A&B Healthcare Week in Review, January 16, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On January 14, 2015, the Health Resources and Services Administration (HRSA) announced that the agency is updating the scoring criteria for determining mental health professional shortage areas (HPSAs) of greatest need. In accordance with the requirements of section 333A(b)(1) of the Public Health Service (PHS) Act, as amended by the Health Care Safety Net Amendments of 2002, 42 U.S.C. 254f- 1(b)(1), the Secretary of the Department of Health and Human Services (HHS) shall establish the criteria which she will use to make determinations under section 333A(a)(1)(A) of the HPSAs with the greatest shortages. This notice sets forth revised criteria for determining mental health HPSAs with the greatest shortage. This updates the previous criteria published on May 30, 2003, and is effective January 14, 2015. More information may be found here.
• On January 16, 2015, the Food and Drug Administration (FDA) released a notice announcing the availability of a draft guidance for industry entitled ‘‘Evaluating Drug Effects on the Ability to Operate a Motor Vehicle.’’ The purpose of this guidance is to assist sponsors in the evaluation of the effects of psychoactive drugs on the ability to operate a motor vehicle. This draft guidance recommends using a systematic effort to identify drugs that increase the risk of motor vehicle accidents as a critical component of assessing drug risk and designing strategies to reduce this risk. FDA invites comments on the draft guidance through March 17, 2015. 
• On January 14, 2015, the National Institutes of Health (NIH) announced requirements and registration for its ‘‘Innovations in Measuring and Managing Addiction Treatment Quality’’ Challenge. Through the Challenge, the National Institute on Drug Abuse (NIDA), a component of NIH, challenges the general public to make concrete advances toward improving the quality of addiction treatment. Specifically, through this Challenge, NIDA hopes to incentivize the development of innovative concepts for quality measurement and quality management systems based on the latest science of addiction and its treatment and of quality measurement and management. The submission period begins January 14th and ends June 1st, 2015. Winners will be announced September 30, 2015. 
• On January 14, 2015, the Department of Veterans Affairs announced that an information collection activity entitled “A Locality Pay for Nurses and Other Health Care Personnel, VA Form 10–0132” had been submitted to the Office of Management and Budget (OMB) for review. The collection of this information is necessary to comply with the provisions of Public Law 101–366 (Department of Veterans Affairs (VA) Nurse Pay Act of 1990) as amended by 106–419 (Veterans Benefits and Health Care Improvement Act of 2000), which specifically provides for a locality pay system for certain health care personnel within VA. Rates of pay are established by VA medical facility Director based on rates of compensation for corresponding positions in the local labor market. Comments are due February 13, 2015. 
• On January 12, 2015, FDA announced the availability of a Study Data Technical Conformance Guide, Version 2.0 (Guide), and an update to the Data Standards Catalog (Catalog). The Guide supplements the final guidance for industry entitled ‘‘Providing Regulatory Submissions in Electronic Format—Standardized Study Data’’ (eStudy Data guidance) and provides specifications and recommendations for, as well as general considerations on, submitting standardized study data using FDA-supported data standards specified in the Catalog. The Guide is intended to complement and promote interactions between sponsors and FDA review divisions. More information may be found here. 
• On January 16, 2015, CMS announced 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–372(S) Annual Report on Home and Community Based Services Waivers and Supporting Regulations; 2) CMS–10500 Outpatient/Ambulatory Surgery Patient Experience of Care Survey (O/ASPECS); 3) CMS–10221 Site Investigation for Independent Diagnostic Testing Facilities (IDTFs); and 4) CMS–R–263 Site Investigation for Suppliers of Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS). Comments are due March 17, 2015. More information may be found here. 
• On January 13, 2015, FDA announced that a proposed information collection entitled “Disclosure Regarding Additional Risks in Direct-to-Consumer Prescription Drug Television Advertisements” had been submitted to OMB for review and clearance. Public comments are due February 12, 2015. 
• On January 16, 2015, CMS announced an opportunity for the public to comment on an information collection request that was submitted for OMB review. The information collection is entitled “National Provider Identifier (NPI) Application and Update Form and Supporting Regulations in 45 CFR 142.408, 45 CFR 162.406, 45 CFR 162.408”. The National Provider Identifier (NPI) Application and Update Form is used by health care providers to apply for NPIs and furnish updates to the information they supplied on their initial applications. The form is also used to deactivate their NPIs if necessary. The NPI Application/Update form has been revised to provide additional guidance on how to accurately complete the form. The NPI Application/Update form has been revised to provide additional guidance on how to accurately complete the form. Comments are due February 17, 2015. 
• On January 7, 2015, the OMB Office of Information and Regulatory Affairs received a proposed rule entitled “Application of the Mental Health Parity and Addiction Equity Act to Medicaid Programs (CMS-2333-P)”. This proposed rule would address the requirements under the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) to Medicaid Alternative Benefit Plans (ABPs), Children's Health Insurance Program (CHIP), and Medicaid managed care organizations (MCOs). A final rule implementing MHPAEA was published in the Federal Register on November 13, 2013. These final MHPAEA provisions do not apply to Medicaid MCOs, ABPs, or CHIP State plans. This rule proposes to address how MHPAEA requirements, including those implemented in the November 13, 2013, final rule, apply to MCOs, ABPs, and CHIP.

