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Breaking News for Aug. 9, 2004
CMS has issued 1,342 pages of proposed rules governing Medicare's voluntary prescription drug benefit that begins in January 2006. Confessing unfamiliarity with medication therapy management, CMS is seeking more input about possible requirements for such programs. The agency is assuming that pharmacists will be the primary providers of such services but noted that medication therapy management programs (MTMPs) could also use other healthcare providers. While MTMPs will be required to pay for provider services, CMS will not set the fees. To read the proposed rules, go to www.cms.hhs.gov/medicarereform/, scroll down in the "Highlights" section, and click on the proposed rule. The MTMP section begins on page 209. CMS will take comments for 60 days after the July 27 publication date.
The FDA has approved a supplemental New Drug Application (sNDA) for the use of atorvastatin (Lipitor, Pfizer) to reduce the risk of myocardial infarction and angina and the risk for revascularization procedures in persons without clinically evident coronary heart disease, but with multiple risk factors. The sNDA also provides for changes to the "Clinical Pharmacology," "Indications and Usage," and "Adverse Events" sections of the atorvastatin package insert.
CMS has issued a proposal to reduce Medicare reimbursements to medical specialists for some oncology and respiratory drugs administered in doctors' offices. CMS claims taxpayers have been paying up to twice the actual prices doctors negotiate with drug manufacturers. The proposed rules would reduce doctors' Medicare reimbursements by as much as 89% for about 30 of the most expensive oncology and respiratory drugs. The proposed cuts are expected to save Medicare $16 billon over 10 years. Most of the reimbursement reductions will involve drugs that have generic versions.
CMS has issued a final rule stating that it is changing the way it calculates interest on Medicare overpayments and underpayments to healthcare providers. The change reduces the amount of interest assessed on overpayments and underpayments and simplifies the way the interest is calculated. Interest will be charged for each 30 days after an overpayment was due. For more information on the rule, which takes effect on Oct. 1, refer to the July 30 Federal Register.
Ezetimibe/simvastatin (Vytorin, Merck/Schering-Plough) has been approved as adjunctive therapy to diet for the reduction of elevated total cholesterol, LDL cholesterol, triglycerides, and non-HDL cholesterol, and to increase HDL cholesterol in those with primary hypercholesterolemia or mixed hyperlipidemia. Ezetimibe/simvastatin is also indicated as an adjunct to other lipid-lowering treatments for the reduction of elevated total cholesterol and LDL cholesterol in persons with homozygous familial hypercholesterolemia. Across the dosing range, the ezetimibe component of Vytorin is held constant at 10 mg, while the simvastatin component ranges from 10 mg to 80 mg.
GAO has come out with a report warning about HHS' Pharmacy Plus waiver program, which offers low-income people not eligible for Medicaid benefits drug coverage with the help of state and federal funds. GAO said the program, now in effect in Florida, Illinois, South Carolina, and Wisconsin, does not look like it will be budget neutral. GAO urged HHS to take greater care before awarding other states a waiver for the program.
ASHP is pleased with a bill the Senate has passed that enables healthcare providers to voluntarily report medical errors to patient safety organizations without fear of being sued. The Patient Safety and Quality Improvement Act must now be reconciled with a House version, which passed last year.
The FDA has issued a Talk Paper warning about counterfeit versions of simvastatin (Zocor) and carisoprodol that were imported from Mexico by individual Americans. Tests indicate that the counterfeit simvastatin did not contain any active ingredient and the counterfeit carisoprodol differed in potency compared with the authentic product. The bogus drugs were reportedly purchased at Mexican border town pharmacies and sold under the names Zocor, 40/mg (lot # K9784, expiration date November 2004), and Carisoprodol, 350/mg (lot # 68348A). Those who may have purchased these phony drugs should consult with their physician as well as notify their local FDA field office.
DEA is proposing to require that manufacturers, distributors, and exporters of pseudoephedrine, ephedrine, and phenylpropanolamine implement security procedures to prevent the theft and diversion of these List I chemicals. These chemicals are available in OTCs and are widely used in the illicit production of methamphetamine and amphetamine. Based on the number of reports and the size of thefts from manufacturers and distributors of these chemicals, DEA is proposing that these companies implement security measures similar to or as effective as those used for Schedule III though V controlled substances. Written comments must be sent on or before Oct. 28. For more information, call (202) 307-7297. Comments may be sent to dea.diversion. firstname.lastname@example.org or www.regulations.gov.
Alamo Pharmaceuticals has launched clozapine (FazaClo, USP) orally disintegrating tablets, indicated for the management of severely ill patients with schizophrenia who fail to respond adequately to standard drug therapies for the disease. The product, which uses proprietary OraSolv technology licensed from CIMA Labs, is Alamo's first product to reach the market. Clozapine was previously approved in tablet form as Clozaril (Novartis Pharmaceuticals).
A new liquid formulation of palivizumab (Synagis, MedImmune) has been approved to prevent serious lower respiratory tract disease caused by respiratory syncytial virus in pediatric patients at high risk for RSV disease. The new formulation is supplied as a sterile solution ready for injection, eliminating additional preparatory steps. The company plans to end production of the current formulation for the United States and begin manufacturing liquid palivizumab, which should be available here for the 2005-2006 RSV season.
Beginning Jan. 1, 2005, Medicare will pay for an initial comprehensive physical examination for new beneficiaries. The "Welcome to Medicare physical" will include influenza and hepatitis B vaccines, mammograms, Pap smears, pelvic exams, and screening tests for prostate cancer, colon cancer, glaucoma, osteoporosis, and other conditions. New beneficiaries will have to obtain the exam within six months of enrollment. In addition, Medicare will cover two diabetes screening tests per year for high-risk beneficiaries and tests every five years to detect cardiovascular diseases in beneficiaries with no outward symptoms. Medicare will cover patient education efforts to address medical problems that are detected in the exam.
The FDA has approved acamprosate (Campral, Forest Laboratories/ Merck) delayed-release tablets for the maintenance of abstinence from alcohol in those with alcohol dependence who are abstinent at treatment initiation. Acamprosate is the first new medication in nine years to receive FDA approval for this indication. The drug will be available to physicians, patients, and pharmacies by the end of the year.
GAO has come out with a report highly critical of JCAHO. The report said that in a study of 500 hospitals surveyed by JCAHO from 2000 to 2002, the accrediting agency failed to identify many deficiencies later detected by state regulators. GAO added that it's unsure whether JCAHO's new accreditation process, implemented in 2004, would do a better job of detecting hospitals not in compliance with Medicare requirements. GAO urged Congress to give CMS the authority to adequately oversee JCAHO and patient safety in hospitals. In response, JCAHO claimed the GAO analysis used "misleading metrics" and omitted information about its effectiveness.
Asked whether Congress will approve drug importation, John Gans said, "Over APhA's dead body." During a visit to Drug Topics headquarters, the APhA executive VP-CEO said his sense is that drug importation is "a really, really bad way" to deal with what is fundamentally a pricing issue. He added that U.S. pharmacists can't get involved in foreign drugs because they and their employers lack liability insurance coverage.
Four Minnesota Medicaid recipients filed a class-action lawsuit alleging the state's co-pays are illegal. The suit arose after pharmacies refused to fill Medicaid scripts or threatened to stop dispensing them if the recipients didn't pay up on overdue co-pays. State law adopted last October allows R.Ph.s and physicians to deny service to Medicaid recipients who fall behind in their co-pays. The co-pay is $3 for brand drugs and $1 for generics.
Breaking News. Drug Topics Aug. 9, 2004;148:4.