Legal News

The clinical success of an ongoing pay-for-performance (P4P) pilot project by the Centers for Medicare & Medicaid Services requires extensive participation by health-system pharmacists.

Now that we have electronic record technology, how should we set up a postmarketing surveillance system for drugs, biologicals, and medical devices?

Diabetes is a deadly, common and costly disease, so the debate about biogenerics is ardent when it concerns insulin. The drug is expensive and indispensable, and scientists agree that creating generic insulin is simpler than creating most other potential biologic equivalents.

A group of researchers at the University of Florida College of Pharmacy recently submitted a citizen's petition asking the Food & Drug Administration to increase the maximum allowable dose of phenylephrine (PE) from 10 mg to 25 mg and to withdraw approval of phenylephrine for children under 12 years of age. The petition also called for additional research to validate the safety and effectiveness of the higher recommended dose.

Pharmacy industry critics are "gravely concerned" that the Safe Drug Compounding Act of 2007, a draft Senate bill, would sharply curtail the practice of compounding by giving the Food & Drug Administration authority to regulate compounding. A coalition of nine pharmacy organizations drafted a letter to the bill's expected sponsors-Senators Edward Kennedy (D, Mass.), Pat Roberts (R, Kan.), and Richard Burr (R, N.C.)-insisting that the bill "would negatively impact patient access to necessary compounded prescription medications and create onerous, new requirements for prescribers and pharmacists."

The National Community Pharmacists Association is warning that implementation of a proposed rule for reimbursement for generic drugs through Medicaid may result in many pharmacies pulling out of the program or going out of business. Citing the results of a recent Government Accountability Office study and its own internal polling of members, Bruce Roberts, NCPA executive VP/CEO, warned that under the new rule patients would face a "serious danger of losing access to lifesaving prescriptions. What we're faced with is not a natural disaster but a public policy disaster."

Seeking to provide hard data on the efficacy and impact of medication therapy management (MTM) sessions, a Florida Quality Improvement Organization (QIO) is studying the MTM results of Humana and AvMed Medicare patients in that state. The Florida Medicare Quality Improvement Organization (FMQAI) is working with the two prescription drug plans (PDPs) and pharmacists to set up the programs and educate patients and will publish its results in late 2007. FMQAI is the third-largest QIO in the country and has the second-largest beneficiary population.

NIOSH, the National Institute for Occupational Safety and Health, is updating its list of hazardous pharmaceutical products. The new list will become part of the organization's 2004 alert, Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings.

When Michelle Rutledge, Pharm.D., heard about the fatal shooting of a hospital pharmacist at Shands Jacksonville hospital in Florida last November, it really hit home. The victim, 37-year-old Shannon McCants, was a fellow graduate of the Florida A&M College of Pharmacy. McCants was shot by a customer who was waiting for a prescription to be filled in the outpatient pharmacy. Rutledge, an associate investigator at the James A. Haley VA Hospital in Tampa, said that e-mails from former student-colleagues began pouring in.

South Carolina officials looking to reduce costs in the state Medicaid program have tapped pharmacists to help in the effort by improving drug selection and adherence. The South Carolina Department of Health & Human Services is offering a $1.98 million grant to the South Carolina College of Pharmacy (SCCP) to implement the program, which will focus on Medicaid patients diagnosed with mental health disorders, HIV/AIDS, or cancer.

The Food & Drug Administration continues to warn pharmacies that compounded medications are new drugs under FDA jurisdiction. The FDA is insistent, despite a U.S. District Court ruling in August 2006 that called into question the federal agency's authority to regulate compounded medications. In at least eight instances covering a range of compounded medications, the FDA has warned pharmacies that the compounded drugs either posed danger to patients or too closely resembled FDA-approved products.

State and federal authorities are increasingly cracking down on pharmacies for fraud, waste, and abuse

Consultant pharmacists are busy preparing to implement the Centers for Medicare & Medicaid Services' newly revised survey guidance for Pharmacy Services and Unnecessary Medications (F-Tags 329, 425, 428 and 431) in Appendix PP of the State Operations Manual (SOM). CMS released the revised guidelines on Sept. 15, with the changes scheduled to become effective on Dec. 18. They represent the first substantive changes in these sections in nearly seven years.

