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NACDS expresses concerns with new FUL list for pharmacy Medicaid reimbursement

BY Antoinette Alexander

ALEXANDRIA, Va. — The National Association of Chain Drug Stores submitted on Friday comments to the Centers for Medicare and Medicaid Services regarding the draft federal upper limit list published by CMS.

"We offer these comments in the spirit of implementing a Medicaid pharmacy reimbursement policy that maintains the strong link between chain pharmacies and Medicaid patients," NACDS wrote. "In our comments, we focus on the following issues: [average manufacturer price] is an inaccurate benchmark for pharmacy reimbursement; lack of consistent AMP reporting by manufacturers; whether to calculate a federal upper limit; amount of federal upper limit; and accurate dispensing fees are critical."

NACDS has consistently emphasized that — in addition to providing access to medications and to pharmacists who enhance the effectiveness of medications by helping patients take them as prescribed — community pharmacy access is vital because such additional services as vaccinations, screenings, health education and innovative programs help to improve patient health and prevent more costly forms of care.

Dating back to the enactment of the Deficit Reduction Act of 2005 and the issuance of rules by CMS in 2007 to implement this law, NACDS has fought for patients’ medication access and to prevent unreasonable — and even below-cost — reimbursement to pharmacies for generic prescriptions filled through the Medicaid program.

NACDS and the National Community Pharmacists Association won a preliminary injunction in federal court in 2007 to block CMS’ approach to pharmacy reimbursement with the average manufacturer price model, and CMS eventually withdrew all of the contested rules.

The AMP-based reimbursement model created by the DRA was modified by provisions in the Patient Protection and Affordable Care Act, and other legislation. In addition to the FUL list, CMS shortly is expected to issue a proposed rule to implement pharmacy Medicaid reimbursement according to AMP.

Regarding the published FULs, NACDS wrote in its comments, "NACDS continues to have significant concerns with [AMP] as a basis for pharmacy reimbursement. AMP is not a price paid in the marketplace. Instead, it is a benchmark to determine manufacturer rebates in the Medicaid program."

Substantiating this concern, NACDS wrote, "After a comprehensive analysis, one NACDS member company found that more than half of the draft federal upper limits were below the pharmacy’s cost to acquire these products from a wholesaler. Other NACDS member companies have reported similar findings."

NACDS said that further undermining this approach to pharmacy reimbursement is the fact that "The absence of any specific agency guidance or regulation means there is no clear regulatory standard for manufacturers, which leads to great variability in how AMPs are calculated and reported to CMS."

NACDS also raised the issue of the applicability of the published FULs given the current absence of a new AMP rule. "Because CMS has withdrawn the 2007 AMP rule, including the sections pertaining to the calculation of FULs, there is no regulatory process in place to govern calculation of Federal Upper Limits," NACDS wrote. "As a result, NACDS believes that the draft FULs, calculated without regulatory guidance and seemingly inaccurate, should neither be made available for nor used as a basis for pharmacy reimbursement. Furthermore, no further draft FUL lists should be published before a final AMP rule is effective. At the completion of rulemaking, CMS should again issue a draft FUL list for public review and comment."

NACDS described instances in which CMS will need to make adjustments to FULs, in accordance with the new healthcare-reform law, to foster workable reimbursement. "The Affordable Care Act provides CMS with the authority to calculate Federal Upper Limits at ‘no less than’ 175%," NACDS explained. "The ‘no less than’ language in the ACA is critical. While Congress created a floor of 175% for calculating FULs, it clearly recognized that CMS would require flexibility in the level of multiplier in order to maintain patient access to prescription medications. Congress did not limit the ability of CMS to increase the multiplier to calculate FULs, but rather provided broad authority. Based on analysis of the draft FUL list, it appears that at least initially, CMS may need to increase the multiplier for calculating all FULs."

