A&B Healthcare Week in Review, February 6, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On February 6, 2015, the Centers for Medicare and Medicaid Services (CMS) released a final rule entitled “Medicare Program; Contract Year 2016 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs”. This final rule amends the Medicare Advantage (MA) program (Part C) regulations and Medicare Prescription Drug Benefit Program (Part D) regulations to implement statutory requirements; improve program efficiencies; strengthen beneficiary protections; clarify program requirements; improve payment accuracy; and make various technical changes. The provisions of the final rule are effective 30 days after publication in the Federal Register, except amendments to § 423.154, which are effective January 1, 2016. 
• On February 5, 2015, CMS issued a final national coverage determination that provides for Medicare coverage of Screening for Lung Cancer with Low Dose Computed Tomography (LDCT). The coverage is effective immediately. Medicare will now cover lung cancer screening with LDCT once per year for Medicare beneficiaries who meet all of the following criteria: they are age 55-77, and are either current smokers or have quit smoking within the last 15 years; they have a tobacco smoking history of at least 30 “pack years” (an average of one pack a day for 30 years); and they receive a written order from a physician or qualified non-physician practitioner that meets certain requirements. Medicare coverage includes a visit for counseling and shared decision-making on the benefits and risks of lung cancer screening. 
• On February 6, 2015, the Food and Drug Administration (FDA) announced the reopening of the docket to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and the GDUFA Commitment Letter that accompanies the legislation. A public hearing in September 2014 provided an opportunity for public input on future policy priorities. FDA is seeking additional written comments from all interested parties, including, but not limited to, regulated industry, consumers, patients, caregivers, health care professionals, and patient groups. Comments should be submitted by March 9, 2015. More information may be found here. 
• On February 4, 2015, the Patient-Centered Outcomes Research Institute (PCORI) announced a funding opportunity entitled “Clinical Management of Hepatitis C Infection”. PCORI seeks to fund pragmatic clinical trials (PCTs), or observational studies that compare two or more alternatives for addressing diagnosis, treatment, or management of hepatitis C infection. The research is expected to examine treatment options as well as systems-level interventions or those aimed at eliminating health or healthcare disparities. Proposed studies must address clinical and healthcare delivery choices faced by patients, their caregivers, clinicians, and/or delivery systems. Proposed studies must compare two or more active interventions. They must involve patient populations that are representative of the US population and be large enough to provide precise estimates of hypothesized effectiveness differences and to support evaluation of potential differences in treatment effectiveness in patient subgroups. For this solicitation, relevant patient organizations, professional organizations, payer or purchaser organizations, and/or manufacturers must be included as partners and active participants in developing the application and carrying out the research. Applications are due by 5:00 PM on May 5, 2015. 
• On February 3, 2015, the Government Accountability Office (GAO) issued a notice requesting letters of nomination for candidates for the Health Information Technology Policy Committee. The American Recovery and Reinvestment Act of 2009 (ARRA) established the Health Information Technology Policy Committee and gave the Comptroller General responsibility for appointing 13 of its 20 members. As the result of terms ending in April 2015, GAO is accepting nominations of individuals for four openings on the committee in the following categories of representation or expertise required in ARRA: Advocate for patients or consumers, health care provider, representative of a health plan or third party payer, and expertise in health care quality measurement and reporting. For appointments to the HIT Policy committee to be made in April 2015 in these categories, GAO is announcing the following: Letters of nomination and resumes should be submitted by February 27, 2015 to ensure adequate opportunity for review and consideration of nominees. More information may be found here. 
