340B Program 

• Expanded Participation in 340B Program. Expands covered entities receiving discounted prices. Effective 1/1/10. (PPACA § 7101)
• Improvements to 340B Program Integrity. Requires HHS to provide for improvements in compliance in order to prevent overcharges and other violations of discounted pricing requirement. Includes provisions for the resolution of claims by covered entities that they have been overcharged, and claims by manufacturers. Effective 1/1/10. Appropriates necessary funds for each FY beginning in 2010. (PPACA § 7102)
• GAO Study. By 18 months after enactment, requires a GAO report to Congress on whether those individuals served by the covered entities under the program under section 340B are receiving optimal health care services. The report must include recommendations on whether the program should be expanded, whether mandatory sales of certain products could hinder patient access to those therapies and whether income from the program is being used by the covered entities under the program to further program objectives. (PPACA § 7103)

 Biosimilars

• Payment for Biosimilars under Medicare. Allows a Part B biosimilar product approved by the Food and Drug Administration and assigned a separate billing code to be reimbursed at the ASP of the biosimilar plus 6% of the ASP of the reference product. (PPACA § 3139)
• Approval Pathway for Biosimilars. Specifies requirements for licensure of generic (“biosimilar”) biological products. Provides for a period of exclusivity for the first generic biological product approved; also provides 12 years of exclusivity for the brand products. Authorizes a user fee program for generic biologic applications. Requires IOM studies of the number and importance of biological products for children. (PPACA § 7002)

 Generic Drug Labeling

 Indian Health Care Improvement

 Malpractice

•  “Sense of Senate” encouraging states to test alternatives to the current civil litigation system. Congress should consider establishing a State demonstration program to evaluate alternatives for medical malpractice claims. (PPACA § 6801)
• Demonstration Grants. Provides $50 million in funding over 5 years (starting in FY 2011) for state demonstration grants to encourage development of alternatives to litigation for resolving medical malpractice disputes. Requires models to emphasize patient safety, disclosure of health care errors, and the early resolution of disputes. Permits patients to opt-out of these alternatives at any time. Requires multiple evaluations of the effectiveness of the alternatives being tested, including: annual evaluations by state programs; annual assessments by HHS; an overall evaluation of the program, also conducted by HHS; and independent reviews by MedPAC and MACPAC. Requires these reports to evaluate impact of the demonstrations on quality of care, medical errors, medical resources used, time for dispute resolution and availability and price of liability insurance and to assess the overall effectiveness of the alternatives being tested. (PPACA § 10607)

 Miscellaneous Access Provisions

• Infrastructure to Expand Access. Provides $100 million in funding for FY 2010 to be used for construction or debt service on hospital construction or renovation costs for health facilities meeting certain criteria. (PPACA § 10502)
• Demonstration to Provide Access to Affordable Care. Establishes a 3-year demonstration project in up to 10 states to provide access to comprehensive health care services to the uninsured at reduced fees. (PPACA § 10504)
•  Extension of Malpractice Coverage to Free Clinics. Extends the protections from liability contained in the Federal Tort Claims Act to free clinics. (PPACA § 10608)

 Other

• Elder Justice
  • Elder Justice Coordinating Council. Creates an Elder Justice Coordinating Council to make recommendation to HHS for the coordination of activities of relevant federal, state, local and private agencies and entities relating to elder abuse, neglect and exploitation and other crimes against elders.
  • Advisory Board. Establishes an Advisory Board on Elder Abuse, Neglect and Exploitation to create short- and long-term strategic plans for the development of the field of elder justice, and to make recommendations to the Council. Establishes and provides funding for the establishment and operation of elder abuse, neglect and exploitation forensic centers.
  • LTC Enhancements. Provides for a number of enhancements to long-term care, including grants and incentives for staffing and training, certified EHR technology to improve patient safety and reduce adverse events and the adoption of electronic standards for the exchange of data.
  • Adult Protective Services. Provides for grants to enhance the provision of adult protective services on the state and local levels. (PPACA §§ 6701- 6703)
• Support for Pregnant and Parenting Teens and Women. Appropriates $25 million for each of the fiscal years 2010-2019 to award grants to states to assist and provide support to pregnant and parenting teens and young women. Funds could be used for programs such as those that help pregnant or parenting teens stay in or complete high school, for assistance to states in providing intervention services and for outreach so that pregnant and parenting teens and women are aware of services available to them. (PPACA §§ 10211-10214)