Tuesday, May 13, 2008
E-Prescribing, MA Marketing, DTC Ads And USP
• Will CMS’ MA Marketing Plan Preempt Senate Action?
• AMA Signals New Willingness To Embrace E-Prescribing
• FDA Preemption Spotlight Shifts From High Court To Congress
• Drug Industry Backed Into Corner On DTC Ads
• USP Faces Heat For Outdated Monographs
• FDA May Stop Testing Compounded Drug Samples
WILL CMS’ MA MARKETING PLAN PREEMPT SENATE ACTION?
Lawmakers, beneficiary advocates and the insurance industry cautiously praised CMS’ proposal last week to stem Medicare Advantage and Part D marketing abuses. But will CMS’ move preempt Senate Finance Chair Max Baucus (D-MT) from tucking more aggressive controls into his hotly awaited Medicare bill? The health insurance industry clearly hopes so. Baucus says he will, at a minimum, codify CMS’ marketing controls with legislative language, but otherwise is mum.
Last Thursday (May 8), CMS proposed regulatory restrictions on MA and Part D marketing practices, as well as enrollment and quality requirements for special needs plans, as lawmakers were drafting similar proposals, reports Inside CMS’ Theresa T. Morgan. Hoping to preempt strict legislative controls, the insurance industry also came up with its own voluntary plan last month to curb highly publicized MA marketing abuses.
But industry’s move didn’t convince Finance Committee lawmakers to stop their legislative drafting, nor has CMS’ rule, it appears. Patient advocates say there is still a role for Congress to play, especially when it comes to enforcement. CMS’ rule fails to grant states authority to enforce the agency’s proposed restrictions. This is an area where the Senate can help provide further protections, says Paul Precht, policy director for the Medicare Rights Center.
Not a new idea for Baucus, who in the past has called for the states to be given more oversight of MA plans. That is just what America’s Health Insurance Plans may be hoping to avoid.
CMS’ new rule also aims to standardize commission structures for MA and Part D plans. The current compensation structures give agents incentives to enroll beneficiaries in products based on commission, as opposed to the patient’s needs, CMS states. The Medicare agency also proposes to redefine the term “negotiated prices” and “require that Part D sponsors base beneficiary cost sharing on the price ultimately received by the pharmacy or other dispensing provider.”
All eyes on are Baucus, and the MA and Part D-related provisions he will slip into his upcoming Medicare bill.
AMA SIGNALS NEW WILLINGNESS TO EMBRACE E-PRESCRIBING
The powerful physicians lobby on Friday for the first time signaled a willingness to accept e-prescribing mandates – so long as penalties on non-complying doctors are put off for two years after new standards kick in. The American Medical Association, fixated on getting lawmakers to quickly enact legislation to avert Medicare payment cuts, appears to be getting nervous about how the payment patch will be financed.
While lawmakers appear likely to pass a physician payment bill, they are still struggling with how to pay for the likely multi-billion dollar measure. Perhaps AMA rethought its past hesitancy to back E-prescribing, which has unofficially been scored at saving $3 billion over five years, after House and Senate lawmakers shocked doctors last week by proposing to block physician-owned specialty hospitals as part of the Iraq War supplemental bill. The specialty hospital “pay for”—enthusiastically embraced by hospitals—could potentially be pushed into the Medicare bill. But, maybe not, if e-prescribing is used as a bill payer instead.
Meanwhile, pharmaceutical benefit managers have been lobbying hard for lawmakers to use the Medicare bill to ramp up electronic prescribing, as have other stakeholders, reports Inside CMS’ Amy Lotven. The idea is also widely backed by lawmakers and the Bush administration. It was included in an early draft of last year’s Medicare fix, but did not make the final cut.
E-prescribing legislation pending in both chambers of Congress encourages physicians to integrate e-prescribing into their practices by offering a 1 percent per-claim bonus. The bill, as it currently stands, would slap a 10 percent per-claim schedule cut on physicians who do not adopt the mechanism by January 2011. The bill’s advocates complain that physicians are not voluntarily adopting e-prescribing.
