Wednesday, May 28, 2008
Last-Ditch Maneuvering On Medicare Reform
• Last-Ditch Maneuvering On Medicare Reform
• CMS Faces Bipartisan Probe Of Unapproved Drug Payments
• Part D Data Sharing, Comparative Effectiveness Resurface
• FDA Unveils Its Own Drug Data Sharing Plan
• DeLauro Hikes Push For 1-800 Numbers In DTC Ads
• FDA Closes Loop On Pregnancy Side Effect Labeling
LAST-DITCH MANEUVERING ON MEDICARE REFORM
Time is running out for a Medicare physician payment fix, and last-ditch maneuvering is in full play. Senate Finance Committee Chair Max Baucus (D-MT) angered Republicans by breaking off bipartisan talks after GOP negotiators failed to budge on their opposition to Medicare Advantage cuts. The Senate Republican leader blasted Baucus for cutting off talks, and the White House upped the ante by signaling a doc pay fix that includes MA cuts and reforms to Part D would draw a veto.
As Baucus and committee Democrats go it alone in drafting a Medicare reform package, they are also being bombarded by providers and beneficiary advocates looking to link other reforms to the package, reports Inside CMS.
• Pharmacy groups have backing from some House lawmakers in their bid to attach pharmacy friendly drug reimbursement reforms.
• Beneficiary advocates got the Senate Cancer Coalition to press Baucus to expand off-label reimbursement under Part D. Advocacy groups also have some bipartisan backing to revamp the low-income subsidy program – a program that continues to face questions from Congress’ investigative arm and for which CMS has yet to explain its retroactive payment to plans.
• The intravenous immune globulin lobby is pushing hard for increased IVIG reimbursement.
• And a coalition of consumer, provider and government groups hopes lawmakers will use the Medicare bill to launch a demonstration program providing coverage for overweight and obesity interventions.
AARP is also on Finance members’ backs to ensure a physician payment fix doesn’t lead to increased beneficiary premiums. A major ad campaign launched by the powerful group irked a physician specialty, which denounced AARP’s attempt to blame physician payment relief for premium hikes.
Finance Committee staffers likely have put their phones and e-mails on standby mode over the Memorial Day recess.
CMS FACES BIPARTISAN PROBE OF UNAPPROVED DRUG PAYMENTS
As advocacy groups try to expand Part D off-label drug reimbursement, CMS is in the hot seat to explain sudden, recent shifts in its reimbursement of unapproved drugs. Finance leaders accidentally discovered that CMS drug reimbursement logs it downloaded several months ago were changed around the time they started asking CMS about its reimbursement policies for unapproved drugs.
Finance ranking GOP member Charles Grassley (IA) is so upset at CMS’ apparent loose policies that he may use the upcoming Medicare bill to force FDA, CMS and others to put together an authoritative list of approved drugs. FDA is mum on why CMS might have reimbursed certain unapproved drugs, and in some cases incorrectly noted on its log that the drugs were approved. FDA told Grassley to “ask CMS.”
Grassley, in a May 28 e-mail to Inside CMS’ Amy Lotven, assailed CMS for failing to adequately monitor prescribing and reimbursement of drugs not approved by FDA and therefore ineligible for payment. The e-mail came two weeks after FDA, responding to Finance requests for information on how the FDA and CMS ensure taxpayers are not financing unapproved drugs, said the panel should ask CMS why certain unapproved drugs were covered.
The committee’s probe stemmed from a USA Today report in 2006 describing how many doctors were unaware they were prescribing unapproved drugs. Staffers discovered there is no master list of approved and unapproved drugs, which leaves the public and providers with the arduous task of comparing information from a number of sources to confirm a drug’s approval status.
Legislation forcing FDA and CMS to maintain such a list is a possibility, a Grassley aide told Lotven. Avalere is also calling for such a list, reports Lotven.
CMS has yet to respond to Nov. 13 and Jan. 11 Finance letters on the issue.
Politico reported on May 22 that Senate investigators discovered during the probe sharp deviations in information regarding the number of prescriptions and the amount reimbursed for five drugs – Dytan, Avandia, Guaifenex, Oyster-Cal-D and Vytorin – listed in the 2006 State Drug Utilization Data for the Medicaid Drug Rebate program.
PART D DATA SHARING, COMPARATIVE EFFECTIVENESS RESURFACE
CMS last Thursday issued a long-promised rule giving other federal agencies, congressional oversight bodies and states access to Part D claims data. But the rule may not be enough to keep lawmakers from legislating on the issue. Senate Finance leaders vowed to “continue to consider legislation on this issue, to make certain that this data is shared safety, quickly, and in the most useful manner.
The data is crucial to the lawmakers’ plans to mandate studies on the comparative effectiveness and safety of drugs. Baucus and Grassley say they are anxious to ensure that “congressional support and federal oversight agencies have access to all Medicare data they need – including Part D data – to advise Congress on Medicare and on the usefulness of the new CMS rule.”
Sounds like a familiar tune. When CMS, facing criticism from Congress for its lack of oversight of MA marketing, came out with an MA marketing oversight plan, lawmakers reacted cautiously. While initially praising CMS, Baucus quickly reiterated his plan to cement marketing reforms as part of the Medicare bill. The administration last week bristled at the idea, suggesting to Grassley that the agency’s MA reforms are fine as is – no additional legislation needed. It’ll be interesting to see if CMS has a similar reaction to upcoming comparative effectiveness legislation.
