Mar 23, 2015

Washington Healthcare Update

This Week: Bipartisan, Bicameral Permanent SGR Fix Introduced... House Budget Committee Advances FY2016 Budget Proposal... National Coverage Determinations Proposed for Removal... HHS Releases Proposed Rules on EHR Incentive Programs and Health IT Certification Criteria... Departments of Justice/Health and Human Services Announce Medicare Fraud Successes... Indiana Adds Hundreds of Providers and Networks to its Medicaid Program Since Expansion

1. Congress

House of Representatives


2. Administration

3. State Activities

4. Regulations Open for Comment

5. Reports

1. Congress


House Members Introduce Bipartisan Post-Acute Care Coordination Bill

On March 19, Reps. David McKinley (WV-1), Jerry McNerney (D-CA) and Tom Price (R-GA) introduced bipartisan legislation, H.R. 1458 , the Bundling and Coordinating Post-Acute Care (BACPAC) Act, which creates a new approach that coordinates care for seniors when they leave the hospital by bundling post-acute care Medicare payments. “For the past three years, we have been working on this legislation to help reduce the stress for seniors dealing with Medicare after a hospital visit. This bipartisan reform addresses the complicated decisions Medicare patients face by providing private-sector coordinators to guide patients through the process. BACPAC will strengthen Medicare for decades to come, help seniors receive the most effective care, and save taxpayers tens of billions of dollars,” said Rep. McKinley in a press release. Under the model established by the Bundling and Coordinating Post-Acute Care Act, post-acute care providers would manage a patient’s care for up to 90 days, using a bundled payment that is initiated on the day of discharge from the hospital. The bill attempts to reduce hospital readmissions by holding medical providers accountable for their costs, while simultaneously rewarding providers if the total cost of care is lower than the payment amount.

Upcoming: E&C Oversight Subcommittee Hearing on Prescription Drug and Opioid Abuse

The House Energy and Commerce Subcommittee on Oversight and Investigations, chaired by Rep. Tim Murphy (R-PA), has scheduled for Thursday, March 26, a hearing entitled, “Examining the Growing Problems of Prescription Drug and Heroin Abuse: State and Local Perspectives.” The hearing will be held at 10:00 a.m. in Room 2123 of the Rayburn House Office Building. At the event, the panel will continue its review of the growing prescription drug and opioid abuse crisis, and will follow up on last year’s subcommittee hearing that brought together several representatives from federal agencies to discuss the issue. Subcommittee members will hear from witnesses about what steps are being taken at a state and local level, what has worked and what hasn’t, and how to improve federal efforts aimed at addressing this challenge. “The scourge of prescription drug and opioid abuse has blazed a destructive trail of tragedy and sorrow across the United States. Lives are lost, families are left in turmoil and communities feel helpless to respond. Compounding the problem is that 40% of drug abusers have an underlying mental illness,” said Chairman Murphy. “The Subcommittee on Oversight and Investigations will continue examining solutions at next week’s hearing with experts from across the country who are confronting these challenges head on and can share their experiences on what steps we can take to restore communities and save lives.” The hearing comes as a bipartisan, bicameral bill was introduced March 19, the Protecting Our Infants Act, which directs the Department of Health and Human Services (HHS) to make recommendations for diagnosis and treatment of infants born with neonatal abstinence syndrome, a condition linked to opioid abuse by pregnant mothers; the bill also directs HHS to coordinate and review federal research on the issue and to help states collect relevant data. The legislation was introduced by Reps. Katherine Clark (D-MA) and Steve Stivers (R-OH) and Sens. Mitch McConnell (R-KY) and Bob Casey (D-PA).

