April Congressional Hearings

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).
  • 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.”

Children's Hospital GME Reauthorization Act Signed

On April 7, 2014, President Obama signed into law S. 1557, the Children’s Hospital Graduate Medical Education Support Reauthorization Act, which provides funding to children’s hospitals for their pediatric medical residency programs.

President Signs Medicare Physician Fee Schedule/SGR Patch with Numerous Health Policy Provisions

This post was written by Debra McCurdy, Paul Pitts, Gail Daubert, Thomas Greeson, Susan Edwards, and Katie Hurley.

On April 1, 2014, President Obama signed into law H.R. 4302, the “Protecting Access to Medicare Act of 2014” (“the Act”). The Act includes a one-year Medicare physician fee schedule fix that averts a nearly 24 percent payment cut set for April 1, 2014, but which falls far short of earlier hopes for full repeal of the current sustainable growth rate (SGR) formula. The Act also includes numerous other Medicare payment and policy changes, including skilled nursing facility value-based purchasing provisions, reforms to the physician fee schedule relative valuation process, a new framework for clinical laboratory payments, a variety of changes impacting imaging services, changes in the exceptions for long term care hospitals, and extension of certain expiring provisions. In other areas, the bill includes a one-year delay in the transition to ICD-10, changes to the timetable for Medicaid disproportionate share hospital cuts, and “front-loading” of the 2024 Medicare sequestration reduction.

For more information, read our summary of major provisions of the Act.

As End of 3-Month SGR Patch Approaches, Hope Fading for Permanent Fix This Month

The clock is winding down for Congress to pass Medicare sustainable growth rate (SGR) formula reform legislation before the latest temporary spending patch expires at the end of the month and doctors again face steep cut in Medicare physician fee schedule (MPFS) payments.  While there had been high hopes for a permanent reform once key committee leaders reached agreement on a bipartisan, bicameral SGR reform bill, financing the roughly $180 billion package (including funding for various expiring Medicare provisions) has been the sticking point. When the House of Representatives approved its version of the bill on March 14 (H.R. 4015), it relied on savings attributed to repeal of the ACA individual insurance mandate to finance the bill – a proposal which drew a veto threat from the Administration and which will not be considered by the Senate. On the other hand, Senate Finance Committee Chairman Wyden has suggested offsetting the costs by capturing savings from “overseas contingency operations” funds (future war spending that is not expected to be expended) or not offsetting the costs – neither of which would pass the House.  Given this impasse, lawmakers are exploring another temporary fix, potentially through the end of 2014, with offsets for the smaller package likely to come from reductions in other Medicare spending. If Congress does not reach an agreement, MPFS payments will be subject to an approximate 24% cut on April 1, 2014 (although CMS announced in the final MPFS rule the conversion factor would be reduced by 20.1%, the Congressional Budget Office estimates that given other adjustments in the rule, the effective update to physician payments for 2014 will be a reduction of 23.7% if the rule goes into effect).

March Congressional Health Policy Hearings

Congressional panels continue to hold hearings to address various health policy issues, including the following:

Obama Administration Proposes FY 2015 Budget with Medicare, Medicaid Savings Provisions

On March 4, 2014, the Obama Administration released its proposed federal budget for fiscal year (FY) 2015. Virtually all types of health care providers, health plans, and drug manufacturers would be impacted by the budget provisions if adopted as proposed – an unlikely scenario given the Republican House leadership’s reaction to the document. Nevertheless, the Medicare and Medicaid savings proposals (many of which are carry-overs from prior budgets) could resurface as spending offsets in the pending negotiations on Medicare physician fee schedule reform legislation or in future budget negotiations. Highlights of the Administration’s Medicare and Medicaid legislative proposals include the following (all savings estimates are for the 10-year period of FYs 2015-2024):

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Congressional Health Policy Hearings

 A number of Congressional committees have held hearings recently to address various health policy issues, including the following:

