Legal News

When the Medicare Part D program starts up next year, one group that will be monitoring the quality of services provided by pharmacists is made up of the state-based quality improvement organizations (QIOs). So reported Karen Bell, M.D., M.S., division director of the Quality Improvement Group at the Centers for Medicare & Medicaid Services.

While the Medicare Part D drug benefit is still on track to begin on Jan. 1, 2006, another CMS program that was scheduled to kick off then—Medicare Part B's competitive acquisition program (CAP)—will now have a delayed start. Two days before all bids to the CAP program were due to the Centers for Medicare & Medicaid Services, as outlined in an interim rule published in the July 6 Federal Register, the agency announced that it's returning all the bids it has received and suspending the bidding process. CMS explained that it is setting back the program in order to make it more attractive and efficient.

An Institute of Medicine panel began a year-long investigation last month with hope of recommending fixes to the nation's foundering drug safety system. The panel was commissioned by Food & Drug Administration officials, who pledged to seek improvements to safety monitoring in the wake of highly publicized problems with COX-2 drugs, selective serotonin reupake inhibitor (SSR) antidepressants, and other products.

Just because pharmacists or pharmacies don't know that certain actions are prohibited by the Healthcare Insurance Portability & Accountability Act doesn't mean they can't be brought up on criminal charges for violations, according to a ruling issued by the U.S. Department of Justice (DOJ).

As California and Florida gear up to implement new pedigree laws—legislation that requires a paper trail on prescription drugs to thwart counterfeiting—there are growing signs of resistance and complaints that it will be very costly to install a uniform tracking system.

Until now, all distributions of Schedules I and II controlled substances required the completion of the Drug Enforcement Administration's Form 222. As of May 31, DEA came out with an electronic alternative to the paper form. DEA says the system will "go live" soon, although it has not released a specific date.

A new patient enters a pharmacy with an Rx for OxyContin (oxycodone, Purdue). The patient seems nervous, the script is smudged, and there was a recent front-page news article about stolen Rx pads. What's the next step here?

T o counter the rise in drug counterfeiting, three states now have prescription drug pedigree laws on their books, another 15 have similar legislation in the pipeline, and the Food & Drug Administration is threatening to enforce its long- dormant Prescription Drug Marketing Act (PDMA) regulations related to drug pedigrees by the end of 2006.

How do you know when a prescription is forged or when the prescription drug a customer refills at your pharmacy is being resold on the street? And when you have a suspicion about an Rx, what are the best courses of action to take?

How do you know when a prescription is forged or when the prescription drug a customer refills at your pharmacy is being resold on the street? And when you have a suspicion about an Rx, what are the best courses of action to take?

The Centers for Medicare & Medicaid Services is designing a comprehensive Medicare information Web site for pharmacists, as well as a pharmacy kit. The agency will also be sharing more information through continuing education and special pharmacist outreach events.

The administrator of the Centers for Medicare & Medicaid Services, Mark McClellan, is in a big hurry. A telltale sign is the rapid-fire way in which he spoke before pharmacists at the American Pharmacists Association annual meeting in Orlando last month. McClellan knows there are still many plans to be laid in the remaining months before Medicare Part D can be rolled out next January. But on schedule it will be, he vowed repeatedly at APhA's opening general session.

More and more hospitals are using specialty pharmacies as suppliers of injectable biotech therapies. For the most part, the drugs are shipped directly to the patients, physician offices, or home infusion vendors, but there are times when the drugs are delivered to a hospital to be given at an on-site infusion clinic or in hospital-based physician offices. Pharmacy directors may be wondering exactly where their responsibility for these drugs begins and ends.

Drug manufacturers breathed a collective sigh of relief last month after a Food & Drug Administration advisory panel concluded, at the end of three days of hearings, that COX-2 inhibitors should be allowed to stay on the market. The panel urged strict limits on the drugs as a condition of their continued sale, reflecting a sense of unease among experts and many patients over whether the benefits are worth the risks. The committee's narrow approval allowing Vioxx (rofecoxib, Merck) back on pharmacy shelves also reflected the public's willingness to accept the drug after widespread media coverage of its potential for cardiovascular harm.

A civilian pharmacist at a medical clinic tied to the U.S. Naval Hospital at Pensacola, Fla., was suspended for two weeks without pay last month for refusing to let a technician check prescriptions he had filled.

