Five influential stakeholders representing the entire pharmaceutical distribution chain have asked CMS to drop its proposal to overhaul the existing presumed inclusion policy for the calculation of average manufacturer payments (AMP) for Medicaid-covered drugs.

FDA removed language limiting use of animal antibiotics for disease prevention purposes before finalizing highly anticipated judicious use guidelines, which the agency released alongside policies that have been otherwise criticized by consumer advocates for outlining a voluntary as opposed to mandatory approach for restricting the use of antibiotics in animals, particularly for growth promotion.

It would take decades and millions of dollars to pursue mandatory market withdrawals of antibiotics used in animals, a top FDA official said as the agency outlined a new approach Wednesday (April 11) that relies on companies voluntarily changing product labeling to remove growth promotion indications and require veterinary consultation.

An upstate New York medical group with close ties to freshman GOP Rep. Nan Hayworth, a vocal opponent of the health law who was elected during the Tea Party wave of 2010, is one of the 27 organizations that CMS selected to participate this week in Medicare's accountable care organization program.

The National Community Pharmacists Association is again voicing its support for an industry-backed lot level drug tracking proposal, instead of the lot level plan advocated by FDA, and is also urging lawmakers to consider Medicaid reimbursement hikes among other options to stem drug shortages, crack down on online pharmacies and institute prescription drug labeling for blind consumers.

American Health Information Management Association is telling its members to continue pushing for the original ICD-10 implementation date despite CMS' proposal Monday (April 9) to set the new ICD-10 compliance date at Oct. 1, 2014, a one-year delay from the planned Oct. 1, 2013 deadline.

The Occupational Safety and Health Administration (OSHA) has launched a new enforcement program targeting workplace hazards in nursing and residential care facilities, and while health care worker safety advocates laud the program as a needed step to address issues such as ergonomics and workplace violence, they are concerned that the agency has not reached more broadly into the health care sector.

FDA's top drug officials view a newly unveiled clinical trial program for tuberculosis conducted by a public-private partnership as a possible model for development of other combination treatments and are urging drug companies to join in similarly structured coalitions to conduct pivotal trials.

Of the 27 ACOs that CMS announced on Tuesday (April 10), only two chose the model that penalizes accountable care organizations for not meeting cost and quality measures in exchange for bigger bonuses when they do achieve those benchmarks.

Insurers are seeking greater flexibility to offer plans that would have actuarial values close to the levels defined in the health reform law but do not exactly hit the percentages that are assigned to the four “metal tiers” of coverage.

FDA has put off for six months enforcing a health reform mandate that drug companies disclose drug samples they have provided to practitioners, following industry concerns about how the requirement will be implemented, including possible conflict with current sample accountability rules.

The White House is criticizing a new study by GOP Medicare and Social Security Public Trustee Charles Blahous that finds the health reform law will add at least $340 billion to the deficit over the next decade, saying the claims are false and that the study uses “another brand of 'new math'” to come to its conclusions.

FDA Deputy Commissioner for Foods Michael Taylor said the upcoming produce safety rule will focus on worker health and hygiene, agricultural water, soil amendments, animal intrusion, buildings and equipment, and the regulation will allow for alternative practices if they are backed by science.

FDA's plans to collect staffing and capacity information on the state and local level will lay the groundwork for using state agencies to meet inspection mandates in the Food Safety Modernization Act, a state food regulatory official said.

HHS unveiled the third in a series of proposed regulations implementing provisions in the health law aimed at simplifying transactions with private and governmental insurers and other third-party payers.

HHS in its recently issued final exchange rules affirms that the new consumer oriented and operated health insurance plans -- known as CO-OPS -- created under the law, will be able to participate in any health insurance exchange -- even one that chooses a “selective” purchasing plan -- once it has been approved by CMS.

Democratic governors had pitched to lawmakers a plan that would allow states to move beneficiaries dually eligible for Medicare and Medicaid into managed care and said the proposal would generate $164 billion in federal savings over 10 years, according to documents obtained by Inside Health Policy.

CMS revealed plans to set the new ICD-10 compliance date at Oct. 1, 2014, a one-year delay from the planned Oct. 1, 2013 deadline which physician groups had complained was not viable for many physicians.

Pharmacists, healthcare providers and medical groups are taking issue with a provision in a draft Senate drug shortage bill that would let drug makers in certain situations give FDA less time than the six-month notice required by the bill for production interruptions.

A special population limited medical use designation could ensure the restricted population necessary to allow orphan drug incentives for antibiotics, FDA drug center Director Janet Woodcock said recently in reference to a new designation floated by infectious disease experts who seek to include the plan in antibiotic incentive legislation to be considered alongside FDA user fees.