Bipartisan/Bicameral SGR Reform Bill Released; Offsets Not Yet Identified

The bipartisan leadership of the House Energy and Commerce Committee, House Ways & Means Committee, and Senate Finance Committee have released a consensus Medicare physician fee schedule reform bill expected to be considered by Congress before the latest temporary payment patch expires at the end of March. Highlights of H.R. 4015, the SGR Repeal and Medicare Provider Payment Modernization Act, include the following:

  • The bill would repeal the statutory “Sustainable Growth Rate” (SGR) provision, which has called for deep cuts in Medicare rates in recent years. Congress has routinely stepped in to override the full application of the formula – most recently replacing a 20.1% cut scheduled to go into effect January 1, 2014 with a 0.5% update for the first three months of 2014 – but H.R. 4015 would offer a permanent fix.
  • For five years (2014-2018) the bill would provide annual Medicare physician fee schedule updates of 0.5% during a transition period to a new quality-based system (thus for 2014, the temporary 0.5% update in place through March would be extended for the full year). 
  • Three current physician quality programs would be consolidated into a single value-based program called the “Merit-Based Incentive Payment System,” which starting in 2018 would tie payment to performance in four categories: quality; resource use; electronic health record meaningful use; and clinical practice improvement activities. Quality measures will be developed and updated in consultation with physicians and other stakeholders.
  • The bill would provide bonus payments to providers who receive a significant portion of their revenue from an alternative payment model (APM) or patient centered medical home (PCMH); the threshold would begin at 25% in 2018 and increase over time. 
  •  The measure includes a number of other provisions designed to improve payment accuracy for individual provider services, promote appropriate use criteria for certain advanced diagnostic imaging services, expand care coordination for individuals with chronic care, and expand the use of Medicare data for transparency and quality improvement.

A formal budget estimate for the package has not yet been released, although earlier versions of the plans have had 10-year costs of more than $121 billion over 10 years. The Committees have not yet identified what “offsets” would be used to pay for the package, but cuts impacting a broad range of health care provider types, health plans, and drug manufacturers have all been unofficially floated as options.  

House Panel, GAO Examine Drug Shortages

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.

Congress Approves 1-Year Extension of Medicare Sequestration

On February 11, 2014, Congress approved a one-year extension of Medicare sequestration cuts as part of a bill (an amendment to S. 25) to restore certain military retiree pension benefits.  Under the legislation, current 2% across-the-board cuts to Medicare provider payments would be extended through 2024 (instead of 2023).  While the savings from the sequestration extension would primarily be used to finance the military pension benefits, $2.3 billion would be set aside to help finance pending Medicare physician fee schedule reform legislation (a fraction of the estimated cost of reform).  The measure now awaits the President’s signature.

There is obviously hope that Congress will reach an alternative budget solution in the intervening years before the sequestration extension would be imposed.  Nevertheless, this is the second time in two months that Congress has turned to an extension of Medicare sequestration as a funding mechanism -- a troubling new trend for Medicare providers. 

Omnibus Government Spending Signed to Fund HHS, Other Departments

President Obama has signed into law the Consolidated Appropriations Act of 2014, which provides $1.012 trillion in discretionary funding for the operations of the federal government through September 30, 2014. In addition to setting overall funding levels for HHS agencies, the law specifies funding for numerous HHS policies and initiatives, such as additional funding for program integrity effort involving the 340B drug pricing program and research on the impact of health information technology on patient safety, and reduced funding for the IPAB and certain other ACA activities. The agreement also includes directives for HHS to improve fraud and abuse efforts, including using the latest technology to ensure only valid beneficiaries and valid providers receive benefits (although on the other hand, the agreement raises concerns that the Recovery Audit Contractor program includes incentives “to take overly aggressive actions”). In addition, the agreement highlights more Congressional interest in more narrow HHS policies, such as objections to the criteria CMS uses to package drug costs under the hospital outpatient prospective payment system, and concerns that rural patients maintain access to needed health services if CMS proceeds with a proposal to remove critical access hospital status from certain facilities.

