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Photo of Healthcare Law Blog Christopher J. Shaughnessy
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cshaughnessy@mcbrayerfirm.com
859.231.8780; ext. 1251
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There has been one constant in Chris Shaughnessy’s 30-year career in healthcare law: change. As the most regulated industry in the American economy, healthcare has an ever-evolving …

Showing 20 posts by Christopher J. Shaughnessy.

OIG Alert Shows Increased Concern over Data Blocking

By Christopher J. Shaughnessy on October 27, 2015
Posted In Anti-Kickback Statute, EHR Systems, Electronic Health Records (“EHR"), Office of Inspector General of the United States Department of Health and Human Services (OIG)

In a report to Congress last April, the Office of the National Coordinator for Health Technology addressed the growing issue of data blocking. Data blocking occurs when some person or entity knowingly and unreasonably interferes with the exchange or use of electronic health information (“EHI”), and this happens due to business incentives that cause those persons or entities to want to control and limit availability to that information. For instance, if one ACO has the capability to send EHI of a patient safely and securely to another ACO treating that patient through a certified health IT system, but instead faxes that patient’s information, it has engaged in data blocking. It has made it more difficult, inefficient and expensive for the rival ACO to treat that patient. In essence, data blocking prevents the exact purpose of the HITECH Act and provisions of the Affordable Care Act which were designed to increase interoperability of electronic health information systems and facilitate the exchange of information. These broad concerns over data blocking found footing in a recent Office of Inspector General (“OIG”) Alert stressing that data blocking can run afoul of the Federal Anti-Kickback Statute. More >

FCC Guidance on Cellphones Puts the Squeeze on Medical Debt Collectors

By Christopher J. Shaughnessy on September 15, 2015

In July, the FCC released an order it touted as strengthening “consumer protections against unwanted calls and texts.” It was a series of rulings based on the Telephone Consumer Protection Act meant to clarify the use of autodialers, procedures for wrong numbers and consent to call, mainly concerning cellphones. Under these new regulations, healthcare providers must get express written consent to be able to contact patients on their mobile phones about medical debt and billing. More >

Providers Wary after First Ruling on 60-Day Rule

By Christopher J. Shaughnessy on August 11, 2015
Posted In Centers for Medicare & Medicaid Services (“CMS”), False Claims Act, Medicaid

The False Claims Act (“FCA”) is already a minefield for healthcare providers, especially when coupled with the Stark Law. Treble damages and fines of up to $11,000 per violation add up quickly under the FCA. The U.S. District Court for the Southern District of New York just made further FCA “reverse false claims” nightmares that much more of a reality in the case of Kane v. Healthfirst. That case is illustrative of how the government will interpret and enforce the Centers for Medicare & Medicaid Services’ (“CMS”) “60-day rule” for retention of overpayments, and the result should make all healthcare providers take notice. More >

Structuring Healthcare Provider Agreements for Compliance

By Christopher J. Shaughnessy on June 25, 2015
Posted In Anti-Kickback Statute, Health Care Fraud, Office of Inspector General of the United States Department of Health and Human Services (OIG), Stark Laws

On June 23rd, the Healthcare Law Blog discussed the Fraud Alert recently issued by the Office of Inspector General of the United States Department of Health and Human Services regarding physician compensation arrangements which telegraphed the Office of Inspector General’s intention to increase scrutiny of financial arrangements between physicians and providers to whom physicians make referrals. In today’s post, we examine the steps physicians and other healthcare providers should take to ensure that any financial relationships are in compliance with federal statutes and regulations. More >

OIG Fraud Alert Targets Physician Compensation Arrangements

By Christopher J. Shaughnessy on June 23, 2015
Posted In Anti-Kickback Statute, Fraud, Health Care Fraud, Office of Inspector General of the United States Department of Health and Human Services (OIG), Stark Laws

