- Massachusetts grabs spotlight by proposing new twist on Medicaid drug coverage (healthcarefinancenews.com)
Massachusetts' state Medicaid program hopes to road-test an idea both radical and market-driven. It wants the power to negotiate discounts for the drugs it purchases and to exclude drugs with limited treatment value..."This is a serious demonstration proposal,"..."They're not simply using [this idea] as an excuse to cut Medicaid. They're trying to take a step toward efficiency."...If the Department of Health and Human Services approves the...plan, others will likely take similar action...Currently, state Medicaid programs are required to cover almost all drugs that have received Food and Drug Administration approval, including multiple drugs from different manufacturers used for the same purpose and in the same category. In exchange, manufacturers must discount those drugs -- typically based on a set percentage of the list price...The idea is Medicaid's vulnerable beneficiaries get medications they need and the state doesn't go broke paying for them...Massachusetts wants to go a different route, requesting a federal exemption known as a Section 1115 waiver, which is meant to let states test ways of improving Medicaid. It wants to pick which drugs it covers based on most beneficiaries' medical needs and which medicines demonstrate the highest rates of cost effectiveness...It says it will be able to negotiate better prices as a result, saving public dollars while maintaining patients' access to needed therapies...
- Heated And Deep-Pocketed Battle Erupts Over 340B Drug Discount Program (khn.org)
A 25-year-old federal drug discount program has grown so big and controversial that it faces a fight for survival as federal officials and lawmakers furiously debate the program’s reach...The program, known as 340B, requires pharmaceutical companies to give steep discounts to hospitals and clinics that serve high volumes of low-income patients...The Centers for Medicare & Medicaid Services...cut Medicare payments for hospitals enrolled in the program by 28 percent...About 40 percent of the hospitals in the U.S. now buy drugs through the program...the hospital lobbying group 340B Health, said that for some small, rural hospitals the funding cut “could actually be the difference between staying open and closing.”...those supporting the cut, including drugmakers, argue that the program has grown beyond its original intent because hospitals have pocketed the discounts to pad profits — not to help indigent patients...Stephen Ubl, president of drug industry group PhRMA, said the program “needs fundamental reform” and that the latest rule change is merely a good first step. His group, which has deep pockets and an advertising campaign geared at pinpointing the program’s flaws, has a list of changes that Congress and the Trump administration could tackle. Those include limiting which hospitals should be eligible for 340B price breaks and making sure needy patients benefit when hospitals buy discounted drugs.
- Pfizer in fight with states over their intent to use its drugs for executions (fiercepharma.com)
Pfizer is in a tug of war with several states that intend to use some of its drugs to carry out executions...The drugmaker sent letters last month to both Nevada and Nebraska asking for the return of drugs, which include the sedative diazepam and the opioid painkiller fentanyl, if the states intended to use them for executions...The company said it would reimburse the states...Nevada has already indicated it does not intend to return the drugs, which the state obtained from wholesaler Cardinal Health...“We have communicated to the Departments of Correction in the 31 states permitting use of lethal injection for capital punishment that Pfizer strongly objects to the use of its products as lethal injections for capital punishment. We have asked all such states to return any Hospira or Pfizer manufactured Restricted Product in their possession and provided them with procedures to follow in return for a full refund.”...Nevada, in its first execution in 11 years, wants to use an execution cocktail containing the never-before-tried combination of diazepam, fentanyl and the muscle paralytic cisatracurium...Last week's scheduled execution was delayed while the state supreme court reviews the matter after a state judge rejected the prison system's intent to use cisatracurium in the lethal cocktail. The state attorney general is appealing that decision.
- Pharmacy Week in Review: November 24, 2017 (pharmacytimes.com)
Nicole Crisano, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- New FIP report on the role of pharmacists in reducing harm associated with drugs of abuse includes marijuana (fip.org)Reducing harm associated with drugs of abuse: The role of pharmacists (fip.org)
New FIP report on the role of pharmacists in reducing harm associated with drugs of abuse includes marijuana...The value of involving pharmacists in reducing harm from drugs of abuse is highlighted in a report released...by the International Pharmaceutical Federation (FIP). The report describes harm reduction services such as needle exchange and opioid substitution in different regions and countries, including Europe, the USA, Canada, central Asia and the Middle East...FIP’s Working Group on Pharmacists’ Role in Harm Reduction...would like pharmacy organisations to engage with policymakers and health authorities to remove barriers to more involvement of pharmacists in harm reduction services...the benefits of harm reduction are many — both to individuals and society — including prevention of infection by HIV and hepatitis C, fewer overdoses and less drug-related criminal activity...The report specifies that a comprehensive service should include: syringe and needle exchange (with the provision of low-dead space syringes where possible); opioid substitution therapy (preferably with pharmacist prescribing or dose adjustment); naloxone supply for overdoses (including pharmacist-initiated supply); and health promotion (including advice on sexual health).
