A&B Healthcare Week in Review, June 13, 2014

I. REGULATIONS, NOTICES, & GUIDANCE

• On June 10, 2014, the Food and Drug Administration (FDA) issued a final rule entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements”. FDA is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information. The rule is effective June 10, 2015.
• On June 10, 2014, FDA announced the availability of draft guidance for industry entitled “Draft Guidance for Industry on Providing Submissions in Electronic Format-Postmarketing Safety Reports”. This draft guidance provides general information pertaining to electronic submission of postmarketing safety reports (individual case safety reports (ICSRs), attachments to ICSRs (ICSR attachments), and other postmarketing safety reports) for certain human drug and biological products. FDA is issuing the draft guidance to help persons required to submit postmarketing safety reports comply with the final rule. Comments must be submitted by August 11, 2014 in order to be considered for inclusion in final guidance.
• On June 12, 2014, the Centers for Medicare and Medicaid Services (CMS) filed a rule at the Public Inspection Desk entitled “Medicare Program; Additional Extension of the Payment Adjustment for Low-Volume Hospitals and the Medicare-dependent Hospital (MDH) Program Under the Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals for Fiscal Year 2014”. This document announces changes to the payment adjustment for low-volume hospitals and to the Medicare-dependent hospital (MDH) program under the hospital inpatient prospective payment systems (IPPS) for the second half of FY 2014 (April 1, 2014 through September 30, 2014) in accordance with sections 105 and 106, respectively, of the Protecting Access to Medicare Act of 2014 (PAMA). The rule will be published in the Federal Register on June 17, 2014.
• On June 10, 2014, FDA issued an information collection request entitled “Medical Devices; Humanitarian Use Devices (HUD)”. The information collected will assist FDA in making determinations on the following: (1) Whether to grant HUD designation of a medical device; (2) exempt an HUD from the effectiveness requirements under sections 514 and 515 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), provided that the device meets requirements set forth under section 520(m) of the FD&C Act; and (3) whether to grant marketing approval(s) for the HUD. Failure to collect this information would prevent FDA from making a determination on the factors listed previously in this document. Further, the collected information would also enable FDA to determine whether the holder of an HUD is in compliance with the HUD provisions under section 520(m) of the FD&C Act. Comments are due August 11, 2014.
• On June 10, 2014, FDA submitted to the Office of Management and Budget (OMB) guidance entitled “Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products”. In the Federal Register of December 27, 2013, FDA published a 60-day notice requesting public comment on the proposed collection of information. Six comment submissions were received, and may be viewed here. Comments are due July 10, 2014.
• On June 10, 2014, FDA announced the availability of grant funds for the support of the Center for Drug Evaluation and Research/Office of Medical Policy's Kidney Health Initiative Program. FDA, Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP) is announcing its intent to accept and consider a single source application for the award of a grant to the American Society of Nephrology (ASN) to support the Kidney Health Initiative (KHI). KHI is a public-private partnership whose mission is to advance scientific understanding of the kidney health and patient safety implications of new and existing medical products and to foster development of therapies for diseases that affect the kidney by creating a collaborative environment in which FDA and the greater nephrology community can interact to optimize evaluation of drugs, devices, biologics, and food products. FDA/CDER intends to fund up to $500,000 in total costs (direct and indirect) in fiscal year (FY) 2014. Applications are due June 30, 2014. More information may be found here.
• On June 9, 2014, CMS issued three information collection requests: 1) Request for Certification in the Medicare and/or Medicaid Program to Provide Outpatient Physical Therapy and/or Speech Pathology Services, and (CMS-1893) Outpatient Physical Therapy—Speech Pathology Survey Report; 2) Medicare Ombudsman Customer Service Feedback Survey; and 3) Independent Renal Dialysis Facility Cost Report Form. Comments are due August 8, 2014. More information may be found here.
• On June 9, 2014, FDA announced that a proposed information collection entitled “Testing Communications on Biological Products” had been submitted to OMB for review and clearance. The information collected will serve three major purposes. First, as formative research it will provide knowledge about target audiences to develop messages and campaigns about biological product use. Second, as initial testing, it will allow FDA to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences. Third, as evaluative research, it will allow FDA to ascertain the effectiveness of the messages and the distribution method of these messages in achieving the objectives of the message campaign.
