A&B Healthcare Week in Review, January 30, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On January 29, 2015, the Centers for Medicare and Medicaid Services (CMS) announced the extension of a temporary moratoria, effective immediately, on the enrollment of new ambulance suppliers and home health agencies (HHAs) in specific locations within designated metropolitan areas in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, in order to prevent and combat fraud, waste, and abuse. Existing providers and suppliers can continue to deliver and bill for services, but no new provider and supplier applications will be approved in these areas. The new moratoria (on the enrollment of home health agencies in Fort Lauderdale, Detroit, Dallas and Houston) and the six-month extension of the existing moratoria (of new ground ambulance suppliers in the Greater Philadelphia area) are expected to remain in place for a period of six months. CMS may lift the moratoria earlier or extend it another six months by issuing another notice in the Federal Register. 
• On January 26, 2015, the Internal Revenue Service (IRS) released an advanced copy of Notice 2015-9 providing certain relief from penalties for taxpayers who have a balance due on their 2014 income tax return as a result of reconciling advance payments of the premium tax credit (as allowed for coverage under a qualified health plan, or QHP) against the premium tax credit allowed on the tax return. Specifically, this Notice provides relief from the penalty under § 6651(a)(2) of the Internal Revenue Code for late payment of a balance due and the penalty under § 6654(a) for underpayment of estimated tax. To qualify for the relief, taxpayers must meet certain requirements described in the notice. This relief applies only for the 2014 taxable year. This relief does not apply to any underpayment of the individual shared responsibility payment resulting from the application of § 5000A because such underpayments are not subject to either the § 6651(a)(2) penalty or the § 6654(a) penalty. 
• On January 28, 2015, the Office of the National Coordinator for Health Information Technology (ONC) released a notice announcing availability of approved test tools and test procedures for the testing of EHR technology to the 2014 Edition Release 2 EHR certification criteria under the ONC HIT Certification Program. The approved test tools and test procedures are identified on the ONC Web site at: http://healthit.gov/ policy-researchers-implementers/ testing-and-test-methods. The test tools and test procedures for the ‘‘optional— transitions of care’’ certification criterion (§ 170.314(b)(8)) and the optional testing and certification for the ‘‘view, download, and transmit to 3rd party’’ certification criterion (§ 170.314(e)(1)) have not yet been approved. More information may be found here. 
• On January 27, 2015, the Food and Drug Administration (FDA) announced the availability of a draft guidance for industry and FDA staff entitled ‘‘Current Good Manufacturing Practice Requirements for Combination Products.’’ The guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products, including presenting general considerations for CGMP compliance as well as analysis of hypothetical scenarios. Comments on the draft guidance should be submitted by March 30, 2015. More information may be found here. 
• On January 27, 2015, FDA announced a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 038’’ (Recognition List Number: 038), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. Comments may be submitted to FDA at any time. 
• On January 27, 2015, FDA announced the availability of a guidance for industry entitled ‘‘S10 Photosafety Evaluation of Pharmaceuticals.’’ The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance outlines details on when photosafety testing is warranted and on possible assessment strategies; it should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The purpose of the guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals. This guidance finalizes the draft guidance issued on February 4, 2013. 
• On January 27, 2015, the Department of Veterans Affairs (VA) released a notice entitled “From War to Home: Improving Patient-Centered Care and Promoting Empathy for ‘‘Operation Enduring Freedom’’ and ‘‘Operation Iraqi Freedom’’ (OEF/OIF) Veterans in the Veterans Health Administration Patient Aligned Care Team Demo Lab VISN 4”. This notice solicits comments on information needed to obtain an accurate and comprehensive assessment of satisfaction of patients who receive mental health care services and on outcomes for Veterans who seek mental health treatment from VHA. Data will allow the program office to ensure that the target audience is being reached, effective treatments are being offered, and tangible, quantitative results are being measured and tracked for continual program improvement. Comments are due March 30, 2015. 
• On January 27, 2015, FDA announced that the agency is providing interested persons with the opportunity to submit written comments and to request an informal public meeting concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice and/or public meeting will be considered in preparing the United States position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 2015. More information may be found here. 
• On January 27, 2015, FDA announced an opportunity for the public to comment on the information collection in Form FDA 3792 ‘‘Biosimilars User Fee Cover Sheet’’. Comments are due March 30, 2015. 