II. LEGISLATION & COMMITTEE ACTION 

• On January 12, 2015, the House passed the “Protecting Volunteer Firefighters and Emergency Responders Act” (H.R. 33). The legislation would exempt emergency services volunteers from being counted as employees under the shared responsibility requirements contained in the Affordable Care Act (ACA). The same evening the House passed a military and veterans’ suicide prevention bill (H.R. 203), which includes a requirement for an annual third-party review of Veterans Affairs (VA) and Defense Department mental health and suicide-prevention programs and amends the rules for reviewing discharges of military service members diagnosed with traumatic brain injury or post-traumatic stress disorders. 
• On January 13, 2015, House Energy and Commerce Committee members Fred Upton (R-MI) and Diana DeGette (D-CO) published an op-ed outlining five broad areas of reform that will be addressed by the Committee’s forthcoming bill 21st Century Cures Bill. (The “Cures” initiative, which began last year, explored ways to “accelerate the discovery, development, and delivery of new treatments to patients”). The article discusses several areas of reform to be addressed by the Cures bill, including: modernizing clinical trials to streamline the approval of drugs and devices; integrated the patient perspective into the regulatory process; promoting better access to and sharing of information such as genomic and other clinical data; investing in young, emerging scientific talent; and incentivizing new drugs and devices for unmet medical needs. 
• On January 14, 2015, the House Energy and Commerce Committee issued a press release announcing that the Committee will hold a two-day hearing on January 21st and 22nd in room 2322 of the Rayburn House Office Building to “…discuss how to bring Sustainable Growth Rate (SGR) reform to the president’s desk before the current patch expires at the end of March 2015.” Said full committee Chairman Fred Upton (R-MI), “For too long, the specter of uncertainty has threatened seniors’ access to their trusted doctor. Last year we came closer than ever to finally solving SGR – we even passed a bipartisan bill out of committee 51 to zero. In the coming months, we have an opportunity to build upon that momentum in finding a fiscally responsible path to keep the promise to our seniors and put this issue to bed once and for all. This hearing will provide an important opportunity for members to discuss a path forward, on behalf of seniors and their doctors, in this new Congress.” The hearing Memorandum, a witness list, and witness testimony will be available here as they are posted.