• On June 11, 2014, FDA announced the availability of draft guidance for industry entitled “Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products-Recommended Practices”. This guidance describes FDA's current thinking on recommended practices for drug manufacturers and their representatives to follow when distributing to health care professionals or health care entities scientific or medical journal articles that discuss new risk information for approved prescription drugs for human use, including drugs licensed as biological products, and approved animal drugs. The recommendations in this draft guidance are intended to address issues specific to the distribution of new information about risks associated with a drug that further characterizes risks identified in the approved labeling. Comments must be submitted by August 25, 2014 in order to be considered for inclusion in final guidance. More information may be found here.
• On June 11, 2014, FDA announced the availability of draft guidance for industry entitled “Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.” The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Supply Chain Security Act (DSCSA). The draft guidance is intended to aid certain trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) in identifying a suspect product and terminating notifications regarding illegitimate product. This draft guidance identifies specific scenarios that could significantly increase the risk of a suspect product entering the pharmaceutical distribution supply chain; provides recommendations on how trading partners can identify the product and determine whether the product is a suspect product as soon as practicable; and for product that has been determined to be illegitimate, or (for manufacturers) has a high risk of illegitimacy, sets forth the process by which trading partners should notify FDA of illegitimate product and how they must terminate the notifications, in consultation with FDA. Comments must be submitted by August 11, 2014 in order to be considered for inclusion in final guidance. More information may be found here.
• On June 11, 2014, FDA announced the availability of guidance entitled “Global Unique Device Identification Database (GUDID): Guidance for Industry”. FDA has updated sections of the document, “Global Unique Device Identification (GUDID): Draft Guidance for Industry” in order to finalize the sections with the most questions from GUDID submitters. The guidance includes information about how device labelers (in most instances, the device manufacturer) will interface with the GUDID by establishing GUDID accounts and beginning their initial submissions. Draft guidance sections on the device identifier (DI) module have not been finalized in this document and will be addressed in a future document. Comments may be submitted at any time. More information may be found here.
• On June 12, 2014, FDA announced that it would extend the comment period for a proposed rule, entitled “Medical Device Classification Procedures”, which appeared in the Federal Register on March 25, 2014. In the proposed rule, FDA requested comments on its proposal to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA), to update its regulations by proposing changes unrelated to the new FDASIA requirements, and to codify the procedures and criteria that apply to classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. Comments are now due September 22, 2014.
• On June 12, 2014, FDA announced the availability of draft guidance for industry entitled “ANDA Submissions—Content and Format of Abbreviated New Drug Applications”. The guidance document is intended to assist applicants in preparing complete and high-quality original abbreviated new drug applications (ANDAs) for submission to FDA under the Federal Food, Drug, and Cosmetic Act. The guidance summarizes the statutory and regulatory requirements for ANDAs, references existing guidance documents, and incorporates additional recommendations on the content and format of ANDA submissions. This guidance describes the Common Technical Document format for human pharmaceutical product applications and specifies the information to be submitted in each section of the application. Comments must be submitted by August 11, 2014 in order to be considered for inclusion on final guidance. More information may be found here.
• On June 12, 2014, FDA issued a proposed information collection entitled “Good Laboratory Practice Regulations for Nonclinical Studies”. Comments are due August 11, 2014.
• On June 12, 2014, FDA issued a request for comments on “Guidance for Industry on Specification of the Unique Facility Identifier System for Drug Establishment Registration”. The guidance modifies the currently approved information collections associated with drug establishment registration, consistent with subsequent statutory enactment. Comments are due July 14, 2014.
• On June 13, 2014, CMS announced that an information collection entitled “Disclosure for the In-Office Ancillary Services Exception” had been submitted to OMB for review. Physicians who provide certain imaging services (magnetic resonance imaging, computed tomography, and positron emission tomography) under the in-office ancillary services exception to the physician self-referral prohibition are required to create the disclosure notice as well as the list of other imaging suppliers to be provided to the patient. Comments are due July 14, 2014.
• On June 13, 2014, CMS issued several information collection requests for public comment: 1) Fast Track Appeals Notices: NOMNC/DENC; 2) Medicare Prescription Drug Coverage and Your Rights; 3) Data Use Agreement (DUA) Certificate of Disposition (COD) for Data Acquired from the Centers for Medicare & Medicaid Services; 4) Medicare Part C and Part D Data Validation; 5) Survey Tool for www.medicare.gov and www.cms.hhs.gov. Comments are due August 12, 2014. More information may be found here.