Congressional Health Policy Hearings

Recent Congressional hearings have addressed a number of health policy issues, including the following:

SGR Reform/IPAB Connection - Will Medicare Physician Fee Schedule Fix Trigger IPAB Provider Cuts?

The Congressional Budget Office (CBO) has raised the specter that pending legislation to reform the Medicare physician fee schedule statutory update formula could increase the likelihood that the Affordable Care Act’s (ACA) Independent Payment Advisory Board (IPAB) mechanism would be triggered – potentially resulting in as much as $0.6 billion in Medicare provider cuts during the 2015-2023 period. 

As previously reported, House and Senate panels are proceeding with plans to reform the unpopular “sustainable growth rate” (SGR) formula – the statutory provision that outlines how Medicare physician fee schedule rates are updated annually.  In recent years, the formula has called for deep cuts in Medicare rates – although Congress has routinely stepped in with temporary patches to avert the full application of the formula.  Most recently, the SGR contributed to a 20.1% cut in the Medicare physician fee schedule update for 2014 – but Congress approved the Bipartisan Budget Act of 2013 in December to replace that cut with a 0.5% increase for services provided only during the first three months of 2014.  The temporary patch is intended to give lawmakers time to finalize pending bipartisan proposals to permanently repeal the SGR policy and replace it with a period of stable payment followed by reimbursement linked to quality of care.

Congressional panels tasked with drafting the SGR legislation have not yet revealed how they intend to pay for the costs of their bills.  In the absence of such offsets, the CBO has estimated that the version of the legislation approved by the House Ways and Means Committee in December (H.R. 2810) would increase spending by about $121 billion over the 2014-2023 period, while the Senate Finance Committee package (S. 1871) would increase direct spending by $150.4 billion during that period.  According to the CBO, such spending increases would result in the IPAB mechanism being triggered.

By way of background, under the ACA, the IPAB is charged with submitting detailed proposals to Congress and the President to reduce Medicare per-capita spending if projected spending growth exceeds a specified target based on inflation and growth in the economy, beginning in 2015.  IPAB’s proposals will go into effect automatically unless Congress enacts alternative legislation to achieve the required savings (with certain exceptions).  The IPAB is barred from submitting proposals that reduce Medicare payments prior to 2020 for providers that had reimbursement cuts under the ACA beyond a productivity adjustment (such as acute care hospitals, long-term care hospitals, inpatient rehabilitation facilities, and outpatient hospital services, among others), thereby potentially increasing the impact of the IPAB cuts on physicians and Medicare Advantage and Part D plan sponsors.  Note that none of the 15 members of the IPAB have actually been nominated yet, so the panel currently exists in name only (but failure to appoint a panel would not forestall the cuts – if IPAB does not submit a plan, the responsibility falls to the HHS Secretary).  

Last May, the CBO had projected that Medicare per-beneficiary spending would be below the IPAB triggers for fiscal years 2015 through 2023.  In budget estimates released last week, however, the CBO estimates that under the House SGR reform bill, the IPAB mechanism would be required to produce a $0.5 billion reduction in Medicare spending over the 2015-2023 period.  The Senate Finance SGR package would require even higher IPAB savings -- $0.6 billion over the same period. 

Congressional negotiators finalizing the SGR package are expected to eventually identify their own spending offsets, which could impact spending on a potentially broader range of health care provider types, health plans, and drug manufacturers, but minimize the potential that the IPAB makes those decisions.  The question now – if SGR reform actually proceeds -- is whether it will be Congress or the IPAB panel that identifies the offsetting savings.  Either way, however, it appears that SGR reform could be a good news/bad news proposition, with long-overdue SGR reforms adopted, but at a currently-unknown price. 

House Panel to Examine Medicare "Extenders" Policy

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).

