The American Hospital Association said that it was getting the runaround from CMS about concerns it has with a productivity adjustment to ambulatory surgical center payments called for in the health reform law and that the dearth of information in a proposed rule makes it hard to comment intelligently about the proposal.

Community and chain drug store pharmacists are praising CMS' recent proposal to withdrawal regulations affecting reimbursement to pharmacies for generic Medicaid prescriptions, including the definition of average manufacturer prices (AMPs) for use in calculating federal upper limit (FUL) reimbursements and the definition of a “multiple source drug.”

Key stakeholders are questioning why HHS' planning shop has moved to build an inventory of comparative effective research (CER) prior to the establishment of independent CER that was created under the health reform law.

CMS informed states that the National Correct Coding Initiative is the only system it will allow Medicaid programs to use to curb inappropriate payments to providers, according to an agency letter sent to state Medicaid directors Wednesday (Sept. 1).

Democratic lawmakers in Minnesota are discussing whether to sue Gov. Tim Pawlenty (R) for standing by his pledge not to apply for federal health reform funds despite a state law calling for him to apply for a $1 million federal insurance exchange grant, state lawmakers told Inside Health Reform.

A pilot program to jointly inspect drug manufacturing facilities recently launched by FDA and its European Union counterpart could set the groundwork for further opening U.S. borders to drugs manufactured or stored abroad by harmonizing safety standards, sources said.

HHS Secretary Kathleen Sebelius and members of a Minnesota health reform task force lashed out at GOP Gov. Tim Pawlenty on Tuesday, after hearing that the 2012 presidential hopeful had issued an executive order blocking state agencies from applying for federal funding to help implement the health reform law.

Mandating comparative effectiveness studies in premarket drug reviews could reduce the number of new pharmaceutical applications for products that are exhausting limited FDA review resources without providing substantive improvement over what has already been marketed, according to a prominent researcher with a history of provoking the drug industry on both safety and efficacy issues.

Almost 2,000 employers have been accepted into the Early Retiree Reinsurance Program, including large and small businesses, state and municipal governments, colleges, non-profits and unions, according to an e-mail blast to congressional staff sent early Tuesday by the HHS assistant secretary for legislation.

Denied access to the stimulus law's health IT bonus payments for each campus of their hospital systems, some hospitals are applying for additional CMS Certification Numbers (CCNs) to create separate hospitals so they can receive more than one incentive payment for installing electronic health records, an industry source says.

The focus of FDA's internal drug safety advisory panel has changed since its inception five years ago and is open to considering comparative safety, but not effectiveness, as part of its deliberations, agency officials said.

As HHS steps up its efforts to ferret out fraud with the passage of health reform, health care providers may need to worry more about Zone Program Integrity Contractors than Recovery Audit Contractors, sources say, even though RACs have received most of the attention for being “bounty hunters” paid on a contingency basis to identify improper payments made by Medicare.

CMS is soliciting hospitals in 20 states to participate in an extension of the rural community hospital demonstration program, which was included in the health reform law.

Sen. Charles Grassley (R-IA) on Thursday assailed CMS Administrator Don Berwick's response to his request for information on donations to Berwick's Institute for Healthcare Improvement.

An ongoing dispute between Watson Pharmaceuticals and the Federal Trade Commission on the extent of the agency's efforts to oppose drug patent settlements was partially resolved this week when a U.S. District Court judge found that the drug maker could not prove that the government disclosed confidential information or pressured the product developer to waive its exclusivity, ordering the firm's CEO to testify before an agency investigative panel.

An independent, five-member board would oversee a health insurance exchange with the power to be a selective purchaser of insurance plans under legislation that passed the California legislature Wednesday.

The Senate's HHS appropriations bill includes an unrequested $40 million to expand medical home demonstration programs called for in the health overhaul law and gives the agency just 90 days to get those demonstrations underway.

FDA is indicating that it might begin enforcing healthcare reform's food menu labeling provisions soon after the November elections, clarifying in proposed guidelines the types of establishment and products governed by the new law and that the agency will determine its enforcement timetable after the promulgation of a final policy -- which could occur as early as December.

A new report by AARP's Public Policy Institute, which concluded that prices for Medicare's most commonly used brand-named drugs dramatically increased in 2009, has prompted debate among several players in the health care sector.

HHS Secretary Kathleen Sebelius defended the cable TV advertisement featuring Andy Griffith that HHS is running prior to Medicare open enrollment, but Sen. Tom Coburn (R-OK), who tried to get HHS to yank the ad, isn't happy with the administration's response and sent another letter to the department with more demands.