FDA PREEMPTION SPOTLIGHT SHIFTS FROM HIGH COURT TO CONGRESS
Industry advocates of FDA preemption have been on a roll. The Supreme Court recently ruled that FDA regulations preempt state tort suits involving FDA-approved medical devices, and a drug preemption case will be taken up by the court later this year. All good news for preemption advocates. But House Democrats are about to rain on their parade.
Oversight and Government Reform Committee Chair Henry Waxman (D-CA) is livid at the high court’s ruling, and has drafted a bill to overturn it. Plus, he will hold a hearing on Wednesday on the hot-button issue of whether FDA drug and medical device regulations should bar state liability claims. Waxman has clearly already made up his mind.
In announcing the hearing, Waxman said that FDA approval of drugs and high-risk medical devices does not necessarily guarantee safety. He plans to probe the implications of “preemption” of state liability laws in the FDA context and whether FDA regulation of drugs and medical devices should bar injured patients from seeking compensation under state law.
Industry proponents of FDA preemption might have reason to be nervous. The simple addition of a couple of legislative words to a pending bill could settle the issue once and for all, undoing years of industry battles to get judges to side in favor of FDA preemption.
Wednesday’s hearing will certainly be a headline grabber. Among those slated to testify are parents of newborn twins who were victims of a heparin overdose. The tainted heparin scandal is viewed as a prime example of how FDA approval decisions may overlook safety concerns.
More than 30 House Democrats have said they will cosponsor Waxman’s upcoming bill,.
DRUG INDUSTRY BACKED INTO CORNER ON DTC ADS
Direct-to-consumer advertising seems to reemerge as a hot issue every time Congress is ready to pass an FDA bill. As Congress debates FDA drug import safety legislation, lawmakers again are rattling drug companies by probing DTC advertising. The topic is not part of pending drug import bills, but a House investigations panel raised major concerns about DTC ads at a hearing last week, reports FDA Week’s Sam Baker.
Subcommittee Chair Bart Stupak (D-MI) made it crystal clear he is not happy with the drug industry’s track record. “I believe that Congress needs to decide whether the U.S. should continue to be one of the two countries in the world that allow DTC ads, and if we continue to allow such advertising, whether any further limits to DTC ads should be required.”
Lest there be any doubt, he answered his own question: “If the three ads that we will discuss today are indicative of typical DTC ad campaigns, it appears that we need to enforce significant restrictions on DTC ads to protect American consumers from manipulative commercials designed to mislead and deceive for the profit of pharmaceutical companies.”
Now that’s a lot to chew for drug companies. It seems the industry’s insistence that DTC ads are mainly designed to educate consumers about new products has not gained traction with key Democrats on Capitol Hill.
FDA is also on the hot seat. FDA has made little or no progress on improving its oversight of DTC ads, the Government Accountability Office told lawmakers last week. In fact, problems GAO identified in 2006 have gotten worse. GAO places much of the blame on FDA’s policy of having lawyers review warning letters before they are sent out.
Republicans said Congress should wait for the new authorities in the FDA Amendments Act to play out before passing judgment. FDAAA gave FDA new some new power over the ads, but tougher DTC provisions were stripped out of early drafts. GOP lawmakers also said FDA should be allowed to use the extra money Congress gave to the agency’s ad reviewers in this year’s budget. Stupak disagreed: More money for reviews won’t do much good if enforcement actions are caught in a “bottleneck” in the Office of Chief Counsel, he said.
Meanwhile, drug maker AstraZeneca is urging lawmakers to revive a program that would have let FDA collect user fees in exchange for reviewing DTC ads. An appropriations bill killed the fee, and resurrecting it would require changes to the FDA Amendments Act as the law says the program is hinged on FDA collecting a certain amount in the first year.
AstraZeneca may want to think twice, however, about urging lawmakers to reopen FDAAA to broach DTC ad issues.