NACDS also emphasized the importance of appropriate dispensing fees: "We urge CMS to make clear to states that in order to maintain patient access to pharmacies, dispensing fees must be reviewed and adjusted to reflect no less than the true cost of dispensing prescription medications to Medicaid patients."

NACDS concluded its comments, "We are committed to working with you to implement these provisions in a manner that complies with current law and maintains access to prescription drugs and services for Medicaid beneficiaries."


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Measles cases highest in 15 years, at 212 and counting

BY Michael Johnsen

BOSTON — This year’s jump in measles in the United States and Canada was costly and occurred among unvaccinated children and adults, suggested several studies being presented at the 49th Annual Meeting of the Infectious Diseases Society of America here Thursday.

In 2011 to date, 212 people with measles have been reported in the United States, 68 were hospitalized and at least 12 of them had pneumonia, reported the Centers for Disease Control and Prevention. This is the largest number of measles cases since 1996. Rapid public health response efforts prevented measles cases and outbreaks from becoming much larger by isolating cases and vaccinating those who were unvaccinated.

Of those infected, 183 (86%) were unvaccinated or their vaccination status was unknown, and 27 (13%) were less than 1 year old. Most of the imported measles cases occurred among U.S. residents traveling overseas to Western Europe (47%), Africa or Asia, where vaccination rates are significantly lower and measles is an ongoing problem.

An outbreak of measles in spring 2011 in Salt Lake County, Utah, began when an unvaccinated local high school student returned home after traveling in Europe, where he was infected. Rapid response to control the outbreak limited it to nine people in Salt Lake County, yet managing the outbreak cost approximately $300,000 for infection control measures by two local hospitals and the local and state health departments. That cost includes physician and staff time, vaccines, immunoglobulin and blood tests, according to the Utah Department of Health.

When a child or adult with measles goes to school, everyone in the school is exposed, and Utah state law dictates that unvaccinated children and teachers — including those who cannot locate their vaccination records — must stay home for 21 days after the exposure. To contain the outbreak, 12,000 people were contacted about possible exposure and 184 people were quarantined, including 51 students. Costs to the schools associated with these actions — such as the hiring of substitute teachers and state money that is withheld from the schools when kids stay home — were not factored into the study.

“Forest fires start with sparks, but unless there is sufficient dry tinder, they won’t roar out of control,” stated James Hughes, IDSA president. “The same is true of outbreaks. The occasional case is not an issue, but when it occurs in a community where a fair number of people are not vaccinated it can cause serious problems," he said.

Thanks to a successful infant measles, mumps and rubella vaccination program, measles has been declared eliminated in the United States — meaning the illness hasn’t had continuous spread — since 2000. But outbreaks can occur when the infection is imported, typically by unvaccinated Americans who are infected while traveling to Europe or other continents and then return home, or by foreign tourists who are infected and travel to this country.

Before measles vaccination was available in the 1960s, about 3 million to 4 million people were infected with measles in the United States every year — 48,000 were hospitalized, 1,000 were permanently disabled and about 500 died, according to the CDC.

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Study: Risk of breast cancer more apparent among women with Type 2 diabetes

BY Allison Cerra

NEW YORK — A study conducted by the University of Alberta found that women with Type 2 diabetes have an increased risk of developing breast cancer.

The study, which was published in the Oct. 4 issue of Diabetes Care, examined 170,000 premenopausal (under the age of 55 years) and postmenopausal women (ages 55 years and older), half of which were diagnosed with Type 2 diabetes. After following up with them four to five years later, 1.4% of all women were diagnosed with breast cancer; however, postmenopausal women diagnosed with Type 2 diabetes were more likely to develop breast cancer.

Commenting on the results, study author Jeffrey Johnson told Reuters Health that "the relationship that we see (between diabetes and cancer), we wondered if it was something about the fact that people with diabetes go to the doctor’s office more often. When a new diagnosis of diabetes is made, people undergo a lot of tests and general health exams."

"I think there are so many things going on in the relationship that this is maybe only one part of it. We’re really early on in understanding this relationship," he said.

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