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Facing Pharmacy Pressure, CMS Proposes Rule For Calculating Medicaid Rx Reimbursement Caps

Following months of pressure from pharmacies, CMS issued a proposed rule on Friday (Jan. 27) that explains how drug makers should calculate Average Manufacturer Prices (AMPs), which in turn is used to determine caps on Medicaid generic-drug reimbursement, called Federal Upper Limits (FULs).

Pitts Wants To Cut ACA Spending To Pay For SGR Fix In Lieu Of Using War Savings

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.

WLF Tells Court FDA Illegally Used Guidances To Expand Drug Definition

Free speech advocates are using a district court case as an opportunity to challenge FDA guidance released last year outlining the difference between drugs and devices, with the advocates saying the agency's policy conflicts with the statutory definition of medical devices.

Industry Stakeholders Say FDA-Mandated FOP System Would Limit Speech

Industry stakeholders said an FDA-regulated system for front-of-package labels could limit free speech if such an approach banned companies from using other labeling systems, and a free speech advocate said the agency could only bar companies from using labels if it found they listed misleading information.

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).