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The end of what has become a decades long battle around fair reimbursement for Medicaid programs and pharmacy appears to be in sight...the Centers for Medicare & Medicaid Services issued the Covered Outpatient Drugs final rule with comment that addresses key areas of Medicaid drug reimbursement and changes made to the Medicaid Drug Rebate Program by the Affordable Care Act. According to a fact sheet published by CMS, this final rule assists states and the federal government in managing drug costs, establishes the long term framework for implementation of the Medicaid drug rebate program and creates a more fair reimbursement system for Medicaid programs and pharmacies...the final rule is designed to ensure that pharmacy reimbursement is aligned with the acquisition cost of drugs and that the states pay an appropriate professional dispensing fee. The final rule:

• Creates an exception to the FUL calculation, which allows for the use of a higher multiplier than 175% to calculate the FUL based on acquisition costs for certain multiple source drugs;
• Establishes actual acquisition cost as the basis by which states should determine their ingredient cost reimbursement so payments are based on a more accurate estimate of the prices available in the marketplace, while still ensuring sufficient beneficiary access;
• Implements the use of the term professional dispensing fee to ensure that the dispensing fee paid to pharmacies reflect the cost of the pharmacist’s professional services and cost to dispense the drug product to a Medicaid beneficiary;
• Clarifies that states are required to evaluate the sufficiency of both the ingredient cost reimbursement and the professional dispensing fee reimbursement when proposing changes to either of these components; and
• Requires states to specify in the Medicaid state plan that reimbursement methodology to pharmacies that purchase drugs through the Federal Supply Schedule and the 340B Drug Pricing Program is consistent with overall AAC requirements.

China, which manufactures most of the ingredients for Western products, has a reputation for having some pretty questionable manufacturing operations. Czech inspectors got a firsthand look at one plant that they said posed "extreme risks" to consumers...According to two reports on the plant posted by the European Medicines Agency, authorities dropped by the Huanggang City facility of Hubei Hongyuan Pharmaceutical in October after the plant had been mentioned as an intermediate manufacturing site for the antibiotic metronidazole. The company acknowledged in its introduction that the site didn't follow EU GMP standards, the report says. During a walk-through, inspectors confirmed that...They said they found a plant in a devastated state, with "huge layers of dust and product" that indicated that neither the plant nor the equipment was being cleaned or that equipment was being maintained. It was noted the situation posed "an extreme risk of cross-contamination." Additionally, almost none of the products that they saw had been labeled and there was no batch manufacturing documentation...Western authorities have stepped up inspections of Chinese plants, both of those owned by Chinese companies and those owned by Western drugmakers, and found problems in both cases.

Two Indian states have put sales of...Roche's blockbuster drug Avastin on hold, officials said on Tuesday, after it hampered the vision of 15 patients who used it for a condition it is not officially meant to treat...Avastin (bevacizumab) is a cancer drug but is often used by doctors to treat vision loss even though it has not been approved by the U.S. Food and Drug Administration for that purpose. Studies have shown that eye injections of Avastin curb vision loss...Roche's India unit said the company does not promote the use of Avastin for treatments for which it is not approved, but has initiated an internal investigation...H.G. Koshia, the top drug controller in western Gujarat state, said he had directed distributors to recall one batch of the medicine given to the patients last week. Its samples were being tested following the incident at a hospital in Ahmedabad city...The hospital said all standard protocols were followed. Koshia, Gujarat's drug regulator, said they would need to ascertain whether the drug was a fake copy of Avastin.

Nevada officials on Wednesday assured advocates in Clark County that any process to privatize Medicaid services for the elderly, blind and disabled will move slowly and will be transparent...Advocates with Nevadans for the Common Good, a coalition of Las Vegas Valley institutions advocating for several issues including protection for vulnerable senior citizens...met privately with state officials. Attendees at the closed-door meeting included Richard Whitley, director of the state's Health and Human Services Department...Barbara Paulsen, leader with Nevadans for the Common Good, said the meeting was positive and that advocates were pleased with what they learned. She said the coalition's push for transparency and the Las Vegas Review-Journal's reporting to get the information on the potential switch out to the public may have had an "impact on the process."..."Our concern was that the decision was already made and it was just all going to go very quickly without getting any input (from the public)," she said Wednesday. "That doesn't seem to be the case."...After gathering information, state officials will develop a report that will be sent to the governor and the Legislature, she said. The governor would ultimately have to make a recommendation, which the state's Interim Finance Committee would have to approve, according to the legislation.

