A&B Healthcare Week in Review, March 13, 2015

I. REGULATIONS, NOTICES, & GUIDANCE

• On March 9, 2015, the Department of Health and Human Services (HHS) announced the availability of draft guidance for industry entitled “Clinical Investigators, and Institutional Review Boards—Use of an Electronic Informed Consent in Clinical Investigations— Questions and Answers”. The draft guidance provides recommendations for clinical investigators, sponsors, and institutional review boards (IRBs) on the use of electronic media and processes to obtain informed consent for Food and Drug Administration (FDA)-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services Office for Human Research Protections (OHRP) and FDA have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subject research, and the draft guidance document was developed as a part of these efforts. Although the document is issued by FDA and is drafted as guidance that would apply to FDA-regulated clinical investigations, OHRP is considering whether to adopt the positions and recommendations proposed in this guidance for research regulated under the HHS protection of human subjects regulations, 45 CFR part 46, and to issue a joint OHRP and FDA guidance document on this topic when the final guidance document is developed. OHRP asks for public comment about whether a joint guidance document would be useful for the regulated community. In particular, OHRP is interested in public comment regarding whether FDA’s draft guidance would be appropriate for all research regulated under 45 CFR part 46, including research studies other than clinical investigations or clinical trials, such as social and behavioral research studies. If different guidance should apply to social and behavioral research, or other non-FDA-regulated studies, OHRP asks that the public comments address how the guidance should differ from the proposed guidance for FDA-regulated clinical investigations. OHRP specifically welcomes feedback regarding when it might or might not be appropriate, for studies other than clinical trials, for OHRP to recommend that researchers verify that the person signing the informed consent form is the subject participating in the research. OHRP and FDA will consider these comments in deciding whether to issue a joint OHRP/FDA guidance document on this topic when the final guidance document is developed. The public should submit comments by May 7, 2015. 
• On March 9, 2015, FDA announced that it is establishing a public docket to receive information, recommendations, and comments on matters related to the Agency’s regulation of compounding of human drug products under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This docket is intended for general comments related to human drug compounding that are not specific to documents or issues that are the subject of other dockets. More information, including instructions to submit comments through the docket, may be found here. 
• On March 9, 2015, FDA announced that it is extending the comment period for the proposed rule that appeared in the Federal Register of December 18, 2014. In the proposed rule, FDA requested comments on its proposal to amend its labeling regulations for human prescription drugs and biological products to require that the prescribing information intended for health care professionals that is on or within the package from which the product is dispensed be distributed electronically and not in paper form, except as provided by the proposed rule. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. FDA is extending the comment period on the proposed rule published on December 18, 2014 (79 FR 75506). Submit either electronic or written comments by May 18, 2015. More information may be found here. 
• On March 9, 2015, the Centers for Medicare and Medicaid Services (CMS) released an information collection request entitled “Small Business Health Options Program (SHOP) Effective Date and Termination Notice Requirements”. CMS is requiring that for plan years beginning on or after January 1, 2017, the Small Business Health Options Program (SHOP) must ensure that a qualified health plan (QHP) issuer notifies qualified employees, enrollees, and new enrollees in a QHP through the SHOP of the effective date of coverage. As required by the Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameter for 2016 (CMS– 9944–F), which published February 27, 2015, if any enrollee’s coverage through the SHOP is terminated due to nonpayment of premiums or a loss of the enrollee’s or employer group’s eligibility to participate in the SHOP, the SHOP must notify the enrollee or the qualified employer of the termination of such coverage. In the termination of coverage the SHOP must include the termination date and reason for termination to the enrollee or qualified employer. Comments are due May 8, 2015. 
• On March 11, 2015, FDA announced the availability of a draft guidance for industry entitled ‘‘Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products.’’ This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products (‘‘products’’). This draft guidance revises the guidance for industry entitled ‘‘Formal Meetings Between the FDA and Sponsors or Applicants’’ published May 19, 2009. Comments on the draft guidance should be submitted by June 9, 2015. More information may be found here. 
• On March 13, 2015, FDA announced that the Agency is extending the comment period by 30 days to April 29, 2015, for the notice entitled “Current Good Manufacturing Practice Requirements for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,” that appeared in the Federal Register of January 27, 2015 (80 FR 4280). In that document, FDA announced the availability of a draft guidance for industry and FDA staff and requested comments. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. More information may be found here. 
• On March 11, 2015, the Department of Labor sent a final rule entitled “Amendments to Excepted Benefits” to the Office of Management and Budget (OMB) for review.