Event Notices:

• July 10-11, 2014: On July 10th-11th, the FDA Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee will hold a public meeting from 8:00 AM to 6:00 PM at FDA’s White Oak Campus in Silver Spring, Maryland. On July 10 and 11, 2014, the committee will discuss the safety of laparoscopic power morcellator devices as it pertains to their potential to disseminate and upstage a confined, but undetected (occult) uterine malignancy during laparoscopic hysterectomy or myomectomy. On July 11, 2014, during the afternoon session, the committee will also be asked to discuss the regulatory classification of laparoscopic power morcellator devices when used to cut and extract tissue during gynecologic laparoscopic procedures and to assist FDA in determining the appropriate level of regulatory control necessary for this device type, including discussion of class II (special controls) or reclassification to class III (subject to premarket approval application (PMA)). More information may be found here.

II. LEGISLATION & COMMITTEE ACTION

U.S. Senate

• On June 10, 2014, the Senate Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies conducted a markup of the 2015 appropriations bill for Labor, Health and Human Services, and Education, and Related Agencies. The bill was approved by the Subcommittee by voice vote. More information on the markup may be found here. A markup bill summary may be found here.
• On June 11, 2014, the Senate passed the Veterans' Access to Care through Choice, Accountability, and Transparency Act of 2014 (S. 2450). The bill will allow veterans to see private doctors outside the VA system if they experience long wait times or live more than 40 miles from a VA facility for a two year period, provide the VA Secretary authority to immediately dismiss poorly performing administrators and employees who manipulated wait-time data, and help the VA swiftly hire staff to decrease the scheduling backlog.
• On June 12, 2014, Senate Finance Committee Chairman Ron Wyden (D-OR) and member Chuck Grassley (R-IA) issued a letter to stakeholders seeking “new ideas for improving overall transparency in healthcare”. “Health care-related data, specifically, is a growing but largely untapped resource for accelerating improvements in health care quality and value,” the letter states. “This data has great potential for use by consumers who can be empowered to choose providers that best fit their specific needs; by providers who can improve and deliver higher-quality care; and by payers who can design the most efficient and effective delivery models.” The letter, sent to a broad spectrum of health care stakeholders, asks for input on how to make health care data more useful and readily available. The letter asks that comments from stakeholders and the public be submitted by e-mail to data@finance.senate.gov before August 12, 2014. Wyden and Grassley previously introduced the Medicare Data Access for Transparency and Accountability Act (Medicare DATA Act) to make the Medicare claims database available to the public online at no cost.

