Healthcare Law Blog

ALERT – ACA Section 1557 Now in Effect – Is your rural health clinic in compliance?

On October 16^th, Section 1557 of the Affordable Care Act (“ACA”) went into effect, requiring all recipients of money from federal health care programs to provide language assistance for individuals with Limited English Proficiency at no cost. This section applies to rural health clinics (“RHCs”) as well, which means they must now comply with notice and assistance regulations as well as grievances in the cases of larger entities.  More >

Implied False Certification - Supreme Court Upholds New False Claims Act Standard

While the news for healthcare practitioners regarding regulatory liability under Federal law had largely been positive as of late, the Supreme Court of the United States upheld a new standard of liability under the False Claims Act in the case of Universal Health Services v. United States ex rel. Escobar. The standard of liability approved by SCOTUS is referred to as “implied false certification” and the implications for healthcare providers are numerous. More >

Recap of the Webinar, "What Providers Should Know: Overpayments and the False Claims Act"

On May 24th and 25th, 2016, McBrayer held a webinar on what providers should know regarding overpayments and the False Claims Act.  Lisa English Hinkle and Chris Shaughnessy, McBrayer healthcare law attorneys, guided participants through the interplay between overpayments from various federal healthcare programs and violations of the False Claims Act that can accrue heavy penalties. For further information on this webinar, contact McBrayer’s Marketing Director, Morgan Hall.

Some of the information shared by the presenters is also summarized below. More >

The One Simple Rule for Practitioners to Avoid Overpayments and False Claims Act Penalties

In December, the Centers for Medicare and Medicaid Services (“CMS”) released its “Supplementary Appendices for the Medicare Fee-for-Service 2015 Improper Payments Report,”[1] an annual compilation of statistics from investigations into overpayments and other instances of fraud, waste and abuse in Medicare payments. What should shock Kentucky providers is that Kentucky has the seventh highest percentage of projected overpayments at 15.4%, or $897.7 million.[2] More than one out of every seven Medicare fee-for-service payments made in the Commonwealth is projected to be an overpayment in 2015, yet many of these problems could have been avoided by following one simple rule: document claims properly.

[1] U.S. Department for Health and Human Services, the Centers for Medicare and Medicaid Services. (2015). The Summary Appendices for the Medicare Fee-for-Service 2015 Improper Payments Report. Retrieved from  https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/CERT/CERT-Reports-Items/Downloads/AppendicesMedicareFee-for-Service2015ImproperPaymentsReport.pdf

[2] Ibid. at 13. More >

OCR Updates HIPAA Audit Protocol for Phase 2

Recently, the Office of Civil Rights (“OCR”) provided an updated protocol that it will use when assessing compliance with HIPAA rules. OCR recently began Phase 2 of its HIPAA compliance audits, extending coverage of these audits to Business Associates (“BAs”) as well as Covered Entities (“CEs”). Both BAs and CEs should pay particular attention to these revised audit protocols, as they indicate exactly what OCR will be looking for when conducting these audits. More >

CMS Issues Proposed Rule to Cast a Wide Program Integrity Net

On March 1, 2016, the Centers for Medicare & Medicaid Services (“CMS”) quietly issued a proposed rule that would give the agency far-reaching tools in the area of program integrity enforcement. On its face, the Rule addresses enrollment and revalidation reporting requirements for Medicare, Medicaid and CHIP, but it also significantly increases its authority with regard to the denial or revocation of providers’ Medicare enrollment. More >

Good News, Providers: A Mere Difference of Medical Opinion Does Not A False Claim Make

FINALLY, some good news for providers related to false claims. In a very important Alabama case, a federal trial court granted summary judgment to AseraCare, Inc., in a False Claims Act[1] action where it had been alleged that the hospice program had knowingly submitted false claims to Medicare for patients who were allegedly not terminally ill. In its opinion, the U.S. District Court ruled that the Government may not prove falsity for purposes of the False Claims Act based solely upon the opinion of one medical expert who disagrees with the certifying physician and the patient's treating physicians about whether the medical records reported eligibility for the hospice benefit. In a ruling that all health providers can cheer, the court held that "[a] mere difference of opinion between physicians, without more, is not enough to show falsity."[2]

[1] 31 U.S.C. §§ 3729–3733

[2] United States v. AseraCare, lnc., No. 2:12-CV-245-KOB (MD

Alabama March 31, 2016) at 2. More >

HHS Finalizes Exception to HIPAA Privacy Rule for Firearm Background Checks

In January of 2016, the Department of Health & Human Services (“HHS”) issued a final rule modifying the HIPAA Privacy Rule.[1] This modification allows certain covered entities to disclose the identities of certain individuals to the National Instant Criminal Background Check System (“NICS”), a database maintained by the FBI. The information disclosed by the entities would pertain to an individual’s mental health, preventing those subject to a federal “mental health prohibitor” from possessing or receiving a firearm. Such a disclosure naturally creates a tension in the patient-provider relationship, however, and critics contend it could potentially discourage mentally ill individuals from seeking treatment.

[1] 45 C.F.R. §164 (2016) More >

New Stark Law Exception Breathes Life into Primary Care, Especially in Underserved Areas

With the recent and significant shortages of primary care providers, the Centers for Medicare & Medicaid Services (“CMS”) recently created a rather important exception to the Stark Law as a means to expand access to primary care and mental health care through incentives for non-physician practitioners.  The Stark Law prohibits referrals for Medicare and Medicaid services from physicians to other entities if the physician has a financial relationship with that entity, such as ownership, investment or a structured compensation arrangement. Under the new exception, hospitals, federally qualified health centers (“FQHCs”) and rural health clinics (“RHCs”) may give financial assistance to a physician or a physician practice to hire a non-physician provider (“NPP”), and this relief opens the door for expanded practices in primary care and mental health at a time when the need is critical. More >

New Guidance Maps HIPAA Security Rule to NIST Cybersecurity Framework to Help Providers Manage Cybersecurity Risk

In a world of looming data breaches and significant penalties for the release of protected health information, the complexities of cybersecurity and compliance with the HIPAA Security Rule can be incredibly daunting. In 2014, in response to the growing threat of data breaches, the National Institute of Standards and Technology (“NIST”) released the Framework for Improving Critical Infrastructure Cybersecurity (“the Framework”) as a means to standardize best practices in cybersecurity across organizations. To assist providers with implementing the Framework while remaining in compliance with the HIPAA Security Rule, the Department of Health and Humans Services Office for Civil Rights (“OCR”) published a HIPAA Security Rule Crosswalk (“the Crosswalk”) to tie the standards together and help strengthen cybersecurity preparedness. More >