Meeting Notices

• March 24, 2015: The FDA, in co-sponsorship with the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO), is announcing a public workshop entitled ‘‘Complexities in Personalized Medicine: Harmonizing Companion Diagnostics Across a Class of Targeted Therapies.’’ The objective of the workshop is to facilitate an in-depth discussion of harmonization of companion diagnostic devices across a class of targeted therapies. The workshop aims to foster collaborations in the clinical cancer research community; provide a deeper understanding of anticancer drug and device development related to personalized medicine; provide a unique perspective of personalized medicine; and help incorporate emerging scientific findings to harmonize companion diagnostics across a class of targeted therapies. The public workshop will be held on March 24, 2015, from 8:30 a.m. to 4:30 p.m. The workshop will be held at the Mayflower Hotel, Grand Ballroom, 1127 Connecticut Ave. NW., Washington, DC 20036.

II. CONGRESSIONAL LEGISLATION & COMMITTEE ACTION

• On March 13, 2015, House Energy and Commerce Committee Chairman Fred Upton (R-MI) and Ranking Member Frank Pallone (D-NJ) and House Ways and Means Committee Chairman Paul Ryan (R-WI) and Ranking Member Sander Levin (D-MI) released the following joint statement regarding Congressional efforts to repeal of the Sustainable Growth Rate (SGR): “Last year, the Ways and Means and Energy and Commerce Committees came together, on a bipartisan basis, to propose a permanent alternative to the broken SGR system. We are now engaging in active discussions on a bipartisan basis – following up on the work done by leadership – to try to achieve an effective permanent resolution to the SGR problem, strengthen Medicare for our seniors, and extend the popular Children’s Health Insurance Program."
• On March 12, 2015, the Senate Appropriations Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Subcommittee convened a hearing entitled “Agriculture Subcommittee Hearing on FY2016 FDA Budget Request”. Witnesses for the hearing included Dr. Margaret Hamburg, Commissioner, U.S. Food and Drug Administration (FDA); Jay Tyler, Chief Financial Officer, FDA; and Norris Cochran, Deputy Assistant Secretary for Budget, Department of Health and Human Services (HHS). More information on the hearing may be found here. 
• On March 10, 2015, the Senate Health, Education, Labor and Pensions (HELP) Committee convened a hearing entitled “Continuing America’s Leadership in Medical Innovation for Patients.” Witnesses for the hearing included Dr. Francis Collins, MD, PhD, Director of the National Institutes of Health (NIH); and Dr. Margaret Hamburg, MD, Commissioner of the Food and Drug Administration (FDA). In February of this year, 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 NIH in that process. The Committee has formed a working group to discuss how to proceed with a bipartisan effort in this area, and will use the topics discussed during this hearing as a launching point. More information on the hearing may be found here. 
• The House of Representatives was not in session this week.

