Mutual Matters

By Joseph J. Lazzarotti, Jason C. Gavejian and Maya Atrakchi

For years you’ve been told that informed consent is a process, not just a piece of paper. That’s true, and now there’s increasing scrutiny of those forms by regulatory agencies. What we’ve found, as with many of the Centers for Medicare and Medicaid Services (CMS) regulations, is that enforcement by state Department of Health investigators and review by The Joint Commission surveyors has been somewhat inconsistent. Interpretation of the regulations largely depends on the investigator’s or surveyor’s background. New Conditions of Participation (CoP) from CMS went into effect in 2007, but several hospitals and physician practices aren’t aware of all the changes.

When initially prescribing controlled substances , the physician must:

• Obtain a medical history
• Conduct a physical examination (in a documented emergency can prescribe an amount to cover less than 72 hours without the physical exam)
• Obtain informed consent
• Make a diligent effort to obtain prior diagnostic records related to the condition for which the controlled substances are being prescribed and prior pain treatment records and document such efforts (not applicable if the condition is terminal) 

A series of recent enforcement actions confirms just how serious the government is about assessing monetary penalties against covered entities who disclose protected health information (PHI) to business associates without written business associate agreements (BAAs) in place.

Can I text or email my patients?

Yes, healthcare providers can communicate with patients via text messages, but only if:

By Joshua D. Aubuchon, Nichole Lydon and Carrie Lowe

On December 28, 2017, the Center for Medicare and Medicaid Services (CMS) announced that texting patient information among healthcare providers is acceptable if done through a secure platform, but the texting of orders is prohibited - even if the orders are encrypted.

A new FDA alert issues a warning about prescribing the antibiotic clarithromycin (Biaxin) for patients with heart disease due to a potential increased risk of cardiac problems or death that can occur years later. The FDA recommendation is based upon a review of a ten-year follow-up study of patients with heart disease from a large clinical trial. 

On February 9, 2018, Congress passed and the President signed into law the Bipartisan Budget Act of 2018 (BBA), a comprehensive piece of legislation that provides for a two-year budget agreement and funds the federal government through March 23, 2018. The BBA’s sweeping measures address federal spending for the military, domestic programs, and disaster relief, and contain several provisions impacting federal healthcare programs. Among other things, the BBA:

Healthcare providers and other HIPAA covered entities have until March 1, 2018 to report to the U.S. Department of Health & Human Services’ Office for Civil Rights (“OCR”) breaches involving fewer than 500 individuals that were discovered in the 2017 calendar year. Although covered entities must notify HHS of breaches involving 500 or more individuals within 60 days of the date the breach is discovered, breaches affecting fewer than 500 individuals may be documented in a breach log and reported on an annual basis. Covered entities who elect to report smaller breaches on an annual basis must make their submissions to HHS through the OCR online portal within 60 days after the end of the year in which the breaches were discovered, giving them a March 1, 2018 notification deadline.