• On January 28, 2015, FDA issued a final order entitled “Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems”. The final order requires the filing of premarket approval applications (PMA) for automated external defibrillator (AED) systems, which consist of an AED and those AED accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., pad electrodes, batteries, adapters, and hardware keys for pediatric use). The order is effective January 29, 2015. 
• On January 28, 2015, FDA announced that a proposed information collection entitled “Blood Establishment Registration and Product Listing” had been submitted to the Office of Management and Budget (OMB) for review. Comments are due March 2, 2015. 
• On January 29, 2015, FDA announced an opportunity for the public to comment on the proposed information collection activity entitled “Guidance for Industry and Food and Drug Administration Staff—Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Principle”. This notice solicits comments on the collection of information concerning class II special controls for an automated blood cell separator device operating by centrifugal or filtration separation principle. Comments are due March 30, 2015. 
• On January 29, 2015, FDA announced that a proposed information collection activity entitled “Medical Device Labeling Regulations” had been submitted to OMB for review and clearance. Comments are due March 2, 2015. 
• On January 27, 2015, VA released a notice soliciting comments on the information needed to evaluate Patient Aligned Care Team (PACT) implementation by providing education about the needs and experiences of ‘‘Operation Enduring Freedom’’ and ‘‘Operation Iraqi Freedom’’ (OEF/OIF) Veterans that is emotionally resonant and engaging to learners on a visceral level, as well as promoting a greater sense of alignment with VA’s mission of providing patient-centered care. Comments are due March 30, 2015. More information may be found here. 
• On January 30, 2015, CMS announced an opportunity for the public to comment on two information collection activities that have been submitted to OMB for review: 1) Ambulatory Surgical Center Quality Reporting Program; and 2) Certification as a Supplier of Portable X-Ray and Portable X-Ray Survey Report Form and Supporting Regulations. Comments are due March 2, 2015. More information may be found here. 
• On January 30, 2015, CMS announced an opportunity for the public to comment on the following information collections: CMS–R–306 Use of Restraint and Seclusion in Psychiatric Residential Treatment Facilities (PRTFs) for Individuals Under Age 21 and Supporting Regulations; CMS–10371 Cooperative Agreements to Support Establishment of State Operated Health Insurance Exchanges; CMS–10392 Consumer Operated and Oriented (CO–OP) Program; CMS–10418 Annual MLR and Rebate Calculation Report and MLR Rebate Notices; CMS–10472 Exchange Functions: Standards for Navigators and Non-Navigator Assistance; CMS–10494 Standards for Navigators and Non-Navigator Assistance Personnel; Consumer Assistance Tools and Programs of an Exchange and Certified Application Counselors; and CMS–10549 Generic Clearance for Questionnaire Testing and Methodological Research for the Medicare Current Beneficiary Survey (MCBS). Comments are due March 31, 2015. More information may be found here.

Event Notices 

• February 23-24, 2015: On January 26, 2015, the FDA announced a meeting of the Pharmacy Compounding Advisory Committee. On February 23, 2015, during the morning session, the committee will discuss proposed revisions to the list of drug products that may not be compounded under the exemptions provided by the FD&C Act because the drug products have been withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. During the afternoon session, and on February 24, 2015, the committee will discuss proposed criteria for developing the list of bulk drug substances that may be used to compound drug products in accordance with section 503A of the FD&C Act and will discuss six substances nominated for inclusion on the list. The meeting will take place at FDA’s White Oak Campus in Silver Spring, Maryland. More information may be found here. 
• March 25-27, 2015: Cincinnati District, in co-sponsorship with Xavier University, is announcing a public conference entitled ‘‘FDA/Xavier University PharmaLink Conference: Leadership in a Global Supply Chain.’’ The PharmaLink conference seeks solutions to important and complicated issues by aligning with the strategic priorities of FDA and includes presentations from key FDA officials, global regulators, and industry experts. More information may be found here. 
• March 30-31, 2015: On March 30th and 31st, FDA announced that it will hold a public workshop on gastroenterology regulatory endpoints and the advancement of therapeutics. The purpose of this workshop is to provide a forum to consider issues related to selection of endpoints and clinical outcome measures appropriate for drug development in the following disease areas: Inflammatory bowel diseases and celiac disease. The meeting will take place from 8:30 AM to 5:00 PM at the FDA White Oak Campus in Silver Spring, MD. More information may be found here.

II. LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On January 29, 2015, the Senate Health, Education, Labor and Pensions (HELP) Committee convened a hearing entitled “Employer Wellness Programs: Better Health Outcomes and Lower Costs”. Witnesses for the hearing included Dr. Gary W. Loveman, President and Chief Executive Officer, Caesars Entertainment Corporation, Las Vegas, NV; Dr. Catherine M. Baase , Chief Medical Officer, The Dow Chemical Company; Dr. David C. Grossman , Medical Director for Population and Purchaser Strategy, Group Health Research Institute; Mr. James Matthew Abernathy , Nashville, TN; Mrs. Jennifer Mathis, Bazelon Center for Mental Health Law; and Mr. Eric S. Dreiband , Partner, Jones Day. During the hearing Members and witnesses discussed how the Affordable Care Act (ACA) strengthened incentives for employers to establish employee wellness programs, and the interplay between the ACA and the Americans with Disabilities Act (ADA), particularly in the context of inducements to participate in employer wellness programs. Employer wellness programs have recently come under fire from the Equal Employment Opportunity Commission (EEOC), which charged in a series of lawsuits that some employer wellness programs are effectively mandatory for employees (in violation of the law), and that standards governing their compliance with the health law and with the ADA lack clarity. In her opening testimony, Mathis insisted that “…the ADA and the ACA co-exist easily in their application to wellness programs, and that the requirements of both laws can be followed at the same time…as the two statutes do not even address the same issue—the ACA addresses what constitutes insurance discrimination and the ADA addresses what constitutes employment discrimination—it would be particularly inappropriate to look to the terms of the ACA to determine what constitutes a violation of the ADA.” More information on the hearing may be found here.
• On January 29, 2015, Senators Lamar Alexander (R-TN) and Richard Burr (R-NC) introduced a report, entitled “Innovation for Healthier Americans Identifying Opportunities for Meaningful Reform to Our Nation’s Medical Product Discovery and Development”, which serves as a companion document to complement the House’s “21st Century Cures Act” discussion draft (see below). The Senators are soliciting feedback on their report as Chairman Alexander and HELP Committee Ranking Member Patty Murray (D-WA.) begin a major initiative—including a bipartisan working group and a series of hearings—to examine the time and cost currently involved with the drug and medical device discovery and development process, and how to better align public policies to support medical innovation. In the executive summary, the Senators write: “This report aims to examine the current process of drug and device development and identify the inefficiencies that stand in the way of a modern development and review process. We take a close and honest look at what is, and is not, working well at the NIH and FDA. We want to know what successes we can replicate, and what failures must be learned from and fixed.”

House of Representatives 

• On January 27, the House Energy and Commerce Committee released a discussion draft of the “21st Century Cures Act”, which outlines specific proposals discussed during the Committee’s yearlong “21st Century Cures Initiative”. Over the course of the last year, patients, providers, innovators, regulators, and researchers from around the country have provided a wide range of specific ideas on how Congress can help accelerate the discovery, development, and delivery of promising new treatments and cures for patients and “maintain our nation’s standing as the biomedical innovation capital of the world”. Based on ideas generated during these discussions, the legislative language seeks to address four broad goals: (1) incorporate patient perspectives into the regulatory process and help address their unmet medical needs; (2) build the foundation for 21st Century medicine; (3) streamline clinical trials; (4) accelerate the discovery, development, and delivery cycle and support continued innovation at our Federal public health agencies; and (5) modernize medical product regulation. A section-by-section of the discussion document may be found here, and a one-pager highlighting the legislative ideas may be found here. 
• On January 28, 2015, the House Committee on Veterans’ Affairs convened a hearing entitled “Examining the Quality and Cost of VA Health Care”. Witnesses for the hearing included Carl Blake, Associate Executive Director for Government Relations, Paralyzed Veterans of America (PVA), on behalf of Co-Authors of the Independent Budget (IB); Louis Celli, Jr., Director, Veterans Affairs & Rehabilitation Division, on behalf of The American Legion; Matthew S. Goldberg, Deputy Assistant Director, National Security Division, on behalf of Congressional Budget Office (CBO); and James Tuschschmidt, M.D., Acting Principal Deputy Under Secretary for Health, Veterans Health Administration (VHA), on behalf of U.S. Department of Veterans Affairs (VA). Of note, last year President Obama signed into law the Veterans Access, Choice, and Accountability Act of 2014 (PL 113-146), which requires the VA to offer an authorization to receive non-VA care to any veteran who is enrolled in the VA health care system as of August 1, 2014, or who is a newly discharged combat veteran if such veteran is unable to secure an appointment at a VA medical facility within 30 days (or a future published goal established by VA) or resides more than 40 miles from the nearest VA medical facility, with certain exceptions. During the hearing participants discussed the relative cost of providing care to veterans within and without the VA system. More information on the hearing may be found here. 