Medicare prescription rules are final, but we won't know how the system works until it is thrown into the real world, said a former Department of Health & Human Services policy official who did early work on the program. It is there that the drug plans will strategize to make money and the Centers for Medicare & Medicaid Services will attempt to maintain oversight.

Must pharmacies contact their state boards of pharmacy, DEA, OIG, and other agencies to see if a prospective staff R.Ph. has a license that's in order and has not been excluded from participation in Medicare and state healthcare programs?

State departments of health sometimes seek to circumvent their own procedural codes and avoid their legislatures by lowering Medicaid reimbursements and dispensing fees through emergency fiat. "They declare a state of budgetary emergency, then declare new rules and regulations," said Paul Baldwin, executive director of the Long Term Care Pharmacy Alliance (LTCPA) in Washington, D.C.

Proposed changes to the nursing facility State Operations Manual are well-meaning but far from ideal. That's the reaction from consultant pharmacists who have studied the latest proposals from the Centers for Medicare & Medicaid Services (CMS).

What do the Kansas City pharmacist Robert Courtney, Doc's Pharmacy in Walnut Creek, Calif., and Vioxx (rofecoxib, Merck) have in common? All involve pharmaceuticals, pharmacies, claims of harm to patients—and lawsuits against pharmacists.

If you think the Medicare discount cards were confusing when they took effect last year, wait till the Part D drug benefit starts up in 2006, warned Philip Burgess, R.Ph., national director of pharmacy affairs at Walgreen Co. It might be a good idea for community pharmacists to take cover on Jan. 1, 2006, or better still, go on leave for the whole month of January, he quipped.

Regarding the practice of having pharmacy technicians call for verification/ clarification of prescriptions over illegible drug name, strength, quantity, refills, and directions, I live in Illinois and have worked for an organization that allows this. I am curious to know if the laws were being followed or violated.

The pharmaceutical industry has given a thumbs-up to NABP's voluntary plan to accredit wholesale drug distributors. Nevertheless, representatives from various drug companies gave NABP officials an earful at a seminar for pharmaceutical manufacturers in early November.

After getting extensive comments and other information from the pharmacy community over the past 10 months, the Centers for Medicare & Medicaid Services has significantly increased the "supplying fees" it will pay to pharmacists next year for the anticancer drugs and other medications that are paid for under Medicare Part B.

The inclusion of medication therapy management services (MTMS) as part of the new Medicare outpatient prescription drug benefit (Part D) was one of the American College of Clinical Pharmacy's priorities during the past year, said C. Edwin Webb, Pharm.D., M.P.H., ACCP's director for government and professional affairs. He told attendees at the ACCP annual meeting in Dallas last month that the Part D benefit, to be implemented in 2006, is focused on "high-risk" patients. Those considered to be high-risk require multiple medications, have multiple chronic conditions, and are likely to incur substantial medication costs, he explained.

Medication therapy management services (MTMS), as outlined in the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA 2003), is likely to have a significant impact on pharmacy practice, Jannet Carmichael, Pharm.D., told attendees at the American College of Clinical Pharmacy annual meeting, held last month in Dallas. She is PBM manager at VISN 21 Health Care Services at the VA Sierra Pacific Network in Reno.

If prescribers in your state are not using tamper-resistant prescription pads, they will. So predicted Carmen Catizone, executive director of the National Association of Boards of Pharmacy. California and New York have joined New Jersey, Texas, and at least nine other states in requiring special safety-paper Rx pads for some or all controlled substance Rxs.

Pharmacists in charge of residency programs should be aware that ASHP's Commission on Credentialing has recently approved several new rules related to the way such programs are accredited or reaccredited.

Drug restocking is the resale of previously sold medication that has been returned to a pharmacy or mail-order company unopened. The returns to pharmacies are by a long-term care or assisted living facility after a patient has died or had a prescription that has been discontinued.

A recent Office of Inspector General study of how much states pay R.Ph.s for Medicaid drugs outrages some industry leaders. "I'm disgusted," said John Coster, VP of the National Association of Chain Drug Stores. "Instead of a real analysis of the program, they restate the obvious, which is that states pay [for Medicaid drugs] differently. With all due respect, it reflects a trend of OIG reports that lack methodological rigor."