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 late last year issued a draft recommendation urging Congress to mandate release of Part D data for program evaluation. Under CMS’ rule, GAO and MedPAC may access certain Part D data once they convince CMS the data is necessary for their specific study—what CMS calls its “minimum necessary data” policy, reports Inside CMS’ Theresa T. Morgan. This may be a piece of the rule that Finance leaders are uncomfortable with.
CMS also says 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.” Plus, the collection of Part D data “is limited to the original 37 data elements collected as part of the Part D claims data,” CMS says. The agency promises a “separate rulemaking” to broach if it should “collect any of these additional elements,” which in turn could be shared with outside agencies.
Also not covered by the current rule are data that could affect Medicare program spending, such as rebates, bids, reinsurance, and risk-sharing data.
The upcoming Baucus bill may do more than simply codify CMS’ data-sharing plan.
FDA UNVEILS ITS OWN DRUG DATA SHARING INITIATIVE
The same day CMS announced it will share Part D claims data, FDA unveiled its own drug data sharing plan. Obtaining Part D claims data is just one piece of FDA’s new national electronic monitoring system, reports FDA Week’s Jennifer C. Smith.
Within 30 days, FDA and CMS plan to begin scrubbing patient data to better track post-market drug safety. Eventually, FDA plans to scan multiple agency databases, as well as private insurance databases, in a bid to develop a national electronic system to monitor drugs on the market.
Under the new program, dubbed “The Sentinel,” FDA will study which drugs are prescribed to Part D beneficiaries and the time of prescriptions, said FDA drug center director Janet Woodcock. She said the information will be linked to other databases that include such information as the dates of hospital visits and lab tests.
But FDA’s desire to also tap into some private databases may be premature. When asked during a press call if FDA was in talks with private insurers about accessing their databases, Woodcock said the agency has held a series of meetings with a “large variety of people” and that “no one’s signed on the dotted line yet because we haven’t given them a dotted line.”
“We’ve met with all the federal partners who provide, pay for or research health care,” Woodcock said. “We’ve met with health care plans, people who sell data and hospital systems, and all have indicated interest.”
FDA hopes the new network will detect post-market safety trends for drug classes. That hope is shared by Grassley. “The drug trials that go on before [FDA] approves a drug are no match for the wealth of information that’s available after a drug is on the market and millions of people start taking it,” the Senate’s drug safety maverick said.
DELAURO SEEKS TO REQUIRE 1-800 NUMBERS IN TV DRUG ADS
Should television drug ads include Toll Free numbers or Web addresses for patients to instantaneously report side effects? FDA’s answer is not so instantaneous: The agency says it needs two years to reach a conclusion.
Not possible, say Reps. Rosa DeLauro (D-CT) and Jo Ann Emerson (R-MO). The bipartisan pair introduced legislation last Thursday (May 22) that would force drug and device ads to include a toll-free phone number or Web address for reporting side effects, along with a statement urging such reports.
The bill would also ban consumer ads for prescription drugs and many medical devices until they have been on the market for at least three years, and would let FDA slap civil penalties on violators. Plus it would create a public education campaign for risky drugs, reports Smith.
The bill is good news for consumer groups, who were upset when Congress passed the FDA Amendments Act without a requirement that TV drug ads include a side effects hot line. FDAAA requires all print prescription drug advertisements to list a toll-free phone number or Web address for reporting side effects, but it does not require TV ads do likewise. The law called for FDA to complete a study on the issue by March 27.
FDA Commissioner Andrew von Eschenbach told the Senate health committee and House Energy and Commerce Committee members May 8 that the study will take two more years to finish. Consumers Union complained to an FDA advisory panel on May 16 that two years is too long to wait.
DTC ads could be dubbed the issue of the month. The House Energy & Commerce oversight subcommittee held a DTC ad hearing May 8, and Democratic leaders followed up with a letter Wednesday asking four major drug companies to adopt DTC business practices. Then the Pharmaceutical Research and Manufacturers of America issued a statement last Wednesday defending its voluntary consumer advertising guidelines, which was followed by DeLauro’s bill.
Also last week, Merck agreed as part of a $58 million, multi-state settlement to send its ads to FDA for preclearance.
FDA CLOSES LOOP ON PREGNANCY SIDE EFFECT LABELING
In early 2007 FDA punted on including specific pregnancy side-effect requirements in a physician labeling rule due to controversy surrounding the issue. On Wednesday FDA closed the loop by proposing a new rule that would require prescription drug and biologics labels to summarize risks to women who are pregnant or nursing.
The proposed label requirement is also expected to force drug companies to conduct such studies, reports Smith. FDA has been struggling for years with how to get companies to study the effect of their drugs on pregnant women, partly due to ethical concerns among drug makers.
FDA says women take an average of three to five prescription drugs during pregnancy. Sandra Kweder, deputy director of FDA’s Office of New Drugs, said Wednesday that FDA is particularly concerned about drugs that treat depression, skin conditions and blood pressure.
The rule also addresses nursing mothers. Before the FDA Amendments Act, FDA had no mechanism to force companies to submit lactation clinical trial data as part of new drug or supplemental applications. Companies have also been reluctant to do lactation studies for fear of lawsuits in the event children are hurt during clinical research.
FDA has been studying pregnancy and breastfeeding labeling for nearly a decade. The agency held public meetings and gathered focus groups to get comments on a letter-based category labeling system. Some stakeholders have charged the labeling system would result in an inaccurate and overly simplistic view of risks.
If Wednesday’s rule is finalized, newly approved drugs would use the new pregnancy and lactation labeling format, while labeling for previously approved drugs would gradually change their labels. Stay tuned for the drug industry’s reaction to the proposed requirements.--Donna Haseley