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340B Health today asked the federal government to extend regulatory flexibility and financial support to safety-net hospitals participating in the 340B drug pricing program. In a pair of letters to leaders of the U.S. Dept. of Health & Human Services, 340B Health requested a series of policy changes under the public health emergency caused by the Coronavirus disease 19 pandemic...In a letter to HHS Secretary Alex Azar, 340B Health asked that the department take five key actions:

1. Delay implementation of a proposed survey of 340B hospitals on their drug acquisition costs so hospitals can focus on combating the pandemic;
2. Suspend the nearly 30 percent Medicare Part B payment reduction to 340B hospitals so these providers have the resources they need during this crisis;
3. Allow hospitals subject to the group purchasing organization (GPO) prohibition to purchase covered outpatient drugs through a GPO without the usual documentation requirements so hospitals can access drugs during the public health emergency that are subject to shortages;
4. Waive the Medicare disproportionate share (DSH) adjustment percentage requirements so hospitals currently participating in 340B won’t lose program eligibility due to their treatment of COVID-19 patients; and
5. Waive the quarterly enrollment periods to allow open registration for 340B-eligible covered entities, child sites, and contract pharmacies so safety-net providers can access the resources they need for their pandemic response.

“These steps would provide safety-net hospitals with much-needed assistance and flexibility to focus their attention on the growing patient treatment needs presented by COVID-19,”...READ MORE

In the recent flap over chloroquine and its relative hydroxychloroquine, drugs seen as promising in many quarters for use in treating COVID-19 patients, one commentator typical of many sternly proclaimed that these compounds “have NOT been proven effective against” the novel coronavirus. Implication: These are drugs no reasonable person would want to take, nor a reasonable doctor prescribe...And yet, as Arizona physician Jeffrey Singer notes, “Doctors around the globe, including the U.S., are using these and other drugs to treat their patients, and reporting on their findings in the peer-reviewed medical literature.” It’s both legal and utterly routine for doctors to prescribe a drug for indications other than the one for which it has been approved — so-called “off-label prescribing.”...In fact, an estimated 20% of pharmaceuticals reach patients that way. And this will be true almost by definition for a newly emergent malady, for which there will be no compounds proven effective yet...READ MORE

In a joint statement, the American Medical Association, American Pharmacists Association, and American Society of Health-System Pharmacists have communicated concerns regarding the inappropriate ordering, prescribing, or dispensing of treatments for COVID-19...The AMA, APhA, and ASHP collectively applaud the selflessness of health care professionals during the COVID-19 crisis, and alternatively caution against providers “prophylactically prescribing medications currently identified as potential treatments for COVID-19 for themselves, their families, or their colleagues,” noting that “some pharmacies and hospitals have been purchasing excessive amounts of these medications in anticipation of potentially using them for COVID-19 prevention and treatment.”...“In a time of national pandemic, now is not the time for states to issue conflicting guidance, however well-intentioned, that could lead to unintended consequences,”...READ MORE

The coronavirus has upended the globe...Many companies have sent their employees home...Much attention, and rightly so, is focused on the drugs the biopharma industry is developing to treat COVID-19. But those efforts could disguise a cost to public health, too, in the form of stalled progress on experimental medicines for other diseases...Since the start of March, at least nine companies have reported some sort of disruption to a clinical trial as a result of the coronavirus pandemic. Such news is becoming more common, as medical centers across the world focus their precious resources on treating people infected with the coronavirus...READ MORE

Matthew Gavidia, welcome to This Week in Managed Care

Doctors are hoarding medications touted as possible coronavirus treatments by writing prescriptions for themselves and family members, according to pharmacy boards in states across the country...The stockpiling has become so worrisome in Idaho, Kentucky, Ohio, Nevada, Oklahoma, North Carolina, and Texas that the boards in those states have issued emergency restrictions or guidelines on how the drugs can be dispensed at pharmacies. More states are expected to follow suit...None of the drugs have been approved by the U.S. Food and Drug Administration for that use. Some of them — including chloroquine and hydroxychloroquine — are commonly used to treat malaria, lupus, rheumatoid arthritis and other conditions...Carmen Catizone, executive director of the National Association of Boards of Pharmacy, said state boards across the country were “trying to stop the hoarding and inappropriate prescribing, but balancing what patients need.”...READ MORE

CVS Caremark is setting limits on the quantities of certain medications being used off label to treat coronavirus disease symptoms...The pharmacy benefit manager will set new “appropriate” limits on the quantity of hydroxychloroquine (Plaquenil) and azithromycin (Zithromax Z-Pak), along with 1 protease inhibitor and albuterol inhalers...However, CVS Caremark members who already take the treatments—which are approved for the treatment of lupus, bacterial infections, HIV, rheumatoid arthritis, and asthma—can bypass the new quantity limits...CVS Caremark is “working with clients to implement new measures to balance the burgeoning interest in off-label use of certain medicines to treat COVID-19 pneumonia with the ongoing needs of members who use these drugs for chronic conditions,”READ MORE

Following the first approved Medicaid section 1135 waiver for Florida, the Centers for Medicare and Medicaid Services has approved 33 more waiver requests in the last 2 weeks....The waivers are intended to provide the states with relief during the coronavirus disease 2019 pandemic by providing states the flexibility to focus resources on managing the outbreak. Some waivers available under Section 1135 of the Social Security Act include temporary suspension of prior authorization requirements; extension of existing authorizations; modified timeline requirements for state fair hearings and appeals; and relaxed provider enrollment requirements to allow states to quickly enroll out-of-state or other new providers...READ MORE