House of Representatives

• On June 9th and 10th, the House Energy and Commerce Committee conducted a markup of pending legislation, including: Improving Regulatory Transparency for New Medical Therapies Act (H.R. 4299); Ensuring Patient Access and Effective Drug Enforcement Act of 2014 (H.R. 4709); Combating Autism Reauthorization Act of 2014 (H.R. 4631); Promoting New Manufacturing Act (H.R. 4795); and H.R. 4801, to require the Secretary of Energy to prepare a report on the impact of thermal insulation on both energy and water use for potable hot water. More information on the markup, including amendments and votes, may be found here.
• On June 10, 2014, the House Ways and Means Subcommittee on Oversight held a hearing on the verification system for income and eligibility for tax credits under the Affordable Care Act (ACA). The 2010 law created an income-based premium tax credit for certain individuals who purchase health insurance through the ACA Exchanges. The accuracy of these tax credits, which began this year, depends on multiple pieces of data, including an individual’s income and eligibility for “affordable” employer-sponsored insurance. The hearing focused on the government’s ability to verify income and insurance information, ensure accuracy of premium tax credits, and the likely effect of these challenges on the 2015 tax-filing season. Witnesses for the hearing included Douglas Holtz-Eakin, President, American Action Forum; Ryan Ellis, Tax Policy Director, Americans for Tax Reform; Katie W. Mahoney, Executive Director of Health Policy, U.S. Chamber of Commerce; Bryan C. Skarlatos, Partner, Kostelanetz & Fink; and Ron Pollack, Executive Director, Families USA. More information on the hearing may be found here.
• On June 10, 2014, the House Energy and Commerce Committee passed legislation, the Improving Regulatory Transparency for New Medical Therapies Act (HR 4299), which would require the Drug Enforcement Administration (DEA) to make interim scheduling decisions for new drugs within 45 days of receiving an FDA scheduling recommendation, and to make final decisions on applications for registration to manufacture or distribute a controlled substance within 180 days. The bill was introduced by Health Subcommittee Chair Joe Pitts (R-PA) and Ranking Member Frank Pallone (D-NJ).
• On June 10, 2014, the House passed the Veteran Access to Care Act of 2014 (HR 4810), which would allow patients within the Department of Veterans Affairs to receive government-funded treatment outside the system under certain circumstances.
• On June 11, 2014, the House Energy and Commerce Subcommittee on Health held a hearing entitled “21st Century Cures: Examining the Role of Incentives in Advancing Treatments and Cures for Patients”. Witnesses for the hearing included Dr. Sam Gandy, Mt. Sinai Health System (filling in for Dr. Kenneth Davis); Marc Boutin, Executive Vice President and Chief Operating Officer, National Health Council; Alexis Borisy, Partner, Third Rock Ventures; Mike Carusi, General Partner, Advanced Technology Ventures on behalf of National Venture Capital Association; Dr. Fred Ledley, Professor, Natural & Applied Sciences and Management Director, Center for Integration of Science and Industry; C. Scott Hemphill, Professor of Law, Columbia Law School; and Dr. Steven Miller, Senior Vice President Chief Medical Officer, Express Scripts Holding Company. The hearing provided an opportunity for the Committee to assess how Congress could foster additional investment, particularly in areas where patients lack effective treatments or public health demands innovation. More information on the hearing may be found here.
• On June 12, 2014, the House Energy and Commerce Subcommittee on Health held a hearing entitled “The President’s Health Care Law Does Not Equal Health Care Access”. Witnesses for the hearing included Scott Gottlieb, M.D., Resident Fellow, American Enterprise Institute; Monica Lindeen, Commissioner, Montana Office of the Commissioner of Securities and Insurance; and William F. Harvey, M.D., Chair, Government Affairs Committee, American College of Rheumatology. More information on the hearing may be found here.

