We have looked back over some of the headlines covering healthcare in 2018 for important issues facing healthcare facilities, practitioners, and patients. Here is our round-up:
1. The Opioid Epidemic. Both Tennessee and Mississippi enacted new regulations in 2018 to address the Opioid Epidemic. Federal law was enacted as well:
Tennessee. The following changes relating to opioid prescriptions went into effect on July 1, 2018: (1) limitations of supply and strength of the opioid prescription, (2) requirements that the pharmacy monitor the state's Controlled Substance Monitoring Database the first time a patient brings a prescription to a pharmacy and at least once every six months thereafter if the patient is refilling the prescription, (3) physician documentation requirements when prescribing opioids, and (4) elimination of pharmacist prohibitions when discussing the dangers of opioids with customers. These restrictions do not apply to opioid prescriptions for a three-day (or less) supply.
Mississippi. Effective October 29, 2018, new regulations apply to all individuals with prescriptive authority under Mississippi State Board of Medical Licensure. Such individuals must be registered with the Mississippi Prescription Monitoring Program (MPMP). Each provider must review the MPMP database when prescribing a Schedule II drug or opioid for acute, and/or chronic, non-cancerous, non-terminal pain. Further, each practitioner must review the MPMP database upon initial contact with all new patients and every 3 months thereafter on all patients prescribed, administered or dispensed controlled substances other than opioids. The amendments to the opioid regulations also include new documentation requirements for practitioners prescribing opioids, lowest effective dose limitations, exceptions for certain controlled substances, and specific refill prohibitions and other requirements.
The Federal Opioid Bill. On October 24, 2018, President Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act. The SUPPORT Act includes comprehensive regulations to combat the opioid epidemic. Several significant provisions include:
Initial exams for new Medicare enrollees must include an opioid-use disorder screening and prescription history review.
The bill temporarily freezes Medicare payment at 2016 levels for specified spinal surgery outpatient procedures that are conducted in ambulatory surgical centers.
In general, prescriptions for controlled substances that are covered drugs under Medicare must be transmitted through electronic prescription programs.
2. HIPAA In Review. 2018 saw breaches affecting millions of patients. Also this year, Anthem, an affiliate of BlueCross BlueShield, settled with OCR for a breach occurring in 2015. The settlement includes a $16 million fine, the largest to date for HIPAA violations.
UnityPoint Health, a major health system in Iowa, reported a HIPAA breach affecting 1.4 million patients. It involved a phishing attack that sent emails to employees that appeared to be from a health executive within the system. This tricked some employees into sharing log-in credentials, enabling hackers to have access to various email accounts for over two weeks.
In Texas, 1.25 million records were exposed in a data breach of Employees Retirement System of Texas (ERS). Through a security coding error introduced on January 1, 2018, a function unintentionally enabled certain ERS members to view information about other members and in some cases, certain beneficiaries. The security malfunction was discovered in mid-August.
3. Fraud and Abuse.
Federal Opioid Enforcement Action. On Thursday, June 28, 2018, DHHS announced one of the largest health care fraud enforcement actions in history, resulting in more than $2 billion in fraudulent claims to federal health programs. The enforcement action involved over 601 charged defendants, including 165 doctors, nurses and other licensed health care professionals. Of these, the action involved 84 opioid cases relating to more than 13 million illegal opioid doses. The press release indicates that many of the prescriptions were never even purchased or distributed to patients.
$262 Million Settlement for Improper Inpatient Admissions. On September 25, 2018, Community Health Systems, Inc. ("CHS") announced that it reached a resolution and settlement agreement with the U.S. Department of Justice regarding its investigation into Health Management Associates, Inc.'s ("HMA") hospitals' billing federal healthcare programs for inpatient admissions following emergency room visits occurring between January 2008 and December 2012. According to statements from the federal Justice Department, HMA improperly pressured ER doctors to increase the number of inpatient admissions from emergency departments, even if these were not medically necessary. All activity involved in the investigation occurred prior to CHS's acquisition of HMA. The settlement agreement includes a payment of $262 million. The terms of the corporate integrity agreement should run through 2021.
4. Tennessee Legislative Updates
The 110th General Assembly of the Tennessee Legislature produced several new laws affecting hospitals, physicians and other healthcare providers:
SB2244 permits the commissioner of the Tennessee Department of Health to suspend the admission of any new patients or residents to any facility when the commissioner has a factual basis to believe the conditions in the facility are or are likely to be, harmful to the health, safety or welfare of a patient or resident. This regulation will apply to hospitals, ambulatory surgical treatment centers, nursing homes, etc.
SB1824 permits hospitals to require a maintenance of certification before granting privileges to a physician.
SB2513 requires the Tennessee Board for Licensing Health Care Facilities to create a process for recognizing hospitals with stroke-related designations.
SB2498 imposes certain requirements on individuals practicing ultrasound sonography in a nonclinical 3D/4D ultrasound boutique setting.
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