Healthcare Law Blog

Coronavirus: Section 1135 Waivers Bring Relief to Healthcare Providers

Invoking powers under the National Emergency Act and the Stafford Act on March 13, 2020, the President declared a national emergency, which, in turn, authorized the Secretary of Health and Human Services to waive conditions of participation requirements for payment for healthcare providers through waivers provided under Section 1135 of the Social Security Act.  The 1135 waivers do not replace 1115 waivers that require states to individually submit requests for waiver of selected Medicaid requirements, but the 1135 waivers are designed to temporarily give healthcare providers more flexibility in providing services during the pandemic crisis. The 1135 waiver is very helpful but does not address all situations or answer all questions, and it creates ambiguity in certain circumstances.   More >

A New Opportunity: Centers for Medicare and Medicaid Services Recognizes the Full Potential of Ambulance Crews and Services

In mid-February 2019, the Centers for Medicare and Medicaid Services (“CMS”), Innovation Center and the Department for Health and Human Services (“HHS”) announced a ground-breaking payment and medical services initiative for ambulance providers called “Emergency Triage, Treat and Transport” (the “ET3”). This new model is the first step in allowing providers of Emergency Medical Services to finally “take off the gloves” to fully utilize both their medical skills and unique patient knowledge to implement a more efficient and effective care model. More >

Expanded Certificate of Need Exemptions Poised to Grow Healthcare Industry

In recent months, the Commonwealth of Kentucky has begun to amend the Kentucky Administrative Regulations and the Kentucky Revised Statutes, aiming to deregulate certain healthcare facilities and services to promote growth and expansion of healthcare services to Kentuckians. Kentucky’s ability to regulate the growth of its healthcare industry is based, in part, on the State Health Plan, the Certificate of Need (CON) process and the licensure of healthcare entities through the Office of Inspector General. As a Certificate of Need state, Kentucky-based healthcare providers who wish to initiate or expand healthcare services generally must go through a lengthy and expensive process unless they meet one of the few available exemptions. For years, Kentucky excluded certain physician-owned healthcare entities from both the Certificate of Need process and licensure through a series of strict guidelines established by the Cabinet for Health and Family Services known as the “physician office exemption.” More >

Compliance: Include Prescribing Practices!

Since the implementation of House Bill 1 in 2012, the restrictions on prescribing controlled substances have become more and more stringent, which is a response to the opioid epidemic sweeping Kentucky and the nation. The Cabinet for Health and Family Services, the Kentucky Board of Medical Licensure, the Kentucky Board of Nursing, and the Kentucky Board of Pharmacy are vigilant in policing prescribing practices and have tools through KASPER to closely monitor the prescribing practices of physicians and other practitioners. With the addition of new medications like Gabapentin to the controlled substances hit list, practitioners must be particularly careful to ensure that their prescribing is consistent with regulatory requirements, particularly when patients have been on this medication previously.   Physicians and practitioners must continually monitor compliance as even a minor violation can give rise to investigations, complaints and regulatory penalties.  Assessment of regulatory penalties, even when characterized as “Agreed Orders,” can have devastating consequences for physicians and practitioners’ practices and ability to maintain provider contracts, including Medicare and Medicaid. More >

"Incident to" Billing - Easy to Get Wrong

Billing for medical services is never easy. Despite attempts by the Centers for Medicare & Medicaid Services (“CMS”) to simplify the rule regarding “incident to” billing for Medicare services, it remains misunderstood by a large swath of providers. This proves problematic, as incorrect billing practices may lead to overpayments and False Claims Act violations. Billing for “incident to” services is an important mechanism to reflect the actual value of mid-level services provided under the specific plan of a physician. When properly followed, the “incident to” rules allow physicians to bill for services provided by non-physician practitioners as if they were performed by the physician at physician reimbursement rates. Additionally, the non-physician provider can be an employee, an independent contractor or even a leased employee, provided that they are supervised by a physician and the requirements are met. Because of the confusing nature of allowing a physician to bill for services he or she did not directly provide to the patient, serious landmines exist that can create problems if the rules are not scrupulously followed and documented. More >

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 >

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 >

Webinar - What Health Providers Should Know: Overpayments and the False Claims Act

When CMS released its Medicare Fee-for-Service 2015 Improper Payments Report, Kentucky’s projected overpayment rate was a hefty 15.4%, bringing Kentucky in among the top ten states for overpayment. As healthcare providers should know, failure to report identified payments can lead to violations of the False Claims Act. CMS recently finalized the infamous “60-day rule,” which governs how overpayments can become False Claims Act violations, and practitioners should be fully aware of how overpayments are identified and reported for the purposes of the rule, lest they be subject to extreme penalties. With these fraud and abuse rules working together to provide stiffer penalties for overpayments, what can practitioners do to prevent them?  More >

CMS finalizes the 60-day overpayment rule and providers can breathe a little easier

The wait is over – in February, the Centers for Medicare & Medicaid Services (“CMS”) released its Final Rule on identifying, reporting, and returning overpayments to the Medicare and Medicaid programs. This rule is the result of provisions in the Patient Protection and Affordable Care Act (“ACA”) which created a 60-day safe harbor during which providers can identify overpayments by the two major federal healthcare programs. If a provider fails to report an overpayment within 60 days of the date that it was identified, the overpayment may be considered a violation of the federal False Claims Act (“FCA” - for more information on the FCA, please read my earlier blog posts). The Final Rule implementing this provision became effective on March 14, 2016. More >