On September 9, 2014, the House Energy and Commerce Subcommittee on Health is holding a hearing entitled “21st Century Cures: Examining the Regulation of Laboratory Developed Tests.” The hearing will focus on the FDA’s recent guidance on the regulation of lab developed tests and its “impact on innovation and the practice of precision medicine.” The panel will also host a “roundtable” discussion September 10 at which HHS Secretary Burwell, NIH Director Collins, FDA Commissioner Hamburg, and other experts will address opportunities to accelerate the discovery, development, and delivery of new cures and treatments. In addition, two hearings are scheduled on ACA implementation. On September 10, the House Ways and Means Subcommittee on Health will review ACA Marketplace administration, including verification of tax credit eligibility. On September 18, the House Oversight and Government Reform Committee will address Healthcare.gov transparency, accountability, and information security.
On September 9, 2014, the House Energy and Commerce Subcommittee on Health is holding a hearing entitled “21st Century Cures: Examining the Regulation of Laboratory Developed Tests.” The hearing will focus on the FDA’s recent guidance on the regulation of lab developed tests and its “impact on innovation and the practice of precision medicine.”
On August 8, 2014, President Obama signed into law the following two bills approved by the Senate in July:
- H.R. 4631, the Autism CARES Act, to continue federal research, early identification and intervention, and education related to autism; and
- H.R. 3548, the Improving Trauma Care Act, to include in the Public Health Service Act definition of trauma injuries caused by thermal, electrical, chemical, or radioactive force.
In addition, prior to beginning the August recess, the House of Representatives approved the following bills:Continue Reading...
The Chairman of the House Ways and Means Subcommittee on Health is seeking comments on a draft bill, the Protecting Integrity in Medicare Act of 2014, that is “aimed at combating fraud, waste and abuse in the Medicare program.” The bill covers a range of Medicare and Medicaid policies, from establishing new alternative sanctions for technical physician self-referral violations to providing more flexibility in meeting durable medical equipment (DME) documentation requirements. Among other things, the bill would:Continue Reading...
The Senate Aging Committee has released a staff report entitled “Improving Audits: How We Can Strengthen the Medicare Program for Future Generations.” The report describes the burden audits can impose on providers, and raises concerns that CMS’s current efforts are “aimed more at identifying and recovering improper payments that have already occurred, rather than a proactive strategy to ensure that those errors are not made in the first place.” For instance, the Recovery Audit Contractor (RAC) contingency fee structure “could be viewed as providing an incentive to keep improper payment rates high.” The report also notes that inconsistent local coverage determinations (LCDs) can increase the burden on providers and contractors, since different rules apply depending on the location of the service provided. Moreover LCDs have not been targeted to the most costly, highly-utilized services in a consistent way and may lead to discrepancies in access to care based on the beneficiary’s location. The report includes a series of recommendations for reforms of the audit and local coverage decision processes, including consolidating post-payment review activities; revising the RAC incentive structure to focus on reduced improper payment rates; assessing the effectiveness of pre-payment review processes; improving provider education; and ensuring that LCDs are targeted and do not create inconsistent access to care. The report was issued in connection with a hearing on improving the Medicare audit program.
Congressional panels have held numerous hearings on health policy issues this month, including the following:
- The House Energy and Commerce Committee held a series of hearings on its “21st Century Cures” initiative, focusing on personalized medicine, barriers to evidence development and communication, technological innovations, the patient perspective, and modernizing clinical trials. A separate hearing focused on ACA’s insurance eligibility verification system. Coming up, the Committee will examine plan “bailouts” and cancellations under the ACA (July 28) and the status of ACA payment and verification systems (July 31).
- The Ways and Means Committee held hearings on the integrity of the ACA’s premium tax credit verification system and the future of Medicare Advantage health plans.
- The House Oversight Committee held a hearing on Medicare appeals reform.
- The House Science, Space, and Technology Committee examined “Policies to Spur Innovative Medical Breakthroughs from Laboratories to Patients.”
- A Senate Finance Committee hearing focused on chronic illness and patients’ unmet needs.
- The Senate Health, Education, Labor and Pensions Committee examined preventable deaths and improving patient safety. The Committee also approved a number of bipartisan bills, including S. 315, the "Paul D. Wellstone Muscular Dystrophy Community Assistance, Research and Education Amendments; S 2154, the Emergency Medical Services for Children Reauthorization Act; S. 2405, the Trauma Systems and Regionalization of Emergency Care Reauthorization Act; S. 2406, the Improving Trauma Care Act; and S. 2539, the Traumatic Brain Injury Reauthorization Act.
Senate Finance Committee Chairman Ron Wyden and Ranking Member Chuck Grassley are asking providers, patients, insurers, entrepreneurs, and other stakeholders for ideas on ways to improve the availability and utility of health care data, while protecting patient privacy. In particular, the Senators are requesting information on: the data sources that should be made more broadly available; the form such data should be conveyed; ways to reduce the unnecessary fragmentation of health care data; and reforms to overcome barriers that stand in the way of effective use of existing data sources. Comments will be accepted until August 12, 2014.
Recent Congressional hearings on health policy issues include the following:
- A House Energy and Commerce Health Subcommittee “21st Century Cures Roundtable” discussed steps Congress can take to bridge the gap between medical advances and the regulatory policies that govern them, and ultimately advance digital and personalized health care. The panel also released a related white paper on digital health care and is seeking feedback on this topic through July 22, 2014.
