OIG November 2017 Work Plan Update

The OIG added four items to its Work Plan with the November 2017 update, as listed on the chart below. Interestingly, three of the four new items relate to Medicaid. Hot topics include prescriptions for extreme amounts of opioids and Medicaid’s use of telemedicine. Hospitals will want to know that the OIG is looking into hospital inpatient billing for severe malnutrition. Below are brief descriptions of the four new items.

Following a trend from the previous two Work Plan updates and consistent with the government’s growing focus on the opioid crisis, the OIG will be examining prescriptions for extreme amounts of opioids to Medicaid beneficiaries. The OIG observes that Medicaid beneficiaries, particularly those on disability, are more susceptible to opioid abuse because they are more likely to have conditions that require pain relief. The OIG intends to look at the issue from both the beneficiary side and the prescriber side. The overall goal of the study is to generate “baseline data about beneficiaries receiving extreme amounts of opioids and prescribers with questionable patterns for opioids in Medicaid.”

Authored by: Michaela D. Poizner,
615.726.5695, mpoizner@bakerdonelson.com

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OIG Advisory Opinion 17-06: Another Medigap/PHO Arrangement Approved

Advisory Opinion 17-06 joins a long list of opinions approving arrangements between a Medicare Supplemental Health Insurance (Medigap) insurer and a preferred hospital organization (PHO). While this advisory opinion does not offer new insights with respect to Medigap/PHO arrangements, the OIG has remained consistent in its approach to them.

As with prior similar requests, the Medigap insurer here sought approval of an agreement in which it would contract with a PHO, and the hospitals within the PHO’s network would provide discounts of up to 100 percent on the Medicare Part A inpatient hospital deductibles covered by the insurer. The hospitals would not provide any additional benefits to the Medigap insurer or its policyholders, and the insurer would pay a fee to the PHO for administrative services each time it received a discount. The Medigap insurer would also return a portion of the savings to those policyholders who had an inpatient stay at a network hospital via a $100 credit toward their next renewal premium. The use of non-network hospitals would not subject policyholders to penalties or otherwise affect liability for costs covered by the Medigap plans.

Authored by: Andrew J. Droke,
865.971.5170, adroke@bakerdonelson.com

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“Breaking Bad” News: Sharing PHI During Opioid Crisis

In response to President Trump’s declaration of the opioid crisis as a public health emergency, the Office for Civil Rights (OCR) released guidance intended to educate health care providers on how they can respond to requests for protected health information (PHI) during an opioid crisis. OCR’s guidance does not reveal any new or revised standards for disclosure of PHI, but rather it instructs health care providers on how existing HIPAA rules apply to sharing PHI with a patient’s family members, close friends or legal representative during a crisis situation, such as an opioid overdose.

The guidance illustrates how PHI may be shared without the patient’s consent in an opioid crisis, but the prevailing HIPAA rules permit disclosure of PHI any time the criteria noted below are satisfied. Specifically, providers may share PHI:

• with a patient’s family, and close friends when doing so is in the best interests of an incapacitated or unconscious patient; and
• when doing so would prevent or diminish a serious and imminent threat to the patient’s health and safety.

Authored by: Ashley L. Thomas,
202.508.3429, athomas@bakerdonelson.com
Reviewed by: Tracy E. Weir,
202.508.3481, tweir@bakerdonelson.com

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Physician Practice Penalized by DOJ for 60-Day Overpayment Rule Violation

The Department of Justice (DOJ) imposed False Claims Act penalties against First Coast Cardiovascular Institute (FCCI) for failing to work credit balances and repay overpayments to federal health care programs. On October 13, 2017, DOJ announced that FCCI agreed to pay $448,821 to resolve False Claims Act allegations brought by a former employee of FCCI. The qui tam lawsuit alleged that FCCI wrongfully delayed repayment of approximately $175,000 in potential overpayments to federal health care programs beyond 60 days. This settlement represents a warning to providers who intentionally drag their feet in the face of a potential overpayment, and fail to diligently investigate and repay monies owed to federal health care programs.  Authored by: Stewart W. Kameen,
410.862.1068, skameen@bakerdonelson.com
Reviewed by: William T. Mathias, 410.862.1067, bmathias@bakerdonelson.com

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Webinar | LTC Disaster Readiness: How Your Facility Can Prepare, Respond, and Recover

As recovery efforts take center stage in areas affected by natural disasters that have recently impacted our nation, it is critical that the long term care industry is aware of the unique issues presented by these events.

