Thursday, June 12, 2008
Part D Reforms Caught In Baucus-Grassley Tussle
• Part D Reforms Caught In Baucus-Grassley Tussle
• Agreement On Part D Data-Sharing
• Partial Victory On Part D Off-Label Reform
• California Senate Shocks Consumers By Allowing Drug Data Mining
• High Court Gears Up Again On FDA Preemption
• Déjà Vu: Another FDA Rule With A Preemption Twist
PART D REFORMS CAUGHT IN BAUCUS-GRASSLEY TUSSLE
Senate Finance leaders have just a little over two weeks to hammer out a Medicare physician payment relief bill – and Part D beneficiary reforms are hanging in the balance. Chair Max Baucus (D-MT) and ranking GOP member Charles Grassley (IA) agree doctors need to be bailed out from a pending payment cut, but Grassley is dead set against also giving Part D beneficiaries relief.
As the Senate took up the bill Thursday, the White House vowed to veto the measure, largely over the MA cuts. The White House also railed against raising the threshold for the low-income subsidy as well as Baucus’ plan to delay implementation of a CMS rule limiting federal upper payments for reimbursement of generic drugs at 250 percent of the average manufacturers price.
Baucus was just six votes short Thursday from being able to avert a likely GOP filibuster of his $20 billion Medicare package, and Grassley is pushing an alternative bill. With a presidential veto threat looming, will Democrats blink and scale back the bill’s riders – including Part D reforms – and focus on the $9 billion physician relief portion of the package?
Baucus’ bill, unlike the GOP alternative, would remove bureaucratic obstacles to enrollment in the Part D low-income subsidy program, boost Part B assistance, waive co-pays for the Welcome to Medicare exam and equalize co-payments for mental health parity.
A Republican congressional staffer, referring to the lack of focus on beneficiary-related provisions in the Grassley bill, privately told Inside CMS that the bill could “cost us seats” in the November elections.
But Grassley charged Baucus’ bill is fiscally irresponsible. He said his alternatative bill won’t “expand eligibility for low-income Medicare programs, which would increase long-term entitlement spending and expand coverage under an already unsustainable program.” A surprising statement, said a Medicare Rights Center official. “Last year he came out in favor of eliminating the asset test. What’s changed?” asked Paul Precht, director of MRC’s Washington Office.
Pharmacists are also watching closely, as they scored a major victory by getting Baucus to include provisions requiring prompt payment to pharmacies and delaying changes to the calculation of the average manufacturers price.
Both Baucus and Grassley would bundle payments for anti-anemia drugs, testing supplies and “other elements” into the end-stage renal disease composite rate. The Medical Technology and Practice Patterns Institute estimates Medicare payments for ESAs would fall by half once the bundle is finalized in 2011.
AGREEMENT ON PART D DATA-SHARING
Despite their heated battle over MA cuts and beneficiary relief, Senate Finance leaders – and the administration—agree on one Part D reform: Giving government researchers access to CMS Part D claims data. CMS recently issued a rule allowing just that, but both Baucus and Grassley apparently think legislation is needed to codify the plan.
They may have good reason: When CMS’ proposed rule hit the streets, some stakeholders raised doubts the agency had the authority to share Part D data. It’s possible the agency could land in court unless Congress steps in, reports Inside CMS’ Theresa T. Morgan.
If either Baucus’ or Grassley’s bills were signed into law, CMS would get some legal protection. Both Medicare packages would shore up the CMS rule by amending the Social Security Act to explicitly give CMS the authority it says it already has.
Part D data sharing could also make it easier to conduct comparative effectiveness studies of drugs – which both Baucus and Grassley advocate. Both lawmakers have introduced legislation to boost such studies by giving researchers at federal agencies and university-based and other research organizations controlled access to data on hospital, physician and prescription drug benefits that are provided to Medicare beneficiaries, a Baucus aide told Inside CMS.