A witness list is forthcoming. For more information or to watch the hearing, please visit

Upcoming: House Appropriations Subcommittee Hearing on Neuroscience Research

On Thursday, March 26, at 10:30 a.m. in H-309 of the Capitol Building, the House Appropriations Subcommittee on Commerce, Justice, Science, and Related Agencies will hold an oversight hearing to investigate federal investments in Neuroscience and Neurotechnology. The hearing follows a September 2014 announcement of a bold research collaboration, the BRAIN Initiative, that combines the manpower and funding of the National Institutes of Health (NIH), National Science Foundation (NSF), the Food and Drug Administration (FDA) and the Defense Advanced Research Projects Agency. The initiative aims to revolutionize the study of the human brain through accelerating development and application of innovative technologies that help treat, cure and prevent brain disorders.

Witness List

Dr. Jo Handelsman
Associate Director for Science, Office of Science and Technology Policy

Dr. James Olds
Assistant Director for Biological Sciences, National Science Foundation

Dr. Steven Hyman
Director, Stanley Center for Psychological Research Broad Institute of MIT and Harvard

For more information or to watch the hearing, please visit

Upcoming: E&C Health Subcommittee Hearing on 340B Drug Pricing Program

The House Energy and Commerce Subcommittee on Health scheduled a hearing for Tuesday, March 24, 2015, at 10:00 a.m. in 2322 Rayburn House Office Building entitled “Examining the 340B Drug Pricing Program.” The purpose of the hearing is to review the functionality of the 340B drug program in order to understand how it is impacting patients, providers, manufacturers and other stakeholders. Subcommittee members will hear testimony from witnesses from the Health Resources and Services Administration, the Government Accountability Office and the Department of Health and Human Services Office of the Inspector General about the 340B program, a federal drug discount program. Subcommittee members will review the functionality of the program to ensure it is meeting its goal of improving access to prescription drugs for needy patients at facilities serving these populations. The 340B drug discount program was created by Congress in 1992. Under Section 340B of the Public Health Service Act (PHSA), in order to receive Medicaid reimbursement for their drugs, pharmaceutical drug manufacturers must enter into pharmaceutical pricing agreements that provide discounts on covered outpatient drugs purchased by certain public health facilities. As of May 31, 2013, 10,510 covered entities were participating in the 340B Program, including 1,103 community health centers and 1,039 disproportionate share hospitals (DSH). More have become eligible to participate as Medicaid expands through the Affordable Care Act (ACA). Some 800 pharmaceutical manufacturers also participate in the program.

Witness List

Diana Espinosa, MPP
Deputy Administrator, Health Resources and Services Administration
U.S. Department of Health and Human Services

Accompanied by Krista M. Pedley, PharmD, MS, CDR,
USPHS, Director
Office of Pharmacy Affairs Health Resources and Services Administration
U.S. Department of Health and Human Services

Debbie Draper
Director, Health Care
Government Accountability Office

Anne Maxwell
Assistant Inspector General for Evaluation and Inspections
Office of Inspector General
U.S. Department of Health and Human Services

For more information or to watch the hearing, please visit

House Passes Bipartisan Legislation on Hospital Observation Status and DME Binding Bids

On March 16, the House passed two bills requiring binding bids in Medicare auctions for durable medical equipment (DME) as well as a bill requiring Medicare beneficiaries be notified when they are placed in observation status instead of being admitted to the hospital. The Medicare DMEPOS Competitive Bidding Improvement Act, H.R. 284, sponsored by Reps. Pat Tiberi (R-OH) and John Larson (D-CT), would require Medicare suppliers that bid under a DME prosthetics, orthotics and supplies (DMEPOS) competitive bidding program to obtain a $50,000-$100,000 bid surety bond for each competitive bidding area; if the bidder is offered a contract for any product category in the competitive bidding area, and the supplier’s bid for the product category was at or below the median bid rate, the bid bond would be forfeited if the supplier does not accept the contract. The bill passed the House by voice vote. Moreover, the Notice of Observation Treatment and Implication for Care Eligibility (NOTICE) Act, H.R. 876, passed the House 395-0, with 37 lawmakers not voting. The legislation, sponsored by Lloyd Doggett (D-TX) and Todd Young (R-IN), would help beneficiaries avoid surprise hospital or nursing home costs by requiring hospitals and critical access hospitals to provide written and oral notification to Medicare beneficiaries when they are kept under observation rather than admitted to a hospital as an inpatient. The notice would also require an explanation of the implications of observation status for beneficiary cost-sharing obligations and subsequent skilled nursing facility eligibility. H.R. 284 awaits movement on its Senate companion bill, S.148, sponsored by Sens. Rob Portman (R-OH) and Ben Cardin (D-MD), whereas a Senate version of H.R. 876 has yet to be introduced.

