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.”
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.
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.
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.”
Congressional panels continue to hold hearings to address various health policy issues, including the following:
- The House Energy and Commerce Committee held a hearing on “Allowing Seniors to Keep Their Medicare Advantage Plans If They Like Them." In addition, on March 26, the panel is holding a hearing entitled “Where Have All the Patients Gone? Examining the Psychiatric Bed Shortage,” and on April 1, the Committee will focus on the Food and Drug Administration’s (FDA) proposed changes to generic drug labeling.
- The Obama Administration’s proposed FY 2015 budget for HHS was the subject of hearings by the House Appropriations Committee and the House Ways and Means Committee.
- The Senate Health, Education, Labor and Pensions Committee held hearings on FDA initiatives and priorities, and what the U.S. health care system can learn from other countries.
- On March 26, the Senate Special Committee on Aging is holding a hearing on “Preventing Medicare Fraud: How Can We Best Protect Seniors and Taxpayers?”
A number of Congressional committees have held hearings recently to address various health policy issues, including the following:
- The House Energy and Commerce Committee conducted hearings on Medicare Part D drug policy, the role CMS contractors play in management of the Medicare program, and the public health threat of counterfeit drugs;
- The House Education and the Workforce Committee held a hearing on "Providing Access to Affordable, Flexible Health Plans through Self-Insurance";
- A House Oversight and Government Reform Committee hearing examined the rights of FDA whistleblowers; and
- A Senate Health, Education, Labor and Pensions Committee hearing focused on mental health treatment options and trends.
On February 10, the House Energy and Commerce Subcommittee on Health held a hearing entitled “Examining Drug Shortages and Recent Efforts to Address Them.” In connection with the hearing, the Government Accountability Office (GAO) released a report that concluded that the number of shortages remains high, even though the FDA has taken steps to prevent and mitigate shortages (e.g., expediting application reviews and inspections, exercising enforcement discretion in appropriate cases, and helping manufacturers respond to quality problems). Some of the causes of shortages are beyond the agency’s authority, however, since the FDA “does not have control over private companies’ business decisions,” and cannot, for example, require manufacturers to start producing or continue producing drugs, or to build redundant manufacturing capacity. Nevertheless, the GAO called on the FDA to strengthen its internal controls over its drug shortage data, conduct periodic analyses to routinely and systematically assess drug shortage information, and use this information to proactively identify drug shortage risk factors.
Recent Congressional hearings have addressed a number of health policy issues, including the following:
- House Science, Space, and Technology Committee hearing entitled “Healthcare.gov: Consequences of Stolen Identity”;
- A House Energy and Commerce Oversight Subcommittee hearing on implementation of the ACA, including a discussion of insurance exchange issues;
- Two House Oversight and Government Reform Committee hearings on HealthCare.gov information security issues;
- A Senate Aging Committee hearing on “Medicare Advantage: Changing Networks and Effects on Consumers”; and
- A House Ways and Means Committee hearing on the impact of the ACA’s employer insurance mandate’s definition of full-time employee on jobs.
On January 9, 2014, the House Energy and Commerce Health Subcommittee is holding a hearing on “The Extenders Policies: What Are They and How Should They Continue Under a Permanent SGR (Sustainable Growth Rate) Repeal Landscape?” The so-called extenders are measures that secure the continuation of various temporary Medicare payment and policy revisions impacting hospitals, physicians, therapy providers, and certain other provider types that are routinely extended by Congress (most recently as part of the Pathway for SGR Reform Act).
On December 12, 2013, the Senate Finance Committee is scheduled to take up legislation to repeal the Medicare PFS sustainable growth rate formula and extend certain expiring health care provisions. While the current Congressional calendar leaves little time to address the latest round of SGR cuts before they take effect on January 1, 2014 (as discussed above), Congress may provide a short-term patch to provide additional time to consider more sweeping overhaul legislation. This situation is still very fluid, however, and the timing and scope of ultimate legislative action is still uncertain.
Recent Congressional hearings on health policy issues have included the following, among others:
- A House Small Business Committee hearing focused on the ACA’s Small Business Health Options Program.
- A House Ways and Means Health Subcommittee hearing reviewed “the Challenges of the Affordable Care Act,” focusing on “immediate and long-term challenges Americans face in finding affordable, quality health coverage as a result of the ACA.”
- A December 11 House Energy and Commerce Health Subcommittee hearing is entitled “PPACA (Patient Protection and Affordable Care Act) Implementation Failures: What's Next?”
- A House Oversight and Government Reform Committee hearing was entitled “Roll Out of HealthCare.gov: The Limitations of Big Government,” while a December 12 hearing will focus on “ObamaCare’s Impact on Premiums and Provider Networks.”
- Earlier this month, a House Energy and Commerce Committee hearing reviewed the impact of the ACA on the Medicare Advantage program.