Healthcare Law Blog

HHS OIG RELEASES FISCAL YEAR 2015 WORK PLAN

Recently, the Office of Inspector General of the United States Department of Health and Human Services (“OIG”) released its Fiscal Year 2015 Work Plan summarizing its oversight and enforcement priorities for the 2015 Fiscal Year. Here are some highlights from the Work Plan. 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 >

All Eyes on Hospice Care

In 2013, the Department of Justice (“DOJ”) and Office of Inspector General (“OIG”) charged the nation’s largest for-profit hospice chain, Vitas Innovative Hospice Care (“Vitas”), with false Medicare billings, inappropriately admitting patients with “aggressive marketing tactics,” and misleading patients and families about Medicare hospice benefits. This suit is just one of many recently filed against hospice providers, indicating that they are being watched keenly by enforcement authorities and government agencies. More >

2014 Work Plan for SNFs, Hospice & Home Health Services

If you are a physician and want to know the specific initiatives in the OIG’s 2014 Work Plan applicable to you, check out the post from earlier this week. Today, we will be examining the OIG’s enforcement priorities for skilled nursing facilities (“SNF”), hospice, and home health services. More >

2014 Work Plan Highlights for Physicians

On January 31, 2014, the Office of Inspector General (“OIG”) finally released its Work Plan for fiscal year 2014. The Work Plan is a dense summary of the OIG’s various enforcement priorities for the year. This overview is specifically for physicians, hospitals, and other health care providers. Some of this year’s plan’s significant focus areas are discussed below. More >

Does the Shutdown “Shut Down” Health Care?

The ongoing partial federal government shutdown that began on October 1, 2013, was initiated in an effort to defund the Affordable Care Act (“ACA”). Now, it seems that the shutdown is affecting everything but the ACA. More >

Nearly Two-Thirds of CAHs’ Status in Jeopardy

On August 15, 2013, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) released a report entitled “Most Critical Access Hospitals Would Not Meet the Location Requirements if Required to Re-enroll in Medicare” (“Report”). If the recommendations in the Report are fully executed, it would cause a detrimental blow to rural hospitals. There are approximately 1,300 critical access hospitals (“CAHs”) currently in operation. More >

Final Rule for Long-Term Care Facilities and Hospice Providers Becomes Effective August 26th

On June 27, 2013, CMS published its final rule for hospice agreements with long-term care (“LTC”) providers. LTC facilities are now required to have written agreements specifying what services the hospice and LTC provider will provide to nursing home residents receiving hospice care. This new Condition of Participation (CoP) aims to improve the quality and consistency of care between LTC and hospice providers by specifically defining responsibilities and roles. The agreement must be signed by authorized representatives for both the LTC facility and hospice before hospice care can be provided to patients. The effective date is August 26, 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.