HEALTH

Pharmacy groups praise delay of DME accreditation deadline

BY Michael Johnsen

ALEXANDRIA, Va. Both the National Community Pharmacists Association and the National Association of Chain Drug Stores recently praised Senate and House action to extend durable medical equipment accreditation Medicare deadlines for pharmacies.

H.R. 3663 was introduced by Reps. Zach Space, D-Ohio, and Lee Terry, R-Neb., and passed the House by voice vote last week. The Senate then passed the House bill by unanimous consent on Monday.

The Medicare accreditation deadline was extended through the end of the year from a prior deadline of Sept. 30.

“In the debate over healthcare reform legislation, NACDS continues to advocate for an exemption for pharmacy from this accreditation requirement, as well as from the surety bond requirement – exemptions that have been afforded to other healthcare providers,” stated NACDS president and CEO Steven Anderson.

Stated Bruce Roberts, NCPA EVP and CEO, “The Senate acted wisely to ensure seniors can continue purchasing essential medical supplies from their community pharmacies. Without it, thousands of independent community pharmacies would be forced to stop supplying diabetes testing supplies and other products to their patients.”

If signed into law by President Obama, H.R. 3663 would delay the Centers for Medicare and Medicaid Services deadline for pharmacies to obtain accreditation in order to furnish DME products, like diabetes testing supplies, to Medicare beneficiaries. Both the House and Senate have included provisions to exempt pharmacies from the accreditation requirement in their versions of health reform legislation.

According to NCPA, the DME accreditation requirements have proved to be onerous, expensive and duplicative for community pharmacists, who already must meet state licensing requirements. Pharmacists have not been associated with the fraud targeted by the regulations, NCPA argued, but are the only health care providers not yet exempted. For these reasons, securing an exemption for community pharmacies has been a top legislative priority for NCPA.

In addition to the legislation, 54 members of Congress also wrote a letter to acting CMS administrator Charlene Frizzera, requesting an immediate delay of the DME accreditation and $50,000 surety bond requirements for community pharmacies. The letter was led by Reps. Space, Marion Berry, D-Ark., Jo Ann Emerson R-Mo., and Jerry Moran, R-Kan..

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NPA testifies against illegal steroids

BY DSN STAFF

NEW YORK Here’s the breakdown: Two government officials representing the Food and Drug Administration and the Drug Enforcement Agency joined Travis Tygart of the U.S. Anti-Doping Agency (the body responsible for keeping performance-enhancing drugs out of U.S. Olympic athletes), Daniel Fabricant of the Natural Products Association and Richard Kingham, a litigator specialized in food/drug law, before a panel of senators — less to inform the Senate around the problem of steroids sold as dietary supplements, and more to be grilled by those senators as to why those products are actually on any market.

 

The senators were Sens. Orrin Hatch, R-Utah, and Arlen Specter, D-Pa., who played a sort of good cop/bad cop routine. Hatch was the good cop, at least as the dietary supplement industry goes, as he defended the legislation governing the regulation of dietary supplements that he helped draft some 15 years ago. Specter played the bad cop — questioning the regulatory priorities of the two governing bodies present, while raising the thought of adding more regulations to the FDA and/or DEA already-underutilized toolbox.

 

Following the hearing, dietary supplements emerged as the unwilling participants in all of this talk around performance enhancing supplements. You almost had to wonder why Fabricant was present, except to politely remind everyone that the dietary supplement manufacturers who actually distribute product through mass-channel retailers actually fought for (as in not against) such additional regulations as certified good manufacturing practices or mandated serious adverse event reports, and as such are not likely to field illegal products.

At stake in all of this is whether or not legitimate dietary supplement players ought to seek premarket approval, a condition that if ever really implemented, would decimate any future innovation in the almost $6 billion mass-channel business (according to the latest Nielsen Company figures). It’s also a condition that wouldn’t actually do much to pull those steroid drugs masquerading as supplements off the market, unless you expect those well-respected criminals to actually file an NSA (new supplement application) that contained ingredients that would not only land their consumers in the hospital, but would also land them in jail if ever actually discovered in the trunks of their cars.

The alternative, proposed by Hatch, is to place more resources behind enforcement of the laws on the book, as opposed to creating new laws that would more likely cripple legitimate manufacturers as actually inhibit outliers from selling steroids.

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Study finds pre-pregnancy obesity poses increased risk of heart defects in babies

BY Michael Johnsen

ATLANTA The largest study of obesity during pregnancy and babies with heart defects in the United States found that women who were overweight or obese before they became pregnant had an approximately 18% increased risk of having a baby with certain heart defects, compared with women who were of normal body mass index before they became pregnant, the Centers for Disease Control and Prevention announced in a press release issued Thursday.

Severely obese women had approximately a 30% increased risk, according to the CDC study, “Association Between Prepregnancy Body Mass Index and Congenital Heart Defects,” recently published in the American Journal of Obstetrics and Gynecology.

 “Congenital heart defects are the most common types of birth defect, and among all birth defects, they are a leading cause of illness, death, and medical expenditures,” stated Edwin Trevathan, director of the CDC?s National Center on Birth Defects and Developmental Disabilities. “Women who are obese and who are planning a pregnancy could benefit by working with their physicians to achieve a healthy weight before pregnancy.”

The study looked at 25 types of heart defects and found associations with obesity for 10 of them. Five of these 10 types were also associated with being overweight before pregnancy. Women who were overweight but not obese had approximately a 15% increased risk of delivering a baby with certain heart defects.

“These results support previous studies, as well as provide additional evidence, that there is an association between a woman being overweight or obese before pregnancy and certain types of heart defects,” added Suzanne Gilboa, epidemiologist at CDC?s National Center on Birth Defects and Developmental Disabilities, and primary author of the study. “This provides another reason for women to maintain a healthy weight. In addition to the impact on a woman?s own health and the known pregnancy complications associated with maternal obesity, the baby?s health could be at risk.”

One important limitation of the study is that BMI was calculated based on self–reported weight and height, and weight may have been underreported by women during the study interview. Although the study found an association between overweight and obesity and the risk of certain birth defects, further study is needed to determine whether body weight is the direct cause of these birth defects, the agency noted.

The analysis included 6,440 infants with congenital heart defects and 5,673 infants without birth defects whose mothers were interviewed as part of the National Birth Defects Prevention Study. The NBDPS is funded by the CDC to collect information from mothers of children with and without birth defects in Arkansas, California, Georgia, Iowa, Massachusetts, New York, North Carolina, Texas and Utah. This study is the largest effort ever undertaken in the United States to identify risk factors for birth defects.

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