AHA submits behavioral health recommendations to Senate committee   09/30/2013
AHA today recommended actions to improve financial and other support for behavioral health care services within the context of the broader health care system. Responding to a Senate Finance Committee request for comments on the issue, AHA Executive Vice President Rick Pollack said, “Decades of discriminatory funding and the continued erosion of public financial support for behavioral care services compromises access to behavioral health care, thereby threatening advances in behavioral health care that hold the promise of improving the quality of treatment and reducing the stigma associated with behavioral health and substance use conditions.…The AHA supports a number of policy recommendations to help increase access to and improve the quality of behavioral health care, including: full implementation of the Mental Health Parity and Addiction Equity Act; adequate behavioral health reimbursement and insurance coverage from Medicare and Medicaid to help effectively meet the heath care needs of vulnerable patient populations; broadening the Medicare behavioral health benefit to encompass other components of the health care continuum; support from federal policymakers for innovative care delivery models, as well as quality measurement efforts, to advance behavioral health care; and creating safe harbors from anti-kickback laws for clinical integration programs to help incentivize and encourage providers to collaborate across settings of care.”
House passes compounding, track and trace bill for prescription drugs   09/30/2013
The U.S. House of Representatives Saturday approved by voice vote the Drug Quality and Security Act (H.R. 3204), a compromise measure put forth by House and Senate committees last week to improve the safety of compounded drugs and the security of the drug supply chain. The bill, which now goes to the Senate, would allow facilities that compound sterile drugs to elect to register as “outsourcing facilities” subject to federal oversight by the Food and Drug Administration and have their status publicized on the agency’s website. Registered outsourcing facilities would be required to comply with “current good manufacturing practices” and certain labeling requirements; report adverse events; undergo risk-based inspections by FDA; and pay establishment and reinspection fees. Hospitals and others that choose to remain traditional compounding pharmacies would continue to be primarily regulated by State Boards of Pharmacy as under current law. The bill also would require improvements in the communication between the states and FDA in the event of problems with compounded drug products produced by traditional compounding pharmacies. “Track and trace” provisions of the bill would create a system to track most prescription drugs from the manufacturer to the dispenser (such as hospitals and pharmacies) by establishing nationwide drug serial numbers within four years and electronic unit-level tracing within a decade. The bill also would strengthen licensure requirements for wholesale distributors and third-party logistics providers.
FTC approves proposal to study patent assertion entities   09/30/2013
The Federal Trade Commission Friday voted 4-0 to approve a proposal to begin a formal inquiry into the business practices of about 25 still unidentified companies that buy patents in the wireless communications sector and assert them against people already using the patented technologies, referred to as patent assertion entities or, more commonly, patent trolls. “Patents are key to innovation and competition, so it’s important for us to get a better understanding of how [Patent Assertion Entities] operate,” said FTC Chairwoman Edith Ramirez. “We want to use our 6(b) authority to expand the empirical picture on the costs and benefits of PAE activity. What we learn will support informed policy decisions.” The agency will accept public comments on the proposed information collection for 60 days following publication in the Federal Register. In July, a broad group of 50 organizations, including the AHA, urged congressional leaders to address abuses of the legal system by patent assertion entities.