House Energy and Commerce health subcommittee Chair Joe Pitts (R-PA) said he wants to cut spending from the health overhaul law to pay for delaying for two to three years a 27.4 percent cut to Medicare physician payment, which would do away with the need for hospital-pay cuts that were included in the House-passed Sustainable Growth Rate formula two-year patch.

The Biotechnology Industry Organization's top official said the group is poised to defend the biosimilars component of the Affordable Care Act in the event the Supreme Court or Congress strikes down the entire law, billing it as a potential fight in 2013 to ensure the new pathway's provisions remain intact, and the Generic Pharmaceutical Association warned preventing development of the pathway could bankrupt the healthcare system.

House Democratic lawmakers say a new call by Congress' investigative arm for CMS to improve its risk-adjustment methodology to better reflect the health of Medicare Advantage enrollees shows there is “more to be done” to rein in MA payments, and an analyst says the timing of the study suggests MA cuts could be included in the president’s budget and also reaffirms speculations that the 2013 proposed MA rates -- slated to come out Feb. 17 -- could be negative for industry.

The House Energy and Commerce Committee will focus on early notification mechanisms and Drug Enforcement Administration quotas as it pursues legislation to stem drug shortages, with a congressional source saying debate on reimbursement changes is ongoing but the committee will wait until a February hearing on generic drug user fees -- where the issue will be discussed -- before determining if payment reforms are needed to address the problem.

Drug firms will likely reconsider internal policies surrounding public presentations in light of recent FDA guidance on unsolicited requests for off-label information that sources say limits companies' ability to respond to questions publicly, such as during presentations to doctors or in online posts.

President Barack Obama's newly released plan to make global supply chains more efficient and safe falls in line with FDA efforts in food and drug security, such as increasing collaborations with foreign regulators, and could bolster efforts to push legislative reforms during drug user fee reauthorization, stakeholders said.

A home health industry group estimates that Medicare saved $853 million in 2010 thanks to a cap on outlier home health payments, and home health lobbyist Billy Tauzin says those savings are proof that a proposal he is lobbying for, which uses similar approaches, would also save money.

House Energy and Commerce health subcommittee Chair Joe Pitts (R-PA) is pushing for a two- or three-year Medicare physician payment fix paid for through Medicare cuts, and opposes the idea of using war savings as an offset although other Republicans appear to be warming to the idea.

A letter to the president, spearheaded by the heads of several consumer and patient advocate groups, calling for the administration to adhere to the health reform law's intent when issuing a final rule on the summary of benefits and coverage requirements came less than one week after several administration officials and consumer advocates met on the rule, according to White House Office of Management and Budget meeting records.

The Department of Justice Wednesday (Jan. 25) filed a ground-breaking consent decree against Ranbaxy Laboratories, the India-based generic drug maker that last year gained approval to market generic Lipitor.

Republicans plan to respond to the upcoming Supreme Court decision on the constitutionality of various provisions of the health reform law by unveiling a replacement package that includes several GOP proposals such as medical malpractice reform and allowing the sale of insurance across state lines, Rep. Joe Pitts (R-PA) said Wednesday (Jan. 25).

A coalition of mobile health companies is pressing FDA to revamp its draft guidance on mobile medical applications to better define topics like accessories, wellness claims and electronic health records, and says the overhauled guidance should then go through a second comment period.

This year's appropriations process could be more difficult for FDA than it has been in recent years because of a more constrained budget environment, the unlikelihood that major initiatives -- like the food safety law -- will continue to enjoy funding hikes, new funding needs that could surface through the reauthorization of user fees and a looming budget sequestration put in motion by the super committee's failure to hammer out a deficit plan, although the agency continues to have strong funding advocates, sources said.

The medical device industry and FDA are in the final stages of an agreement on medical device user fees, closing in on a package that includes around $600 million in fees over five years and abandons recent proposals to hike fees in the middle of the program, several sources said.

CMS originally awarded a contract in September for the building of a federal data services hub that is an integral IT piece for the federally facilitated exchange, yet the contract was protested and the agency spent the next several months in further negotiations and discussions with the project's chosen contractor -- Quality Software Services Inc. -- and only re-awarded the contract on Jan. 18, Inside Health Policy has learned.

Sen. Mike Crapo (R-ID) told Inside Health Policy he is open to, though not necessarily supportive of, counting future reductions in war funding to pay for fixing the Sustainable Growth Rate formula that determines Medicare physician pay, and he said other GOP members may also be warming to the idea.

The Medicines Company has resolved all litigation surrounding certain patents for its anti-coagulant Angiomax, the company said as it announced a patent settlement that included a licensing agreement with APP Pharmaceuticals.

Tort reform and war savings should pay for a replacement of the Sustainable Growth Rate formula, not hospital payment cuts as proposed by House Republicans, according to the Federation of American Hospitals.

HHS' intention to offer insurers some flexibility to adjust benefits with respect to essential health benefits is something consumer advocates have flagged as problematic and intend to address in comments on the EHB bulletin, according to a consumer advocate.

Many dietary supplement manufacturers are not complying with current Good Manufacturing Practices by violating quality control standards, supplier verification requirements and record keeping standards, FDA officials said as they vow to step up GMP enforcement and industry groups push companies to come into compliance.