• On January 28, 2015, members of the House Energy and Commerce Committee issued a letter to Department of Health and Human Services (HHS) Secretary Sylvia Burwell, which seeks to examine the extent to which HHS and other relevant agencies are preparing for the possible consequences of the Supreme Court’s decision in the case of King v. Burwell. (The plaintiffs in the case argue that regulations allowing premium tax subsidies through Federally-Facilitated Exchanges (FFEs) are invalid and that subsidies may be provided only through Exchanges established by States.) 
• On January 27, 2015, the House Energy and Commerce Health Subcommittee convened a hearing to discuss several pieces of public health legislation. More information may be found here; legislation under review may be found listed below: 
  • The Ensuring Patient Access to Effective Drug Enforcement Act, authored by full committee Vice Chairman Marsha Blackburn (R-TN) and Reps. Tom Marino (R-PA), Peter Welch (D-VT), and Judy Chu (D-CA). This bill would improve enforcement efforts regarding prescription drug diversion and abuse. This bill was approved by the full House in July of 2014. 
  • The Improving Regulatory Transparency for New Medical Therapies Act, authored in the previous Congress by Subcommittee Chairman Pitts and Frank Pallone (D-NJ), now Ranking Member of the full committee. This bill would amend the Controlled Substances Act to improve the efficiency, transparency, and consistency of the Drug Enforcement Agency’s process for scheduling new drugs approved by the Food and Drug Administration. 
  • The Veteran Emergency Medical Technician Support Act, authored by Reps. Adam Kinzinger (R-IL) and Lois Capps (D-CA). This bill would provide demonstration grants to states with a shortage of emergency medical technicians (EMTs) to streamline state-licensing requirements for military veteran EMTs to prevent unnecessary duplication in training. This bill was approved by the full House in February 2013.
  • The Trauma Systems and Regionalization of Emergency Care Reauthorization Act, authored by Rep. Michael C. Burgess, M.D. (R-TX) and Health Subcommittee Ranking Member Gene Green (D-TX). This bill would reauthorize Trauma Care Systems Planning Grants, which support state and rural development of trauma systems. It would also reauthorize pilot projects to implement and assess regionalized emergency care models. This bill was approved by through the full House in June 2014. A bill to reauthorize language from the Public Health Service Act to fund trauma care centers. This funding is set to expire in Fiscal Year 2015. 
  • The National All Schedules Prescription Electronic Reporting (NASPER) Reauthorization Act. This bill, authored by Rep. Ed Whitfield (R-KY), would reauthorize the NASPER program to support state prescription drug monitoring programs.

III. REPORTS, STUDIES, & ANALYSES 

• On January 26, 2015, the Congressional Budget Office (CBO) released an updated Budget and Economic Outlook for 2015 to 2025. CBO estimates that the deficit for this fiscal year will amount to $468 billion, slightly less than the deficit in 2014. At 2.6 percent of GDP, this year’s deficit is projected to be the smallest relative to the nation’s output since 2007 but close to the 2.7 percent that deficits have averaged over the past 50 years. The report finds that freezing Medicare payment rates for physicians at the current rate would cost approximately $131 million over ten years, an increase from the $119 billion 10-year (2015-2024) cost estimate it released in November, and would raise outlays for Medicare (net of premiums paid by beneficiaries) by $6 billion in 2015. The report further estimates that ACA coverage provisions will result in net costs to the government of $76 billion in 2015 and $1,350 billion over the 2016–2025 period. Compared with the projection from last April, which spanned the 2015–2024 period, the current projection represents a downward revision in the net costs of those provisions of $101 billion over those 10 years, or a reduction of about 7 percent. In addition, CBO finds that about 42 million nonelderly residents of the United States were uninsured in 2014, about 12 million fewer than would have been uninsured in the absence of the ACA. 
• On January 23, 2015, CMS released for the first time estimates of Medicaid enrollees who were newly eligible for coverage as a result of ACA Medicaid expansions. As of last March, the figures show, states reported a total of 3,229,359 individuals were newly eligible for and enrolled in Medicaid. 
