across all Exchanges – not merely those established by a State. In short, the Court maintained the status quo. The Court concludes, in essence, that IRC § 36B, “fairly . . . read consistent with what [the Court] sees as Congress’s plan,” “allows tax credits for insurance purchased on any Exchange created under the Act.” More information on the decision may be found here.
• On June 25, 2015, CMS released a Fact Sheet on the Accountable Care Organization (ACO) “Investment Model”, an initiative developed by the Center for Medicare & Medicaid Innovation for organizations participating as ACOs in the Medicare Shared Savings Program. The ACO Investment Model is a new model of pre-paid shared savings that builds on 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 is expected to help provide support to organizations whose ability to invest in infrastructure and redesigned care processes would be improved with additional access to capital. The application period for ACOs that started in 2014 and 2015 -- or will start in 2016 -- will open July 1st, 2015 and close July 31, 2015. A blog post on the announcement by Dr. Patrick Conway, MD, Deputy Administrator for Innovation and Quality and Chief Medical Officer at CMS may be found here.
• On June 22, 2015, the American Society of Clinical Oncology (ASCO) published an initial version of a conceptual framework for assessing the value of new cancer treatment options based on clinical benefit, side effects, and cost. The framework will serve as the basis for standardized tools that doctors can use with their patients to discuss the relative value of new cancer therapies compared with established treatments. “Value and cost are among the biggest issues in healthcare today, but there are few tools to help doctors and patients objectively assess benefits, side effects and costs,” said ASCO President Julie M. Vose, MD, MBA, FASCO. “Our goal is to help oncologists and their patients weigh potential treatment options based on high-quality scientific evidence and a thoughtful assessment of each patient’s needs and goals. In publishing this initial version of the framework, just the beginning of the process, we hope to drive discussion and debate about a critically important issue.” The ASCO Value Framework, published in the Journal of Clinical Oncology, was developed by ASCO’s Value in Cancer Care Task Force, with input from oncologists, patient advocates, representatives of the pharmaceutical and insurance industries, and others. Of note, ASCO is soliciting comments on the framework.
• Dr. Ryan Howe was recently promoted to Director of the Office of Practitioner Services at the CMS Center for Medicare. Howe previously worked on Physician Fee Schedule policy development and rate setting for in CMS's Division of Practitioner Services. As the deputy director, technical advisor, and as a policy analyst, he contributed to the development and implementation of policies to improve the accuracy and efficiency of physician payment, including cross-agency research on physician payment, the misvalued codes initiative, telehealth policies, and primary care. Ryan’s prior experience includes three years of experience in the Medicare Contractor Management Group where he analyzed and provided recommendations on national contractor workload data and served as a CMS liaison to and change management point of contact for Medicare contractors.