CMS’ rule is vague on specifically what data would be provided to congressional oversight bodies – an issue the Finance leaders also haven’t clarified.
The Government Accountability Office has been in a tug-of-war with CMS over accessing Part D rebate and utilization data, and the Medicare Payment Advisory Commission last year urged Congress to mandate the release of Part D data for program evaluation. Under CMS’ final data-sharing rule, GAO and MedPAC may only access certain Part D data once they convince CMS the data is necessary for their specific study. CMS also said the rule “does not extend to rebate or other price concession data, otherwise known as ‘direct or indirect remuneration’ [DIR], with the exception of DIR that may be reflected in the negotiated price paid for a drug at the point of sale.”
PARTIAL VICTORY ON PART D OFF-LABEL REFORM
Off-label drug coverage is a tricky issue for patient advocates. While prominent consumer groups have urged FDA to take a harder line against drug companies promoting off-label uses, Medicare beneficiary advocates have sought expanded off-label coverage under Part D. The latter scored a partial victory when Baucus included off-label reforms in the Medicare bill he unveiled last week.
Baucus’ Medicare bill would let Part D plans to rely on the same peer-reviewed journals used by Part B when considering off-label coverage of cancer chemotherapy. That’s good news for the Medicare Rights Center and the Senate Cancer Coalition, which floated similar language with Baucus.
But, they didn’t get everything they wanted. Baucus didn’t include language also letting Part D plans to rely on additional journals for treatment of non-cancer off-label therapies. “We’re disappointed … that the provision does not apply uniformly to all off-label use under Part D,” Inside CMS quotes a beneficiary advocate as saying.
CMS is also on an off-label kick. Last week the agency announced it would recognize the National Comprehensive Cancer Network (NCCN). CMS recently created a process to revise its compendia list. And this week CMS said it would recognize Thomson Micromedex Drug Dex as an additional source of information. CMS also considered a request to add Thomson’s Drug Points, but decided it doesn’t fit the criteria.
Again, consumer advocates don’t also agree on off-label issues. The Medicare Rights Center backs CMS’ move to recognize NCCN, but the Center for Science in the Public Interest doesn’t. CSPI complained in a May 28 letter to CMS that the NCCN fails to comply with transparency and conflict of interest standards created in 2006 by a CMS advisory panel.
“Visiting the NCCN Web site tells the public nothing about the financial relationships between drug companies and physicians ... and other scientists who comprise the 44 panels that write clinical practice guidelines and determine which drugs, which indications, and the weight of evidence that are included in its compendium,” CSPI wrote.
By the way, Baucus’ bill would require that, after Jan. 1, 2010, no compendium be used to determine coverage unless it has a publicly transparent process for evaluating therapies and identifying potential conflicts of interest. The MRC source said that’s a good idea, but CSPI fears it wouldn’t change the status quo.
CALIFORNIA SENATE SHOCKS CONSUMERS BY ALLOWING DRUG DATA MINING
On the topic of financial relationships between drug companies and physicians, California’s senate is going in the opposite direction of other states and federal lawmakers. As lawmakers on Capitol Hill seek to restrict such relationships, the Golden State’s senate in late May passed legislation that would allow pharmacies to share patient information with marketing and pharmaceutical firms without patient consent. Consumer advocates are livid, reports Inside CMS’ Amy Lotven.
The bill, authored by Sen. Ron Calderon (D) and sponsored by marketing firm Adheris, comes as several other states are clamping down on efforts by drug companies to influence prescribing habits and lawmakers on Capitol Hill are pushing for greater transparency on the use of prescribing data.
This legislation is an “outrage” that compromises the confidentiality of medical treatment and will add to the bombardment of consumers already overwhelmed with drug industry marketing, Sharon Treat, of the National Legislative Association for Prescription Drug Prices, told Inside CMS.
But California lawmakers have a different take. Allowing companies to send reminders and other communication to patients will increase adherence to prescribed regiments and ultimately improve patient health, the bill’s sponsors say.
