NCPA: U.S. Reps. contact Medicare in support of proposed changes for 2015 drug plans
NCPA: U.S. Reps. contact Medicare in support of proposed changes for 2015 drug plans
February 12, 2014 | By Michael Johnsen
ALEXANDRIA, Va. — Members of Congress are contacting the U.S. Centers for Medicare and Medicaid Services in support of pro-patient improvements the agency proposed for Medicare Part D prescription drug plans in 2015, a development applauded today by the National Community Pharmacists Association.
In response to problems with “preferred pharmacy” networks, CMS has proposed allowing any willing pharmacy to offer a plan’s lowest, or preferred, cost-sharing to give seniors more choice and to foster greater competition among pharmacies.
U.S. Representatives Mike Rogers, R-Ala., and Lynn Westmoreland, R-Ga., have written to CMS to back the change.
“I was encouraged to hear that the proposed rule for Part D dealt with many of the concerns that [community pharmacists] shared with me,” Rep. Rogers wrote. “Not only were these community pharmacies not allowed to even try and compete with lower co-pays that larger stores can offer, but many seniors signed up for these plans not realizing they would no longer be able to continue using their community pharmacy after signing up.”
Rep. Westmoreland wrote to CMS that, “Your agency’s recent release of its proposed rule on Part D has some very encouraging language that addresses” concerns raised by community pharmacists and patients, adding that “I believe the work is not yet complete and that it is crucial that Congress and the Executive Branch make sure small business pharmacies have the ability to compete on a level playing field with all the entities involved.”
Both lawmakers represent rural communities and noted that independent community pharmacies often serve such areas where national chain pharmacies may not exist.
“We commend these lawmakers for voicing their support on behalf of their constituents for the common-sense enhancements that Medicare has proposed for drug plans next year,” said NCPA CEO Douglas Hoey. “Patients will benefit from more choice and competition among pharmacies if CMS’ proposal is made final. Independent community pharmacies deserve the opportunity to match the contract terms and conditions, including pricing, of ‘preferred’ pharmacies. As Medicare officials have noted, this is ‘the best way to encourage price competition and lower costs in the Part D program.’”
In March 2013, 31 U.S. representatives sent a letter to CMS to express concerns over exclusionary preferred networks in Medicare Part D. In particular, the lawmakers said, “We fear these networks could lead to a decrease in access to quality care and threaten the survival of community pharmacies” and further demanded a response from CMS. Shortly thereafter, the agency received a similar letter from 16 U.S. senators. CMS subsequently issued the proposed rule open until March 7, 2014 for public comment.
While preferred pharmacy networks have been championed by pharmacy benefit managers as producing astronomical cost savings, a series of analyses of Medicare data have found repeated instances where preferred pharmacy plans and PBM-owned mail order are more expensive for Medicare.
Read Full Article Here: http://drugstorenews.com/article/ncpa-us-reps-contact-medicare-support-proposed-changes-2015-drug-plans
GAO: Federal upper limits 1.4% lower than National Average Drug Acquisition Cost
GAO: Federal upper limits 1.4% lower than National Average Drug Acquisition Cost
February 7, 2014 | By Michael Johnsen
WASHINGTON — In a report publicly released Thursday by the U.S. Government Accountability Office, the GAO found that the total draft federal upper limits amount based on the new formula under the Patient Protection and Affordable Care Act was about 1.4% lower than the total National Average Drug Acquisition Cost amount in aggregate for 1,035 outpatient drugs subject to the FUL in first quarter 2013. GAO found large differences between the total PPACA-based FUL amount and the total NADAC amount for generic and for branded generic versions — brand-name drugs with other versions that can be substituted for one another — of the drugs subject to the FUL in first quarter 2013.
GAO found that the total PPACA-based FUL amount for the generic versions was 19% higher than the total NADAC amount, but for the branded generic versions was 26% lower. GAO’s work indicates that CMS is close to having a formula under which FULs would better reflect pharmacy acquisition costs, but continues to apply FULs that were calculated more than 4 years ago. Additionally, the relationship between PPACA-based FULs and NADACs may be affected by several factors, including rebates and discounts that are not reflected on pharmacy invoices. To determine whether GAO’s early results of the relationship between the PPACA-based FULs and the NADACs holds over time will require continued monitoring by CMS, GAO reported.
To develop a national benchmark for retail pharmacy acquisition costs of Medicaid covered outpatient prescription drugs — known as the National Average Drug Acquisition Cost — the Centers for Medicare & Medicaid Services within the Department of Health and Human Services surveys each month randomly selected retail community pharmacies for invoice data on their actual drug acquisition costs. CMS then calculates an average acquisition cost for each drug based on invoice data received from about 500 to 600 pharmacies. CMS officials expressed confidence in their current process, but noted that some limitations may exist, GAO noted. For example, CMS officials stated the extent to which NADACs reflect rebates and discounts is limited because most occur off-invoice or are not tied to a specific drug purchase. CMS has developed and published more than 5,000 NADACs, which CMS has estimated apply to more than 90% of the drug claims reimbursed by Medicaid.