House Budget Committee Advances FY2016 Budget Proposal

On March 19, the House Budget Committee passed its FY2016 budget resolution, a blueprint Chairman Price (R-GA) calls “A Balanced Budget for a Stronger America,” by a party line vote of 22-13. The budget resolution is a blueprint for Congress on spending priorities. It is not signed by the president and therefore is not a law. However, at times the budget resolution can include reconciliation instructions, which are directed to authorizing committees usually to reduce spending in specific programmatic areas like Medicare and Medicaid. The budget proposal impacts the health sector in a number of areas:

  • Uses reconciliation to overturn the Affordable Care Act: Both the House and Senate Budget Committees would use the reconciliation process to overturn the Affordable Care Act. House Republican use reconciliation to repeal the Affordable Care Act “in its entirety” and would shift some savings to Medicare’s solvency.
  • Reverses the $700 billion taken from Medicare as part of the enactment of the ACA. The budget would put these savings toward Medicare solvency.
  • Repeals the Independent Payment Advisory Board (IPAB), which was to advise Congress on Medicare cuts but never has been staffed.
  • Repeals the ACA’s funding for expansion of Medicaid. Instead, the resolution provides for new State Flexibility Funds that we believe will operate much like block grants.
  • Reforms Medicare by changing the program to a premium support model, starting for beneficiaries in 2024, and combining Parts A and B so there would be a single premium for seniors. The budget also appears to call for some risk adjustment of premiums. It also provides a catastrophic cap on annual out-of-pocket expenses for Medicare beneficiaries.
  • Unifies Medicaid and the State Children’s Health Insurance program (SCHIP) into a single program, while providing funds to extend SCHIP.
  • Provides for medical liability reform.

For more information, please visit

House Approves Legislation to Improve Medical Therapy Approval

On March 16, the House passed, by voice vote, H.R. 639, the Improving Regulatory Transparency for New Medical Therapies Act, sponsored by Reps. Pitts (R-PA), Pallone (D-NJ) and Greene (D-TX). The legislation aims to improve the transparency and consistency of the Drug Enforcement Agency review of pharmaceuticals. Under current rules, there is no deadline for the DEA to make a scheduling decision. Delays in DEA decisions have increased significantly in recent years. In 1999, the average time between FDA approval and DEA’s final scheduling was 49.3 days. By the end of 2013, the average approval time had risen to 237.6 days. H.R. 639 would require DEA to schedule new drugs no later than 90 days after they are approved or when it receives the FDA’s scheduling recommendation, whichever comes later. After receiving FDA’s recommendation, DEA would continue to conduct its own analysis prior to scheduling the drug, but would now be subject to a deadline for their process. Since 1996, the DEA has not made any scheduling decision for a new drug that was contrary to the FDA recommendation. For more information, please visit


Senate Finance Committee Holds Hearing on ACA Five Years Later

The Senate Finance Committee held a hearing March 19 to explore what’s working and what isn’t when it comes to programs established under the Affordable Care Act (ACA). In his opening statement, Chairman Hatch (R-UT) stressed the difficulties associated with particular aspects of the ACA, including the problems stemming from the rollout of HealthCare.Gov, while Ranking Member Wyden (D-OR) highlighted the benefits being experienced by many individuals who have received health insurance as a result of the law, and the danger associated with attempts to repeal or dismantle it.