USP FACES HEAT FOR OUTDATED MONOGRAPHS
FDA and the U.S. Pharmacopeia have been close partners for years. Now that FDA is under fire for not catching tainted drug imports, it appears to want to share some of the heat with its close partner, USP.
For the second time in two years, FDA is urging the U.S. Pharmacopeia to fast-track revisions of testing standards for a drug or drug ingredient in response to imported products that were intentionally contaminated. FDA has asked USP to upgrade its monograph for heparin to require tests for oversulfated chondroitin sulfate, which is the contaminant found in the blood thinner that FDA officials say caused the deadly side effects in patients. It also will update the monograph more generally for tests of purity. Final changes to the heparin monograph are expected to be announced this month, FDA Week’s John Wilkerson reports.
USP chief Roger Williams says FDA and USP have moved unusually fast on the monograph revision. He told Wilkerson he is “astonished” by the immunological investigation that FDA and outside experts have conducted on the heparin contaminant, which culminated in peer-reviewed papers last month in the New England Journal of Medicine and Nature Biotechnology.
In March USP also finished an expedited revision of the monograph for glycerin. The monograph now includes testing for diethylene glycol. DEG is a poisonous chemical used in industrial solvents and antifreeze. Last year it was found in Chinese imports of toothpaste.
The USP-National Formulary is a book of public pharmacopeial standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements. USP continuously updates monographs, but it typically does so in an orderly fashion as testing methodologies evolve, and without the spurring of FDA officials during public health emergencies.
Some in FDA are also rethinking the agency’s long-standing reliance on USP monographs for OTC drugs, reports FDA Week’s Jennifer C. Smith. FDA needs the authority to require that makers of nonprescription drugs submit chemistry and manufacturing controls in premarket applications, instead of letting companies simply rely on USP’s monographs that are often outdated, an FDA official said. Such a change likely would require legislation.
But M. Scott Furness, director of the Division of Nonprescription Regulation Development, said upper FDA management thinks it impractical to expect such a change because of expected industry opposition and the slow legislative process.
FDA MAY STOP TESTING COMPOUNDED DRUG SAMPLES
Another issue that keeps popping up every few years is drug compounding. FDA has struggled for years with whether pharmacy compounders should be regulated by the agency as drug manufacturers. The courts and lawmakers have also weighed in periodically, compounding the confusion.
An internal agency memo obtained by Wilkerson signals FDA may stop testing new samples of drugs that pharmacists compound. The memo was sent from the drug center to the Office of Regulatory Affairs. However, the drug center is urging field labs to speed up analyses of samples of compounded drugs that already have been collected, as well as other types of drug samples the labs are behind on.
“Please note the need to improve timely and complete sample collection and analysis,” the memo states, referring to the drug analyses the labs do. “It is difficult to predict the volume of samples that will be collected and analyzed in coming years, except to say that near-term continuation of compounded drug surveillance sampling is unlikely.”
Meanwhile, FDA is facing pressure from Capitol Hill to take its easy on pharmacists who compound drugs containing estriol. A bipartisan group of lawmakers introduced a resolution May 6 calling on FDA to reverse its policy that compounded drugs containing estriol are unsafe. FDA told pharmacists in January to stop filling prescriptions for compounded hormones containing estriol, which is commonly used to treat the symptoms of menopause. The result, the lawmakers charge, is that insurers have stopped covering estriol compounds.
Estriol is not a component of any FDA-approved drug. But it has a monograph from U.S. Pharmacopoeia. Congressional opponents of FDA’s estriol policy say that Congress has always considered a USP monograph sufficient to allow a substance to be included in compounded drugs. Oops, maybe lawmakers haven’t been paying close attention to FDA’s concerns about USP monographs, lately.
The International Academy of Compounding Pharmacists praised the House resolution, stating in a release that “FDA’s policy is an unwelcome intrusion of federal bureaucrats into thousands of doctors’ offices.” The National Community Pharmacist Association also applauded the move.--Donna Haseley