Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

On May 8, 2013, the House Energy and Commerce Subcommittee on Health approved by voice vote H.R. 1407, legislation to reauthorize and combine the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act. TheEnergy and Commerce Committee also recently held hearings on: the Administration’s HHS budget proposal; the Center for Consumer Information and Insurance Oversight and implementation of the ACA; the lack of transparency and consumer driven market forces in U.S. health care system; and the impact of HIPAA on patient care and public safety. The House Ways and Means Health Subcommittee held a hearing on Medicare physician payment reform, and the Senate Finance Committee has scheduled a May 14 hearing on this topic.  Other Senate panels also recently held hearings on health policy issues, including: a HELP Committee hearing on "Successful Primary Care Programs: Creating the Workforce We Need"’ a Homeland Security Committee hearing on “Oversight and Business Practices of Durable Medical Equipment Companies”; and a Special Committee on Aging hearing on "The National Plan to Address Alzheimer's Disease: Are We On Track to 2025?"

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This post was written by Kevin Madagan and Debra McCurdy.

Key members of the Senate Health, Education, Labor, and Pensions Committee have released a bipartisan draft legislative proposal intended to improve drug distribution security. The legislation addresses, among other things: lot-level product tracing requirements for “downstream” pharmaceutical supply chain members (drug manufacturers, repackagers, wholesale distributors, and dispensers); a requirement that manufacturers serialize prescription drugs at the unit level; national licensure standards for wholesale distributors and third-party logistics providers; a requirement that members of the supply chain only transact with registered or licensed entities; and preemption of state product tracing requirements, including paper or electronic pedigree systems. The lawmakers will accept comments on the draft legislation until April 26, 2013. In a related development, the House Energy and Commerce Subcommittee on Health has scheduled an April 25 hearing on "Securing Our Nation's Prescription Drug Supply Chain,” which will focus on a House companion version of the draft “track and trace” legislation intended to secure pharmaceutical distribution. 

Update:  On May 8, 2013, the House Energy and Commerce Health Subcommittee approved by voice vote an amended version of its “track and trace” legislation intended to secure pharmaceutical distribution.

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Earlier this month, the Senate Finance Committee held a hearing on the nomination of Marilyn Tavenner to be CMS Administrator. The Senate Health, Education, Labor, and Pensions (HELP) Committee approved the Mental Health Awareness and Improvement Act, legislation that reauthorizes and amends programs administered by both HHS and the Department of Education related to awareness, prevention, and early identification of mental health conditions. The HELP Committee also held a hearing on the effect of guaranteed issue and new insurance rating rules. A House Ways and Means Committee hearing focused on details of the President’s FY 2014 budget proposals for HHS programs. The House Energy and Commerce Committee held hearings on the ACA’s Pre-Existing Condition Insurance Program, reauthorization of FDA animal drug user fees, and “Challenges of Traditional Medicare's Benefit Design.” The Energy and Commerce Committee also plans an April 16 hearing on the fungal meningitis outbreak and whether it could have been prevented, along with an April 18 hearing on the Administration’s HHS budget proposal.

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Recent Congressional hearings have addressed a number of health policy issues. For instance, the House Energy and Commerce Committee held a series of hearings on health information technologies, covering the Administration’s perspectives on innovation and regulation (including a discussion of the Administration’s policies on regulation of mobile medical apps), how innovation benefits patients, and “harnessing wireless innovation.” http://energycommerce.house.gov/press-release/three-day-hearing-series-produces-much-needed-certainty-patients-providers-and-innovators. Separately, a Health Subcommittee hearing focused on Medicare and Medicaid entitlement reform. In addition, the Senate Finance Committee held a hearing on health care delivery reform, focusing on the Center for Medicare and Medicaid Innovation efforts. 

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On March 20, 2013, the Senate Committee on Health, Education, Labor, and Pensions approved an amended version of S. 330, a bill to amend the Public Health Service Act to establish safeguards and standards of quality for research and transplantation of organs infected with human immunodeficiency virus (HIV). Among other things, the bill would remove the ban on research of organ transplantation from HIV-positive donors to HIV-positive recipients. If such research shows that these transplants can be conducted safely, the bill authorizes organ donation standards to be updated accordingly.  The panel also approved an original bill to reauthorize the Animal Drug User Fee Act and Animal Generic Drug User Fee Act. 