Dr. Douglas Holtz-Eakin
President, American Action Forum

Ms. Holly Wade
Director of Research and Policy Analysis, National Federation of Independent Business

Dr. David Blumenthal
President, The Commonwealth Fund,

For more information or to watch the hearing, please visit

Senate Budget Committee Advances FY2016 Budget Proposal

On March 19, the United States Senate Budget Committee, chaired by Senator Mike Enzi (R-WY), approved a plan that would balance the nation’s budget in 10 years with no tax hikes, protect our most vulnerable citizens, strengthen the national defense and boost economic growth and opportunity for hardworking families. The full Senate will consider the committee’s balanced budget proposal next week. The Congressional Budget Act mandates a specific timetable for the Congressional budget process, and by law the Senate Budget Committee must report its concurrent budget resolution by April 1. Congress must then complete and report the joint concurrent resolution by April 15.

“The committee’s approval of this balanced budget represents a significant first step in changing how we do business in order to safeguard the future for our kids and grandkids,” said Chairman Enzi. “The common sense ideas and solutions that are part of this proposal can deliver real results and real progress to hardworking American families. I look forward to consideration of our plan by the full Senate next week.”

Bipartisan, Bicameral Permanent SGR Fix Introduced

On March 19, leaders in the Senate and House introduced bipartisan, bicameral legislation to replace the broken Medicare Sustainable Growth Rate (SGR) formula with an improved payment system that rewards quality, efficiency and innovation. The bipartisan, bicameral bill seeks to end the cycle of annual “Doc Fix” crises that have created uncertainty for millions of Medicare providers and beneficiaries for over a decade and also create a system that promotes higher quality care for America’s seniors. Work continues toward an agreement to put this plan into place as well as make reforms to strengthen Medicare and extend vital health provisions and the Children’s Health Insurance Program.

The legislation — nearly identical to bills introduced in the House and Senate last year — was introduced by Rep. Michael C. Burgess, M.D. (R-TX), Senate Finance Committee Chairman Orrin Hatch (R-UT), House Energy and Commerce Committee Chairman Fred Upton (R-MI), House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), House Energy and Commerce Health Subcommittee Chairman Joe Pitts (R-PA), House Energy and Commerce Health Subcommittee Ranking Member Gene Green (D-TX), House Ways and Means Committee Chairman Paul Ryan (R-WI), House Ways and Means Committee Ranking Member Sander Levin (D-MI), House Ways and Means Health Subcommittee Chairman Kevin Brady (R-TX), House Ways and Means Health Subcommittee Ranking Member Jim McDermott (D-WA) and Rep. Charles Boustany, M.D. (R-LA). Senate Finance ranking Democrat Ron Wyden (OR) on Thursday, March 19, came out in opposition to the SGR package being negotiated by House Republican and Democratic leaders, and his stance is making provider lobbyists nervous because many Senate Democrats are needed to pass the bill and negotiations might now get dragged out past the March 31 expiration of the current patch to the Sustainable Growth Rate formula. For more information, please visit

2. Administration

HHS Report Finds 16.4 Million Enrolled in Health Insurance Coverage Since Passage of ACA; States with Medicare Expansion See Lower Uninsured Rates

The Department of Health and Human Services (HHS) Office of Assistant Secretary for Planning and Evaluation released a report March 16 that found that a net 16.4 million uninsured Americans have gained health insurance coverage since provisions of the Affordable Care Act (ACA) first took effect in 2010; the report includes figures from the 14.1 million adults who enrolled in on- and off-exchange coverage from October 2013 through March 4, and the 2.3 million young adults age 19 to 25 who enrolled in their parents’ insurance before the insurance exchanges opened. Health insurance coverage gains were especially strong in Medicaid expansion states and were concentrated among low and middle income population groups in all states, particularly among families in expansion states with incomes of 138 percent of poverty or less (previously 55 percent of that population were uninsured); that population experienced the largest gain in coverage after expansion, a 13 percentage point increase, nearly twice the percentage point increase that occurred in non-expansion states. Moreover, the report found that states that expanded their Medicaid program saw a slightly larger drop in their uninsured rates, at an average decline of 7.4 percentage points compared to 6.9 percentage points in non-expansion states. On average, the uninsured rate in non-expansion states fell from 23.4 percent to 16.5 percent, while that rate in states that did expand dropped slightly less, from 18.2 percent to 10.8 percent.

