Category:

Nearly 40 drug companies and pharmacy benefit managers submitted reports to the state detailing the costs associated with manufacturing and selling essential diabetes drugs by this month’s deadline, though almost as many have yet to report...27 drug companies identified as manufacturers of essential diabetes drugs have yet to report to the state. Scott Jones, manager of the Primary Care and Health Workforce Development Office, said in an email that the state will be reaching out to those companies to inform them of the law and obtain the required reports. (If they refuse, the state is allowed by law to impose a fine of $5,000 a day.)...

A federal judge has blocked a Trump administration policy that reduces payments to hospitals under a drug discount program, ruling...that the government overstepped its authority in an attempt to address the high cost of prescription medications...The decision is a win for the 2,000-plus hospitals participating in the program, known as 340B, most of which serve large numbers of low-income patients...In 2017, the Department of Health and Human Services reduced its reimbursements for some drugs by about 28 percentage points...

The Food and Drug Administration...issued a reminder to drug manufacturers that data integrity remains high on the regulator's agenda of Good Manufacturing Practice-related concerns, publishing new guidance aimed at helping drugmakers meet its standards...The document, which updates a 2016 version, lays out a series of questions and answers for drugmakers explaining how companies can ensure manufacturing data sets are complete, consistent and accurate. While a technical concern, the FDA makes clear that data errors carry real risk to patient health...Guidance isn't the only lever the FDA can pull to help companies comply. In recent years, the agency has flagged data integrity issues in numerous warning letters following inspections and pre-approval assessments.

Nevada could soon have almost twice as many marijuana dispensaries as it does now after the state issued 61 conditional licenses, although it’s not releasing details about who the winners of the potentially lucrative permits are...“We issued a number of state-level licenses in counties that have thus far declined to allow marijuana establishments,” said spokeswoman Stephanie Klapstein of the Nevada Department of Taxation, which regulates marijuana. “There’s a chance some of those licenses will not ultimately result in operational retail marijuana stores.”...License winners have one year to obtain local approvals and pass a final inspection from the tax agency before they are issued a final state license. At that point, the name of the dispensary will be published on the state list of open retail stores, which currently includes 65 dispensaries in five counties.

Nearly 20 drug manufacturers and pharmacy benefit managers submitted reports to the state detailing the costs of manufacturing and distributing diabetes drugs in advance of a Tuesday deadline, and state officials continue to comb through others received this week as they prepare to undertake their first examination of the factors contributing to the costs of treating Nevadans with diabetes...drug companies and PBMs...,insurers and pharmacies — were required to submit reports to the state explaining the costs associated with essential diabetes drugs and, for some, why the costs of those drugs increased significantly over the prior year...The new law additionally requires the state to compile an annual report analyzing the information it receives from drug companies and PBMs in aggregate to explain the factors contributing to the costs of treating diabetes...

The Food and Drug Administration is looking for "pathways" to legalize the sale of CBD oil and other cannabis-based compounds in food and beverages in a move that could remove one of the last remaining legal hurdles for companies hoping to sell such products across state lines...FDA Commissioner Scott Gottlieb outlined steps the agency is considering in regulating cannabis products after President Donald Trump signed the farm bill into law on Thursday. The legislation — an $867 billion, five-year spending bill that funds agricultural, nutrition and other federal programs — also loosened some federal restrictions on cannabis. It legalized hemp by removing it from the Controlled Substances Act while preserving the FDA's authority to regulate the products...

FYI

Babies requiring care in the neonatal intensive care unit...can cost the hospital thousands of dollars daily, depending on the equipment or medication required to keep them stable, said Sunrise CEO Todd Sklamberg...But Medicaid, the insurer for about 70 percent of the hospital’s NICU patients, only pays up to $1,487 daily per baby...The discrepancy left Sunrise Hospital with $77 million in uncompensated costs for intensive infant care last year...Without a bump in payments for the hospital with the most pediatric acute care beds in the state and the only dedicated pediatric cardiology unit in Nevada, Sklamberg said he worries some of the hospital’s highest cost services...will disappear...Nevada’s Medicaid program is one of just a few nationwide to pay on a per diem rate...Most states reimburse hospitals based on what’s called a diagnosis-related group — a code that ties a reimbursement rate to the level and type of services provided by the hospital. But Nevada uses a flat dollar amount of $1,487 to pay back high-level NICUs, no matter the level of care provided...

Barbara McAneny, president of the American Medical Association, recently described a patient with metastatic prostate cancer who tried to kill himself after he could not get the medication he was prescribed for bone pain because...his insurer...denied coverage...my patient nearly died of an underdose...McAneny was talking about the suffering caused by government pressure to reduce opioid prescriptions, which has led to denials of treatment and arbitrary dose reductions...A Medicare rule that take effect on January 1 will compound that problem...

Today we’re updating some of our proposed policies related to these outsourcing facilities. Among our goals is to make it more feasible for compounding pharmacies to become outsourcing facilities...ottlieb said the FDA’s aim for this guidance is to recognize the differences in drug production between outsourcing facilities and conventional drug manufacturers. The guidance is intended to provide clarity on quality assurance, maintaining suitable facilities, sterility, stability testing, and beyond-use or expiration dates for products that don’t go through the FDA drug approval process...This revised draft guidance includes...revisions related to release testing, stability testing and beyond-use dating, as well as policies that differentiate between the production of sterile and non-sterile drug products...