Legal & Health Regulations

Health

New Hampshire Finalizes Opioid Prescribing Rules

New Hampshire is starting 2017 with stepped-up efforts to manage its oft-described opioid epidemic. Though the most recent regulations are directed at individual prescribers, and do not apply to the administration of opioids to patients in a health care setting, now is the time for New Hampshire hospitals, ambulatory surgical centers, urgent care facilities, and …

What To Know About New HHS OIG Exclusion Regs

On Jan. 12, 2017, the Office of Inspector General of the U.S. Department of Health and Human Services issued the third and final installment of its recent three-part rulemaking effort — a final rule updating its exclusion regulations, 82 Fed. Reg. 4100 (Jan. 12, 2017). This final rule follows two others that were published in December updating the OIG’s civil monetary …

In Bold Move, FDA Approves Cancer Drug For Any Advanced Tumor With Genetic Changes

“For the first time, the FDA has approved a drug for use in cancer—of any type—that harbors certain molecular features. Merck’s Keytruda, an immune oncology drug, may be prescribed for any resistant, metastatic tumor with microsatellite instability (MSI) or other evidence for defective DNA mismatch repair. This is good news for patientsby trying this medication if they have advanced cancer of any form with pathological MSI or DNA mismatch repair defects.”

Ethics Survey: Drug testing remains a clinical tug of war

“In recent weeks, the American Society of Addiction Medicine (ASAM) prepared comprehensive guidelines on drug testing within the continuum of care. The goal is to present evidence-based recommendations for the frequency and application of testing, which payers and providers can adopt as best practices. It’s significant because up until now, there was no true consensus. And there’s also no denying that some treatment operators have aimed to maximize their profit streams through the overuse of testing and subsequent billing of insurance companies.”

21st Century Cures Act Provides Some Welcome Relief

The 21st Century Cures Act (the “Cures Act”) (Pub. L. No. 114-255), which was signed into law by President Obama on December 13, 2016, includes a number of important health care provisions, and several address the long-anticipated relief for Medicare “site-neutrality” policies relating to off-campus outpatient hospital departments (“OCODPs”), certain cancer hospitals, and long-term care …