III. REPORTS, STUDIES, & ANALYSES 

• On January 13, 2015, the National Governors Association (NGA) published a paper entitled “The Expanding Role of Pharmacists in a Transformed Health Care System”. In the paper, the NGA encourages states to amend laws and regulations to expand pharmacists’ scope of practice and integrate pharmacists more fully into the healthcare delivery system. Specifically, the report calls on states to address the “greatest challenges pharmacists face”, specifically: restrictions in collaborative practice agreements (CPAs), recognition of pharmacists as healthcare providers to ensure compensation for direct patient care services; and access to health IT systems. 
• The Congressional Research Service (CRS) recently released an updated report on the status of Medicaid expansion as established under the ACA. (The ACA established 133% of the federal poverty level (FPL) as the new mandatory minimum Medicaid income eligibility level for most nonelderly adults. On June 28, 2012, the United States Supreme Court issued its decision in National Federation of Independent Business v. Sebelius, finding that the enforcement mechanism for the ACA Medicaid expansion violated the Constitution, which effectively made the ACA Medicaid expansion optional for states). The report provides an updated “state of the states”, including a description of “alternative” models used by some states to achieve expansion in non-traditional ways. The report may be accessed here. 
• On January 14, 2015, the Office of Inspector General (OIG) published a report entitled “Medicare Hospices have Financial Incentives to Provide Care in Assisted Living Facilities”. Pursuant to the ACA, CMS must reform the hospice payment system, collect data relevant to revising payments, and develop quality measures. This report provides information to inform those decisions and is part of OIG’s larger body of work on hospice care. OIG based this study on an analysis of all Medicare hospice claims from 2007 through 2012, using Certification and Survey Provider Enhanced Reports data and Healthcare Cost Report Information System reports for information on hospice characteristics. The report finds that Medicare payments for hospice care in assisted living facilities (ALFs) more than doubled in 5 years, totaling $2.1 billion in 2012. Hospices provided care much longer and received much higher Medicare payments for beneficiaries in ALFs than for beneficiaries in other settings. Hospice beneficiaries in ALFs often had diagnoses that usually require less complex care. Hospices typically provided fewer than 5 hours of visits and were paid about $1,100 per week for each beneficiary receiving routine home care in ALFs. Also, for-profit hospices received much higher Medicare payments per beneficiary than nonprofit hospices. Noting that “this report raises concerns about the financial incentives created by the current payment system”, OIG recommends that CMS: (1) reform payments to reduce the incentive for hospices to target beneficiaries with certain diagnoses and those likely to have long stays, (2) target certain hospices for review, (3) develop and adopt claims-based measures of quality, (4) make hospice data publicly available for beneficiaries, and (5) provide additional information to hospices to educate them about how they compare to their peers. CMS concurred with all five recommendations. 
• On January 14, 2015, Avalere released an analysis entitled “New Benefit Designs in Exchange Plans Make Determining Out-of-Pocket Costs for Specialty Drugs Challenging”. Among silver plans sold on Exchanges, 17 percent use multiple specialty tiers in their 2015 formularies. Those plans typically designate generic, preferred, or non-preferred specialty tiers. HealthCare.gov enrollees have the choice of Bronze, Silver, Gold or Platinum plans, which differ in the percentage the plan pays of overall healthcare costs. Silver plans are the top choice for many Americans. For consumers, placement of a medication on a specialty tier typically translates to higher out-of-pocket costs. Avalere conducted a manual search of plan documents for Silver plans because of inaccuracies noted on HealthCare.gov and in associated data sets. Notably, HealthCare.gov reports formulary cost sharing for all plans in a four-tier structure (including only one specialty tier); however, about 35 percent of Silver plans do not use four-tier formularies. Because of this discrepancy, consumer costs appearing on HealthCare.gov may misstate actual enrollee financial responsibility. 
• This week the Commonwealth Fund published a research brief entitled “The Rise in Health Care Coverage and Affordability Since Health Reform Took Effect”. New results from the Commonwealth Fund Biennial Health Insurance Survey, 2014, indicate that the ACA’s subsidized insurance options and consumer protections reduced the number of uninsured working-age adults from an estimated 37 million people, or 20 percent of the population, in 2010 to 29 million, or 16 percent, by the second half of 2014. Conducted from July to December 2014, for the first time since it began in 2001, the survey finds declines in the number of people who report cost-related access problems and medical-related financial difficulties. The number of adults who did not get needed health care because of cost declined from 80 million people, or 43 percent, in 2012 to 66 million, or 36 percent, in 2014. The number of adults who reported problems paying their medical bills declined from an estimated 75 million people in 2012 to 64 million people in 2014. 
• On January 14, 2015, the Institute of Medicine (IOM) released a report entitled “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk”. With support from 23 public- and private-sector sponsors in the United States and abroad, the IOM assembled a committee to develop guiding principles and a practical framework for the responsible sharing of clinical trial data. In its report, the committee concludes that sharing data is in the public interest, but a multi-stakeholder effort is needed to develop a culture, infrastructure, and policies that will foster responsible sharing.

IV. OTHER HEALTH POLICY NEWS 

• On January 14, 2015, HHS released updated enrollment figures for 2015 Open Enrollment on the ACA Health Insurance Exchanges. According to the announcement, since Open Enrollment began on November 15, nearly 6.8 million consumers selected a plan or were automatically re-enrolled in the Federally Facilitated Marketplace (FFM). This is the first weekly snapshot that provides an estimate of plan selections for each state in the FFM. Open enrollment ends on February 15, 2015. 
• The Medicare Payment Advisory Commission (MedPAC) met this week on January 15th and 16th to discuss Medicare payment policy issues. Of note, the Commission voted unanimously to approve site neutral payments for inpatient rehabilitation facilities (IRFs) and skilled nursing facilities (SNFs) for selected conditions; they also voted on a recommendation to replace the existing bonus for primary care doctors with a per-beneficiary payment method. Other topics discussed during the meeting included: trends in payments across sectors and ways to rationalize payments for post-acute care (PAC); assessing payment adequacy and updates for ambulatory surgical centers, dialysis facilities, hospice, IRFs, and long-term care hospitals; the relative cost of Medicare Advantage, Accountable Care Organizations, and fee-for-service Medicare; a status report on Part D Medicare; hospital short stay policy issues; and next steps in measuring quality of care in Medicare. More information on the meeting, including briefs, presentations and transcripts as they become available, may be found here. 
• According to reports, CMS Administrator Marilyn Tavenner will be stepping down from her post in February. Tavenner has been with the agency since 2010. Prior to assuming her CMS leadership role, Tavenner served for four years as the Commonwealth of Virginia’s Secretary of Health and Human Resources in the administration of former Governor Tim Kaine. Shortly after the announcement was made, Senate Majority Leader Mitch McConnell (R-KY) released a statement on her departure: “The role of the Centers for Medicare and Medicaid Services Administrator is supposed to be about overseeing these important programs, not implementing a gigantic, unworkable law that hurts hardworking Americans. While we appreciate her service, no one could have successfully managed a law as unworkable as Obamacare.”