President Signs 2-Year Funding Bill with Medicare SGR Patch, Sequestration Extension for Medicare Providers

This post was written by Debbie McCurdy and Paul Pitts.

On December 26, 2013, President Obama signed into law H.J. Res. 59, the Bipartisan Budget Act of 2013, which includes the Pathway for SGR Reform Act of 2013 (“the Act”). In addition to establishing federal budget targets for fiscal years (FYs) 2014 and 2015, the Act includes a number of provisions impacting the Medicare and Medicaid programs. Most notably, the Act provides a short-term reprieve from a looming Medicare physician fee schedule cut while lawmakers work to finalize a longer-term solution. It also extends Medicare provider payment cuts under existing sequestration authority for two years and makes a variety of other policy changes. The Act’s major Medicare and Medicaid provisions are summarized below.

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Drug Distribution Security Legislation Signed into Law

This post was written by Kevin Madagan.

On November 27, 2013, President Obama signed into law H.R. 3204, the “Drug Quality and Security Act” (the “Act”), bipartisan drug distribution security legislation. Among other things, the sweeping measure: clarifies current federal law and regulatory oversight regarding pharmacy compounding; establishes a uniform, national drug tracking and tracing framework; mandates national licensure standards for wholesale distributors and third-party logistics providers; and preempts state product tracing requirements. The following is an overview of the Act and highlights of initial FDA implementation guidance.

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Senate Finance Committee Schedules SGR Markup

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.

Congressional Hearings Examine ACA Insurance Developments and Other Health Policies

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

HIV Organ Policy Equity, PREEMIE Reauthorization Acts Signed into Law

President Obama recently signed into law S. 330, the HIV Organ Policy Equity Act, which eliminates the restriction on acquiring HIV-positive organs in order to permit research on transplants involving HIV-positive individuals. In addition, the President has signed S. 252, the "Prematurity Research Expansion and Education for Mothers who deliver Infants Early Reauthorization Act" which reauthorizes and expands preterm labor and delivery programs.

House Approves "Keep Your Health Plan Act"

On November 15, 2013, the House of Representatives voted 261 to 157 to approve H.R. 3350, the “Keep Your Health Plan Act,” which would allow health plans available on the individual market as of January 1, 2013 to continue in 2014 without meeting new ACA plan standards. Continued enrollment in such a grandfathered policy would be considered to satisfy the ACA’s minimum essential coverage requirement, exempting the enrollee from the “shared responsibility” penalty under the ACA. . The Obama Administration has stated that the president would veto H.R. 3350 because it “rolls back the progress made by allowing insurers to continue to sell new plans that deploy practices such as not offering coverage for people with pre-existing conditions, charging women more than men, and continuing yearly caps on the amount of care that enrollees receive.” As previously reported, the Obama Administration has announced an alternative transition policy that would allow insurance issuers, subject to state insurance commissioners’ approval, to continue coverage that would otherwise be terminated or cancelled, and affected individuals and small businesses may choose to re-enroll in such coverage if the coverage was in effect on October 1, 2013 and the insurer meets certain conditions.

Older Entries

November 25, 2013 — Congressional Panels Continue Focus on ACA Insurance Enrollment, Security, and Cost Issues, and Other Health Policy Topics

November 14, 2013 — House Schedules Vote on "Keep Your Health Plan Act"

November 14, 2013 — CBO Offers Deficit Reduction Options

November 14, 2013 — Congressional Hearings Focus on HealthCare.gov Enrollment, Other Policy Issues

November 14, 2013 — Health Policy Bills Advance

November 5, 2013 — Key House and Senate Panels Invite Comments on SGR Reform Plan (Due Nov. 12)

October 30, 2013 — Congressional Hearings Focus on Rocky HealthCare.gov Rollout

October 30, 2013 — Continuing Resolution for FY 2014 Adopted; Budget Panel Could Take Up Medicare Issues