Read Full Story Here: http://drugstorenews.com/article/gao-federal-upper-limits-14-lower-national-average-drug-acquisition-cost
Pharmacists work with doctors to assess patients, spot medication errors and even write prescriptions as the face of health care in the USA continues to change
Pharmacists work with doctors to assess patients, spot medication errors and even write prescriptions as the face of health care in the USA continues to change
Anna Gorman, Kaiser Health News 12:29 p.m. EST February 7, 2014
NORTHRIDGE, Calif. — Jill Freedman felt as if her heart was jumping out of her chest. She knew her blood pressure was too high and feared having a heart attack or a stroke.
“I was freaking out,” says Freedman, 55. “You get very emotional when you think you could drop dead at any moment.”
Her doctor doubled one of her medications, she says, but that only made her feel worse. So Freedman turned to the one person she knew she could count on — her pharmacist.
“It was Diana who figured out what the problem was,” says Freedman, referring to her longtime pharmacist, Diana Arouchanova. “Had she not been on top of what I’m going through, God knows how many more weeks this could have potentially gone on.”
Arouchanova, who owns Clinicare Pharmacy, reviewed Freedman’s medications and realized that her problem stemmed from the dangerous combination of two prescriptions. She got the physician to change the medications and started checking Freedman’s blood pressure daily. Soon, it began to drop.
Once limited to filling and dispensing drugs, pharmacists are increasingly providing direct care to patients. Across the country, they work with doctors to give immunizations and help patients safely manage medications. In some places, they can write prescriptions after a physician’s diagnosis.
California is among the states to give pharmacists the greatest flexibility, partly because of a law that took effect this year. Other states, including New Mexico and North Carolina, also allow pharmacists to take on more clinical responsibilities.
It’s all part of a push by druggists and pharmacies to take a greater role in guiding patients and promoting good health. One prominent example is CVS Caremark’s announcement this past week that it will stop selling tobacco products to help customers become healthier — an image shift that the company says will serve it in the long term.
At the same time, health officials are looking for ways to ease the strain on overloaded doctors, improve care and contain costs. With millions of people gaining coverage under the nation’s health law, experts say pharmacists can fill gaps in primary care and help avoid unnecessary hospital admissions.
Read Full Article Here: http://www.usatoday.com/story/news/nation/2014/02/07/pharmacies-healthcare-clinical-medicine-rx/5262645/
CMS’s Newly Proposed Rules Might Level the Playing Field for Independents in 2015
CMS’s Newly Proposed Rules Might Level the Playing Field for Independents in 2015
Posted by: imedicare.com by Kaitlin Strickland on January 24, 2014
In early January, CMS released CMS-4159-P, a document outlining proposed changes for Medicare Advantage and Medicare Part-D in 2015. While these changes are still just proposals, many of the rules are potentially big wins for independent pharmacies. After lobbying hard, it appears CMS has answered the NCPA’s calls on three key issues:
Preferred Pharmacy Networks
CMS’s proposed changes take a stab controlling the rapid and unequal expansion of preferred networks. In 2011, Walmart ushered in the era of preferred pharmacy networks with its Humana-Walmart plan. Now, only a few years later, roughly ¾ of all Part-D plans have a preferred network. Unsurprisingly, independent pharmacies are barely represented in these networks, and as NCPA research has shown, using a preferred pharmacy does not ultimately guarantee lower cost sharing.
CMS’s proposal would give every retail pharmacy, regardless of affiliation, the right to join a preferred network, provided they agree to the plan’s terms and price cuts. On top of that, CMS is also proposing a nomenclature change. “Preferred Pharmacies” are out, and “Preferred Cost Sharing” is in. CMS hopes to remove the perceived fault assigned to “non-preferred pharmacies”, which, for the most part, have never had the chance to join a preferred network to begin with. While this change may seem subtle, it goes to show that CMS understands how uneven the playing field has become in such a short time.
Mail Order Pharmacies
According to the Journal of Managed Care Pharmacy, mail order pharmacies now dispense 23.5% of all prescriptions, with that number being even higher in the senior population. Part-D plans are increasingly pressuring seniors to use mail order, and seniors are switching – often because they don’t fully understand their rights and options.
While mail order pharmacies may be cheaper for the patient, the lower price often isn’t worth the hassle. If there is an issue while filling a prescription via mail, the margin for error is too small to guarantee the patient will get their meds on time. CMS took note of this in their 2015 proposed changes. The new rule would continue to allow mail order pharmacies to offer lower cost sharing than preferred pharmacies in the case of extended days supply, but not in the case of a 1-month supply. CMS even goes on to say that they believe “filling initial prescriptions or routine 30-day supplies at mail-order is not good practice.” It seems CMS is recognizing the difficulties many customers face during the mail order process, and are proposing a fix. The new regulation will also allow for increased competition. Obviously, this is great news for the independent pharmacies. They may actually stand a chance of regaining the monthly customers they lost to mail order.
