State Medicaid payments for therapy are not matching the policy governing payment limits, according to a recent report from the Office of the Inspector General that found states are often not adhering to Medicaid limits on the amount of therapy patients can receive.

Senate Judiciary anti-trust subcommittee Chair Herb Kohl, who had questioned the proposed merger of two of the biggest pharmacy benefit managers, said he is confident that the Federal Trade Commission “thoroughly and carefully” reviewed the merger before allowing it to proceed, and he expects the agency to monitor the market post-merger.

A court intruded on FDA's authority to set its regulatory agenda by requiring FDA to finish a proceeding it started in the 1970s to withdraw animal antibiotics, says a former FDA lawyer.

A top FDA drug center official refuted the idea that the number of oncology drugs going through accelerated approval is on the decline, as industry and patient groups have recently asserted.

CMS backed off plans to require that long-term care consultant pharmacists be independent of nursing home pharmacies, pharmaceutical manufacturers and distributors after receiving a large amount of comments on the proposal, CMS Medicare chief Jonathan Blum said Monday (April 2), and the agency instead will study this industry segment further.

CMS continues to let criminals set up shell companies that defraud Medicare, according to Republicans from committees with Medicare jurisdiction.

Health insurance companies in many large counties are beginning to experience the health reform law's payment cuts to Medicare Advantage, according to an Avalere Health analysis of the final Call Letter CMS issued on Monday (April 2) that includes the growth rates used to determine 2013 benchmarks for MA plans.

Stakeholders will continue to push for civil monetary penalties for companies that fail to comply with an early notification system proposed by both houses of Congress to stem drug shortages, with groups also lobbying for a proposal allowing the Drug Enforcement Administration to increase quotas for controlled substances in shortage, a source said following the recent release of draft Senate drug shortage legislation that did not include these measures.

FDA's top device official on Thursday (March 29) signaled support for a measure to narrowly prohibit devices recalled for safety design flaws from being used as predicates -- similar to a measure being pushed by a Democratic lawmaker.

The pharmacist lobbies and individual companies that filed an antitrust suit in an attempt to stop the proposed merger between pharmaceutical benefit manager (PBM) giants Express Scripts, Inc and Medco Health Solutions will continue their litigation despite the FTC's 3-1 decision that the merger does not violate antitrust law.

Former U.S. Solicitor General Paul Clement alluded to alternatives to the individual mandate while simultaneously trying to kill that provision during health reform law Supreme Court arguments last week, but an insurance industry source said Clement's ideas are unworkable.

Supreme Court Justice Stephen Breyer suggested Wednesday (March 28) that the health reform-created biosimilars pathway could be severable from the broader healthcare reform law if the high court decides the individual mandate is unconstitutional.

Medicare beneficiaries could earn up to $600 for improving their health under the Medicare Better Health Rewards Program (S. 2243), introduced by Senators Ron Wyden (D-OR) and Rob Portman (R-OH) Wednesday (March 29) to praise from doctors and health insurance companies, which have been seeking CMS' permission to offer similar rewards for healthy behavior.

A bipartisan House bill proposes to permanently reauthorize two pediatric-drug statutes that include marketing incentives and clinical-study mandates, which the drug industry supports, while also giving FDA recourse for unfinished pediatric studies and requiring drug sponsors to submit their plans to the agency earlier, measures advocated by pediatricians.

FDA has not made final determinations about the safety of bisphenol A, the agency said as it denied a petition by the Natural Resources Defense Council on Friday (March 30) calling for a ban on the chemical's use in food contact materials.

The Medicare Payment Advisory Commission next week will likely vote on recommendations for redesigning Medicare benefits that will be included in the June report to Congress, according to a MedPAC release.

CMS is working on guidance about the initial review and approval process for a state's first exchange blueprint and hopes to release it soon, a CMS spokesperson tells Inside Health Policy.

A bipartisan Senate drug shortage working group said Thursday (March 29) that it has reached an agreement to address drug dearths with a proposal that includes a mandatory early-warning system, expedited reviews for affected products and detailed records of previous shortages with actions taken to prevent them.

High-profile Georgetown University law professor and staunch Affordable Care Act opponent Randy Barnett tells Inside Health Policy that U.S. Solicitor General Donald Verrilli should not be blamed for what was widely viewed as a failure during Tuesday's Supreme Court oral arguments to articulate the government's position on a limiting principle to Congress' power, saying that it should have been spelled out in the written briefs but was not.

The National Association for Home Care and Hospice (NAHC) is pushing for a telehealth homecare pilot program that advocates say could help reduce hospital readmissions while providing investment capital for home monitoring and communications technologies in a sector left out of electronic health record incentives.