• On January 28, 2015, the Government Accountability Office (GAO) released a report entitled “Geographic Variation in Spending for Certain High-Cost Procedures Driven by Inpatient Prices”. GAO was asked to examine geographic variation in private sector health care spending. GAO examined (1) how spending per episode of care for certain high-cost procedures varies across geographic areas for private payers, and (2) how the mix of service types, and the volume, intensity, and price of services contribute to variation in episode spending across geographic areas for private payers. The report finds that spending for an episode of care in the private sector varied across metropolitan statistical areas (MSA) for coronary stent placement, laparoscopic appendectomy, and total hip replacement, even after GAO adjusted for geographic differences in the cost of doing business and differences in enrollee demographics and health status. MSAs in the highest-spending quintile had average adjusted episode spending that was 74 to 94 percent higher than MSAs in the lowest-spending quintile, depending on the procedure. MSAs with higher spending on one procedure generally had higher spending on the other two procedures. High- or low-spending MSAs were not concentrated in particular regions of the nation. 
• On January 30, 2015, ONC released a report entitled “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Version 1.0”. The draft Roadmap, designed in concert with the Federal Health IT Strategic Plan 2015 – 2020, is based on a core set of building blocks that are needed to achieve interoperability: Core technical standards and functions; Certification to support adoption and optimization of health IT products and services; Privacy and security protections for health information; Supportive business, clinical, cultural, and regulatory environments; and Rules of engagement and governance. The draft Roadmap and Standards Advisory are available for viewing at www.healthit.gov/interoperability. The public comment period for the draft Roadmap closes April 3, 2015. 
• A study published in the January edition of Health Affairs finds that families in states that have expanded Medicaid coverage under the ACA face significantly lower out-of-pocket costs than those who would use the insurance exchanges. This study compared estimated out-of-pocket spending for care and premiums, as well as the financial burdens they impose, for the families of these adults under two simulation scenarios: obtaining coverage through a silver plan with subsidized cost sharing and enrolling in expanded Medicaid. Compared with Marketplace coverage, the study shows, Medicaid would more than halve average annual out-of-pocket spending ($938 versus $1,948), while dramatically reducing the percentage of adults in families with out-of-pocket expenses exceeding 10 percent or 20 percent of income (6.0 percent versus 17.1 percent and 0.9 percent versus 3.7 percent, respectively). Larger reductions would be seen for families with smokers, who under Medicaid would no longer be subject to Marketplace tobacco user surcharges. The findings suggest that Medicaid expansion may offer a greater opportunity than access to Marketplace insurance to promote the financial well-being of previously uninsured low-income adults.

IV. OTHER HEALTH POLICY NEWS 

• On January 26, 2015, the HHS Secretary Burwell announced goals and a timeline to move the Medicare program toward value-based care reimbursement. Specifically, HHS has set a goal of tying 30 percent of traditional, or fee-for-service, Medicare payments to quality or value through alternative payment models, such as Accountable Care Organizations (ACOs) or bundled payment arrangements by the end of 2016, and tying 50 percent of payments to these models by the end of 2018. HHS also set a goal of tying 85 percent of all traditional Medicare payments to quality or value by 2016 and 90 percent by 2018 through programs such as the Hospital Value Based Purchasing and the Hospital Readmissions Reduction Programs. This is the first time in the history of the Medicare program that HHS has set explicit goals for alternative payment models and value-based payments. Secretary Burwell also announced the creation of a Health Care Payment Learning and Action Network. Through the Learning and Action Network, HHS will work with private payers, employers, consumers, providers, states and state Medicaid programs, and other partners to expand alternative payment models into their programs. The Network will hold its first meeting in March 2015, and more details will be announced in the near future. “Whether you are a patient, a provider, a business, a health plan, or a taxpayer, it is in our common interest to build a health care system that delivers better care, spends health care dollars more wisely and results in healthier people. Today’s announcement is about improving the quality of care we receive when we are sick, while at the same time spending our health care dollars more wisely,” Secretary Burwell said. “We believe these goals can drive transformative change, help us manage and track progress, and create accountability for measurable improvement.” A CMS fact sheet, entitled “Better Care, Smarter Spending, Healthier People”, may be found here. A Perspectives piece published in the New England Journal of Medicine regarding HHS efforts to set value-based payment goals may be found here. 
• Following an Associated Press report that Healthcare.gov had been sharing consumer information with advertising and analytic firms, CMS Marketplace Chief Executive Officer (CEO) Kevin Counihan released a blog post explaining that CMS “…immediately launched a review of our privacy policies, contracts for third-party tools and URL construction. We are looking at whether there are additional steps we should take to improve our efforts.” He noted that the website’s “Window Shopping” feature now includes an encrypted URL which helps prevent third parties from viewing the data the consumer entered. 
