Monday, April 21, 2008
Dingell Pushes Import Safety Reforms
• On AMP, House Pushes Overhaul, Pharmacists Eye Moratorium
• CMS Tweaks Part D Policies For Low-Income Patients
• Debate On Medicare Data Sharing Reforms Brewing
• Industry, Patient Groups At Odds On Off-Label Promotion
• Dingell Unveils Draft Import Safety Reforms, Plans Hearings
• Democrats Ready To Roll Back FDA Preemption
INDUSTRY, PATIENT ADVOCATES DISAGREE ON OFF-LABEL PROMOTION
Drug companies and a coalition of consumer and patient groups on Friday sent competing comments to FDA on the free-speech rights of drug makers to disseminate medical articles on off-label drug use, FDA Week’s John Wilkerson reports. A group of 10 drug companies have banded together to lobby in favor of such dissemination, while members of the Patient and Consumer Coalition argue against the practice, noting that the research written about in journal articles often is funded by drug companies and the articles “overwhelmingly reflect the financial interests of the sponsors.”
Manufacturers, on the other hand, point out that drug label revisions typically lag behind advances in medical knowledge, and that many cancer drugs are used off-label. Industry urged FDA last year to expand an expiring policy that allowed manufacturers to disseminate peer-reviewed journal articles on off-label drug uses, and FDA published draft guidelines in February.
Rep. Henry Waxman (D-CA) didn’t even wait for the guidelines’ release to begin criticizing them: He sent a letter to FDA in December after obtaining a draft copy, accusing FDA of skirting lawmakers’ intent that industry get agency approval before distributing such articles.
While the coalition of advocates straight-out opposes FDA’s draft, the 10 drug companies propose a series of changes that would further relax dissemination standards. Industry wants to be able to publish more than just “adequate and well-controlled” research findings, and says it should be up to FDA to demonstrate that information is false and misleading, instead of companies having to demonstrate that reprints meet FDA criteria. The manufacturers are also critical of FDA’s language on financial conflicts, which they claim would effectively ban all financial relationships between journals and companies and, as a result, potentially eliminate the distribution of articles.
The Journal of the American Medical Association reported recently that Merck & Co. had ghostwritten academic articles on its painkiller Vioxx, which has been pulled from the market.
DINGELL UNVEILS DRAFT IMPORT SAFETY REFORMS, SCHEDULES HEARINGS
Recent concerns about a Chinese heparin producer and a series of Government Accountability Office reports have highlighted gaps in FDA’s foreign inspections and prompted frantic congressional action. In a hotly anticipated third discussion draft released Thursday, House Energy & Commerce Committee Chair John Dingell (D-MI) now proposes a massive legislative change for FDA-regulated industries – and not just food.
Dingell wants to force FDA to maintain a permanent foreign inspection corps that meets domestic inspection rates – one inspection every two years per facility – and give the agency broad new power to restrict potentially unsafe imports, reports FDA Week’s Sam Baker. U.S. companies seeking export certification from FDA would have to pay $10,000 under the proposal. FDA would finally be allowed to charge reinspection fees; and policies on registration, inspections, recalls, country-of-origin labeling and penalties would be similar for drugs and devices.
The heparin case, in which a cheaper, more dangerous chemical was used to mimic another, seems to permeate much of the draft: It would create a registry for domestic and foreign drugs and class I and II device manufacturers, including active pharmaceutical ingredients and device components. Makers of drugs and drug ingredients would have to test for contaminants. Drug importers would have to provide FDA with documentation showing compliance with various requirements. Drug makers would have to document the origin of their ingredients, including inactive ingredients. The requirement would include previous producers of ingredients.
Drug and device labels would have to disclose in what country the products are made, and drug labels would list where ingredients are manufactured. Also, FDA agents could destroy drugs that either appear to pose a risk of injury or death or that are worth less than $2,000. Currently, if Customs and Border Patrol suspects a package to contain counterfeit drugs, agents must detain it.
FDA Commissioner Andrew van Eschenbach and others are scheduled to testify before Energy & Commerce today (Tuesday) at a hearing on FDA’s inspection program. Dingell’s draft proposal will surely be front-and-center, as it will be at Thursday’s hearing on import legislation and an April 29 hearing devoted entirely to lessons learned from the heparin debacle. The Senate health panel also announced plans to hold its own hearing on the food and drug safety.
DEMOCRATS READY TO ROLL BACK FDA PREEMPTION
Democrats in the House and Senate are expected to introduce bills this week that would reverse a U.S. Supreme Court decision on FDA preemption, Baker writes. Lawmakers are coordinating their schedules to introduce bills in both chambers on the same day, according to the American Association for Justice, a trial lawyers’ group. It’s unclear whether this year’s tight legislative calendar leaves room for hearings on the issue, however.
Reps. Frank Pallone (D-NJ) and Henry Waxman (D-CA) will introduce the House bill. Senate health committee Chair Edward Kennedy (D-MA) will sponsor companion legislation, according to the trial lawyers’ group.
The Supreme Court ruled in February that the federal Medical Device Amendments, passed in 1976, preempt state tort suits involving FDA-approved devices. Some Democrats say that was not the law’s intent, and their bills would add a new provision to the law stating that it does not “modify or otherwise affect” state common-law claims.
