Last 7 Days of Daily Updates
Wednesday, March 10, 2010
More Than 160 Lawmakers Sign Letter Calling For HIT 'Meaningful Use' Changes
House lawmakers from both parties plan to send a letter to CMS Friday complaining that hospitals will have a hard time meeting the agency's proposed definition of "meaningful use" for electronic health records.
House Budget Committee Rules Add To Health Reform Delay
The House Budget Committee could take up to four days to get health reform language to the Rules Committee, Budget Chair John Spratt (D-SC) said Wednesday morning, because of a set of rules that “necessarily protract the process by several days.”
CMS Plans To Extend DME Bid Review Times Due To Expanded Program In 2nd Round
CMS will extend review times for competitively bid durable medical equipment to deal with an expansion of the program in the second round of bids, Washington insiders learned during a private meeting with agency officials on Tuesday (March 6).
Congressional Dems, White House Put Final Touches On Reform Bill
House and Senate leaders met with White House officials Tuesday to discuss their progress on a health reform reconciliation package in preparation for sending a bill to the Congressional Budget Office for scoring.
High Court Agrees To Hear Case On Preemption In Vaccine Lawsuits
The U.S. Supreme Court has agreed to hear a case on vaccine preemption -- an issue on which the federal government is aligned with drug makers in favor of preemption.
Tuesday, March 09, 2010
Groups Urge Pelosi To Leave PT Employees Out Of Coverage Provision
Seventeen employer groups are urging House Speaker Nancy Pelosi (D-CA) not to include part-time workers in the health reform legislation's coverage requirements.
Harkin Acknowledges Permanent SGR Repeal Could Be A Few Years Away
A permanent 'doc fix' is unlikely this year and may have to wait a “couple, three years” for the federal budget to get in order, Senate health committee Chair Tom Harkin (D-IA) said Tuesday morning.
OMB, Stakeholders Eye Ways To Expedite OSHA Rulemaking
The White House regulatory affairs shop has begun discussions with OSHA on ways to expedite workplace health and safety rulemaking, an Office of Information and Regulatory Affairs official recently confirmed.
FDA's Internal Review Of Device Clearance Process Focuses On De Novo, Postmarket Data, New Technology
An internal FDA workgroup charged with reviewing the 510(k) clearance process has identified 10 areas that could require administrative, regulatory or legislative changes: the De Novo process, incorporation of new technology, postmarket data collection, third-party review, indication definitions, evidence, standards, product bundling, device modifications and the use of predicates.
House Still Working Out Issues With IPAB, Geographic Disparities
House members may be willing to accept the Senate's call for an independent body that could recommend Medicare cuts, a top Democrat said, but have yet to agree on standards that would satisfy both urban and rural stakeholders.
Monday, March 08, 2010
Public Citizen Asks FDA To Pull 3 Drugs, Change Drug Center Leadership
In the midst of renewed congressional scrutiny on drug safety, the consumer advocacy group Public Citizen is urging FDA to fire its top drug official and pull three drugs from the market.
AMA Tells Senate Leaders It Opposes Any Temporary Pay Patch
The American Medical Association has stepped up its lobby against a short-term Medicare physician payment fix, hoping to convince lawmakers to scrap plans to enact a second temporary payment patch and instead institute a permanent fix as proposed earlier by the House.
Deal In Works To Gut McCain's Supplements Bill For Food Safety Approach
Sen. John McCain (R-AZ) has reached a deal with a bipartisan group of lawmakers, including health committee Chair Tom Harkin (D-AI), under which he would scrap his bill hiking FDA's authority over dietary supplements if select provisions are added to pending food safety legislation, sources say.
Scored Reconciliation Bill Expected This Week
House and Senate leaders are ironing out a reconciliation bill that incorporates President Obama's health reform proposals, sources say, and are expected to unveil a lean, scored bill perhaps as early as Tuesday or Wednesday.
Friday, March 05, 2010
White House: 340B Extension In Reform Plan Hews To Senate Bill
An Obama administration official confirms that the health reform proposal released by the White House last Monday (Feb. 22) retains the Senate provision that would extend the 340B drug discount provisions into the inpatient setting as well as more outpatient facilities.
CMS Tells IG It Lacks Authority To Make Plans Report Unlicensed Sales Agents; States Can't Either
CMS' stance that it lacks authority to require that MA plans report unlicensed sales agents to state regulators -- a key recommendation in a recent HHS Inspector General report -- creates a hole in the oversight of health insurance marketing practices, according to consumer advocate and state regulator sources.
Stakeholders Fear Overreach In Possible Drug Import Storage Guide
FDA is considering issuing a guidance on a drug importation procedure that could alter storage requirements for companies seeking to stock-up on their products in the U.S. before completing the drug approval process.
FDA Touts Preemptive Steps On Biosimilars But Still Says Bill Is Needed
FDA is making clear that it intends to get a jump start on biosimilars even if legislation continues to languish, prompting stakeholders to question exactly how far the agency is planning to go on its own.
FDA Eyes Setting Up Two CER Centers To Leverage Agency Data
In order to leverage pre-approval and post-market data collected by FDA to advance comparative effectiveness research and personalized medicine, the agency is considering establishing two centers to provide agency researchers with analytic CER strategies and suggestions for clinical trial designs, according to a notice released to industry earlier this month.
Bigger FDA Role In CER Could Support Payers, Alter Labeling
Recent FDA efforts to examine and potentially redesign the 510(k) device clearance process have reinvigorated a decades-long debate on the agency’s role in comparative effectiveness research, with some stakeholders urging FDA to add superiority -- alongside safety and efficacy -- determinations to its medical product approval process.
Thursday, March 04, 2010
Pelosi Hints At New Concessions As Reform Bill In Final Stages
House Speaker Nancy Pelosi (D-CA) said she expects some new concessions to the House tucked into the soon-to-be-released health reform bill, including a provision affecting part-time workers.
Stakeholders Say Latest REMS Interferes With Medical Practice
FDA’s approval last month of a Risk Evaluation and Mitigation Strategy for erythropoiesis stimulating agents, which includes physician certification, is raising concerns among stakeholders that FDA is encroaching on medical practice without the input of affected parties.
CMS Tightens Marketing Guidance; IG Finds Plans Flouting Guidelines
CMS tightened its marketing guidelines for Medicare Advantage plans this week by requiring translations for non-English speakers and greater plan disclosure in marketing materials and advertisements that use testimonials.
FDA Launches All-Out Blitz On Misleading Food Labels, But Gaps Remain
FDA released a slew of warning letters this week identifying misleading food label claims and cautioned industry to comply with the agency's product labeling expectations, actions lauded by longtime nutrition advocates who also pointed to numerous areas that they say require additional regulatory actions, such as codifying nutrition expectations and increasing oversight of structure/function and whole wheat claims.
FDA, Food Safety Advocates: Salmonella Probe Shows Need For Legislation
FDA and stakeholders are using a massive agency investigation into the contamination of a flavor enhancement product with Salmonella as fodder to urge congressional passage of food safety legislation that would provide the agency with additional authority to prevent such occurrences in the first place.
Industry-Sought FDA Device/Drug Center Coordinating Guide In The Works
FDA is pushing forward on a slew of personalized medicine-related guidance documents, including one that would govern the interaction between the agency’s drug and device centers, an issue that industry stakeholders have brought up in the past.