3. State Activities

Indiana Adds Hundreds of Providers and Networks to its Medicaid Program Since Expansion

In a press announcement March 17 by Governor Mike Pence’s (R-IN) office, the state’s executive branch revealed that the state has added 939 providers, including 335 physicians, to the networks of the Healthy Indiana Plan and other Medicaid programs since CMS approved the state’s alternative Medicaid expansion plan in January. Approved through a Centers for Medicare and Medicaid Services waiver, the Healthy Indiana plan requires participants to contribute to health savings accounts and is the first plan to get CMS’ approval to charge income-based premiums; state residents who don’t pay their premiums are kicked out of the program for six months. “This rapid and meaningful increase in the number of doctors opening their practices to Healthy Indiana Plan members shows how the changes we’ve made to our program here in Indiana are causing real reform to stick,” said Governor Pence. “We still have work to do to continue increasing our provider roles to meet the demand for HIP 2.0, but this immediate response is an indication that the program is popular with members and clinicians alike.” Since the passage of the Affordable Care Act (ACA), the District of Columbia and 28 states have expanded Medicaid to adults making up to 138 percent of the federal poverty line.

4. Regulations Open for Comment

National Coverage Determinations Proposed for Removal

On Aug. 7, 2013, the Centers for Medicare & Medicaid Services (CMS) published a Federal Register notice (78 FR 48164-69), updating the process used for opening, deciding or reconsidering national coverage determinations (NCDs) under the Social Security Act (the Act). The notice replaced the Sept. 26, 2003, Federal Register notice (68 FR 55634) and further outlined an expedited administrative process, using specific criteria, to remove certain NCDs older than 10 years since their most recent review. On March 18, CMS announced its list of NCDs proposed for removal, along with the relevant portion of the Federal Register notice containing the CMS criteria. CMS is soliciting public comment through April 17 on whether any or all of these NCDs should be removed or retained. CMS expects to publish a finalized list by fall 2015. Local Medicare Administrative Contractors (MACs) will be able to determine coverage for items and services that were previously determined by removed NCDs. View the proposed rule:

HHS Releases Proposed Rules on EHR Incentive Programs and Health IT Certification Criteria

The U.S. Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) announced March 20 the release of the Stage 3 notice of proposed rulemaking for the Medicare and Medicaid Electronic Health Records (EHRs) Incentive Programs and 2015 Edition Health IT Certification Criteria to improve the way electronic health information is shared and ultimately improve the way care is delivered and experienced. The proposed rules aim to give providers additional flexibility, make the program simpler, drive interoperability among electronic health records and increase the focus on patient outcomes to improve care.

Specifically, the Meaningful Use Stage 3 proposed rule issued by CMS specifies new criteria that eligible professionals, eligible hospitals and critical access hospitals must meet to qualify for Medicaid EHR incentive payments; the rule also proposes criteria that providers must meet to avoid Medicare payment adjustments (Medicaid has no payment adjustments) based on program performance beginning in payment year 2018. Moreover, the 2015 Edition Health IT Certification Criteria proposed rule aligns with the path toward interoperability — the secure, efficient and effective sharing and use of health information — identified in ONC’s draft shared Nationwide Interoperability Roadmap. The proposed rule also builds on past editions of adopted health IT certification criteria, and includes new and updated IT functionality and provisions that support the EHR Incentive Programs’ care improvement, cost reduction and patient safety across the health system.

Under the Health Information Technology for Economic and Clinical Health Act, doctors, health care professionals and hospitals, including critical access hospitals, can qualify for Medicare and Medicaid incentive payments when they adopt and meaningfully use health IT technology certified by ONC. The Stage 3 proposed rule may be viewed here, and the comment period ends on May 29, 2015. The 2015 Edition proposed rule may be viewed here and the comment period ends on May 29, 2015. The Draft 2015 Edition Certification Test Procedures may be viewed at, and the comment period ends on June 30, 2015.

Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers; Draft Guidance for Industry, Clinical Investigators and Institutional Review Boards

The Food and Drug Administration (FDA or the Agency) is announcing the availability of draft guidance for industry, clinical investigators and institutional review boards, entitled “Use of Electronic Informed Consent in Clinical Investigations: Questions and Answers.” The 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 FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices and combinations thereof. Although public comments will be accepted any time, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by May 8, 2015.

FDA: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

On March 12, FDA announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection. Medical devices intended for repeated use are commonplace in health care settings. They are typically made of durable substances that can withstand reprocessing, a multi-step process designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. While the majority of reusable devices are successfully reprocessed in health care settings, the complex design of some devices makes it harder to remove contaminants. FDA’s guidance document, titled “ Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling ,” includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices. A device manufacturer’s reprocessing instructions are critical to protect patients against the spread of infections. As part of its regulatory review for reusable medical devices, the FDA reviews the manufacturer’s reprocessing instructions to determine whether they are appropriate and able to be understood and followed by end users. The guidance lists six criteria that should be addressed in the instructions for use with every reusable device to ensure users understand and correctly follow the reprocessing instructions.

Compounding of Human Drug Products Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket

On March 9, FDA announced 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). Section 503A of the FD&C Act describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist or licensed physician to be exempt from certain sections of the FD&C Act. Previously, the conditions of section 503A of the FD&C Act also included restrictions on the advertising or promotion of the compounding of any particular drug, class of drug or type of drug and the solicitation of prescriptions for compounded drugs. These provisions were challenged in court and held unconstitutional by the U.S. Supreme Court in 2002.

On Nov. 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA), which contains important provisions relating to the oversight of human drug compounding. This new law removes from section 503A of the FD&C Act the provisions that had been held unconstitutional by the U.S. Supreme Court in 2002. By removing these provisions, the new law clarifies that section 503A of the FD&C Act applies nationwide. In addition, the DQSA adds a new section, 503B, to the FD&C Act that creates a new category of “outsourcing facilities.” Outsourcing facilities, as defined in section 503B of the FD&C Act, are facilities that meet certain conditions described in section 503B, including registration with FDA as an outsourcing facility. 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. Comments may be submitted to this docket at any time.

FDA Solicits Comments on New Methodologies for Generic Drug Clinical Studies

In a notice released March 5 by the Federal Register, the Food and Drug Administration (FDA) is seeking feedback from stakeholders on possible new methodologies for generic drug clinical studies and ways to demonstrate bioequivalence as part of its regulatory science priorities for 2016 under Generic Drug User Fee Amendments (GDUFA). FDA noted it will take feedback from stakeholders into account when creating next year’s regulatory science plan for generic drugs. A public hearing has been scheduled for June 5, where FDA plans to hear from stakeholders on six specific areas including scientific or technical advancements that would help that currently limit generics’ availability, innovative approaches to preapproval development of generic drugs, advancements in scientific approaches to evaluate therapeutic equivalence of generic drugs through later stages of their lifecycle. The agency’s efforts come as House and Senate lawmakers are also looking at ways to revamp clinical trial design, though up to now they haven’t focused on generic drug-specific issues, and identification of high-impact public health issues involving generic drugs, among others. The notice comes as the House of Representatives 21st Century Cures discussion legislative draft also seeks to revamp clinical trials by allowing trial sponsors to propose incorporating adaptive trial designs for alternative statistical methods into proposed clinical trials and streamlining the institutional review board.

FDA Reopens Comment Period for Generic Drug Labeling Rule

In an announcement Feb. 17, the Food and Drug Administration (FDA) revealed that it has formally re-opened the comment period for a controversial generic drug labeling proposed rule and will hold a public meeting next month to address concerns with the rule and possible alternatives. The rule, which FDA proposed in 2013, would allow generic drugmakers to unilaterally update safety information and would require generic drugmakers to modify their labels independently of their brand-name counterparts, something that only brand-name drugmakers can currently do before receiving agency permission. The FDA proposed the rule in response to a 2011 U.S. Supreme Court decision that federal law does not permit generic drugmakers to make such changes independently and, therefore, they should not be held accountable for a failure to warn against a risk. Stakeholders will have until April 27 to comment on the proposed rule; the agency’s public hearing to receive more input from stakeholders will be held on March 27 from 8 a.m. to 5 p.m. at FDA’s White Oak campus.

