With opioid prescribing regulations being updated, national policy announcements, state guidelines as well as daily commentary regarding the opioid epidemic flooding news outlets, the AffirmHealth Weekend Round Up looks at the top headlines that caught our team’s eye. From controlled substance protocols to research focusing on pain management, addiction medicine, the ER and more provided to you in an easy to access summary. News you can use. Welcome to the Weekend Round Up.
April 5, 2018
Drug crisis: Opioid addiction costs employers $2.6B a year for care
Source: USA Today
AffirmHealth Key Take Away: A new report shows large employers spent $2.6 billion to treat opioid addiction and overdoses in 2016, an eightfold increase since 2004. More than half went to treat employees' children.
The analysis released Thursday by the nonpartisan Kaiser Family Foundation finds such spending cost companies and workers about $26 per enrollee in 2016.
Employers have been limiting insurance coverage of opioids because of concerns about addiction. The report finds spending on opioid prescriptions falling 27 percent from a peak in 2009.
Find the Full Article Here: Opioid Addiction Costs Employers 2.6b a Year
CLINICAL LABORATORY NEWS
April 6, 2018
New FDA Regulation of Clinical Decision-Support/Digital Health Applications and Medical Software Has Consequences For Medical Laboratories
Source: DARK Daily
AffirmHealth Key Take Away: Softened FDA regulation of both clinical-decision-support and patient-decision-support software applications could present opportunities for clinical laboratory developers of such tools Late 2017, the Food and Drug Administration (FDA) released guidelines on how the agency intends to regulate—or not regulate—digital health, clinical-decision-support (CDS), and patient-decision-support (PDS) software applications. The increased/decreased oversight of the development of these physicians’ tools could have important implications for anatomic pathology groups and clinical laboratories. Physician decision-support software utilizes medical laboratory test data as a significant part of a full dataset used to guide caregivers. Thus, if the FDA makes it easier for developers to get regulatory clearance for these types of products, that could positively impact medical labs’ ability to service their client physicians.
Find the Full Article Here: New FDA Regulations of Clinical Decision-Support/Digital Health Applications
MEDICAL PRACTICE MANAGEMENT
The Intensifying Conflict Between Opioid Control and Pain Control
Source: Practical Pain Management
AffirmHealth Key Take Away: Many medical experts say the CDC guidelines play up the hazards of opioids while playing down their benefits. The overall message is that clinicians should be stingy with these medications, prescribing them only as a last resort and maintaining the lowest possible doses. Despite the CDC’s protestations to the contrary, the mission of preventing abuse and diversion seems to be interfering with the average pain practitioner’s duty to provide appropriate care, leading in extreme cases to suicides by patients who are unable to get the pain relief they need. After the CDC guidelines were published, Dan Carr, MD, then the president of the American Academy of Pain Medicine (AAPM), worried about unintended consequences. “The CDC guideline makes disproportionately strong recommendations based upon a narrowly selected portion of the available clinical evidence,” he said in an AAPM statement at the time.2 “It is incumbent upon us all to monitor the deployment of the guideline to ensure that it does not inadvertently encourage under-treatment, marginalization, and stigmatization of the many patients with chronic pain that are using opioids appropriately. ”Two years later, Carr’s warning is proving prescient. “There are many pain clinics flooded with patients who have been treated previously by their primary care physician,” said AAPM President-Elect Jianguo Cheng, MD. These refugees include patients who “have been functional” and “responding well” to opioids for “many years,” he said.
Find the full article here: The Intensifying Conflict Between Opioid Control and Pain Control
April 4, 2018
CMS Finalizes Regulations To Curb Opioid Misuse Among Part D Beneficiaries
AffirmHealth Key Take Away: Pharmacies and Part D beneficiaries will start seeing new limits on opioid prescriptions starting next year. As part of a Medicare Advantage final rule, the Medicare agency is also moving forward with policies to curb opioid misuse. And the agency seems to have taken some policy advice from Congress. The rule established a ceiling of 90-milligram morphine-equivalent units for opioid prescriptions under the Part D Medicare program starting in 2019. A prescription at or above 90mg will require the pharmacist to speak with the prescribing doctor regarding the dosage and determine if an override is appropriate. The agency's initial proposal, which would have limited the prescription override to the insurer, received widespread backlash during the comment period.
Find the Full Article Here: CMS is Signaling It Is Taking the Opioid Crisis Seriously
April 3, 2018
CMS Tweak Opioid Proposal After Backlash
Source: The Hill
AffirmHealth Key Take Away: The Centers for Medicare and Medicaid Services (CMS) has released a sweeping final Medicare rule that included altering a draft proposal aimed at curbing the opioid epidemic that had proven controversial. The agency had received pushback on a proposal that would have meant a prescription for high doses of opioids (90 milligrams of morphine per day or more) automatically wouldn’t be filled and the patient would need special permission from their private insurance company in order to receive the medication. Many doctors and patients expressed opposition during the draft proposal’s public comment period, which ended March 5, and the proposal “was strongly opposed by nearly all stakeholder groups for a variety of reasons,” CMS wrote in its final letter on new Medicare policies released Monday.
Find the Full Article Here: CMS Tweaks Opioid Proposal After Sparking Backlash
PHARMACEUTICAL INDUSTRY NEWS
APRIL 4, 2018
FDA Committee Recommends Approval of Lofexidine for Opioid Withdrawal
Source: Pain Medicine News
AffirmHealth Key Take Away: In a nearly unanimous vote, an FDA committee recently recommended approval of lofexidine (Lucemyra, US WorldMeds), a non-opioid drug designed to relieve symptoms of opioid withdrawal and prevent discontinuation of opioid withdrawal treatment.
Find the Full Press Release Here: FDA Committee Recommends Approval of Lofexidine for Opioid Withdrawal
The information presented on or through this website is made available solely for general information purposes and is not intended to substitute for professional, medical or legal advice. We do not warrant the accuracy, completeness, or usefulness of this information. Any reliance you place on such information is strictly at your own risk. We disclaim all liability and responsibility arising from any reliance placed on such materials.