September 17, 2013 — House Approves Bill to Require Verification of ACA Individual Subsidy Eligibility

September 16, 2013 — Upcoming House Hearings on ACA Implementation (Sept. 18 & 19)

September 16, 2013 — Congressional Health Policy Hearings

August 12, 2013 — Ways and Means Committee Releases Draft Medicare Post-Acute Care Reform Legislation

August 6, 2013 — Bill Introduced to Narrow Stark Exception for In-Office Services

July 29, 2013 — House Approves Legislation to Amend ACA to Delay Insurance Mandates

July 29, 2013 — House Panel Approves Bipartisan SGR Reform Bill

July 29, 2013 — Ways and Means Committee Invites Public Comment on Medicare Cost Sharing Proposals

July 29, 2013 — July Health Policy Hearings

July 29, 2013 — HIV Organ Policy Equity Act Advances

July 3, 2013 — House Panel Invites Comments on Draft SGR Reform Legislation

June 27, 2013 — Congressional Committees Seek Input on Post-Acute Care Reforms

June 27, 2013 — Health Policy Hearings

June 11, 2013 — Health Policy Hearings

June 11, 2013 — House Approves ACA Repeal Legislation

June 5, 2013 — House Approves Drug Distribution Security Plan

June 5, 2013 — House SGR Reform Efforts Continue - Hearing Today

May 11, 2013 — Senate Finance Members Seek Physician Input on SGR Reform

May 10, 2013 — Congressional Health Policy Hearings & Markups

April 24, 2013 — Lawmakers Float Draft Drug Distribution Security Plan; Comment Opportunity

April 15, 2013 — April Congressional Health Policy Hearings & Markups

April 11, 2013 — Updated House SGR Reform Proposal

April 10, 2013 — Obama Administration's Proposed FY 2014 Budget Includes $401 Billion in Health Program Savings

March 28, 2013 — President Signs Government Funding Bill Maintaining FY 2013 Medicare Sequestration Cuts

March 28, 2013 — Congressional Health Policy Hearings

March 27, 2013 — Senate HELP Committee Approves Organ Transplant, Animal Drug User Fee Bills

March 13, 2013 — Congress Clears Pandemic and All-Hazards Preparedness Reauthorization Act

March 12, 2013 — Congressional Hearings

March 4, 2013 — Medicare and Sequestration - What Happens Now?

February 18, 2013 — House Panels Invite Comments on Medicare SGR/Physician Fee Schedule Reform

February 18, 2013 — House Approves GME, Pediatric Research, and EMT Bills

February 18, 2013 — February Congressional Health Policy Hearings & Markups

February 18, 2013 — Finance Committee Compilation of Public Recommendations to Address Health Care Fraud and Abuse

February 11, 2013 — House Panel Hearing to Focus on Physician Payment/SGR Reform (Feb. 14)

January 30, 2013 — House Passes Pandemic and All-Hazards Preparedness Reauthorization Act

January 30, 2013 — House Energy and Commerce Committee Approves GME, Pediatric Research, and EMT Bills

January 30, 2013 — Senate HELP Committee Hold Hearings on Mental Health, Primary Care

January 28, 2013 — Reed Smith Analysis of Changes to Medicare Secondary Payer (MSP) Law

January 11, 2013 — New Law Establishes IVIG Demonstration/Makes MSP Policy Revisions

January 4, 2013 — Fiscal Cliff Deal Includes Medicare Cuts and Other Health Policy Changes

December 17, 2012 — December Congressional Hearings and Markups

December 5, 2012 — House Panel Schedules Hearing on Implementation of ACA's Exchanges and Medicaid Expansion (Dec. 13)

November 29, 2012 — GAO Assesses CMS Fraud Prevention System Implementation

November 12, 2012 — November Congressional Health Policy Hearings

October 15, 2012 — Short-Term Government Funding, FDA User Fee & Safe Doses Bills Signed into Law

