Daily News

CMS Rebuts Hospitals' Argument Against 2.9% Cut To Inpatient Payment

CMS rebutted the hospital lobby argument against a 2.9 percent cut to the inpatient prospective payment system (IPPS) that the agency says is needed to offset the so-called “coding creep” caused by the Medicare Severity Diagnosis Related Group (MS DRG) policy.

GPhA Membership OKs Governance Changes As Teva's Role Still Unclear

The Generic Pharmaceutical Association membership approved changes late last week to the group's governance structure that will provide larger firms with more clout, a move that could entice drug industry giant Teva to return to the organization and help provide a more unified industry voice as FDA moves forward on establishing generic drug user fees, according to several informed sources.

CMS' Productivity Factor For ASCs Draws Heat From Hospitals, Physician Specialists

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.

Pharmacists Praise CMS' Proposed Withdrawal Of Controversial AMP Rule

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.”

White House Eyes Bioshield, Flu Funds For Countermeasures Initiatives

The White House is proposing to strip $170 million from existing pandemic flu funding for FDA and up to $400 million from Project Bioshield procurement funds to support new medical countermeasures initiatives outlined in an HHS report released last month, according to documents recently sent to Capitol Hill.

09-02-2010

Stakeholders: HHS Planning Shop's CER Plan May Undermine Health Law's Institute

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.

FDA-Regulated Firms Press High Court To Limit Adverse Event Reporting

As the Supreme Court prepares to examine whether medical product developers and life science firms must disclose all reported adverse events -- not only those situations with a confirmed link to a drug, device or dietary supplement -- to investors, a large swath of FDA-regulated industries are pressing the nation's top justices to reverse a lower court ruling that they say runs counter to a 1995 securities law aimed at reducing litigation.

CMS Tells States To Employ Correct Coding Initiative By Oct. 1 For Medicaid Claims

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).

Lawmaker, Consumers Concerned With Public Notification Of Egg Recall

A key Democratic lawmaker and some consumer advocates are raising concerns with FDA's communication to the public during the recent salmonella outbreak that prompted a massive egg recall.

FDA-TRACK Expansion Fuels Accountability, Monitoring Of New Authorities

FDA's new agency-wide metrics program has improved accountability and will help track the implementation of new statutory authorities as the publicly accessible performance measurement system continues to aggregate more data, according to a top agency official.

09-01-2010

State Lawmakers Eye Lawsuit After Pawlenty Refuses To Seek Grant For Insurance Exchange

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.

Off-Label Uncertainty Persists As Allergan Settles First Amendment Lawsuit

Drug maker Allergan's decision to settle a years-long investigation into its off-label promotion of the popular medication Botox instead of pursuing its First Amendment lawsuit against FDA extinguished hopes from the pharmaceutical industry that resolution of the case would provide manufacturers with greater clarity on permitted discussions of unapproved uses.

OSHA Interim Whistleblower Rules Offer Pluses For Both Industry, Worker Advocates

Stakeholders say OSHA's new interim final rules on whistleblower protections provide advantages to employers by making burdens of proof more stringent on the complainant, but also offer whistleblowers an easier avenue to take their cases to court.

FDA To Examine Drug Safety Communications Effectiveness, Eyes Metrics

In order to establish the impact and effectiveness of drug safety communications, FDA will query relevant stakeholders on how they use new information and plans to develop new metrics on this issue, an agency official said.

FDA-EMA Pilot Could Mitigate Safety Argument Against Drug Importation

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.

Pawlenty Order Blocking Reform Funds Violates State Law, State Rep. Says

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.

08-31-2010

CMS Refuses To Release Names Of Winning DMEPOS Bidders

CMS refused to give lawmakers the list of winning bidders for the first round of the Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) program and took a swipe at the industry by reminding suppliers that the suppliers had originally asked that the names of the winners be kept secret, even though the industry now wants the list released.

CSPI Calls For 'Natural' Labeling Oversight, Eyes FDA And State Action

The Center for Science in the Public Interest is raising concerns with the use of "natural" labeling, and may take its concerns to the FDA or state attorneys general if they aren't properly addressed.

Roche Warns Employees On Social Media Use As FDA Ups Enforcement

Even though FDA is still drafting its social media policy, the agency has already begun targeting advertising violations in this realm, which has resulted in at least one drug manufacturer warning its employees on what product information they are allowed to display on the Web in both a professional and personal capacity.

Researcher: More Premarket CER Would Allow FDA To Focus On Big Therapeutic Advances

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.

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