Healthcare Law Blog

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. 

Services may be performed by others.

This article does not constitute legal advice.

OIG Updates Self-Disclosure Protocol, But Discourages Action

On April 17, 2013, the Office of Inspector General (“OIG”) issued an updated Provider Self-Disclosure Protocol (“SDP”). The initial protocol was created in 1998 (“’98 version”) with the goal of having providers voluntarily identify and disclose potential federal health care program fraud and work with the OIG to resolve the identified abuses. Specifically, the SDP offered guidance to providers (both individuals and entities) on how to investigate conduct, quantify damages, mitigate potential penalties, and report to OIG.  Further guidance came in a series of OIG Open Letters to the health care industry in 2006, 2008, and 2009. The updated SDP provisions supersede both the original version and the subsequent Open Letters. More >

Get Ready to Negotiate: OIG Authorizes Hospitals to Pay Physicians for Call Coverage

Since the enactment of EMTALA in 1986, hospitals have struggled with providing sufficient call coverage to meet federal requirements as physicians have been increasingly hesitant to take on the added responsibility, cost, and risk of responding to emergency department requests for consultation.  With patients often presenting in increasingly acute conditions with no health insurance coverage, physicians understandably find themselves between a rock and a hard place as utilization of hospital emergency departments has skyrocketed, particularly in Eastern Kentucky.  And, it is becoming increasingly difficult to see these patients in the hospital emergency departments without also seeing the patients for follow-up in private physician offices often without payment. Thus, the movement for hospitals to pay for physician call services started amid a tangled web of intricate financial relationships, power struggles between hospitals and medical staff, and a statutory and regulatory maze of the Stark Law and Anti-kickback Statutes.  Finally, good news is on the horizon as a result of a series of recent Department of Health and Human Services Office of Inspector General’s Advisory Opinions, which essentially give the okay for a hospital to pay a per diem fee to specialists providing unrestricted on-call coverage for hospital emergency departments within certain parameters.  For physicians, these OIG Opinions give clear guidance and should be a tool to negotiate payment for call within the parameters of fair market value. More >

OIG 2013 WORK PLAN GIVES DIRECTION FOR PHYSICIANS

The government’s health care fraud prevention and enforcement efforts recovered a record $4.2 billion in taxpayer dollars in Fiscal Year (FY) 2012, up from nearly $4.1 billion in FY 2011. Over the last four years, the administration’s enforcement efforts have recovered $14.9 billion, up from $6.7 billion over the prior four-year period.  During 2012, the Department of Justice (“DOJ”) opened 885 new civil health fraud investigations with 1,023 civil fraud matters pending at the end of the year.  The DOJ also reported a record 647 whistleblower lawsuits and recovered $3.3 billion from lawsuits filed by whistleblowers. On the criminal side, the DOJ opened 1,121 new criminal healthcare fraud investigations with 2,032 healthcare fraud criminal investigations pending at the end of FY 2012.  The DOJ filed criminal charges in 452 cases involving 892 defendants during that time. On the civil side, The Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) excluded 3,131 individuals and entities from participation in the Medicare and Medicaid programs during FY 2012. As the pursuit of health fraud becomes increasingly profitable reportedly returning $7.90 for every $1 spent, providers should expect to see a continued focus and devotion of resources by the federal government to combat healthcare fraud and abuse.  Likewise, the floodgates appear to be opening for healthcare false claims cases as whistleblower suits are predicted to gain popularity as their success breeds volume increases. More >

AN EFFECTIVE COMPLIANCE PROGRAM: PREVENTIVE MEDICINE FOR THE INDIVIDUAL AND SMALL PHYSICIAN GROUP PRACTICE

With federal and state fraud and abuse enforcement efforts on the rise, all health care providers must be vigilant in identifying areas of risk and putting in place mechanisms to ensure regulatory compliance.  This holds true not just for larger institutional providers, but individual and small physician group practices, as well.  With the proliferation of federal and state contractors tasked with performing audits of coding and  billing practices, physician practices must be prepared to demonstrate proper coding and billing practices and proper documentation to support those practices.  The best preventive medicine for the individual and small physician group practice is a carefully drafted compliance program to identify and address areas of risk and to promote a culture of compliance within the practice. More >

Guess Who’s Coming to Visit? Long-Term Care Facility Inspections

Compliance and preparedness are two very real, everyday concerns for long-term care facilities. Not only are these important aspects of daily operations for the safety of the employees and patients, they are paramount because any day a visitor from the Office of the Inspector General (OIG”) or Occupational Safety and Health Administration (“OSHA”) could show up for an inspection.  Is your facility prepared? More >

Compliance Plan – A Provider’s Defense

The Office of the Inspector General (“OIG”) has always encouraged Medicare and Medicaid providers to implement a compliance program. For 14 years, as a matter of fact, OIG has provided compliance guidance in 11 healthcare sectors (including: hospitals, nursing facilities, home healthcare, hospice and third-party billers). With the passing of the Patient Protection and Affordable Care Act (“PPACA”), compliance plans and programs are now mandatory for any provider enrolled in a Federal health care program, including Medicare. More >

Fraud, Waste and Abuse Controls Under The Affordable Care Act

The Affordable Care Act (“ACA”) strives to improve our health care system in three main areas; by expanding consumer protections, strengthening Medicare and reducing health care costs.  One key way the government hopes to achieve these goals is through tougher fraud and waste controls. Given the focus on prevention, penalty and recovery, compliance plans are of the utmost importance for all health care providers. First we examine all of the elements incorporated in the ACA that pertain to fraud, abuse and waste before we can begin to develop a compliance plan for our facilities. The new law contains a host of tools aimed at enforcing fraud and waste prevention.  Let’s review: More >

Federal Government Fight Against Health Care Fraud

FIFTEEN YEARS - $20.6 BILLION – NOT BAD!! More >

ON THE ENFORCEMENT RADAR: MEDICAID AUDITS AND THE 2012 OIG WORK PLAN

Unlike the Department of Health and Human Services Office of Inspector General (“OIG”) which publishes a Work Plan each year, the Department of Medicaid Services (“Medicaid”) generally does not publish guidance on the areas which it plans to investigate and/or audit. In fact, Medicaid’s website states … “Medicaid does not provide guidance on how companies should bill for services, but will direct you to applicable regulations.  If you receive direction from staff about how to bill, the Department will not be bound by such instruction, unless it was given by a Director or Commissioner.” Because the federal integrity programs are now moving through the process, Kentucky Medicaid providers are starting to see lots of audit activities. Unlike the OIG audits, we don’t know the precise subject matter of the Medicaid audits, but the process for appeal is outlined below in addition to the areas announced for review by the OIG. More >