- The Energy and Commerce Oversight Subcommittee held a hearing on “Medicare Program Integrity: Screening Out Errors, Fraud, and Abuse.” The Committee also held hearings on health care access under the ACA.
- The Senate Special Committee on Aging held a hearing entitled “State of Play: Brain Injuries and Diseases of Aging.”
- The Ways and Means Health Subcommittee held a hearing on MedPAC's June Report to the Congress on Medicare delivery reforms.
- The House Oversight and Government Reform Committee held a hearing on health insurance company profits under the ACA.
The Senate has confirmed Sylvia Mathews Burwell to be Secretary of Health and Human Services on a bipartisan vote of 78 to 17. Secretary Burwell was sworn in on June 9, 2014.
On May 28, 2014 the House Energy and Commerce Subcommittee on Health approved by voice vote three bipartisan public health bills:
- H.R. 4299, “Improving Regulatory Transparency for New Medical Therapies Act,” which is intended to improve the Drug Enforcement Agency scheduling process for new FDA-approved drugs under the Controlled Substances Act and the registration process for the use of controlled substances in clinical trials to allow treatments to get to patients in a more timely and predictable manner.
- H.R. 4709, “Ensuring Patient Access and Effective Drug Enforcement Act,” which would amend the Controlled Substances Act to clarify definitions, allow parties to submit a corrective action plan prior to revocation or suspension of a registration, and require a report identifying how collaboration between agencies and stakeholders can benefit patient access to medications and prevent diversion and abuse of controlled substances.
- H.R. 4631, “Combating Autism Reauthorization Act of 2014,” which would continue autism-related federal research, early identification and intervention, education, and activities of the Interagency Autism Coordinating Committee.
A number of Congressional panels have focused on following health policy issues recently, including the following:
- The House Ways and Means Health Subcommittee examined various Medicare hospital issues, including the CMS two-midnights policy, short inpatient stays, outpatient observation stays, Recovery Audit Contractor audits, and the appeals backlog.
- The House Energy and Commerce Committee held a hearing on two bills that seek to equalize payments between different providers: (1) the Medicare Patient Access to Cancer Treatment Act of 2014, which would establish payment parity under the Medicare program for ambulatory cancer care services furnished in the hospital outpatient department and the physician office setting; and (2) the Bundling and Coordinating Post-Acute Care (BACPAC) Act of 2014, which would provide bundled payments for post-acute care services under Medicare Parts A and B.
- The House Oversight and Government Reform Committee held hearings entitled "Examining the Federal Response to Autism Spectrum Disorders" and "Medicare Mismanagement: Oversight of the Federal Government Effort to Recapture Misspent Funds."
- The Senate Special Committee on Aging focused on the role of health care providers in advance care planning.
- The Senate Commerce, Science and Transportation Committee examined the ACA minimum medical loss ratio (MLR) requirements, which requires health insurers to provide rebates to consumers if the plans do not spend sufficient proportion of premium dollars on medical care.
The House Energy and Commerce Committee has scheduled a May 21 hearing entitled “Keeping the Promise: Site of Service Medicare Payment Reforms,” which will focus on two bills that seek to equalize payments between different providers:
- The Medicare Patient Access to Cancer Treatment Act of 2014, which would establish payment parity under the Medicare program for ambulatory cancer care services furnished in the hospital outpatient department and the physician office setting.
- The Bundling and Coordinating Post-Acute Care (BACPAC) Act of 2014, which would provide bundled payments for post-acute care services under Medicare Parts A and B.
The Committee will examine whether such proposals can save money for beneficiaries and the Medicare program without compromising quality of care.
On May 20, the House Ways and Means Health Subcommittee is holding a hearing on current Medicare hospital issues, including the CMS two-midnights policy, short inpatient stays, outpatient observation stays, Recovery Audit Contractor audits, and the appeals backlog.
Congressional Committees to Consider HHS Secretary Nomination, HHS Budget, ACA Implementation, Cancer Research
The Senate Appropriations Committee has scheduled a May 7, 2014 hearing to review the Administration’s FY 2015 budget request for the Department of Health and Human Services (HHS). Also on May 7, the House Energy and Commerce Oversight Subcommittee will examine the status of health insurance enrollment under the ACA, and the Senate Aging Committee will focus on cancer research. On May 8, the Senate Health, Education, Labor and Pensions Committee has scheduled a hearing on the nomination of Sylvia Burwell to be HHS Secretary.
On Wednesday, April 30, 2014, the House Ways and Means Committee will focus on “Ideas to Improve Medicare Oversight to Reduce Waste, Fraud and Abuse." On May 1, the House Energy and Commerce Health Subcommittee is holding a hearing on “Telehealth to Digital Medicine: How 21st Century Technology Can Benefit Patients."
Recent Congressional hearings on health policy issues include the following:
- House Energy and Commerce Committee hearings on the “Helping Families in Mental Health Crisis Act”; the FDA’s proposed changes to generic drug labeling; and legislation intended to improve predictability and transparency in Drug Enforcement Agency and FDA regulation (H.R. 4299, H.R. 4069, and H.R. 4250).
- A House Ways and Means Health Subcommittee hearing on final Treasury Department regulations implementing the employer mandate and employer information reporting requirement provisions of the ACA..
In addition, on April 9, 2014, the Senate Health, Education, Labor and Pensions Committee is holding a hearing on “Addressing Primary Care Access and Workforce Challenges: Voices from the Field.”