Federal Policy Priorities
Approach: Continue to strengthen Congressional delegation relationships; Serve as a consistent and reliable resource for elected officials, staff and advocacy partners
- Engage/partner with national life science organizations & patient groups (BIO, PhRMA, AdvaMed, MDMA)
- Actively participate in “fly-ins” and other grassroots and grasstops advocacy initiatives
- Continue co-chair role with We Work for Health national initiative
- Facilitate membership roundtable discussions with elected officials and staff
- Host Congressional briefings with elected officials and staff
- Support Pennsylvania Congressional delegation in contested races, where appropriate
Federal Policy Issues
- Protect Medicare Parts B and D
Ensure appropriate reimbursement of Part B drugs
Medicare Part B-covered drugs are a limited subset that generally must be injected or infused by a health care professional. Today, physicians providing Part B-covered drugs are reimbursed under a formula established by the Medicare Modernization Act of 2003: Average Sales Price (ASP) plus 6 percent. The 6 percent on top of the ASP recognizes that physicians incur costs for shipping, handling and storage, in addition to the drug preparation and clinical monitoring involved with administering these drugs, as well as variations in acquisition cost by physicians due to their purchasing agreements. Physicians are already dealing with a 2% cut from sequestration, essentially reducing Part B drug reimbursement to ASP+4%. This has a severe impact on the nearly 2.1 million Medicare Part B beneficiaries here in Pennsylvania and on the physicians, primarily those in small towns and rural areas without negotiating leverage, who may not receive sufficient payment from Medicare to meet the costs of the drugs they administer to their patients. Pennsylvania Bio supports appropriate reimbursement of Medicare Part B drugs.Protect Non-interference clause in Medicare Part D
When Medicare Part D was enacted, it included a provision known as the non-interference clause, which prohibits the Secretary of Health and Human Services from interfering in the private price negotiations between Medicare Part D plans and drug manufacturers and pharmacies in the program. Despite numerous claims that repealing the non-interference provision will save money, the nonpartisan Congressional Budget Office (CBO) continues to say (1) private Part D plans can effectively negotiate savings on Medicare drug costs and (2) striking Part D’s non-interference clause is unlikely to achieve any significant savings unless the government also restricts beneficiary access to prescription drugs or fixes prices.
Striking the “Non-Interference” Clause under Part D would undermine the success of the Part D prescription drug benefit, leading to reduced access to drugs and biologicals, decreased competition, and increased premiums. Additionally, inserting price controls into the Part D benefit in particular would threaten the overwhelming satisfaction and robust choice that beneficiaries enjoy today. Any government intervention in the prices paid for prescription drugs under the successful Medicare Part D benefit could distort the competitive dynamic of the program and result in a range of unintended consequences, including a significant increase in beneficiary premiums, a negative impact on innovation, and cost-shifting to other consumers.
Prevent Medicaid-style rebates in Medicare Part D
Private insurance plans in Medicare Part D operate under strong incentives to achieve savings. Part D plans negotiate discounts and rebates with prescription drug manufacturers, helping hold program costs far below projections, while achieving very high marks from seniors. Imposing government price controls in the form of mandatory rebates similar to those required by Medicaid threatens to destabilize this successful program, raise beneficiary premiums, reduce investment in research and development needed to discover new treatments, and cost hundreds of thousands of jobs. Life Sciences PA opposes mandatory Medicaid-style rebates in Medicare Part D.
Prevent Low Income Subsidy (LIS) Brand-Drug Copayment Hike
Increasing brand copays disproportionately impacts patients with certain illnesses. Patients who rely on drugs in classes with fewer generics or for whom changes in drug regimens are likely to be disruptive could be disproportionately affected by higher brand copays. Increasing cost-sharing would penalize patients found to need brand medicines rather than generics. Patients who need multiple brand drugs would be hardest hit. Life Sciences PA opposes any efforts to increase LIS Brand-Drug Copayments.
- Repeal/Restructure Medical Device Tax
As part of health-care reform, Congress passed a 2.3 percent excise tax on most types of medical devices. Medical device companies began to pay that tax in January 2013. The excise tax is based on revenue, not profit, and will ultimately harm small-to-midsize innovative medical device companies the most. This is a devastating blow to one of the few U.S. industries that has a net trade surplus and is responsible for millions of jobs.The excise tax will adversely impact innovation and R&D investment for all medical technology companies and will disproportionately impact small-to-midsize companies, which drive innovation, scientific discovery and job growth. Life Sciences PA supports all efforts to repeal the medical device tax.
- Protect 12-year data exclusivity period for biologics
Biotech companies must be provided with at least 12 years of non-patent data exclusivity to allow for recovery of their original R&D investments and to ensure licensing payments to research institutions. In order to assure these companies continue to make investments in medical progress and take the risks necessary to bring these important products to consumers, innovators should be provided with appropriate incentives, including data exclusivity and protections for their patents. Life Sciences PA opposes any efforts that seek to make changes to the 12 years data exclusivity in current statute.
- Repeal IPAB
As part of the Affordable Care Act (ACA), Congress established the Independent Payment Advisory Board (IPAB), charged with developing proposals aimed at making significant cuts to Medicare providers. The cuts IPAB is scheduled to make come on top of almost $500 billion in cuts already made to Medicare with the ACA’s passage. Cuts by IPAB will only further strain an already fragile health-care system and put additional pressures on providers, could have a devastating impact to job growth and job sustainability in Pennsylvania, and limit access for Medicare beneficiaries. Life Sciences PA supports the full repeal of IPAB.
- Protect Orphan Drug Tax Credit
Congress enacted the Orphan Drug Act of 1983 to help patients affected by rare diseases and disorders, who had no treatment options, by providing a tax incentive to encourage biotechnology and pharmaceutical companies to develop treatments for such rare diseases and conditions. By reducing the costs of developing drugs for smaller patient populations, the Orphan Drug Tax Credit has allowed companies to develop hundreds of new therapies that would otherwise not have been commercially feasible – helping millions of patients suffering from rare conditions get the new medicines they desperately need, while fostering economic growth through new and expanding biotech companies with good jobs and high wages. Life Sciences PA strongly supports the Orphan Drug Tax Credit in its current form and opposes efforts to undermine it.
- Increased NIH Funding
The National Institute of Health (NIH) is the nation’s premier biomedical research agency. The work it conducts and supports provides a critical foundation for further biomedical investment and innovation in both the public and private sectors. Over many years Congress wisely has supported the NIH and increased funding for its essential mission. In return, American life expectancy has increased by more than six years, and NIH-funded discoveries have contributed to new and more effective vaccines, diagnostics, and treatments for many common and rare diseases that afflict so many Americans. Life Sciences PA urges Congress to continue its investment in the nation’s biomedical research enterprise by supporting growth in NIH funding. The experiences of the past decade have demonstrated the problems caused by cyclical periods of rapid funding growth followed by periods of stagnation. Since the doubling of the NIH funding between 1998 and 2003, funding has failed to keep pace with biomedical research inflation. When NIH funding is measured against the rising cost of conducting medical research (known as the biomedical research and development price index or BRDPI), NIH funding has decreased by 22% between 2003 and 2013 and, as a result, the success rate of meritorious research proposals has fallen to one in six, down from one in three in 2003. Consistent sustainable growth in NIH funding is critical to knowledge development that contributes to advancing better health for all Americans. Funding for the NIH has real economic benefits to the United States. Every 1 research grant awarded results in 7 new jobs and, for every $1 million that NIH invests, $2 million in new state business activity is generated.
Specifically, Life Sciences PA requests that the NIH is provided with at least $32 billion for Fiscal Year (FY) 2016.