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HHS, FDA nominations still clouded

BY Jim Frederick

WASHINGTON Reports are surfacing that Kansas Gov. Kathleen Sebelius may be out of the running as Pres. Obama’s nominee for secretary of Health and Human Services, even as two strong candidates have emerged for the post of commissioner of the Food and Drug Administration.

Sebelius, a highly regarded state executive and an early supporter of Obama’s bid for the presidency, was considered a front-runner for the post of HHS secretary following the withdrawal of Tom Daschle from consideration following revelations of a delinquent tax payment problem. However, some Republican lawmakers in the Senate have voiced strong disapproval over Sebelius’ support of pro-choice abortion policies as Kansas governor, and have warned they’ll oppose her nomination.

The White House is said to be concerned about the void in health care leadership following Daschle’s withdrawal from consideration, and is moving quickly to vet potential nominees for both HHS secretary and FDA commissioner. Among the top prospective nominees for the FDA post, according to a report in The Washington Post, are two health policy experts with strong ties to some powerful congressional leaders. 

Joshua Sharfstein, one of the names most frequently cited for the post, is Baltimore health commissioner. He once served California Democratic Rep. Henry Waxman, co-author of the Hatch-Waxman generic drug compromise legislation, as a health policy advisor. 

Margaret Hamburg, also cited as a potential front-runner for FDA commissioner, served in the Clinton Administration as assistant secretary of health and human services for policy and evaluation. Hamburg also served as health commissioner for the City of New York.

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CVS Caremark pulls in record results

BY Drug Store News Team

News that CVS Caremark pulled in record results for the fourth quarter and year 2008, in light of the current economy, not only speaks volumes of the company’s well-oiled team of merchants, marketing and operations executives but is also a testament to its evolving role as a pharmacy healthcare service company focused on healthcare reform.

There’s no doubt that 2008 was a difficult year for the nation as unemployment soared, housing prices plummeted and Wall Street crumbled, yet CVS Caremark managed to pull through with strong financials and ended the year with a list of significant accomplishments. On that list: industry leading retail same-store sales growth; the introduction of its Proactive Pharmacy Care offering; solid client retention and industry leading sales in its PBM business; and the acquisition of more than 500 Longs Drug Stores and the RxAmerica PBM unit. It also ended the year with more than 500 MinuteClinics.

The news came just days after Tom Ryan, chairman, president and CEO, took his message to mainstream America via an interview with BusinessWeek. He told BusinessWeek that his goal is to help transform America’s costly and often ineffective healthcare system and plans to take advantage of President Barack Obama’s commitment to healthcare reform.

That goal has already started to take shape as CVS Caremark works to bolster its arsenal of offerings aimed at increasing adherence and cutting costs (read: Proactive Pharmacy Care) and further leverages its network of MinuteClinics. In fact, during 2009 the company will make use of its retail ad spend to drive MinuteClinic awareness, will expand its service offerings to extend relevance and will further increase the number of in-network covered lives.

This is not to say that CVS Caremark is without its share of challenges given the recession, but it certainly seems well positioned for the road ahead.

As Ryan told analysts during Thursday’s conference call, “There’s no silver bullet.” No, there isn’t a silver bullet; it is doing a lot of different things well and, so far, CVS Caremark seems to be doing just that.

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Court delays action, yet again, on Medicaid AMP payment plan

BY Jim Frederick

ALEXANDRIA, Va. In a decision praised by chain and independent pharmacy groups, a federal judge today moved to postpone a hearing regarding a government plan to implement new payment guidelines for generic drugs dispensed under Medicaid.

U.S. District Judge Royce Lamberth agreed to a joint request from the National Association of Chain Drug Stores, the National Community Pharmacists Association and the U.S. Department of Health & Human Services to delay a hearing on HHS’ plan to shift Medicaid generic drug reimbursements to a new formula, based on the average manufacturer’s price [AMP] of the drug. Behind the delay: the same issue that has hampered previous government efforts to impose the new AMP formula: the dispute over the definition of a “multiple source drug” for purposes of payment to pharmacies.

The hearing was originally set for Feb. 25. Judge Lamberth’s postponement decision is expected to freeze any further action on the case until at least mid-May, according to NACDS.

The request by NACDS, NCPA and HHS to delay the hearing came “in light of the change in administration at HHS,” noted the pharmacy groups in a joint statement. In addition, noted NACDS and NCPA, the Centers for Medicare and Medicaid, a division of HHS, “must resolve any regulatory issues related to yet another revised definition of ‘multiple source drug,’ and is not prepared to proceed with the case at this time.”

This will be CMS’ fourth attempt to define “multiple source drug.” The agency’s last attempt at a definition was rendered invalid after NACDS and NCPA argued in court that CMS failed to take into consideration an NACDS-NCPA economic report that examined the impact of AMP-based Medicaid reimbursements when developing its definition of a multi-source, or generic, medication.

“Unfortunately, the story of CMS’ Medicaid AMP rule can be summarized by the often-used phrase, ‘mistakes were made,’” said NACDS president and CEO Steven Anderson and NCPA CEO and executive VP Bruce Roberts in a joint statement. “We are committed to getting the Medicaid pharmacy reimbursement rule right, for the good of pharmacy, patients and nation’s entire healthcare delivery system.

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