- AHIP thanks CMS for adding flexibility in 2019 Medicare Advantage and Part D rule (healthcarefinancenews.com)
New proposed rule offers insurers more plan flexibility and eases regulations...The proposed rule released last week by the Centers for Medicare and Medicaid Services would strengthen and improve the Medicare Advantage and Part D programs...CMS's proposed 2019 Medicare Advantage and Part D rule offers insurers greater flexibility in reporting and makes changes to how star ratings are calculated...Star ratings determine bonuses for insurers. Another plus for plans that have an overall 5-star rating is the ability to offer a year-round open enrollment period for Medicare Advantage...The rule has an open enrollment period for MA plans of Jan. 1 through March 31, 2019. It allows enrolled individuals to make a one-time election to go to another plan or to original Medicare...The proposed rule would get rid of artificial limits on the variety of plans an insurer can offer in a certain region, ease the medical loss ratio, allow for more tailored benefits and would revise regulations for maximum out-of-pocket limits, among other changes.
- Nevada wants $11.3M for Children’s Health Insurance Program (reviewjournal.com)
Nevada has requested an extra $11.3 million in federal funding to continue the state’s Children’s Health Insurance Program while Congress decides if it will renew funding for the decades-old program...If the federal Centers for Medicare and Medicaid Services approves the state’s request, it will keep the Nevada Check Up program running through February, according to Chrystal Main, a spokeswoman for the state Department of Health and Human Services...Without it, the state will run out of funding by the end of the year, and families will need to find health coverage elsewhere...Congress missed its Sept. 30 deadline to reauthorize the program, which covers more than 27,500 Nevada children whose low-income families make too much to qualify for Medicaid. The state’s Division of Health Care Financing and Policy was working to find alternate funding sources for the program, deputy administrator Cody Phinney said at the time...The program costs $43 million annually, covered almost entirely by federal funding.
- FDA issues guidance that could make it easier for EpiPen rivals to come to market (cnbc.com)
When the controversy over the price of the EpiPen exploded late last summer, many consumers asked why there was no substitutable generic version available...The answer was complex: while the key ingredient in the anaphylaxis treatment, epinephrine, has been available for decades and is no longer covered by a patent, the delivery device proved hard for generic competitors to copy to a degree that would satisfy regulators...the Food and Drug Administration announced guidance seeking to change that, potentially streamlining a path to market for generic copies of complex medicines like the EpiPen and others...The FDA guidance says that generic copies with some design differences may be approved as substitutable products, as long as those differences don't affect patients' ability to use the product the way it's intended...Dr. Scott Gottlieb, said.."Under this guidance, so long as the generic applicant is able to demonstrate with data, where appropriate, that differences in design of the generic product do not affect the clinical effect or safety profile when the generic is substituted for the branded product, the generic product can be approved as a competitor to the branded drug where all other requirements for generic approval are met,"...
- AmerisourceBergen says civil penalty to resolve DOJ probe now at $625M (fiercepharma.com)
It turns out that the quarter-crushing $575 million that drug wholesaler AmerisourceBergen set aside to settle civil litigation with the Justice Department was not enough. It is going to take another $50 million...That comes on top of the $260 million the drug distributor has already paid to resolve a criminal misdemeanor charge tied to its sales of injected cancer meds produced in a plant that was not FDA certified...the company has now agreed to pay $885 million to resolve both civil and criminal allegations which are tied to issues that reach back more than 15 years...The company...in a filing reported it increased its Q4 set aside to $625 million to cover the agreement, which is awaiting court approval...The civil case stemmed from alleged violations of the federal False Claims Act. The DOJ has alleged that between 2001 and 2014 two of the wholesaler’s...subsidiaries—Oncology Supply Co. and the now-defunct Medical Initiatives—prepared millions of syringes of cancer medicines, including Aloxi and Anzemet and generics of Neupogen and Procrit, in an unapproved facility...the complaint did not indicate any patients were harmed by the drugs and that FDA testing of syringes that were seized in the case had not found any “quality concerns.”
- This Week in Managed Care: November 24, 2017 (ajmc.com)
Laura Joszt, assistant managing editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network