III. REPORTS, STUDIES, & ANALYSES 

• This week the Medicaid and CHIP Payment and Access Commission released the March 2015 Report to Congress on Medicaid and CHIP. The State Children’s Health Insurance Program (CHIP) confronts exhaustion of federal funds, with the last allotments to states being made under current law in fiscal year 2015. MACPAC began analyzing the implications of this scenario in its March and June 2014 reports to Congress, documenting problems with affordability and adequacy of both exchange plans and employer-sponsored insurance for children who would lose CHIP coverage. In those reports, the Commission recommended extending CHIP for two years while these issues could be addressed. The first four chapters of the March 2015 report to Congress follow up on that recommendation in depth. Meanwhile, Medicaid is expanding coverage in over half of states to a new group of low-income adults. The March report offers perspective on two approaches being tested in Iowa and Arkansas to use Medicaid funds to purchase exchange coverage for the new adult group. The Commission also looks closely at whether current policies for Medicaid payment of Medicare cost sharing affect access to care for beneficiaries who are dually eligible for Medicaid and Medicare. The report outlines a new payment analysis framework and concludes with an update on the primary care payment increase that expired in December 2014. 
• The Bipartisan Policy Center released a report entitled “The Role and Future of the Children’s Health Insurance Program” on March 12, 2015. As discussed above, the Patient Protection and Affordable Care Act (ACA) reauthorized the Children’s Health Insurance Program (CHIP) through FY 2019, but it did not provide new funding beyond FY 2015. Congressional leaders on both sides of the aisle and the administration have indicated a desire to extend CHIP funding. In addressing the lack of funding, policymakers face numerous considerations, including whether to extend funding for the remaining four years of the program’s authorization, whether to extend funding for a shorter period of time, and whether to make other changes to the program as part of the funding extension. This document outlines a number of these considerations, and recommends that policymakers extend CHIP for a minimum of two years, at the current authorized 2015 level of $21.1 billion per year. 
• On March 13, 2015, the Medicare Payment Advisory Commission (MedPAC) released its March 2015 Report to Congress. The Medicare Payment Advisory Commission (MedPAC) is required by law to annually review Medicare payment policies and make recommendations to the Congress. The 2015 report includes payment policy recommendations for ten of the health care provider sectors in fee-for-service (FFS) Medicare. MedPAC also reviews the status of Medicare Advantage (MA) plans and Medicare’s prescription drug plans (Part D). A fact sheet on the report may be found here; press release may be found here; and the executive summary may be found here.
• On March 12, 2015, the Congressional Budget Office (CBO) released a cost estimate of the President’s Fiscal Year 2016 Budget. This report by CBO presents an analysis of the proposals in the President’s budget request for fiscal year 2016. The analysis is based on CBO’s economic projections and estimating models (rather than on the Administration's), and it incorporates estimates of the effects of the President's tax proposals that were prepared by the staff of the Joint Committee on Taxation (JCT). CBO’s estimate of the healthcare proposals included in the President’s FY 2016 Budget may be found here. According to the estimate, the proposal would result in a net Medicare spending reduction of $240 billion over 10 years. 
• On March 9, 2015, the Committee for Responsible Federal Budget released a report entitled “The PREP Plan: A Permanent Fix for the Sustainable Growth Rate”. The report outlines $215 billion in healthcare offsets that could be used to fund SGR repeal, building off of a similar report issued last year (available here). Suggested policies include expanding the use of bundled payments and reforming Accountable Care Organizations (ACOs); equalizing payments for similar services performed in different settings; encouraging low-cost physician-administered drugs; modernizing the Medicare Part A and Part B cost-sharing rules; restoring the provider tax threshold to 5.5%; and rebasing Medicaid Disproportionate Share Hospital (DSH) payments. 
• On March 6, 2015, the Office of Inspector General (OIG) released a report entitled “Medicare Could Have Saved Billions at Critical Access Hospitals If Swing-Bed Services Were Reimbursed Using the Skilled Nursing Facility Prospective Payment System Rates”. Swing-bed usage at critical access hospitals (CAHs) significantly increased from calendar years (CYs) 2005 through 2010; Medicare spending for swing-bed services at CAHs steadily increased to, on average, almost four times the cost of similar services at alternative facilities. Of the 100 CAHs OIG sampled for this report, 90 had alternative facilities within a 35-mile radius with alternative skilled nursing care available. On the basis of these sample results, OIG estimated that swing-bed services provided at 1,080 of the 1,200 (or 90 percent) of the CAHs in the sampling frame could have been provided at alternative facilities within 35 miles of the CAHs during CY 2010. The report estimated that Medicare could have saved $4.1 billion over a 6-year period if payments for swing-bed services at CAHs were made using skilled nursing facility prospective payment system (SNF PPS) rates. OIG recommended that CMS seek legislation to adjust CAH swing-bed reimbursement rates to the lower SNF PPS rates paid for similar services at alternative facilities. CMS agreed with OIG’s finding that CAHs' swing-bed utilization has increased but disagreed with OIG’s recommendation because of concerns with the agency’s findings on the availability of skilled nursing services at nearby alternative facilities and its calculation of savings.

