NACDS, NCPA seek to amend CMS AMP complaint over “multiple source” definition
ALEXANDRIA, Va. National Association of Chain Drug Stores president and chief executive officer Steve Anderson and National Community Pharmacists Association chief executive officer and executive vice president Bruce Roberts submitted an amended complaint to their lawsuit regarding the definition of multiple source drugs filed against the Centers for Medicare and Medicaid Service in November.
Last week, the two chiefs submitted comments to CMS to withdraw the rule that revised the definition of multiple source drugs based on two legal concerns.
According to the groups, “The first concern is that the rule was not subject to the normal notice and comment rulemaking process in accordance with the Administrative Procedure Act, which requires public notice and a comment period prior to such rule changes.
“Second, the Social Security Act provides that a drug is not a multiple source drug unless two or more equivalent drug products are ‘sold or marketed in the State,’—that is, whether particular drug products are generally available to the public through retail pharmacies in each state. CMS did not comply with this law in its interim final rule.”
Both organizations state that as a result of this as well as other “flaws,” Medicaid reimbursement to pharmacies will be improperly reduced and a “burden” will be left on pharmacies and states.
“America’s pharmacies are at risk of improper and inadequate Medicaid reimbursements due to the AMP rule and the revised definition,” said Anderson and Roberts, “This lawsuit amendment furthers our commitment to getting the formula right on AMP so pharmacists and their patients will not have to suffer.”
This amended complaint will not have any impact on the lawsuit.
GlaxoSmithKline forms an alliance with Regulus for microRNA research
BOSTON GlaxoSmithKline and Regulus Therapeutics LLC announced an alliance to develop and market microRNA-targeted therapeutics, according to published reports.
The Micro-RNA therapeutics would be used to treat inflammatory diseases, including rheumatoid arthritis and inflammatory bowel disease.
As a result of the deal Regulus, which is a joint venture between Alnylam Pharmaceuticals and Isis Pharmaceuticals, will receive $20 million upfront by GlaxoSmithKline and will be responsible for the discovery and development of the micro-RNA antagonists. GlaxoSmithKline, however, will be able to license the product candidates, according to published reports.
Medco breaks ground on world’s largest pharmacy
ANSON, Ind. —Medco Health Solutions has broken ground here on what will be the world’s largest automated pharmacy, scheduled to be operational by early next year.
This is Medco’s third automated pharmacy, and it will be the most advanced in terms of the efficiency of its technology and robotics, said Rich Jones, vice president and general manager of the facility.
The $140 million mail-order pharmacy also will boast a state-of-the-art research center for personalized medicine.
Located in AllPoints industrial complex, the pharmacy will be 318,000 square feet, or the size of six-and-a-half football fields, and will employ 1,300 people. Because of its scale, at peak capacity, which it’s expected to reach by 2012, the automated pharmacy will be able to process more than a million prescriptions per week.
This compares with Medco’s other facilities in Willingboro, N.J., which also processes about a million prescriptions per week, and the Las Vegas facility, which services about 700,000 prescriptions weekly.
Another advantage of the Indiana facility is its central geographic location, making it easy and cost-effective to send prescriptions anywhere in the country.
The advanced technology that Medco uses means that mistakes are rare. “In Las Vegas the only mistake has been through human intervention,” Jones pointed out.
The high level of technology also frees up the pharmacists to do the things they’re good at and allows them to use their knowledge to interact with patients and doctors, Jones said. “They can spend their time checking prescriptions and picking up potential errors.”
And because of the size of this new facility, pharmacists will each specialize in disease states, so that with this expertise, they can dig down a couple of layers deeper into patients’ medical history.
The new personalized medicine research center also will help with accuracy and is Medco’s latest move into the realm of personalized medicine.
The center will lead to active collaborations between Medco, universities and the local colleges of pharmacy to investigate how to deliver more precise pharmacy care through innovations in personalized medicine.
The PBM has partnered with clinical leaders to study the use of pharmacogenomics to advance pharmacy care. More attention is being focused on this field as more drug labels feature patients’ specific genetic information.
“Personalized medicine will really let us take patient care to another level,” Jones said.
Medco is backing pharmacogenomics because it promises to improve the safety, quality and efficiency of health care. Genetic testing can prevent adverse drug events that lead to hospitalizations, disability and even death. And because not all patients respond to medication the same way, personalized medicine can prevent patients being given ineffective medications.
Jones pointed to the example of breast cancer patients, 10 percent of whom do not respond to tamoxifen. Reactions to this drug can be tested with a simple cheek swab, which can be mailed to patients, and ensure they are put on a medication that will help their condition.
As time passes, and more data is collected, individual prescriptions will become more specific as the pharmacy knows what works for each patient and builds data profiles.
“We envision that the center will help bring personalized medicine into the mainstream of health care,” said Robert Epstein, Medco’s chief medical officer. “The science in this area is ‘popping,’ and Medco is leading the charge on translating this new science into clinical solutions on a national scale.”