• On February 6, 2015, the Department of Health and Human Services (HHS) released a “Solicitation of Written Comments on the Draft National Adult Immunization Plan”. The National Vaccine Program Office (NVPO) is located within the Office of the Assistant Secretary for Health (OASH). NVPO provides leadership and fosters collaboration among the various federal agencies involved in vaccine and immunization activities. In 2011, NVAC recommended the development of a strategic plan with the goal of improving adult immunization. Through an environmental scan of past reports issued by vaccine stakeholders, a survey, several focus groups, and in-depth interviews with subject matter experts, and in consultation with federal partners, NVPO has developed the draft National Adult Immunization Plan (NAIP). The NAIP details background on the immunization landscape and provides a strategic plan for federal and nonfederal stakeholders. NVPO is soliciting public comment on the draft NAIP from a variety of stakeholders, including the general public, for consideration as they develop their final report to the Secretary. It is anticipated that the draft NAIP, as revised with consideration given to public comment and stakeholder input, will be presented to the Secretary in the first quarter of 2015. Comments for consideration by NVPO should be received no later than 5:00 p.m. EDT on March 9, 2015. 
• On February 3, 2015, FDA announced an opportunity for the public to comment on a proposed information collection activity entitled “General Licensing Provisions; Section 351(k) Biosimilar Applications”. This notice solicits comments on the information collection in an application for a proposed biosimilar product and an application for a supplement for a proposed interchangeable product. Based on the number of 351(k) applications FDA received through FY 2014, FDA estimates that the Agency will receive approximately five 351(k) applications annually. 
• On February 2, 2015, CMS released its “Quarterly Listing of Program Issuances—October Through December 2014”. This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from October through December 2014, relating to the Medicare and Medicaid programs and other programs administered by CMS. 
• On February 6, 2015, CMS released a notice for public comment which sets out a summary of the use and burden associated with the following information collections: CMS–10410 Medicaid Program: Eligibility Changes under the Affordable Care Act of 2010; CMS–R–74 Income and Eligibility Verification System Reporting and Supporting Regulations; CMS–2552–10 Hospital and Hospital Health Care Complex Cost Report; and CMS–855R Medicare Enrollment Application: Reassignment of Medicare Benefits. More detailed information can be found in each collection’s supporting statement and associated materials, available here. Comments are due April 7, 2015. 
• On February 6, 2015, FDA announced that a proposed information collection acidity entitled “Export of Food and Drug Administration Regulated Products: Export Certificates” had been submitted to the Office of Management and Budget (OMB) for review and clearance. The Food, Drug and Cosmetic Act (FD&C Act) authorizes FDA to issue export certificates for regulated pharmaceuticals, biologics, and devices that are legally marketed in the United States, as well as for these same products that are not legally marketed but are acceptable to the importing country, as specified in sections 801(e) and 802 of the FD&C Act. FDA has developed four types of certificates that satisfy the requirements of section 801(e)(4)(B) of the FD&C Act: (1) Certificates to Foreign Governments, (2) Certificates of Exportability, (3) Certificates of a Pharmaceutical Product, and (4) Non-Clinical Research Use Only Certificates. Comments on the proposed information collection activity are due March 9, 2015. 
• The National Coordinator for Health Information Technology (ONC) has announced a new funding opportunity entitled “Advanced Interoperable Health Information Technology Services to Support Health Information Exchange”. The awards will fund efforts to provide training, education, and technical assistance to support clinical and non-clinical caregivers with incorporating health information exchange into their existing workflows to improve care coordination, population management, and measurement reporting. Grantees will use interstate and intrastate partnerships to enable clinical and non-clinical caregivers to send, receive, find, and use a common clinical data set across unaffiliated organizations, with the goal of improving care coordination and promote a learning environment. Grantees working with individuals will support self-management and the ability for individuals to view, download, and/or transmit health information to a destination of their choice. Ten (10) to twelve (12) new awards will be made in the form of cooperative agreements to states, territories, or state designated entities (SDE). Letters of Intent Due: March 2, 2015, 11:59 PM EST; Application Deadline: April 6, 2015, 11:59 PM EST; Informational Webinars: Tuesday, Feb. 24th 3-4pm EST. 
• On January 29, 2015, CMS proposed that the evidence is adequate to conclude that screening for HIV infection for all individuals between the ages of 15 and 65 years, as is recommended with a grade of A by the United States Preventive Services Task Force (USPSTF), is reasonable and necessary for the early detection of HIV and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B. CMS is seeking comments on the proposed decision. More information may be found here.

II. LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On February 4, 2015, the Senate Committee on Finance convened a hearing entitled “The President's Budget for Fiscal Year 2016”. The sole witness for the hearing was HHS Secretary Sylvia Mathews Burwell. During the hearing Committee members discussed the recently-released White House Budget proposal for HHS in fiscal year (FY) 2016. During the hearing Committee Chairman Orrin Hatch (R-UT) and several other Republican Members repeatedly insisted that Burwell provide Congress with the Department’s contingency plans in the case that the Supreme Court rules against the Administration in King v. Burwell, which deals with the availability of premium tax credits in states with Federally-Facilitated Exchanges (FFEs). Burwell declined to discuss whether HHS would seek a legislative fix in the case that the Court rules against the Administration, or whether the Department has the authority to implement an “administrative fix”. More information on the hearing may be found here. 
• On February 3, 2015, Senators Lamar Alexander (R-TN) and Patty Murray (D-WA), Chairman and Ranking Member of the Senate HELP Committee, announced that they are launching a bipartisan initiative to examine the process for getting safe treatments, devices and cures to patients, and the roles of the FDA and the National Institutes of Health (NIH) in that process. The senators are planning to begin a bipartisan staff working group next week and a series of hearings in March that will examine the drug and medical device discovery and development process, and how to better align public policies to support medical innovation while maintaining high standards of consumer and patient safety. More information may be found here.

House of Representatives

• On February 3, 2015, the House passed H.R. 596 by a 239-186 margin. The measure would repeal the Affordable Care Act (ACA) and require the committees of jurisdiction to present a replacement bill in six months. . The vote follows an announcement last Friday that House leadership had formed a working group—consisting of Energy and Commerce Committee Chairman Fred Upton (R-MI), Ways and Means Committee Chairman Paul Ryan (R-WI), and Education and the Workforce Committee Chairman John Kline (R-MN)—tasked with replacing the 2010 health law.
• On February 3, 2015, the House Energy and Commerce Subcommittee on Oversight and Investigations convened a hearing on the United States response to seasonal influenza. This hearing focused on the role of U.S. public health agencies in protecting the U.S. population from the spread of seasonal influenza. The Subcommittee examined the strain selection decision-making process, how U.S. public health agencies are improving the effectiveness of response to seasonal flu, and the progress of Federal efforts into developing a universal flu vaccine, advanced diagnostics, new flu vaccine manufacturing technologies, and new anti-viral drugs for treatment of influenza. Witnesses for the hearing included Dr. Anne Schuchat, Director, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention (CDC); Dr. Karen Midthun, Director, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration (FDA); Dr. Robin Robinson, Director Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response , U.S. Department of Health and Human Services (HHS); and Dr. Anthony Fauci Director National Institute of Allergy and Infectious Diseases (NAID), National Institutes of Health (NIH). More information on the hearing may be found here. 
• On February 4, 2015, the House Energy and Commerce Committee convened a markup of a number of public health-related bills, including H.R. 639 "Improving Regulatory Transparency for New Medical Therapies Act"; H.R. 471 "Ensuring Patient Access and Effective Drug Enforcement Act of 2015"; the “Access to Life-Saving Trauma Care for All Americans Act"; and the "Trauma Systems and Regionalization of Emergency Care Reauthorization Act". More information on the markup may be found here.

III. REPORTS, STUDIES, & ANALYSES 

• As part of its broader ACA implementation monitoring project, the Robert Wood Johnson (RWJF) and the Urban Institute released a report entitled “Insurance Brokers and the ACA: Early Barriers and Options for Expanding Their Role”. The information presented in this brief is based upon interviews conducted with stakeholders (e.g., providers, insurers, consumer advocates, navigators, assisters and brokers) in 21 states and the District of Columbia during the first half of 2014. Most broker respondents reported that the marketplaces did little to engage them or to adopt brokers as part of their marketing and enrollment strategy. The broker community was treated as “an afterthought,” a broker in Washington reported, echoing a common theme, and brokers in Minnesota and New Hampshire sensed that state officials preferred to work with navigators for their outreach and enrollment efforts. Brokers in almost every state studied viewed the compensation structure as a barrier to assisting consumers with marketplace enrollment. For some, the primary concern was that they were not sufficiently paid for the amount of time it took to help someone through the enrollment process (although the length of time per client did decline as the open enrollment period progressed). Sources interviewed offered a variety of suggestions for increasing broker sales of Marketplace plans, potentially increasing enrollment under the ACA. 