• On January 27, 2015, HHS announced that 9.5 million consumers selected or were automatically enrolled in health insurance coverage through the ACA Health Insurance Marketplaces through the second month of 2015 Open Enrollment. Of those, over 7.1 million were in states using the HealthCare.gov platform and 2.4 million were in the 14 states (including Washington, D.C.) using their own Marketplace platforms. Open Enrollment ends on February 15th. A full report containing detailed data on enrollment figures for the Federal and State-Based Marketplaces may be found here. 
• On January 27, 2015, Indiana Governor Mike Pence (R) announced that the state received CMS approval for a non-traditional Medicaid expansion plan known as the Healthy Indiana Plan (HIP) 2.0. The program requires participants to contribute to a health savings account known as a POWER account, and rewards individuals for use of primary care. Consequences for non-payment range from mandatory co-pays for services to loss of coverage. In addition, the plan includes a co-pay for emergency room use. Indiana caps participation in Medicaid to 60,000 residents, and the Healthy Indiana Plan 2.0, which begins Feb. 1, eliminates that cap. The state expects to cover about 350,000 people. “Since the beginning of my administration, we have worked hard to ensure that low-income Hoosiers have access to a health care plan that empowers them to take charge of their health and prepares them to move to private insurance as they improve their lives,” said Governor Pence. “This has been a long process, but real reform takes work.” Pence is the ninth Republican Governor to expand Medicaid under the ACA. 
• On January 29, 2015, CMS announced in a blog post that the agency intends to engage in rulemaking to update the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs beginning in 2015. The new rule, expected this spring, would be intended to be responsive to provider concerns about software implementation, information exchange readiness, and other related concerns in 2015. It would also be intended to propose changes reflective of developments in the industry and progress toward program goals achieved since the program began in 2011. Specifically, the agency is considering proposals to: 1) realign hospital EHR reporting periods to the calendar year to allow eligible hospitals more time to incorporate 2014 Edition software into their workflows and to better align with other CMS quality programs; 2) modify other aspects of the program to match long-term goals, reduce complexity, and lessen providers’ reporting burdens; and 3) shorten the EHR reporting period in 2015 to 90 days to accommodate these changes. 
• On January 30, 2015, the White House released a fact sheet outlining additional specifics on the “Precision Medicine Initiative” the President referenced in his recent State of the Union address. Launched with a $215 million investment in the President’s 2016 Budget, the document explains, the Precision Medicine Initiative will “pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients”. Objectives of the Initiative include: more and better treatments for cancer; creation of a voluntary national research cohort; commitment to protecting privacy; regulatory modernization; and public-private partnerships. 
• On January 28, 2015, HHS announced plans to collaborate with a number of non-profit organizations and tax preparers to “ensure that the public understand show health care and their taxes intersect”. For the first time, individuals and families will have to report their health insurance status on their tax returns. Individuals who purchased coverage through the Health Insurance Marketplaces and received federal subsidies will see their reported subsidies on a new form, 1095-A. Said Secretary Burwell: “When it comes to health care and taxes, the only change the vast majority of people will notice is the requirement to check a box to indicate that they had health insurance all year through their job, Medicare, Medicaid, Tricare or the Veterans Affairs. A smaller number of people, including those who purchased coverage through the Health Insurance Marketplaces or those who were uninsured for some or all of the year - will need to take additional steps when filing their taxes. We are working to provide taxpayers with the tools and information they need to file their returns and answer their questions.” 
• On January 23, 2015, CMS released an informational bulletin describing existing flexibilities that can: 1) assist states in meeting their obligations to screen Medicaid enrollees for Medicare Savings Programs and other categories of Medicaid when the enrollees become Medicare-eligible; and 2) improve the stability and continuity of Medicare Savings Program coverage. In the guidance, Melanie Bella, director of the CMS's Medicare-Medicaid Coordination Office, and Cindy Mann, director of the Center for Medicaid and CHIP Services, described ways for states to meet their obligations to screen Medicaid enrollees for Medicare Savings Programs—including the Qualified Medicare Beneficiary (QMB) Program, Specified Low-Income Medicare Beneficiary Program (SLMB) and Qualifying Individual (QI) Program—and other categories of Medicaid when the enrollees become Medicare-eligible. The guidance also urged states to enter into an agreement with the agency that would allow low-income individuals to receive premium-free Medicare Part A.