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Tauzin Says Savings From Home Health Outlier Cap Bolster Case For Coinsurance Alternative

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.

GAO Call For CMS To Improve MA Risk Assessment May Portend More Cuts

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.

House Panel Eyes Early Notification, Quotas To Stem Drug Shortages; Undecided On Pay Issues

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.

Obama Supply Chain Security Plan Mirrors FDA Bid To Hike Global Collaboration

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.

Pitts Says GOP Ready To Unveil ACA Replacement Once Supreme Court Rules

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).

Advocates' Letter To Obama Urging Strong Summary Of Benefits, Coverage Rule Follows White House Meeting

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.

mHealth Coalition Presses FDA To Revamp Mobile App Guide, Seek More Input

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.

DOJ Uses Pending Generics' Exclusivity As Leverage In Consent Decree Against Ranbaxy

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.

FDA 2013 Approps Clouded By Unclear Impact Of User Fees, Sequestration

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.

Rx Drug

• House Panel Eyes Early Notification, Quotas To Stem Drug Shortages; Undecided On Pay Issues
• Off-Label Guide Could Prompt Re-Evaluation Of Public Presentation Policies
• Obama Supply Chain Security Plan Mirrors FDA Bid To Hike Global Collaboration

Medicare

• GAO Call For CMS To Improve MA Risk Assessment May Portend More Cuts
• House Panel Eyes Early Notification, Quotas To Stem Drug Shortages; Undecided On Pay Issues
• Off-Label Guide Could Prompt Re-Evaluation Of Public Presentation Policies

Congress

• GAO Call For CMS To Improve MA Risk Assessment May Portend More Cuts
• House Panel Eyes Early Notification, Quotas To Stem Drug Shortages; Undecided On Pay Issues
• Obama Supply Chain Security Plan Mirrors FDA Bid To Hike Global Collaboration

Food Safety

• Obama Supply Chain Security Plan Mirrors FDA Bid To Hike Global Collaboration
• FDA 2013 Approps Clouded By Unclear Impact Of User Fees, Sequestration
• Quality Control, Records Cited As Dietary Supplement GMP Compliance Issues