- Healthy Nevada Project Adds 5,000 Testing Slots (ktvn.com)
The Healthy Nevada Project is opening up 5,000 more testing slots for people interested in their genetics study...researchers at Renown Health and DRI have partnered with Helix to assess personal health risks of Nevadans and build a demographic profile of our area...Since kicking off the second phase of the Healthy Nevada Project, researchers have collected 10,000 DNA samples.
- FDA chief questions protections on drug rebates, stocks fall (reuters.com)
...Food and Drug Administration chief Scott Gottlieb....questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law, sparking new concerns on Wall Street over efforts to curb drug pricing...Gottlieb was referring to the common practice of pharmaceutical companies setting a high “list price” for a drug, and then lowering the cost for health plans through hefty rebates in exchange for the broadest access to patients. In recent weeks, he has criticized these practices for keeping drug prices high and locking out competitors...“What if we took on this system directly, by having the federal government reexamine the current safe harbor for drug rebates under the Anti-Kickback Statute?”...“Such a step could help restore some semblance of reality to the relationship between list and negotiated prices, and thereby boost affordability and competition.”...The anti-kickback law makes it illegal to pay an incentive for drugs or services that Medicare, Medicaid or other federal healthcare programs cover...
- Medicare chief says it’s time health care caught up to other industries to benefit consumers (cnbc.com)
The head of the Centers for Medicare and Medicaid Services said...it's time that health care catches up with other industries when it comes to providing consumers greater transparency about prices up front and easier access to their records and health data once they have received care..."We know that any other place in the economy you can know what things are going cost. Somehow in health care it's a big mystery," said CMS administrator Seema Verma...CMS issued a series of new proposals aimed at promoting greater interoperability of digital health-care records. They include forcing hospitals to post their prices online, and pushing them to transfer patients' discharge records to their doctors electronically, even if the doctors are not part of the same health system...Doctors who treat Medicare patients are already required to write prescriptions electronically. CMS now wants them to also make it easier for patients to access those records digitally...The administration's 2019 budget outline includes a proposal to give Medicare Part D plans for seniors more power to negotiate lower prices from manufacturers, and it initiates a pilot program that would allow state Medicaid programs to test drug formularies aimed getting more competitive prices...
- This Week in Managed Care: April 27, 2018 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- U.S. drug agency suspends Louisiana distributor over opioid sales (reuters.com)
...Drug Enforcement Administration said...it had suspended a Louisiana pharmaceutical distributor from selling controlled substances for allegedly selling unusually large quantities of opioids to pharmacies without reporting the sales...Morris & Dickson Co...investigation showed “it failed to properly identify large suspicious orders for controlled substances sold to independent pharmacies with questionable need for the drugs.”...Morris & Dickson filed in federal court...an injunction against the suspension, and U.S. District Judge Elizabeth Foote in Shreveport has scheduled a hearing...on its request for a temporary restraining order...The probe, which focused on purchases of Oxycodone and Hydrocodone, showed that in some cases, pharmacies were allowed to buy as much as six times the quantity of narcotics they would normally order...
- NIH opens nationwide enrollment for huge precision medicine initiative (statnews.com)
The All of Us initiative, which will be launched on May 6, aims to compile detailed health profiles of 1 million Americans, with a special focus on communities historically underrepresented in biomedical research...The program, which began as a pilot last year, is the most ambitious attempt yet to compile health and behavioral data, as well as genetic sequencing, from a representative sample of the American population. It will collect electronic health records, survey data, and even information from its participants’ wearable fitness devices – with the goal of helping scientists better understand how to craft personalized treatments, seen by many as the future of biomedicine...
- Drug co-pay groups: Critical patient charities or fronts for drugmakers? (usatoday.com)
Co-payment assistance groups, created to help patients with the increasingly higher price of drugs...are under investigation by federal authorities for possibly skewing the cost of health care to favor drug companies...Critics of these groups, such as Patients for Affordable Drugs...say they drive up the cost of health care by masking the price of drugs and forcing higher costs on the insurance companies that pass them along to consumers and employers...The money to pay for the groups’ support of patients comes almost entirely from the drug companies themselves or other charities they fund...These groups are a marketing arm of pharma, and the fact that patients are caught in the middle...The U.S. attorney in Massachusetts and the Health and Human Services inspector general have been investigating this insurance co-payment assistance for more than three years...It's illegal under federal "anti-kickback" law for drug companies to pay patients' Medicare drug co-pays, and any patient group that covers these co-pays can't steer consumers to their pharmaceutical donors' drugs...the Justice Department reached a settlement agreement with drugmaker United Therapeutics...The government accused UT of paying kickbacks to Medicare patients through a charity, Caring Voice Coalition, "that held itself out as an independent charitable foundation." The drugmaker paid $210 million to resolve the allegations, and the Justice Department rescinded an advisory opinion it issued CVC because the group "allowed its drug company donors to funnel money through CVC in potentially illegal ways that served the drug companies’ financial interests."
- This Week in Managed Care: May 4, 2018 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Pharmacy Week in Review: May 4, 2018 (pharmacytimes.com)
Laura Joszt, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- EMA and the Netherlands Finalize Seat Agreement (biopharminternational.com)
...the European Medicines Agency announced that the text for the Seat Agreement between the agency and the Netherlands has been finalized. The agreement describes how EMA will be treated by the Dutch government when EMA relocates to Amsterdam. The agency also announced that the Dutch Council of Ministers had agreed to sign the agreement...The agreement will be signed after the legislative process on the relocation is completed by the European Council, the European Parliament, and the European Commission...According to EMA, the Seat Agreement allows EMA to function independently in the Netherlands. Similar agreements apply to other EU agencies located in the Netherlands...As this transition needs to be supported by EMA staff in the Netherlands, a timely signing of the agreement would make sure that EMA staff and their families have clarity on their treatment and can settle in the Netherlands...