This webinar covers the regulatory framework relevant to this industry, including new requirements that went into effect on November 15, 2017, as well as additional changes sometimes implemented post-event, and the rules and requirements specifically applicable to entities who may be eligible for aid through federally funded relief programs, including those administered through the Federal Emergency Management Agency. The session concludes with recommendations for disaster response and preparedness, including a summary of common issues and best practices to minimize risks. Presented by Baker Donelson attorneys Ernest B. Abbott, Wendy Huff Ellard, Meredith N. Larson, and Danielle Trostorff.

View the webinar here.

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Co-Chairs, Health Care Regulatory Group

Jonell B. Beeler Jackson 601.351.2427 jbeeler@bakerdonelson.com

Catherine A. Martin Baltimore 410.862.1120 cmartin@bakerdonelson.com

By Alisa L. Chestler, CIPP/US and Andrew J. Droke

A multi-year discovery dispute regarding the adverse medical incident reports of a Jacksonville, Florida hospital concluded on October 2, 2017 when the United States Supreme Court denied a petition for a writ of certiorari in Southern Baptist Hospital of Florida, Inc. v. Charles. Because the Supreme Court declined to hear the case, the Supreme Court of Florida’s January 2017 decision will continue to limit the protections afforded to certain peer review activities under the federal Patient Safety and Quality Improvement Act (PSQIA).

Health care providers that collect and report information to patient safety organizations (PSOs) should perform a detailed review of their patient safety evaluation (PSE) systems, as reporting systems may require restructuring to ensure that the privileges afforded by PSQIA will apply.

The Patient Safety and Quality Improvement Act vs. Florida Constitution Amendment 7

PSQIA was enacted in 2005 with the goal of improving patient safety and health care quality by establishing a voluntary, confidential, and non-punitive system for the reporting of medical errors and near-miss data. The free-flow of information was intended to improve patient outcomes. As a result, providers, facilities, and health systems have established PSE systems to collect and report data to PSOs, which then aggregate, analyze, and use the information to help minimize medical risk by providing feedback and assistance.

Recognizing that the collection and reporting of this data also presents the potential for increased liability exposure, Congress established a statutory privilege for “patient safety work product,” which generally includes “any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements” created for or supplied to a PSO.

In contrast, in 2004, Florida adopted a constitutional amendment commonly referred to as “Amendment 7,” which established a state-wide right of access to the adverse medical incident records of health care providers. Because of the breadth of this provision, Amendment 7 has frequently been relied upon by plaintiffs in medical malpractice litigation to collect records from defendant providers.

The conflict between the confidentiality afforded by PSQIA and the access secured via Amendment 7 was squarely before the court in Charles. There, a medical malpractice plaintiff served written discovery requests seeking all adverse medical incident reports in the defendant hospital’s history as well as other records of treatment and care during specific time periods. In response, the defendant hospital produced two occurrence reports related to the patient at issue, but objected to providing any additional adverse medical incident data based upon the privileges afforded by PSQIA.

After the trial court granted the motion to compel and the First District Court of Appeal reversed, the plaintiff appealed to the Supreme Court of Florida. Favoring access under Amendment 7, Florida’s high court held that the hospital’s adverse medical incident records did not qualify as patient safety work product under PSQIA and that the federal act did not preempt Amendment 7. Thus, the adverse medical incident data sought was discoverable.

The Florida Supreme Court specifically opined that the requested reports were not privileged because Florida law required the hospital to maintain the records. In so holding, the court effectively established a rule whereby Florida health care providers must create reports solely for the purpose of submission to a PSO in order for the reports to qualify as privileged patient safety work product. Further, even if this conflicts with the stated purposes of PSQIA, the United States Supreme Court’s October 2, 2017 denial of the hospital’s petition for a writ of certiorari concludes the inquiry.

Now, even if prepared via a PSE system and reported to a PSO, PSQIA will not protect from discovery the adverse medical incident reports created by Florida health care providers to comply with state reporting obligations. Health care providers should take steps to revise their PSE systems accordingly.

What You Need to Know

Because the U.S. Supreme Court will not revisit the decision in Charles, Florida health care providers should review and consider whether their PSE systems combine state-required reporting obligations with reports to PSOs. The combination of reporting functions is likely to limit the ability to shield such reports from discovery in civil litigation.

If you have any questions or would like assistance in evaluating your PSE systems, please contact a member of the BakerOber Health Law Group or Health Care Litigation Team.

About the Authors

Alisa L. Chestler, CIPP/US Nashville 615.726.5589 achestler@bakerdonelson.com

Andrew J. Droke Knoxville 865.971.5170 adroke@bakerdonelson.com