• On February 5, 2015, the Pew Charitable Trusts, in conjunction with a number of healthcare organizations, released a report exploring measures that should be considered to address the ongoing issue of drug shortages in the United States. The report summarizes manufacturing, regulatory, and economic issues related to drug shortages, as well as potential solutions identified at a 2014 Summit attended by 22 stakeholder groups, including health care professionals, non-profit organizations, industry, public interest, and government agencies. The report explores the potential manufacturing, economic, and regulatory causes of drug shortages, and considers several possible solutions that merit further exploration. 
• On February 5, 2015, the New England Journal of Medicine published a study entitled “Appointment Availability after Increases in Medicaid Payments for Primary Care”. Providing increases in Medicaid reimbursements for primary care, a key provision of the ACA, raised Medicaid payments to Medicare levels in 2013 and 2014 for selected services and providers. The federally funded increase in reimbursements was aimed at expanding access to primary care for the growing number of Medicaid enrollees. The reimbursement increase expired at the end of 2014 in most states before policymakers had much empirical evidence about its effects. The study authors measured the availability of and waiting times for appointments in 10 states during two periods: from November 2012 through March 2013 and from May 2014 through July 2014. The availability of primary care appointments in the Medicaid group increased by 7.7 percentage points, from 58.7% to 66.4%, between the two time periods. The states with the largest increases in availability tended to be those with the largest increases in reimbursements, with an estimated increase of 1.25 percentage points in availability per 10% increase in Medicaid reimbursements. The study provides early evidence that increased Medicaid reimbursement to primary care providers, as mandated in the ACA, was associated with improved appointment availability for Medicaid enrollees among participating providers without generating longer waiting times. 
• On February 3, 2015, the Journal of the American Medical Association published a study entitled “Association of Hospital Participation in a Quality Reporting Program With Surgical Outcomes and Expenditures for Medicare Beneficiaries”. The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) provides feedback to hospitals on risk-adjusted outcomes. Previously, it was not known if participation in the program improved outcomes and reduced costs relative to nonparticipating hospitals. This study used Medicare data from 2003 to 2012 to evaluate the association of enrollment and participation in the ACS NSQIP with outcomes and Medicare payments compared with control hospitals that did not participate in the program. After accounting for patient factors and preexisting time trends toward improved outcomes, there were no statistically significant improvements in outcomes at 1, 2, or 3 years after (vs. before) enrollment in ACS NSQIP. With time, the authors concluded, hospitals had progressively better surgical outcomes but enrollment in a national quality reporting program was not associated with the improved outcomes or lower Medicare payments among surgical patients. They suggest that feedback on outcomes alone may not be sufficient to improve surgical outcomes. 
• On February 2, 2015, the Congressional Budget Office (CBO) released a document entitled “Medicare's Payment to Physicians: the Budgetary Effects of Alternative Policies Relative to CBO's January 2015 Baseline”. The table includes estimates for several replacement and short-term alternatives to the current rules for setting Medicare’s payment rates for physicians’ services. The starting date for all of these alternative policies would be April 1, 2015. The table includes an updated estimate for H.R. 4015 and S. 2000, the SGR Repeal and Medicare Provider Payment Modernization Act of 2014, which are identical bills introduced on February 6, 2014. This updates the CBO cost estimate of that legislation for the April 2014 baseline—which incorporates H.R. 4302, the Protecting Access to Medicare Act of 2014 (Public Law 113-93), enacted on April 1, 2014—and the final physician fee schedule rule. 
