2012-05-01

ASH Committee on Government Affairs Goes to Capitol Hill to Discuss Research Funding and Drug Shortages

Following its March 21 meeting in Washington, DC, the ASH Committee on Government Affairs visited more than 40 congressional offices to explain to Members of Congress and their staff the impact of potential cuts in funding to the National Institutes of Health (NIH) for research aimed at developing effective treatment strategies for patients with serious hematologic diseases. Committee members also discussed the topic of drug shortages with congressional offices. Last year, ASH helped bring the drug shortage crisis to Congress’s attention and called for congressional hearings to understand what was causing the problem. This year, the ASH Committee urged support for legislative initiatives (H.R. 2245, the Preserving Access to Life-Saving Medications Act, H.R. 3839, the Drug Shortage Prevention Act, and S. 296, the Preserving Access to Life-Saving Medications Act).

These meetings with Congress are an important component of ASH’s advocacy efforts, providing an opportunity for Members of Congress and their staff to gain insight into issues of concern to hematologists. However, the Society needs the help of all members to bring issues important to the future of hematology to the attention of the U.S. Congress and other governmental agencies. Society members are encouraged to let the ASH Government Relations & Practice Department know when you are in Washington, DC, and available to meet with your congressional delegation. You can also have your voice heard in the halls of Congress and play an important role in the Society’s advocacy efforts by visiting the ASH Advocacy Center and participating in the ASH Grassroots Network. For more information, visit www.hematology.org/takeaction.  

Health Reform Law Marks Second Anniversary: What the Health Law Has Done 

As this issue of The Hematologist was going to press, the U.S. Supreme Court was ready to hear three days of arguments on the constitutionality of the Patient Protection and Affordable Care Act (PPACA), signed into law two years ago. The Court’s ruling is expected in June or July. Meanwhile, the Obama Administration continues to implement provisions of the law.

While many of the most significant provisions of the 2010 health law don’t take effect until 2014, below is a list of the changes that have been implemented:

Expanding Coverage 

• Pre-Existing Condition Insurance Program provides health coverage from 2010 to 2014 for adults who have been uninsured for at least six months and who have a pre-existing medical condition.
• Insuring young adults provision requires private insurers to extend coverage of children until age 26, effective September 23, 2010, regardless of their tax status or whether they are students, unless he or she has another offer of employer-based coverage.
• Children with pre-existing conditions younger than 19 cannot be denied coverage. The provision applies to all job-related health plans as well as to individual health insurance policies issued on or after March 23, 2010.
• Owners of small businesses may qualify for tax credits up to 35 percent of their contribution to employees’ health insurance. The credits were made available beginning in tax year 2010.
• Early Retiree Reinsurance Program encourages employers and unions to continue coverage of early retirees and their families by providing temporary reimbursement for some of their insurance costs.
• Sales tax on indoor tanning services, effective July 1, 2010, to help fund coverage expansions.
• Many preventive benefits must be provided without cost-sharing to people with private health insurance if they are enrolled in plans issued after March 23, 2010.

Seniors Benefits 

• Rebates for prescription drugs, in the form of a one-time, tax-free payment of $250, were sent to Medicare Part D beneficiaries for drugs purchased in 2010 when they reached the coverage gap, or “doughnut hole.”
• Prescription drug discounts are to be provided to Medicare Part D beneficiaries beginning in 2011 on covered brand-name and generic drugs when they reach the coverage gap, or “doughnut hole.”
• Many preventive benefits must be provided without cost-sharing to Medicare beneficiaries, effective January 1, 2011.

• Proposed premium rate increases of 10 percent or higher for individual or small group plans must be justified to state or federal reviewers beginning in September 2011 for plans issued after March 23, 2010. Regulators in 37 states can reject a requested increase. If a state has no review authority, federal regulators can step in. However, federal officials can ask, but not require, an insurer to reduce a proposed hike.
• Insurers must spend at least 80 percent of beneficiaries’ premiums on medical care or health quality improvements. “Mini-med” plans that offer limited benefits have a oneyear exemption. Self-insured employers, who pay claims directly instead of through an insurance company, are not covered.
• Grants for consumer assistance to help states strengthen consumer assistance programs.
• Insurers can no longer impose lifetime dollar limits on essential health services for plans issued or renewed after September 23, 2010.

ASH Advocacy in Action 

ASH is active in representing the interests of its members to Congress and federal agencies. Below is a list of the latest advocacy efforts of the Society and an update on the progress of these initiatives. Complete details on all of these issues can be found on the ASH website.

Combating Drug Shortages – ASH has endorsed several bills (S. 296/ H.R. 2245, The Preserving Access to Life-Saving Medications Act, and H.R. 3839, the Drug Shortage Prevention Act)that would give the Food and Drug Administration (FDA) the authority and resources it needs to effectively prevent or mitigate future drug shortages. It is expected that drug shortage legislation would be bundled or incorporated into a larger bill known as the Prescription Drug User Fee Act (PDUFA) rather than being passed as individual bills. Initial drafts of the PDUFA legislation are being circulated currently with the expectation that the bill will come to the floor for debate in the summer.

Supporting FY 2013 Funding for NIH – ASH has called for at least $32 billion for NIH in FY 2013. Advocacy activities so far have included an online campaign by the ASH Grassroots Network; Capitol Hill Day of the ASH Government Affairs Committee; the development of personalized fact sheets indicating how much NIH funding has meant to a legislator’s state, district, and local institution; and obtaining congressional support for efforts in the House of Representatives and the Senate to notify the Appropriations Committees about the need to protect NIH funding.

Opposing the Grant Review and New Transparency (GRANT) Act – ASHopposed legislation that would require the publication of all grant proposals and publication of the names of all peer reviewers. The legislation has been derailed in the House of Representatives and taken off the calendar for consideration at this time.

Delaying ICD-10 Compliance Date – ASH shared with the Department of Health & Human Services its concerns about the administrative burdens created by the significant change to ICD-10 and advocated reexamination of the pace at which HHS implements this change to the health-care system. HHS has announced the initiation of a process to postpone the date by which certain health-care entities are required to comply with ICD-10.

Reducing the Scope of the Proposed Rule on Transparency Reports and Reporting of Physician Ownership or Investment Interests – ASH submitted comments to the Centers for Medicare and Medicaid Services (CMS) urging modifications to a proposed rule concerning the implementation of the Physician Payments Sunshine Act (“Sunshine Act”). The Sunshine Act was incorporated into the Patient Protection and Affordable Care Act of 2010 and mandates disclosure of physicians’ financial relationships with drug and device manufacturers. Though ASH supports the proposed rule’s goal of discouraging inappropriate influence on clinical decision-making by increasing transparency, the Society’s recommendations focus on reducing the scope of the rule and reducing regulatory burdens on physicians. Specific recommendations included the following: stating that attending an industry-supported educational session is not reportable as long as the program meets CME-certification requirements, stating that reprints of peer-reviewed articles intended for physician education meet the educational materials reporting exemption; and delaying reporting until a final rule has been issued.

Supporting National Priorities for Patient Outcomes Research – Health reform included the creation of the Patient-Centered Outcomes Research Institute (PCORI), an independent organization focused on comparative effectiveness research. The goal of PCORI is to commission research that is guided by patients, caregivers, and the broader health-care community and that is designed so as to produce high-quality, evidence-based information. ASH submitted comments on PCORI’s proposed National Priorities for Research and its initial research agenda. ASH’s comments offered considerations for how to include research on hematologic diseases and related conditions.

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