FDA Releases Five Draft Guidance Documents on Drug Compounding

On Feb. 13, U.S. Food and Drug Administration (FDA) issued five draft guidance documents related to drug compounding and repackaging that will help entities comply with important public health provisions; guidance will be applicable to pharmacies, federal facilities, outsourcing facilities and physicians and comes as an outcrop of the Drug Quality and Security Act (DQSA), enacted by Congress in November 2013, in response to a deadly fungal meningitis outbreak that was linked to contaminated sterile compounded drug products. Specifically, the documents include potential direction on outsourcing facility registration, outsourcing facility adverse event reporting, drug repackaging, mixing, diluting and repackaging biological products, and a draft Memorandum of Understanding (MOU) with the states. The draft guidance documents are available for public comment until May 14, while draft comment for the draft MOU is open until June 13.

FDA Releases Draft to Streamline Experimental Drug Applications

On Feb. 4, the Food and Drug Administration (FDA) released draft guidance, entitled Individual Patient Expanded Access Applications: Form 3926, for a new, shorter application for patient access to experimental drugs. The draft comes in response to concerns that the existing process for “compassionate use” for experimental drug applications was too arduous. In the guidance, FDA says the newly proposed form would take doctors 45 minutes to complete whereas the existing form is estimated to take 100 minutes. Under the old system, FDA required that a “cover sheet” be included with any IND submission, known as Form 1571. However, that form was originally intended to be used by companies involved in drug development, not physicians, who submit the vast majority of expanded access requests. FDA said it was “concerned” that some physicians might not understand how to complete that cover sheet “and associated documents because it is not tailored to requests for individual patient expanded access.” Peter Laurie, FDA’s associate commissioner for public health strategy and analysis, said the changes would greatly simplify the compassionate use process. The old form “called for 26 separate types of information and seven attachments,” he noted. “The new form calls for a small fraction of that. The new draft form, when finalized, will require only eight elements of information and a single attachment.” The changes announced by the agency are expected to affect a significant number of patients each year; in 2014, FDA processed 1,758 single patient investigational new drug applications and emergency investigational new drug applications—97 percent of all expanded access requests. Comments and suggestions for the draft document should be submitted by April 13, 2015.

5. Reports

Departments of Justice/Health and Human Services Announce Medicare Fraud Successes

According to a report released March 19, more than $27.8 billion has been returned to the Medicare Trust Fund over the life of the Health Care Fraud and Abuse Control (HCFAC) Program. The government’s health care fraud prevention and enforcement efforts recovered $3.3 billion in taxpayer dollars in Fiscal Year (FY) 2014 from individuals and companies that attempted to defraud federal health programs, including programs serving seniors, persons with disabilities or those with low incomes. For every dollar spent on health care-related fraud and abuse investigations in the last three years, the administration recovered $7.70. This is about $2 higher than the average return on investment in the HCFAC program since it was created in 1997. It is also the third-highest return on investment in the life of the program.

If you have any questions, contact the following individuals at McGuireWoods Consulting:

Stephanie Kennan, Senior Vice President
Charlyn Iovino, Vice President
Brian Looser, Vice President
Amanda Anderson, Research Assistant

Founded in 1998, McGuireWoods Consulting LLC (MWC) is a full-service public affairs firm offering state and federal government relations, national/multistate strategies, infrastructure and economic development, strategic communications and grassroots issue management services. McGuireWoods Consulting is a subsidiary of the McGuireWoods LLP law firm and in 2010 was ranked in the Top 20 of The National Law Journal's "The Influence 50," an annual report of the top public affairs firms in Washington, D.C.

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