Healthcare Law Blog

Getting Long-Term Lost with Compliance for Long Term Care? OIG Has A Roadmap

Long Term Care (“LTC”) facilities have been a renewed area of focus for regulators in recent years, due to changes in Medicare and the potential for harm to a vulnerable population at the hands of bad actors. In April of 2019, for instance, the U.S. Department of Health & Human Services Office of Inspector General (“OIG”) put out a Data Brief with the ominous headline, “Trends in Deficiencies at Nursing Homes Show That Improvements Are Needed To Ensure the Health and Safety of Residents.” Unfortunately, this renewed focus exponentially increases the need for a push to instill compliance as a key tenet of a facility’s culture. Luckily, in 2000 and again in 2008, the OIG released a very clear roadmap for compliance that’s still reliable today. We’ll hit some of the highlights. More >

OIG Alert Shows Increased Concern over Data Blocking

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 >

Structuring Healthcare Provider Agreements for Compliance

On June 23^rd, 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

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 >

Should Health Care Providers Pay Attention to the Seventh Circuit’s New Definition of “Referral”? - Part Two

Tuesday’s post discussed the Seventh Circuit’s holding in United States v. Patel, broadly expanding the definition of “referring” under the Anti-Kickback Statute. Today’s post turns to the question of how other circuits have dealt with the issue. More >

Should Health Care Providers Pay Attention to the Seventh Circuit’s New Definition of “Referral”? - Part One

The Seventh Circuit Court of Appeals, in the case of United States v. Patel[1], just expanded the definition of “referring” under the federal Anti-Kickback Statute[2] (“Statute”). In light of this case, health care providers should again review any arrangements with their peers and colleagues, as previous arrangements may now be considered illegal under the Statute. More >

Changes Proposed for Anti-Kickback Statute

It has been said before—healthcare is changing. Most often providers must adapt their practices to comply with governing regulations. Sometimes, governing regulations must be revised to adapt to providers practices. And on occasion, governing regulations must be revised to be consistent with other governing regulations. This is one of those occasions. More >

Labs & Referring Physicians Take Note of OIG’s Special Fraud Alert

Recently, the U.S. Department of Health & Human Services, Office of Inspector General (“OIG”) issued a Special Fraud Alert (“Alert”) entitled, “Laboratory Payments to Referring Physicians.” The Alert focuses on (1) Specimen Processing Arrangements and, (2) Registry Arrangements. These arrangements, according to the OIG, pose substantial risks for fraud and abuse under the federal Anti-Kickback Statute. More >

The Sun is Not Setting on the EHR Safe Harbor

The Centers for Medicare & Medicaid Services (“CMS”) and the U.S. Department of Health & Human Services Office of the Inspector General (“OIG”) recently announced that the regulation allowing certain health care entities to donate electronic health records (with the entity subsiding up to 85% of the donor’s costs) to physicians has been extended to December 31, 2021. The regulation, which provided a safe harbor from the Stark Law and Anti-kickback statute, was set to expire on December 31, 2013. More >

OIG Updates Self-Disclosure Protocol, But Discourages Action, cont.

On Tuesday, the changes to eligibility and disclosure requirements for the OIG’s Self-Disclosure Protocol (“SDP”) were discussed. Now, let’s take a look at certain disclosures and what has changed from the ’98 version.

Disclosures Involving Excluded Persons

Many SDP disclosures involve violations of employing or contracting with individuals who are on OIG’s List of Excluded Individuals and Entities (“LEIE”).  With the update, OIG has specified what is needed for a complete disclosure of this violation. A disclosure must include, among other things, biographical information on the excluded party, description of the disclosing party’s screening process, and a description of how the conduct was discovered.  The disclosing party must also screen all current employees and contractors against the LEIE.

OIG has also provided guidance on calculating damages for this disclosure. For direct providers who bill separately, the disclosing party must provide the total amounts claimed and paid by federal health care programs for the items or services. If items or services are not billed separately, a formula will be used based on the excluded party’s total cost of employment or contracting. This amount will be multiplied by the disclosing party’s federal program payor mix.

Disclosures Involving Anti-Kickback and Stark Law

Since the 2009 Open Letter, conduct involving only potential violations of the Stark Law is not eligible for SDP. To qualify, violations must potentially involve both the AKS and Stark Law. It is the disclosing party’s responsibility to describe each disclosed arrangement and determine on their own why each arrangement may violate the AKS and, if applicable, the Stark Law.

If a disclosure is limited solely to the Stark Law, this potential violation should be disclosed to the Centers for Medicare and Medicaid Services (“CMS”) through their Self-Referral Disclosure Protocol (“SRDP”). Providers should be prepared for the possibility that OIG and CMS will work together.

A disclosing party must include the total remuneration provided through the agreement, but a party may explain why portions of the remuneration should not be considered by the OIG when determining the settlement amount.

Disclosures Involving False Billings

For potential improper claim disclosures, a disclosing party must estimate the total financial impact to government health care programs. To do this, a party can either disclose all claims with specific information or use a sample size. When using the latter method, a party must use a statistically valid sample of, at minimum, 100 claims and use the mean point estimate for calculating the effect. The ’98 version only required 30 claims and called for a “minimum precision level.”

The updated SDP does offer a short list of benefits for disclosing parties. Resolution will continue to occur in most matters without a corporate integrity agreement. This has been the general policy since the 2008 Open Letter. OIG will maintain its general practice to require a minimum multiplier of 1.5 times the single damages for many instances. Lastly, there will be a suspension of the obligation to report and return overpayments to the federal health care programs while the SDP is pending.

In evaluating the pros and cons of the updated SDP, the scales weigh heavily in favor of OIG and against self-disclosure. Entry into the SDP should be carefully considered. The new version offers only minor benefits while posing significant risks to a disclosing party who is seeking to come forth with potential violations.

Christopher J. Shaughnessy is a member at McBrayer law.  Mr. Shaughnessy concentrates his practice area in healthcare law and is located in the firm’s Lexington office.  He can be reached at cshaughnessy@mcbrayerfirm.com or at (859) 231-8780, ext. 1251. 

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This article does not constitute legal advice.