• The February issue of Health Affairs features a number of articles on Biomedical Innovation, including: 
  • Treating Age-Related Macular Degeneration: Comparing The Use Of Two Drugs Among Medicare And Veterans Affairs Populations
    o Decline In Economic Returns From New Drugs Raises Questions About Sustaining Innovations 
  • Medicare Is Scrutinizing Evidence More Tightly For National Coverage Determinations 
  • Biosimilar Competition In The United States: Statutory Incentives, Payers, And Pharmacy Benefit Managers 
  • Improving Pharmaceutical Innovation By Building A More Comprehensive Database On Drug Development And Use 
  • Medicaid Expansion In Opt-Out States Would Produce Consumer Savings And Less Financial Burden Than Exchange Coverage

IV. OTHER HEALTH POLICY NEWS 

• On February 3, 2015, President Barack Obama released the White House Budget proposal for Fiscal Year (FY) 2016. The HHS Budget in Brief, available here, provides an overview of the HHS-related provisions in the budget. Highlights from the HHS Budget in Brief may be found here, and a video of Secretary Sylvia Mathews Burwell speaking on the Budget may be found here. The Budget proposes $83.8 billion in discretionary funding for HHS (a $4.8 billion increase), and includes targeted reforms to Medicare and Medicaid projected to save approximately $400 billion over the next ten years. 
• On February 4, 2015, HHS released enrollment figures for Open Enrollment Week 11, spanning January 24th through January 30th. HHS announced that nearly 7.5 million consumers selected a plan or were automatically re-enrolled through the HealthCare.gov platform, which includes the Federally Facilitated Marketplace (FFM), State Partnership Marketplaces and supported State-Based Marketplaces. This week’s snapshot includes weekly and cumulative data for the FFM, cumulative data for states and for the first time, cumulative data for certain local areas. “There are just eleven days before the February 15 deadline and the end of this year’s Open Enrollment,” HHS Secretary Sylvia Burwell said. “Time is running out… Eighty-seven percent of those who have signed up for coverage through HealthCare.gov quality for financial assistance to help lower the cost of their premiums.” 
• On February 5, 2015, FDA Commissioner Margaret Hamburg announced that she would be stepping down from her role in March. In a message to her FDA colleagues, Hamburg wrote, “It has been a privilege to serve as your FDA Commissioner for almost six years. So it is with very mixed emotions that I write today to inform you that I plan to step down as FDA Commissioner at the end of March 2015.” Hamburg was confirmed on May 18, 2009 by a unanimous Senate voice vote to become the 21st Food and Drug Commissioner. Dr. Stephen Ostroff will serve as Acting Commissioner following Hamburg’s resignation. Ostroff has been with the Agency since 2013. 
• On February 4, 2015, the Tennessee legislature defeated Governor Bill Haslam’s (R) proposal to expand Medicaid under the ACA. Haslam had called a special session to address this issue, but the measure failed to advance out of the Senate Health and Welfare Committee, losing in a 7-4 vote. The plan has little chance of being revived during the regular legislative session. 
• On February 2, 2015, CMS released a new enrollment report for Medicaid and CHIP, which covers the month of November 2014. This report measures eligibility and enrollment activity for the entire Medicaid and CHIP programs in all states, reflecting activity for all populations receiving comprehensive Medicaid and CHIP benefits in all states, including states that have not yet chosen to adopt the new low-income adult group. The report shows that there were a total of 68,973,900 individuals enrolled in Medicaid and CHIP in November 2014. This enrollment count is point-in-time (on the last day of the month) and includes all enrollees in the Medicaid and CHIP programs who are receiving a comprehensive benefit package. 
• This week Anthem Health Insurance announced that the group was the target of a “very sophisticated cyber attach”, in which attackers gained unauthorized access to Anthem’s IT system and obtained personal information from its current and former members such as names, birthdays, medical IDs/social security numbers, street addresses, email addresses and employment information, including income data. According to a press release from Anthem: “Based on what we know now, there is no evidence that credit card or medical information, such as claims, test results or diagnostic codes were targeted or compromised. Once the attack was discovered, Anthem immediately made every effort to close the security vulnerability, contacted the FBI and began fully cooperating with their investigation. Anthem has also retained Mandiant, one of the world’s leading cybersecurity firms, to evaluate our systems and identify solutions based on the evolving landscape.”