It bears repeating so much that even the Office of Inspector General of the Department of Health and Human Services just issued a Fraud Alert on it – physician compensation arrangements are fraught with potential violations of the Anti-Kickback Statute (“AKS”) as well as the Stark Statute and regulations. The AKS is a large enough trap that it catches even the most above-board agreements in its net, and physicians should be wary of the implications. Likewise, the Stark Statute and regulations are broad and are strict liability laws: if you do not meet a Stark exception, the referral and the resulting claim are tainted and the money received based upon the tainted claim must be repaid to the government. More >

FDA Issues Guidance for Mobile Medical Apps

By Christopher J. Shaughnessy on May 14, 2015

Just so you know, that iPhone or iPad you have with you may be an FDA-regulated medical device. More precisely, the apps on the device may meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).[1] In February of this year, the FDA released a revised set of guidance concerning how it will apply regulatory oversight to mobile apps, addressing the growing number and potential uses of these apps as they proliferate alongside rapidly changing mobile technology. More >

OIG Guidance for Healthcare Boards

By Christopher J. Shaughnessy on May 12, 2015
Posted In Compliance, Department of Health and Human Services (HHS), Office of Inspector General of the United States Department of Health and Human Services (OIG)

In April, the Office of the Inspector General for the U.S. Department of Health and Human Services (“OIG”), in conjunction with the American Health Lawyers Association, the Association of Healthcare Internal Auditors, and the Health Care Compliance Association, released “Practical Guidance for Health Care Governing Boards on Compliance Oversight.” Rather than merely discussing aspirational goals or stating governing principles, the guide lives up to its name in giving practical suggestions for how health care governing boards oversee compliance programs, a true product of a partnership between the OIG and associations that represent those regulated by the office. The document stressed new compliance challenges for healthcare governing boards, such as value-based payment systems and the effect of ever-expanding publicly available data (under the Sunshine Rule, for instance). The guidance covered specific topic areas of concern, each of which will be discussed briefly. More >

Important Recommendations from the MedPAC March Report to Congress, Part Two

By Christopher J. Shaughnessy on April 2, 2015
Posted In Medicare, Part D

Important Recommendations from the MedPAC March Report to Congress, Part Two More >

Important Recommendations from the MedPAC March Report to Congress, Part One

By Christopher J. Shaughnessy on March 31, 2015
Posted In Accountable Care Organizations (“ACO”), Fee for Service, Medicare, Part D

Medicare. Medical Concept.Each March, the Medicare Payment Advisory Commission (“MedPAC” or the “Commission”) is tasked with reporting to Congress on the current state of the Medicare fee-for-service (“FFS”) payment systems, the Medicare Advantage (“MA”) program and the Medicare prescription drug program (“Part D”). This report gives lawmakers recommendations on ways to improve and enhance the Medicare system, as well as shore up areas of concern. This year’s report again struck at the root of systemic problems, specifically noting that an increasing issue within Medicare is a fundamental problem with FFS payment systems – the system incentivizes the delivery of more services without taking into account the value of those additional services. Several reforms in the report are the subject of current Congressional legislation as well. In the posts for both today and Thursday, we’ll parse the various statements and recommendations in MedPAC’s March report with an eye for their effect on the workings of the system. More >

HIPAA and “Meaningful Use” Audits: Issues to Consider and How to Prepare

By Christopher J. Shaughnessy on February 19, 2015
Posted In Audit, Electronic Health Records (“EHR"), Health Insurance Portability and Accountability Act of 1996 (HIPAA), HIPAA Risk Assessment, Meaningful use incentives

As more and more providers adopt electronic health records (“EHRs”) systems (and with new regulations concerning their required use for purposes of Medicare billing for chronic care management, their popularity can only continue to grow), a myriad of compliance issues continue to surround them. To that end, the federal government has stepped up auditing programs to ensure compliance with HIPAA/HITECH as well as making sure taxpayer money has been invested wisely through the Meaningful Use program. The bent of these audit programs is clearly along the lines that applicable covered entities and business associates should be preparing with a “when” mindset, rather than “if,” as these audits are going to happen. More >

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