MAC (Maximum Allowable Cost)
Ignorance is not Bliss. CMS is aware that pharmacies are basically forced into signing contracts without any promises or guarantees on their future reimbursements. This issue rose to the forefront in 2013 after the huge spike in generic drug prices. Of course, there are a variety of reasons for the recent increase in generic drug prices (low supply, market consolidation, etc), but common generics are now chipping away at pharmacy revenue, and independents need to know what they’re getting themselves into. Thankfully, CMS’s new proposal would be a fantastic step in the right direction towards pricing transparency. The proposal redefines the meaning of “prescription drug pricing standards”, closing the semantic loophole that has allowed PBMs to keep their pricing secret. If passed, the proposal requires that all prescription drug pricing standards must be updated on “January 1st of each contract year, and not less frequently than once every 7 days”, essentially every week. This means your reimbursement estimates just got a lot more accurate.
We won’t find out the final word on these proposed rules until later in the year, but in the meantime, the plan is open for comments until March 7th. The NCPA’s initial response was positive, and it went on to thank CMS for listening to the requests they’ve been making for years. Seems like big changes are ahead.
You can read the NCPA’s response here, or make your own comment on the rule by visiting www.regulations.gov and referencing CMS-4159-P. Make your voice heard!
Original post: http://imedicare.com/cmss-newly-proposed-rules-might-level-the-playing-field-for-independents-in-2015
FDA Prohibits Facility from Producing and Distributing Drug Ingredients for US Market
FDA Prohibits Facility from Producing and Distributing Drug Ingredients for US Market
January 29, 2014 5:20 PM
A Food and Drug Administration (FDA) decree has prohibited Ranbaxy Laboratories, Ltd, from manufacturing and distributing active pharmaceutical ingredients (APIs) from the company’s facility in Toansa, India, for use in FDA-regulated drug products. An inspection of the facility on January 11, 2014, identified significant current good manufacturing practice violations, including retesting of raw materials, intermediate drug products, and finished APIs in order to produce acceptable findings after items failed analytical testing and specifications. According to an FDA press release, the facility is now subject to certain terms of a consent decree of permanent injunction entered against Ranbaxy in January 2012.
Under the decree, FDA has issued an order prohibiting Ranbaxy from:
◾Distributing drugs manufactured using APIs from Toansa in the United States, including drugs made by Ranbaxy’s Ohm laboratories in New Jersey;
◾Manufacturing APIs at its Toansa facility for FDA-regulated drug products;
◾Exporting APIs from Toansa to the US for any purpose; and
◾Providing APIs from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers.
If FDA determines that a medically necessary drug is in shortage or at risk of shortage as a result of this action, the agency may modify this order in order to preserve patient access to the drugs manufactured under controls that are sufficient to assure quality, safety, and effectiveness, indicates the press release.
Read Full Article: http://www.nabp.net/news/fda-prohibits-facility-from-producing-and-distributing-drug-ingredients-for-us-market
Ranbaxy’s repeat violation elicits swift FDA action
Ranbaxy’s repeat violation elicits swift FDA action
During an inspection of Ranbaxy Laboratories’ key active pharmaceutical ingredient plant more than a year ago, plant officials were warned: Lock down access to a standalone computerized system so unauthorized workers couldn’t mess with data. But in an inspection earlier this month, FDA investigators not only found that their directions had been ignored but they also uncovered evidence that what they feared would happen, the deletion of data, had in fact taken place. The response from Washington was swift and severe this time. Last week the FDA banned the API plant from shipping any more products to the U.S.
The API plant in Toansa, India, now joins Ranbaxy formulation plants in Mohali, Dewas and Paonta Sahib in India that are banned from shipping products to the U.S. The FDA made 8 observations during the Jan. 5 through Jan. 11 inspection of Toansa, according to a Form 483 inspection report the FDA posted publicly on Monday. Particularly troubling, the FDA said, was that workers at the plant had been retesting products that failed analytics until they got the results that were needed, overwriting the old results in its database. Proper analysis procedures were not followed, and equipment was not properly calibrated.
In terms of plant condition and sanitation, inspectors noted that a refrigerator where samples were stored was dripping, leaving a pool of water beneath it. They also said cabinets where important documents were stored were broken and didn’t close. In addition, windows in the quality-control analytics lab could not be closed, allowing in flies “Too Numerous To Count.” The FDA is not having the generic drugmaker pull products already on the market and is assessing what the ban will mean in terms of potential drug shortages
Read more: Ranbaxy’s repeat violation elicits swift FDA action – FiercePharma Manufacturing http://www.fiercepharmamanufacturing.com/story/ranbaxys-repeat-violation-elicits-swift-fda-action/2014-01-27#ixzz2rklMLOdE
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