As the month draws to a close, here are some of the more significant regulatory news stories from July.
THE COMPREHENSIVE ADDICTION AND RECOVERY ACT (CARA) BECOMES LAW
Congress voted to approve the first bill specifically designed to fight opioid addiction. The Comprehensive Addiction and Recovery Act (CARA) passed 92-2 and has been signed by President Obama. Negotiations had been going on for some time. For the last two years, republicans and democrats have disagreed on the scope and funding levels for the program. However, top Senate democrats, including Harry Reid, backed away from the funding demands, and the rest followed. So the bill passed with overwhelming support.
Specifically, HR 953 expands the availability of Naloxone (on the street it’s called Narcan) to counter the effects of an opioid overdose. This will be given to more first responders like law enforcement and EMTs. The bill will improve prescription drug monitoring programs to help states monitor and track prescription opioid use. The bill will also shift resources to help identify and treat incarcerated people who are suffering from opioid addiction.
SB 482 WOULD REQUIRE PHYSICIANS TO CHECK PDMP “CURES” MORE OFTEN
SB 482, a bill cycling through the Assembly, has been amended to require physicians to check the CA PDMP “CURES” more often. Originally, the bill instructed physicians to check a patient’s medical history on CURES before prescribing a controlled substance for the first time, then once a year for as long as the drug remained part of the patient’s care. Now, the bill has been amended to require the physician to check CURES before prescribing a controlled substance, then at least once every four months.
The California Medical Association has opposed the bill because they claim it would “create an unnecessary regulatory burden on prescribers.”
However, New York saw a 75 percent decrease in doctor shopping one year after passing the law requiring physicians to check their PDMP. According to Consumer Watchdog, if California’s doctor shopping decreased by the same percentage as New York’s, state and local spending on prescription drugs for Medi-Cal patients alone would dip by up to $300 million per year.
As you may recall, existing law required every prescribing doctor to register with CURES by July 1st, 2016. However, nothing requires them to actually check it. SB 482 would change that and make it mandatory.
FDA SCRUTINY OF COMPOUNDED DRUGS INCREASES
Among the latest FDA actions is the release of draft guidance on compounded medications that are essentially copies of commercially available drugs. While the draft guidance is not legally enforceable, it is intended to indicate the agency’s position on a particular topic. The draft guidance has been released for 90 days of public comment.
Another issue prompting recent guidance involves bulk substances used in compound medications. The FDA released two final guidance documents regarding the use of bulk drug substances in compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Here, prescribing a compounded drug may be appropriate when a patient is allergic to an inactive ingredient in a commercially available drug or needs a liquid formulation because they have trouble swallowing pills. In these instances, drugs products for individually identified patients can be compounded by licensed pharmacists in state-licensed facilities and federal facilities and by licensed physicians operating under Section 503A of the FD&C Act. Drug products can also be compounded by outsourcing facilities under Section 503B for identified individual patients pursuant to prescriptions for distribution without first receiving the prescription.
NEW REPORT SUGGESTS FEWER PAINKILLERS PRESCRIBED IN STATES WHERE MEDICAL MARIJUANA IS LEGAL
A new report by the Department of Public Administration and Policy at the University of Georgia looked at prescription drugs used to treat nine categories of conditions: pain, anxiety, depression, glaucoma, nausea, psychosis, seizures, sleep disorders and spasticity. Specifically, prescriptions for most of those drugs fell significantly in states that implemented medical marijuana laws. In contrast, a change in the prescribing pattern was not seen for classes of drugs for which medical marijuana is not thought as a potential treatment alternative, including antibiotics and blood thinners.
Paul Tauriello, director of the Colorado Division of Workers’ Compensation, hadn’t yet read the report. But he noted that chronic pain and the use of opioid painkillers are big issues in workers’ compensation. “Whether medical marijuana is such a solution remains to be seen. Clinical studies are needed to determine not only marijuana’s effectiveness for treating particular conditions, but also what appropriate doses are and which cannabinoids contained in marijuana are responsible for a given effect.”
TENNESSEE TO HOLD PUBLIC HEARING ON AUGUST 31 TO DISCUSS NEW PROPOSED UR CHANGES
Tennessee will hold a public hearing on Aug. 31 on new rule changes within the Bureau of Workers’ Compensation. While Dr. Robert Snyder, medical director of TN State Bureau of Workers’ Compensation, has described the rules as “housekeeping measures,” UniMed Direct’s regulatory team believes the proposed changes are more substantial.
The proposed rule changes are:
- Any treatment or procedure (including medications) that follows the treatment guidelines does not have to go through utilization review.
- Any modification of a treatment request will be considered a denial of the entirety of the treatment for purposes of utilization review, appeals and determinations.
- If a claimant pursues an appeal to the TN Bureau, the employer (and any utilization review organization) must send a copy of the utilization review report and all records reviewed within five business days after request for documents from the TN Bureau.
- Utilization review decisions to deny treatment will remain effective for six months (in a manner similar to the 1 year rule in California).
- All utilization review organizations must file the Notification form (C-35) electronically within three business days upon initiation of utilization review. Only one form should be filed for each date of utilization review even if the referral contains more than one treatment request.
- All utilization review organizations must file a Closure form (C-36/C-37) electronically, three business days after closure of utilization review services.