Not so, says the Consumers Federation of California. Instead, the group argues that the bill would give drug marketing and pharmaceutical companies exactly what they want: a way to increase customer allegiance to their particular brand name through direct mail.
The California bill was defeated the first time it hit the floor, but supporters were able to muster enough support to pass the bill the third time around.
HIGH COURT GEARS UP AGAIN ON FDA PREEMPTION
The White House, drug makers and conservative thinkers all made their pitches last week for the Supreme Court to side in favor of FDA preemption in a landmark case the high court will hear in its next term. Bush administration lawyers dealt a lot of time explaining recent clarifications to FDA’s controversial “changes being effected” regulation – which lays out a process for drug companies to add new safety warnings to a drug’s label without waiting for FDA’s permission.
FDA recently sought to clarify that the rule only applies to new information, and that such information must establish a causal link between the drug and an adverse event. The move was viewed by critics as another agency try to assert federal preemption, and prompted 25 congressional Democrats to urge FDA to withdraw the proposal.
The agency’s CBE policy has become a central issue in the preemption debate. FDA told the Supreme Court that the proposed rule merely “codifies the agency’s longstanding view” of CBE, reports FDA Week’s Sam Baker.
The latest Supreme Court preemption case, Wyeth v. Levine, originated in Vermont, where musician Diana Levine had to have her arm amputated after receiving a dose of the drug Phenergan administered through a so-called “IV push” instead of being dripped through an IV bag. Levine sued Wyeth, charging the company should have changed Phenergan’s label to specifically warn against the use of an IV push.
Levine says the company could have used a CBE supplement to specifically direct physicians not to use an IV push. But the government says that would have gone against the point of CBE supplements—which is to account for safety information that FDA didn’t already know about.
The drug and biologics industry trade groups take the argument a step further. “The threat of liability under state law encourages manufacturers to warn physicians and patients about risks that are speculative and scientifically unsupported,” the groups state in a joint brief.
The case is the third in a quick succession of FDA preemption cases. First was Riegel v. Medtronic, a case that delivered a win for preemption in suits involving FDA-approved medical devices. Then came Warner-Lambert v. Kent, a narrower case in which the justices issued a 4-4 split decision that upheld a lower court’s anti-preemption ruling, but without setting any precedent.
DÉJÀ VU: ANOTHER FDA RULE WITH A PREEMPTION TWIST
Once again, FDA appears to be using its regulatory muscle to nudge the courts to back federal preemption. This time in a rule involving labeling of drug risks to pregnant and nursing women, reports FDA Week’s John Wilkerson.
Observers say the agency’s newly proposed pregnancy labeling rule reinforces FDA’s position in support of federal preemption, if only slightly. The move may give drug companies a hand in fighting lawsuits in which plaintiffs claim that companies have failed to warn about risks to pregnant and nursing women, Wilkerson reports.
The proposal, issued late last month, amends the Physician Labeling Rule, which is significant because FDA caused a stir in 2006 when it used the rule’s preamble to assert primacy over state tort suits. In the new proposal, FDA asserts that risk summaries for pregnant and nursing women preempt conflicting state tort claims.
Mark Herrmann, a partner at Jones Day, told Wilkerson that the proposal puts preemption into the specific context of pregnancy labeling, As a result, when claims cover neonatal injuries, companies have a specific regulation to use in their defense, he said.
“As it turns out, this latest proposal does have something—not a great deal—to say on the subject of preemption, and it’s supportive of the defense position,” Herrmann wrote on his Drug and Device Law blog. The more consistently FDA repeats its position on preemption, the more likely courts will side with FDA in other tort suits, Herrmann said.
New York University Professor Catherine Sharkey agrees with Herrmann. She says the proposal is all the more important given that the Supreme Court is to hear the preemption case Wyeth v. Levine in its next term, Wilkerson reports.--Donna Haseley