Are you liable for technician mistakes?

In a move that surprised both compounding proponents and advocates, the American Medical Association Board of Trustees adopted a resolution calling for Food & Drug Administration oversight of pharmacy-compounded bioidentical hormones. The resolution, which, according to sources at the AMA, passed with little opposition, also included an amendment that called on the FDA to regulate the use of the term bio-identical hormones.

Pharmacists who commit insurance fraud better watch out. Not only are regulatory authorities going to come after them the way they do after the Italian Mafia, they're going to use every forensic trick in the book that investigators on the TV show "CSI" employ-and more.

Community R.Ph.s could face a friendlier climate in Congress with Democrats having won the majority of both houses during the mid-term elections. Democrats will now take control of Congressional committees responsible for key pieces of healthcare legislation and financing.

At 5:00 a.m. one April morning last year, agents of the Drug Enforcement Administration and some sheriff's deputies burst into Scherer's Medical Clinic, a pain management center in Slidell, La., near New Orleans. Additional raids that day at area clinics and pharmacies led to the arrest of Scherer's owner, a nurse named Cookie Armstrong, and three staff doctors. All were charged with running narcotic pill mills. Twenty-three patients were also arrested over the next few days.

When First DataBank agreed to settle a lawsuit last month and pledged to stop publishing AWP (average wholesale price) data in two years, it sent ripples through the pharmacy industry. AWP has long been a key measure for determining pharmacy payments, and there is no easy answer for how to replace it. As John Rector, senior VP and general counsel at the National Community Pharmacists Association, cautioned, "This is the very beginning of what will probably be a very lengthy process."

After years of false starts, stalls, and missteps, Congress may soon be ready to tackle the thorny question of how to regulate generic biologic pharmaceuticals, lawmakers noted at the Generic Pharmaceutical Association's 2006 Annual Policy Conference held recently in Washington, D.C.

Predictions of a revolt against Republicans at the ballot box did not deter Mike Barrett, R.Ph., from running for the House of Representatives. Barrett, a pharmacist at a 34-bed hospital, challenged eight-term Democrat Collin Petersen to represent northwestern Minnesota. "Many people have told me that it is probably not a good year to be a Republican, but my district is almost evenly split between both parties with about 10% undecided," said Barrett, pharmacy manager at Long Prairie Memorial Hospital and Home.

Very few drug plan providers left the Medicare market in 2007, but their offerings have shifted. There are fewer plans offering basic coverage and more offering enhanced coverage. Beneficiaries in most states have 50-60 prescription drug plans to consider including 15 or 16 that offer partial or complete coverage in the donut hole.

Squeezed by low and slow reimbursement from Medicare Part D, independent pharmacists have certainly taken their lumps this past year. But they still managed to eke out some victories, according to leaders of the National Community Pharmacists Association, which held its annual meeting in Las Vegas last month.

In a recently issued policy statement, the Drug Enforcement Administration proposed a new rule that would ease current restrictions on prescribing Schedule II controlled substances. Under the new rule, doctors will be able to prescribe 90-day supplies of Schedule II medications such as OxyContin (oxycodone, Purdue Pharma), methylphenidate HCl, and codeine. The public can submit comments about the new rules through Nov. 6.

Closing the only pharmacy in Holly Ridge, a small town in eastern North Carolina, was not an easy decision for Randy Spainhour. The 58-year-old pharmacist knew that the closest pharmacy was 15 miles away and that it would put a big strain on many of his customers. "I felt I had no choice," he insisted. "It was either that or going bankrupt."

A new era is coming for the Medicaid program-one that will spare the state and federal governments from overpaying for drugs and provide more pricing transparency to all parties involved.

Hoping to stem a new season of confusion over Medicare's Part D prescription drug benefit, the Centers for Medicare & Medicaid Services is asking pharmacists to prepare patients for the upcoming enrollment period.