III. REPORTS, STUDIES, & ANALYSES

• The Medicare Payment Advisory Commission (MedPAC) issued its June 2014 Report to Congress this week, “Medicare and the Health Care Delivery System”. As part of its mandate from Congress, each June MedPAC reports on issues affecting the Medicare program as well as broader changes in health care delivery and the market for health care services. The report outlines a set of questions for the Medicare program as it develops new ways of financing and organizing care for beneficiaries. According to MedPAC Chairman Glenn Hackbarth, “This report represents the beginning of a dialogue within MedPAC about how Medicare’s policies across fee-for service, Medicare Advantage, and Accountable Care Organizations might evolve and how these differing policies might affect beneficiaries, providers, and taxpayers.” A MedPAC press release with major highlights from the report may be found here. Next week the House Ways and Means Committee is scheduled to hold a hearing on the report. More information on the hearing may be found here.
• On June 13, 2014, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its June 2014 Report to the Congress on Medicaid and CHIP. Commissioners recommended that the Congress allow states, at their option, to extend continuous Medicaid eligibility to adults for an entire year to mitigate “churning” in the Medicaid program. The Commission also recommended extending the current transitional medical assistance program, which enables poor parents to move into the workforce without immediately losing Medicaid.
• On June 12, 2014, researchers from the Georgetown University Center on Heath Insurance Reforms issued a brief entitled “The Extended "Fix" for Canceled Health Insurance Policies: Latest State Action”. The post provides an update on state action following a decision by the Obama Administration in November 2013 to let states and insurers allow people to reenroll in and renew plans that were noncompliant with the ACA requirements. The authors note that at least nine states that did not adopt the administration’s original transitional policy—Alaska, Arizona, Arkansas, Colorado, Indiana, Nebraska, Oklahoma, Oregon, and West Virginia—are now allowing renewals of noncompliant policies after January 1, 2014. Eight of the nine modified their approach through regulatory action; in Oregon the legislature passed a law permitting renewal of noncompliant policies through at least 2014. The authors suggest that this could drive premium rates up in 2015, but they point to a recent Commonwealth Fund analysis which suggests that the impact could be fairly small.
• This week consulting firm McKinsey & Company released an issue brief providing an updated national view of configurations of hospital networks on the Exchanges. Among the report’s key findings, consumers now have an expanded choice of network offerings at the point of health plan purchase on Exchanges, and broad networks are available to close to 90 percent of the addressable population. Compared to plans with narrowed networks, McKinsey found, products with broad networks have a median increase in premiums of 13 to 17 percent, and the maximum increase is 53 percent. The full report may be found here.
• The State Health Access Data Assistance Center (SHADAC) released a report this week which finds that between September 30, 2013, and May 1, 2014, the number of uninsured Minnesotans fell by 180,500, or 40.6%, from 445,000 (8.2% of the population) to about 264,500 (4.9% of the population). SHADAC produced the report at the request of Minnesota's State-Based Health Insurance Marketplace, MNsure. Researchers compiled data from a variety of sources to analyze, at an aggregate level, the shifts in health insurance coverage that have taken place in Minnesota since the fall of 2013. The report may be found here.

IV. OTHER HEALTH POLICY NEWS

• On June 9, 2014, former OMB Director Sylvia Mathews Burwell was sworn in as the 22nd Secretary of Health and Human Services (HHS). She replaces outgoing Secretary Kathleen Sebelius, who had held the post since Obama’s first term.
• On June 10th, CMS announced the availability of $60 million in funding for Navigator grants in Federally Facilitated Exchanges and State Partnership Marketplaces for 2014-2017. This amount is $7 million less than was awarded before the first open enrollment period. The award opportunity may be found here.
• On June 10th, CMS released the list of federal Exchange states where employee choice will not be available for the Small Business Health Options Program (SHOP). “Employee choice” provides employers the opportunity to allow employees to choose any health plan at the actuarial value, or “metal,” level selected by the employer. In total, 18 states with a Federally-facilitated SHOP will allow for this transition relief in 2015. These include: Alabama, Alaska, Arizona, Delaware, Illinois, Kansas, Louisiana, Maine, Michigan, Montana, New Hampshire, New Jersey, North Carolina, Oklahoma, Pennsylvania, South Carolina, South Dakota, and West Virginia. The remaining 14 states with a Federally-facilitated SHOP will join most State-based SHOPs and have employee choice available to small businesses in 2015, doubling the number of states offering this option.
• On June 10, 2014, the White House released a statement on the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015 (HR 4800). According to the document, the Administration strongly opposes passage of the bill because it “…undermines key investments in financial oversight, injects political decision-making into science-based nutrition standards, and includes objectionable language riders. If the President were presented with H.R. 4800, his senior advisors would recommend that he veto the bill.” The Administration opposes provisions that “unduly interfere with FDA’s rulemaking process”, including a provision that withholds $20 million from FDA's Salaries and Expenses account until FDA issues final guidance on abuse-deterrent formulations of opioids.

This advisory is published by Alston & Bird LLP’s Health Care practice area to provide a summary of significant developments to our clients and friends. It is intended to be informational and does not constitute legal advice regarding any specific situation. This material may also be considered attorney advertising under court rules of certain jurisdictions.