NOTICE OF TOWN HALL AND LISTENING SESSION ON MEDICAID MANAGED CARE EXPANSION OPTIONS

• 1/20/2016 Clark County Library - 1401 East Flamingo Road - Las Vegas
• 2/2/2016   Sahara West Library - 9600 West Sahara Avenue - Las Vegas
• 2/2/2016 Summerlin Library - 1771 Inner Circle - Las Vegas
• 2/17/2016 William Bee Ririe Hospital - 1500 Avenue H - Ely
• 2/19/2016 Humboldt General Hospital - 118 E. Haskell Street - Winnemucca

All Party Pharmacy Group has warned...Between 1,000 and 3,000 pharmacies — as many as one in four — could close in England as a result of government cuts to funding for pharmacy...A letter to the Pharmaceutical Services Negotiating Committee in December 2015 announced a 6% funding cut from £2.8bn ($4bn) to £2.63bn ($3.7bn)...there would be further reductions in future years...there is also much more to this picture than a cut in funding. There is a clear intention to reduce the number of pharmacies...In some parts of the country there are more pharmacies than are necessary to maintain good access. 40% of pharmacies are in a cluster where there are three or more pharmacies within ten minutes’ walk...The Department will separately consult on changing the Human Medicines Regulations 2012 to allow all pharmacies to access the efficiency created by ‘hub-and-spoke’ dispensing...This could help pharmacies to lower their operating costs and free up pharmacists to provide more clinical services and public health services...the government would not decide which pharmacies should close. Pharmacies would need to decide whether they were "viable" in light of the change to the funding level. He admitted that independents will be "squeezed" and that this is a matter of concern for the government to look at...Warehouse dispensing, or ‘hub and spoke’, raises questions around safety, quality and access...The supply of prescription medicines cannot be treated like buying clothes and DVDs. High quality, safe dispensing depends on the opportunity for a face-to-face discussion between the pharmacist and the patient. I don’t see how that can be done in a warehouse.

Look out, pharma: Britain's competition watchdog is coming for you....The U.K.'s Competition and Markets Authority is planning to levy "substantial fines" this year, marking a "big step up in the scale and impact" of its enforcement activity, Alex Chisholm, head of the agency, told the Financial Times. And one of those fines will likely be directed at a pharma company...The CMA has been probing drugmakers including GlaxoSmithKline and Pfizer for alleged wrongdoing. "In high-value markets with big players, they should face big fines,"...For Pfizer, though, a resolution could still be a ways off. In August, the CMA accused the drugmaker and partner Flynn Pharma of running afoul of U.K. and European laws by jacking up costs for their epilepsy drug...The pair charged "excessive and unfair prices"...the CMA said at the time, raising costs by as much as 2,600%. Regulators plan to hand down a decision in the case in about three months..."While businesses are generally free to set prices as they see fit, those that hold a dominant position have a special responsibility to ensure that their conduct does not impair genuine competition and that their prices are not excessive and unfair,"...

U.S. patent officials...denied petitions by Amgen to review two formulation patents on AbbVie's Humira, a potential setback in Amgen efforts to market a biosimilar version of the world's top-selling prescription medicine...In June, Amgen...asked the U.S. Patent and Trademark Office for the review, arguing that the patents in question should not have been granted in the first place for Humira, an injected rheumatoid arthritis treatment with annual sales approaching $14 billion...In declining to review the patents, the agency said "we determine, based on the petition and the accompanying evidence, that Amgen has not shown a reasonable likelihood of prevailing on any of its challenges."...Amgen said it still plans to challenge the legality of the patents.

Master Herbs, Inc. (Ma Ying Long Pharmaceutical Group) is voluntarily recalling ALL LOTS of Licorice Coughing Liquid, cough syrup in 100 ml bottles to the consumer level. This product has been found to contain morphine, which is an opioid, and it is not declared on the label. Opioid is an ingredient of Compound Camphor. Compound Camphor is declared on the label of the product, but not its ingredients...The product is used for the temporary relief of cough due to cold, minor throat and bronchial irritations...identified by the Chinese Product Name: Licorice Coughing Liquid The product was distributed to Chinese grocery stores in various cities in California, New Jersey, Hawaii, Illinois, Ohio and Nevada.

In the first enforcement action from the FDA's marketing police this year, the Office of Prescription Drug Promotion put Hospira in the hot seat over a YouTube video for its sedative Precedex (dexmedetomidine)...The OPDP sent an untitled letter dated Jan. 14 to the Pfizer-owned company, charging the video "omits risks and material facts" about the drug. The agency also rebuked Hospira for publishing the promotional video without submitting it to the OPDP for review...The letter orders Hospira to "cease violating the FD&C Act, as described," and submit a written response before Jan. 29. The response should include a plan for "discontinuing use of such violative materials," the letter states.

Community pharmacy negotiators are refusing to negotiate with the government over its planned 6% cut in community pharmacy funding in England until it has seen details of the government’s long-term plans and the evidence behind them...The move comes as the Pharmaceutical Services Negotiating Committee voiced its fears that the government is deliberately keeping it in the dark about deeper cuts to come...We cannot agree to commence negotiations before we have had an opportunity to understand fully your plans and the analysis underpinning them…We believe we are entitled to this material but it has not been forthcoming. The government appears to have a settled intention to proceed on a course of action that will run counter to its stated ambition to develop a clinically focused pharmacy service, and be damaging to patient care...the 6% cut will force pharmacies to cut staff and damage patient confidence in the profession; the PSNC is also suspicious of government plans to create more online pharmacy services.