Trial laywers aren’t the only ones interested in FDA preemption: AARP and the National Conference of State Legislatures, for instance, have also met with lawmakers to discuss the issue.
But could opponents of federal preemption strike a better reform “deal” next year? A Democratic White House could reverse the Bush administration’s full-throated defense of preemption, under which FDA regards itself as the nation’s sole arbiter of the safety and efficacy of drugs and medical devices. The agency now argues that state tort suits undermine that authority, and manufacturers – always eager to avoid litigation – share that view.
HOUSE PUSHES AMP OVERHAUL, PHARMACISTS EYE MORATORIUM
Medicaid stakeholders are still pushing for legislative relief from last year’s controversial CMS rule on drug-specific average manufacturer prices (AMPs), which would have already begun to cut pharmacy reimbursement drastically if a district court injunction didn’t rain on the agency’s parade. But strategies have changed slightly.
Community pharmacists have also been in talks with congressional staffers about delaying the AMP rule’s start date – yet another moratorium lawmakers would have to get past a veto-inclined White House. Pharmacists know this year’s congressional calendar is shrinking fast, and that broad AMP reform, like the ones proposed by Sen. Max Baucus (D-MT) or Reps. Jo Ann Emerson (R-MO) and Nancy Boyda (D-KS), may run into a roadblock.
But they may still be some chance of an AMP overhaul moving forward. At last week’s markup of legislation to delay CMS’ implementation of seven Medicaid rules, Rep. Nathan Deal (R-GA), ranking member of the health subcommittee, offered and then withdrew an amendment that would have increased federal payments for Medicaid drugs as opposed to actually delaying the rule, Inside CMS’ Amy Lotven writes.
An AMP rule delay may actually be cheaper than many stakeholders think. For its spending estimations, the Congressional Budget Office assumes the injunction that has been placed on CMS’ policy will last until the end of the year, one pharmacy representative says. That means a delay would only begin to cost pharmacists starting in January.
The final score would depend on the moratorium’s length, which, according to the pharmacy source, would most likely depend on the legislative vehicle – in other words, the length of a widely expected physician fix or broad Medicaid rulemaking moratorium.
CMS TWEAKS PART D POLICIES FOR LOW-INCOME PATIENTS
Three years into Medicare Part D, CMS is reevaluating the drug benefit’s effect on vulnerable low-income enrollees. Patient advocates are following the agency’s moves with a mixture of appreciation and skepticism.
This is not surprising, considering that CMS’ stance on several issues – from marketing oversight to plan reassignment strategies – has prompted concern. Just Friday, the agency admitted that it had underestimated the number of low-income subsidy (LIS) recipients who would be reassigned new drug plans under new premium benchmark calculations issued March 31 at the suggestion of the insurance lobby.
CMS is keeping advocates on their toes with regard to another issue: late-enrollment penalties. For the first three years of the drug benefit, the agency used demonstration authority to waive these penalties, which apply to Medicare beneficiaries who delay their Part D sign-up. In a final rule issued last Tuesday (April 15), CMS laid out next year’s penalty structure while promising to evaluate the demo’s success and, perhaps, recommend that Congress ax penalties for LIS recipients.
The rule codifies guidances on drug plans’ coverage of insulin treatments and supplies, and on the reconciliation between Part D plans and other payers. The agency said it would address through a separate rulemaking process drug costs used by Part D sponsors to calculate beneficiary cost-sharing and by CMS to determine reinsurance reconciliation and risk sharing, InsideHealthPolicy’s Rolf Rosenkranz writes.
In an interpretation of the Medicare Modernization Act that riles patient advocates and drug companies alike, CMS said it would not reimburse weight-loss drugs under Part D even if the treatments are used for non-cosmetic purposes, Inside CMS’ Theresa Morgan writes.
DEBATE ON MEDICARE DATA SHARING REFORMS BREWING
Improving the collection and transfer of patient-specific medical data has been a main goal of health IT legislation now being pushed in Congress. But data sharing is key to several other initiatives and, as such, may soon move center-stage.
States, for instance, have been pushing for years to gain broad access to Medicare data in order to improve care coordination for vulnerable beneficiaries, especially seniors also covered under Medicaid. The creation of Part D has complicated states’ job as dual eligibles’ drug coverage switched from Medicaid to private plans sponsored by the federal government.
State representatives are now pushing Congress to let states handle all care for dual eligibles as part of a yet-to-be created demonstration project. Such a proposal may conceivably allow states to receive Medicare dollars from CMS or enter into financial relationships with managed care plans, including those in the Medicare Advantage program.
The Medicare Payment Advisory Commission (MedPAC) also delved into data sharing territory April 9, when it suggested that Congress initiate a Medicare pilot project for patient-centered “medical homes” that meets stringent criteria on the care provided, health information technology used, records kept and access granted to patients, writes Rosenkranz. Medicare should provide these medical homes with timely information on patient utilization, the panel held, and several MedPAC members said this should include Part D data.
HHS last week filed an appeal in the U.S. Court of Appeals for the District of Columbia of an August 2007 court decision that requires the department to release physician-identified Medicare Part B claims data.
Senate Finance Committee leaders are also interested in data sharing or, more precisely, data transparency reforms. Public release of data on the Physician Quality Reporting Initiative, Part D claims and physician-identified Part B claims could be among the senators’ goals.--Rolf Rosenkranz