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There have been many Congressional health policy hearings recently, with more scheduled. Highlights include the following:

• House Ways and Means Committee. Recent hearings have examined traditional Medicare’s benefit design and tax-related provisions in the ACA, and on March 15, the Health Subcommittee is holding a hearing on the Medicare Payment Advisory Commission's annual March Report to the Congress.
• House Energy and Commerce Committee. The Health Subcommittee has reviewed innovative ways to fight health care fraud and abuse, and the panel has scheduled hearings on the impact of the ACA on jobs (March 13) and health insurance premiums (March 15). A March 18 hearing will focus on “Saving Seniors and Our Most Vulnerable Citizens from an Entitlement Crisis.”
• Senate Hearings. The Finance Committee held a hearing on the status of CMS delivery reform efforts. A Health, Education, Labor and Pensions Committee hearing examined animal drug user fees. The Commerce Committee has reviewed transparency in the individual health insurance market. An Aging Committee hearing focused on ways to strengthen Medicare.

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House Energy and Commerce subcommittees have held hearings on “Influenza: Perspective on Current Season and Update on Preparedness” and on “SGR: Data, Measures and Models; Building a Future Medicare Physician Payment System.” On the Senate side, the Senate Health, Education, Labor, and Pensions Committee voted to approve H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (which was approved by the House last month), and S. 252, “The Prematurity Research Expansion and Education for Mothers who deliver Infants Early (PREEMIE) Act.” In addition, the Finance Committee held a hearing on ACA health insurance exchanges. 

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On February 14, 2013, the House Energy and Commerce Health Subcommittee is holding a hearing entitled “SGR: Data, Measures and Models; Building a Future Medicare Physician Payment System.” 

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The House Energy and Commerce Committee approved three health policy bills on January 22, 2013, versions of which were passed by the full House during the last Congress. Specifically, the panel voted to approve: H.R. 297, the Children’s Hospital Graduate Medical Education (GME) Support Reauthorization Act of 2013 (which provides support to children’s hospitals for pediatric medical residency programs); H.R. 225, the National Pediatric Research Network Act of 2013 (to allow the National Institutes of Health to fund pediatric research networks to conduct research on conditions and diseases affecting children); and H.R. 235, the Veteran Emergency Medical Technician (EMT) Support Act (which would provide funding to states with EMT shortages to streamline licensing requirements for military veteran EMTs). 

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The Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on January 24, 2013 to assess the state of America’s mental health system. In addition, the HELP Subcommittee on Primary Health and Aging held a January 29 hearing entitled “30 Million New Patients and 11 Months to Go: Who Will Provide Their Primary Care?”
 

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On December 13, 2012, the Senate Finance Committee held a hearing to focus on improving care for beneficiaries dually eligible for Medicare and Medicaid. In addition, the House Energy and Commerce Subcommittee held a hearing entitled "State of Uncertainty: Implementation of Patient Protection and Affordable Care Act Exchanges and Medicaid Expansion." On December 20, 2012, the Senate Judiciary Committee was scheduled to consider S. 1560, the Nursing Home Resident Pain Relief Act of 2011, which would make amendments to the Controlled Substances Act that are intended to help ensure that nursing home residents have timely access to pain medication in emergency situations.  Note that the markup has been postponed and not rescheduled at this time.

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On December 13, 2012, the House Energy and Commerce Health Subcommittee is holding a hearing entitled  “State of Uncertainty: Implementation of PPACA's Exchanges and Medicaid Expansion."  The hearing announcement states that “With less than 13 months until implementation, the committee intends to press the administration to finally respond to the numerous critical questions that remain unanswered nearly 1,000 days since enactment of the health care law.”

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A recent Government Accountability Office (GAO) report reviews CMS efforts to implement the Fraud Prevention System (FPS), which uses predictive analytics technologies to identify fraudulent claims before they are paid. CMS and its program integrity contractors began using the FPS in July 2011 in compliance with the Small Business Jobs Act. According to the GAO, while the FPS can generate automatic alerts on specific claims and providers for further review and investigation, the system has not yet been integrated with CMS’s payment-processing system to block payment until the suspect claim can be determined to be valid. The GAO also reports that CMS has not yet defined or measured quantifiable benefits or established appropriate performance goals for the FPS. The GAO therefore recommends that CMS develop schedules for completing integration with existing systems, define and report to Congress quantifiable benefits and measurable performance targets and milestones for the FPS, and conduct a post-implementation review of FPS. In a related development, on November 28, 2012, the House Energy and Commerce Subcommittee held a hearing entitled "Examining Options to Combat Health Care Waste, Fraud and Abuse" to examine CMS’s use of predictive analytics technologies.