September 28, 2012 — Congress Clears Short-Term Government Funding Bill

September 27, 2012 — Generic Drug User Fee Fix Cleared by Congress

September 27, 2012 — Senate Approves Legislation to Combat Medical Product Theft

September 27, 2012 — House Approves "Taking Essential Steps for Testing (TEST) Act"

September 27, 2012 — House, Senate Committee Votes on Health Research Measures

September 27, 2012 — House Panel Approves Changes to Medicare Secondary Payer (MSP), Medical Loss Ratio Rules

September 27, 2012 — Congressional Health Policy Hearings

September 17, 2012 — Budget Sequestration ("Fiscal Cliff") to Cost Medicare Providers $11 Billion in FY 2013, White House Reports

September 11, 2012 — Aging Committee Hearing on Physician Payments Sunshine Act (Sept. 12)

September 5, 2012 — Congressional Hearings

August 29, 2012 — Jumping Off The 'Fiscal Cliff'? What Can Happen When Congress Returns?

July 31, 2012 — Congressional Health Policy Hearings

July 19, 2012 — House Votes to Repeal ACA

July 19, 2012 — July Congressional Hearings

July 19, 2012 — House Appropriations Panel Votes to Defund ACA, AHRQ

July 6, 2012 — Congressional Panels Schedule Hearings on ACA Issues (Tax Policy, Physician/Economic Impact)

June 28, 2012 — Supreme Court Upholds ACA Insurance Mandate, Limits Withholding of Medicaid Funds to States

June 28, 2012 — Congress Clears FDA Safety & Innovation Act

June 27, 2012 — House Approves Medical Product Counterfeiting Act

June 18, 2012 — House Panel Clears Legislation to Address Medical Product Theft, Counterfeiting

June 18, 2012 — June Congressional Health Policy Hearings

June 8, 2012 — House Approves ACA Device Tax Repeal Bill in Face of Veto Threat

May 31, 2012 — House, Senate Approve FDA User Fee/Drug Safety Bills

May 31, 2012 — House Panel Takes Up ACA Medical Device Tax Repeal, Other Health Tax Policy Bills

May 31, 2012 — Congressional Health Policy Hearings

May 25, 2012 — House Leaders Plan June Vote on ACA Medical Device Tax Repeal

May 14, 2012 — Finance Committee Members Seek Public Input on Medicare/Medicaid Fraud

May 14, 2012 — Congressional Health Policy Hearings

May 11, 2012 — House Approves Sequestration Replacement Plan with Health Provisions

May 11, 2012 — House Panel Unanimously Approves FDA User Fee Act

April 23, 2012 — Ways & Means Bill Would Recapture Additional ACA Subsidy Overpayments.

April 23, 2012 — April Congressional Health Policy Hearings and Markups

April 18, 2012 — New Hampshire Quietly Considers Prohibition Of Physician Relationships With Medical Device Companies

April 2, 2012 — House Approves GOP Budget with Medicare, Medicaid Provisions

April 2, 2012 — House Approves IPAB Repeal/Medical Liability Reform Legislation

March 29, 2012 — Congressional Health Policy Hearings

March 14, 2012 — 340B Enforcement Activities.

March 14, 2012 — Two House Panels Approve IPAB Repeal Legislation

March 14, 2012 — Emergency Preparedness Legislation Clears Senate

March 14, 2012 — Senate Approves Bill to Increase Counterfeit Drug Penalties

March 14, 2012 — Congressional Hearings on Drug Issues.

February 28, 2012 — President Obama Signs Payroll Tax Bill with Medicare/Medicaid Provisions

February 24, 2012 — Congressional Health Policy Hearings & Markups

February 13, 2012 — House Votes to Repeal ACA CLASS Program

February 10, 2012 — February Congressional Health Policy Hearings

January 25, 2012 — Second House Committee Votes to Repeal ACA CLASS Program

January 25, 2012 — E&C Health Subcommittee Plans FDA User Fee Hearings in February