Category:

With four days left in the sign-up period, Nevada's health insurance exchange is closing in on 80,000 customers...Nevada Health Link had enrolled 79,055 people by Saturday, the U.S. Department of Health and Human Services said Wednesday...The sign-ups include automatic renewals from 2015, though the federal government didn't break down numbers by existing versus new enrollments...With three days left until the Jan. 31 enrollment deadline, Nevada Health Link has already bested the 72,000 sign-ups it had a year ago.

Martin Shkreli appears to be a big step closer to testifying before a congressional committee...US Department of Justice wrote a letter Sunday to a federal judge overseeing a securities fraud case against Shkreli to say “the government does not object to (Shkreli) traveling to Washington, D.C., to comply with the House Committee’s subpoena” to testify at a hearing on prescription drug pricing. As part of his $5 million bail order, Shkreli is prevented from traveling outside parts of New York City and nearby Long Island...The letter paves the way for Shkreli to appear before the House Oversight and Government Reform Committee, which wants to explore the rising cost of medicines. A hearing had been scheduled for Tuesday, but it has been postponed to Feb. 4 due to the recent blizzard.

Pam Perondi feels she's been blindsided by her health insurance provider, Prominence Health Plan..."It feels like bait and switch."...She says her open enrollment period was closing in mid-December. At the same time, Prominence was informing the Carson Medical Group, which includes the lion's share of the Carson medical community, it was cutting its compensation to them by a third....That was more than the medical group could absorb...Administrator Michael Lollich says the group held off for a week, hoping for reconsideration. Then on the 28th, they notified their patients they were no longer accepting Prominence insurance...The news came after the deadline for Pam Perondi and 700 others to make their decision...Carson Medical Group says it feels for its former patients...the group had no choice and the late notification left them with no time to work on a solution...Perondi isn't sure what she'll do now..."I'm just angry," she says, "and I feel sorry for all the others this has happened to."

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.

Cheaper "biosimilar" copies of expensive biotech drugs received a boost in Britain...when the country's health cost-effectiveness agency NICE (National Institute for Health and Care Excellence) said patients needing such medicines "should be started with the least expensive drug"...So-called biosimilars are gaining ground in Europe, which has been faster to adopt their use than the United States, offering savings to healthcare systems and threatening sales of companies making original products...The latest ruling by the National Institute for Health and Care Excellence is a further victory for the biosimilar lobby and may help two cheaper copies win market share from five other original brands...The potential for biosimilars to win business from pricey original brands is not only a focus for healthcare providers but also a growing concern for investors, worried about the impact on large drug company earnings...A growing number of biosimilar versions of top-selling biotech medicines are set to reach the market in the next few years, although the scale of their impact is unclear...

Federal inspectors will soon release details on problems at blood-testing facility...U.S. health inspectors have found serious deficiencies at Theranos Inc.’s laboratory in Northern California...The problems were found during an inspection by the Centers for Medicare and Medicaid Services, the chief federal regulator of clinical labs, at the blood-testing company’s facility in Newark, Calif. Failing to fix the problems could put the Theranos lab at risk of suspension from the Medicare program...inspection results are expected to be publicly released soon...

New York Governor Andrew Cuomo has become the latest entrant in the escalating war over rising drug prices with a budget provision that would effectively cap prices and require drug makers to provide a raft of information about their costs...proposal marks yet another high-profile attempt to force the pharmaceutical industry to respond to the intensifying clamor over the cost of medicines...Under the proposal...the state health department would "develop a list of critical prescription drugs for which there is a significant public interest in ensuring rational pricing." The department would then assess the value of the drugs in order to set a "ceiling price" and could require a minimum rebate to the state Medicaid program...the administration wants companies to provide data about development, manufacturing, and marketing costs for drugs on this list...also require drug makers to submit information about the prices charged other purchasers in the state and outside the United States, any rebates offered customers, and profit margins...the Pharmaceutical Research and Manufacturers of America...have "significant concerns" with the proposal..."Not only will implementing price controls have a very negative impact on innovation and send a signal that risk taking will not be rewarded, but also the so-called ‘transparency’ information called for in the proposals would be virtually impossible to achieve because it does not include the cost of failures inherent in the search for new treatments and cures.

Senator Edward Markey is using Senate rules to block the nomination of a proposed new leader of the Food and Drug Administration in an attempt to force the agency to rescind its approval of a prescription opioid for children and change its regulatory practices...Using parliamentary procedures, the Massachusetts Democrat has put a "hold" on the nomination of Dr. Robert Califf, which prevents the Senate taking a confirmation vote...Markey, who has made the growing wave of opioid addiction one of his legislative priorities, is demanding that the FDA agree to reverse its 2015 decision allowing the pediatric use of the prescription painkiller OxyContin. He also wants the agency to commit to convening expert advisory panels to provide advice whenever considering the approval of an opioid drug, and to ensure that the risks of drug addiction and abuse are taken into account whenever the agency considers approving a prescription opioid...

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.

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.