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On November 14, 2012, the House Science, Space, and Technology Committee is holding a hearing entitled “Is 'Meaningful Use' Delivering Meaningful Results -- An Examination of Health Information Technology Standards and Interoperability.”  Two hearings are scheduled to examine the recent outbreak of fungal meningitis: a November 14 House Energy and Commerce Oversight Subcommittee hearing on "The Fungal Meningitis Outbreak: Could It Have Been Prevented?"  and a November 15 Senate Health, Education, Labor, and Pensions Committee hearing entitled “Pharmacy Compounding: Implications of the 2012 Meningitis Outbreak.”

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A number of recent Congressional hearings have focused on health policy issues, including the following:

• A House Small Business Healthcare Subcommittee hearing on “Medicare's Durable Medical Equipment Competitive Bidding Program: How Are Small Suppliers Faring?”
• Senate Aging Committee hearings on “Implementing the Physician Payments Sunshine Act” and “Eliminating Waste and Fraud in Medicare: An Examination of Prior Authorization Requirements for Power Mobility Devices.” 
• A House Oversight Committee hearing entitled “Administration's Failure to Prevent/End Medicaid Overpayments.” 
• House Ways and Means Committee hearings on (1) implementation of ACA health insurance exchanges and related provisions; (2) the status of Medicare Advantage (MA) plans; and (3) the Internal Revenue Service’s (IRS) implementation of various ACA tax provisions.
• A House Energy and Commerce Committee hearing on HHS’s use of special hiring authorities under Title 42 to appoint and compensate specialized science and research positions. 

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On September 12, 2012 the Senate Aging Committee will hold a roundtable forum entitled “Let the Sunshine in: Implementing the Physician Payments Sunshine Act.”   The ACA's Physician Payment Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP to report annually to the HHS Secretary certain payments or other transfers of value to physicians and teaching hospitals. Additionally, applicable manufacturers and applicable group purchasing organizations must report certain information regarding the ownership or investment interests in them that are held by physicians or their immediate family members.  For our previous reports on the Sunshine Act provisions, click here.

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The Senate Health, Education, Labor and Pensions Committee held a field hearing in Connecticut on “Lyme Disease: A Comprehensive Approach to an Evolving Threat.”  On September 11, 2012, the House Ways and Means Oversight Subcommittee is holding a hearing on the Internal Revenue Service’s implementation of various ACA tax provisions. Also on September 11, the House Small Business Healthcare Subcommittee is holding a hearing on "Medicare's Durable Medical Equipment Competitive Bidding Program: How Are Small Suppliers Faring?"

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Recent Congressional hearings have focused on the following health policy issues, among others:  

• A House Ways and Means Health Subcommittee hearing entitled “Physician Organization Efforts to Promote High Quality Care and Implications for Medicare Physician Payment Reform";
• A Senate Commerce, Science and Transportation Committee hearing on short-supply, “gray market” prescription drugs; and
• A House Oversight and Government Reform Committee hearing on the Obama Administration’s Medicare Advantage Quality Bonus Payment Demonstration. The Panel also has scheduled an August 2 hearing on IRS enforcement of the ACA’s tax provisions.

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Congressional panels have examined a number of health policy issues recently, including:

• ACA Hearings: The House Ways and Means Committee held a hearing on the implications of the Supreme Court's ruling that the individual mandate in the ACA is constitutional, particularly as it relates to Congress' taxing authority.  The House Oversight and Government Reform Committee held separate hearings on the ACA’s impact on doctors and patients, and on job creators and the economy.
• Medicare Physician Payments: The Senate Finance Committee held a hearing on “Medicare Physician Payments: Perspectives from Physicians,” while the House Energy and Commerce Health Subcommittee examined “Using Innovation to Reform Medicare Physician Payment.” (http://energycommerce.house.gov/hearings/hearingdetail.aspx?NewsID=9692).
• Dual Eligibles: The Senate Aging Committee held a hearing on Medicare and Medicaid coordination for dual-eligibles.

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On July 18, 2012, the House Appropriations Subcommittee on Labor, Health and Human Services, and Education approved legislation funding federal programs in its jurisdiction. Among other things, the bill would block funding to implement the ACA (except for select provisions) and cut funding for various government entities established by the ACA, including the Center for Medicare & Medicaid Innovation, the Center for Consumer Information and Insurance Oversight, the Independent Payment Advisory Board, the Patient-Centered Outcomes Research Trust Fund, and the Prevention and Public Health Fund. Also notably, the bill would terminate the Agency for Healthcare Research and Quality, effective October 1, 2012, and set spending rates for other federal health programs.  Note that the version of the legislation approved by the Senate Appropriations Committee in June includes funding for ACA implementation. The differences in the House and Senate appropriations bills are unlikely to be resolved until a probable lame duck session of Congress after the November elections.

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