IV. OTHER HEALTH POLICY NEWS 

• On March 10, 2015, CMS announced that it is unveiling a new initiative, the Next Generation Accountable Care Organization (ACO) Model of payment and care delivery for “ACOs that are experienced in coordinating care for populations of patients”. The Next Generation ACO Model will allow these provider groups to assume higher levels of financial risk and reward than are available under the current Pioneer Model and Shared Savings Program (MSSP). The goal of the Model is to test whether strong financial incentives for ACOs, coupled with tools to support better patient engagement and care management, can improve health outcomes and lower expenditures for Original Medicare fee-for-service (FFS) beneficiaries. CMS expects approximately 15 to 20 ACOs to participate in the Next Generation ACO Model. CMS will accept ACOs into the Next Generation ACO Model through two rounds of applications in 2015 and 2016, with participation expected to last up to five years. For round one consideration, interested organizations must submit a Letter of Intent no later than 11:59p.m. EDT on May 1, 2015. Round one applications must be submitted electronically no later than 11:59p.m. EDT on June 1, 2015. Round two Letters of Intent and applications will be made available in March 2016. The round two Letter of Intent must be submitted electronically no later than 11:59p.m. EDT on May 1, 2016, and the application no later than 11:59p.m. EDT on June 1, 2016. An HHS press release on the initiative may be found here. 
• On March 11, 2015, the Alliance for Health Reform convened a briefing entitled “Chronic Care Management: Is Medicare Advantage Leading the Way?” Senator Ron Wyden, ranking member, Senate Committee on Finance, made opening remarks. Mark Miller, executive director of the Medicare Payment Advisory Commission (MedPAC), explained the structure and financing of Medicare Advantage, fee-for-service Medicare, and ACOs through the lens of efforts to improve chronic care management. Bob Master, chief executive officer of the Commonwealth Care Alliance, discussed key issues for Medicare beneficiaries with chronic conditions and outline promising models and challenges for chronic care coordination. Helen Kurre, director of medical practice integration for Providence Health Plans, discussed how Providence’s Medicare Advantage plan helps beneficiaries manage chronic conditions and provide perspectives on challenges, successes, and policy considerations. Ed Howard of the Alliance and Kent Thiry of DaVita HealthCare Partners (DHCP), co-moderated. More information on the meeting, including copies of speaker presentations, may be found here.
• On March 10, 2015, HHS announced that nearly 11.7 million consumers selected or were automatically re-enrolled in health insurance coverage through the Health Insurance Marketplace as of February 22nd. Of those, 8.84 million (76 percent) were in states using the HealthCare.gov platform and 2.85 million (24 percent) were in the 14 states (including Washington, D.C.) using their own Marketplace platforms. Nearly 7.7 million individuals with a plan selection in the states using HealthCare.gov qualified for an average tax credit of $263 per month and more than half (55 percent) paid $100 or less per month after tax credits. According to the report, more than 4.1 million consumers under the age of 35 are signed up for Marketplace coverage. An HHS press release touting the findings may be found here. The monthly enrollment report may be found here.