Agency takes action on Darvon, Darvocet,Onsolis and others.
After the media buzz on Vicodin, Percocet, and Tylenol due to public concern over acetaminophen toxicity, the Food and Drug Administration has focused its attention on pain medications containing propoxyphene and opioid. The agency recently issued successive actions and warnings.
FDA announced in a press release that it is requiring manufacturers of propoxyphene-containing products to strengthen the label, including the boxed warning, emphasizing the potential for overdose when using these products. These manufacturers will also be required to provide a medication guide to patients that stresses the importance of using the drugs as directed. Data linking propoxyphene and fatal overdoses triggered the new labeling requirement.
Propoxyphene manufacturers are required to submit the requested safety labeling changes to the FDA within 30 days or to provide a reason why they do not believe such changes are necessary. If they do not submit new language, or if the FDA disagrees with the language the companies propose, the Food, Drug, and Cosmetic Act provides strict timelines for discussions regarding the changes. At the end of these discussions, the FDA may issue an order directing the labeling changes as deemed appropriate to address the new safety information.
Onsolis Approved with Required Risk Reduction Plan
Meanwhile, FDA approved Onsolis, a medication intended for certain patients with cancer to help manage severe flares of pain that break through regular pain medication.
Onsolis is in a class of drugs that deliver the potent opioid fentanyl through the mouth’s mucous membranes via an absorbable film that sticks to the inside of the cheek. Since fentanyl is subject to abuse and misuse, Onsolis was approved with a Risk Evaluation and Mitigation Strategy, or REMS, which is a required plan for managing risks associated with a drug or biological product.
The drug is indicated for the management of breakthrough pain in patients with cancer, ages 18 and older, who already use opioid pain medication around the clock and who need and are able to safely use high doses of an additional opioid medicine. Such patients are considered opioid tolerant because of their current opioid medication use.
“Onsolis can provide strong pain relief to patients who are opioid tolerant. But for patients who are not opioid tolerant, it can lead to overdose, sudden serious breathing difficulties, and death,” said Bob Rappaport, MD, director of the Division of Anesthesia, Analgesia, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research.
FOCUS to Be Onsolis Watchdog
Onsolis will only be available through a restricted distribution program called the FOCUS program. Only prescribers, patients, and pharmacies registered with the program will be able to prescribe, dispense, and receive Onsolis. Prescription orders would be filled only by participating pharmacies that send the product directly to the patients’ homes.
Onsolis was approved with a boxed warning, which states that the medication should not be used for the management of migraines, dental pain, or postoperative pain or by patients who use opioids intermittently, or on an as-needed basis. It also warns that the drug should be kept out of the reach of children and should not be substituted for other fentanyl products.
HHS is set to roll out program in 2011.
The government's goal to cut healthcare costs has conjured up an old idea that has hospitals and post-acute care venues nervous: post-acute care payment bundling.
There are calls for the Health and Human Services to formulate a plan for post-acute payment reform, including bundled payments to hospitals, home health agencies, skilled nursing facilities, and other post-acute providers.
Provider groups, including physicians, came out strongly against post-acute bundling in a June 25 hearing held by the House Energy and Commerce Committee, noted the National Association for Home Care.
A post-acute care bundling model could compromise the quality and availability of Medicare home care, cause major disruption to the health care industry, be anti-competitive, and increase the federal regulatory burden, the trade group protested.
Post-acute providers like HHAs and SNFs are especially concerned about the proposal that hospitals administer the bundled payments. “Hospitals have no experience in the management of post-acute care and no infrastructure to manage utilization review… If bundled payments are considered, they should go to community-based providers that have a breadth of experience in providing post acute care and avoiding unnecessary hospitalizations,” said Val Halamandaris of NAHC.
Meanwhile, providers in long-term acute care hospitals and inpatient rehab facilities are worried that by being high-cost post-acute providers, that hospitals may be less likely to want to share their bundled payments with them, as opposed to the cheaper venues of skilled nursing and home health.
NAHC affiliate the Home Health Financial Management Association is also fighting against a rebasing provision. MedPAC’s rationale for recommending rebasing is that HHAs now deliver fewer visits per episode than before the Home Health Prospective Payment System began in 2000.
MedPAC claims PPS was based on an average of 31 visits per episode, compared to the latest figures showing 22 visits. But the Centers for Medicare & Medicaid Services actually adjusted the visit average down to about 25 to calculate the original PPS base rate, according to HHFMA.
“MedPAC also failed to account for a decrease in lower-cost home health aide visits and an increase in higher-cost therapy services over the 1998-to-2007 period,” said HHFMA. It added that CMS has made “a series of reductions that have lowered the home health base payment rate subsequently by more than 28 percent.” Today’s base is actually less than the 2002 rate.
President Barack Obama originally wanted the House and Senate to agree on a healthcare reform bill before the recess. But now the administration will be lucky to see Congress pass two very different bills on the topic before that deadline.
If the Senate does pass a health care reform bill by then, the hard work of reconciling the two pieces of legislation will come after recess. The Senate bill is expected to garner more bipartisan support than the House version, which could make its provisions more crucial to the final health care reform bill.
Stay tuned to future issues of Medicine & Health for more developments on post-acute payment reform.