The U.S. Department of Health and Human Services Office of Inspector General (OIG) released today, August 24, 2016, an updated guidance on the OIG’s views on the applicable independence and objectivity standards for Independent Review Organizations (IROs) that perform reviews required under Corporate Integrity Agreements (CIAs), such as claims reviews and cost report reviews. The OIG has previously issued guidance in 2004 and 2010 to reflect updated standards and the additional types of IRO reviews included in CIAs. This OIG guidance released today is to reflect the 2011 revisions to the GAO accounting standards.
Health care providers and other entities often enter into CIAs as a result of a settlement with the OIG related to allegations of violating certain civil false claims statutory provisions. Health care providers or entities agree to certain obligations in a CIA, including retaining an independent review organization to conduct annual reviews.
A copy is available on the OIG’s website at www.oig.hhs.gov
Written by: Clay J. Countryman
On August 5, 2016, the United States Attorney for the Middle District of Georgia announced a civil settlement in which Sweet Dreams Anesthesia, a partnership of certified registered nurse anesthetists (CRNAs), paid over $1,015,000 to resolve allegations that Sweet Dreams paid kickbacks to ambulatory surgery centers to induce Medicare and Medicaid patients by providing free anesthesia drugs and through other financial transactions. Continue reading
On July 28, 2016, the U.S. Department of Justice announced, “The Lexington County Health Services District Inc. d/b/a Lexington Medical Center located in West Columbia, South Carolina, has agreed to pay $17 million to resolve allegations that it violated the Physician Self-Referral Law (the Stark Law) and the False Claims Act by maintaining improper financial arrangements with 28 physicians.”
According to the government press release, “The United States alleged that Lexington Medical Center entered into asset purchase agreements for the acquisition of physician practices or employment agreements with 28 physicians that violated the Stark Law because they took into account the volume or value of physician referrals, were not commercially reasonable or provided compensation in excess of fair market value.
Also as part of the settlement, Lexington Medical Center will enter into a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services-Office of the Inspector General (HHS-OIG) that requires Lexington Medical Center to implement measures designed to avoid or promptly detect future conduct similar to that which gave rise to this settlement.
Written by: Clay J. Countryman
In settling allegations of violating the False Claims Act (FCA), healthcare providers often enter into a Corporate Integrity Agreement with the OIG in exchange for the OIG’s agreement not to exclude the provider from participation in Medicare or other federal health care programs. Corporate Integrity Agreements (CIAs) generally require a provider to establish or supplement an existing compliance program, with detailed requirements described in the CIA. Continue reading
Nearly 211,000 Louisiana residents covered under an “Obamacare” plan can expect to see rate hikes between 16.4 and 30.75 percent in 2017. The premium hikes are meant to cover the massive losses the plans have accumulated. Insurer’s filings with the Louisiana Insurance Department detail enrollee’s increased use of services, higher costs of benefits and prescription drugs and lower payments from a federal program meant to protect insurers from unexpectedly high claims and losses. Among the plans proposing increases are Blue Cross and Blue Shield of Louisiana, Aetna Health Inc., Humana Health Benefit Plan of Louisiana Inc., and Vantage Health Plan Inc. In April, UnitedHealth pulled itself from the ACA Exchanges in Louisiana and most other states after it says their plans in those states accumulated losses of more than $1.1 billion nationally over a two-year period. UnitedHealth’s departure from Louisiana’s ACA Exchange will leave approximately 29,000 people looking for a new insurer for 2017.
On June 1, 2016, Gov. John Bel Edwards signed a bill into law that bans the second-trimester abortion procedure known as “dilation and evacuation.” This makes Louisiana the sixth state to prohibit this abortion method. Under the new law, called the “Unborn Child Protection from Dismemberment Abortion Act,” the procedure will only be allowed if necessary to prevent “serious health risk” to the mother. The law takes effect on August 1, 2016. Only the performing physician will be legally responsible and subject to penalties for violations of the ban. The penalties could include loss of license to practice medicine and the possibility of a fine up to $1,000 and a prison sentence of up to two years.
It is unclear whether this law will stand up to a legal challenge. A similar law was blocked by state courts in Kansas and Oklahoma as violating the state Bill of Rights and the Due Process Clause of the Fourteenth Amendment of the U.S. Constitution.
See full text of the Unborn Child Protection from Dismemberment Abortion Act here.
Written by: Catherine Moore
Beginning June 1, 2016, Louisiana residents with a household income below 138 percent of the federal poverty level will be eligible to obtain healthcare coverage through the state’s Medicaid program. On January 12, 2016, Gov. John Bel Edwards signed an executive order to expand the Medicaid program, making Louisiana the 31st state to extend Medicaid.
The U.S. Department of Health & Human Services also approved a new approach to Medicaid enrollment that will allow Louisiana to use information from the Supplemental Nutrition Assistance Program (SNAP) to determine eligibility and enroll individuals in Medicaid. Louisiana is the first state to be approved to use this enrollment strategy through the use of a state plan amendment.
- Enrollment began on June 1
- Coverage will be effective July 1
- The State of Louisiana estimates that 375,000 new adults will enroll in coverage, with about 105,000 people already enrolled in SNAP identified as likely eligible for coverage.
- Through 2016, the coverage for newly enrolled adults of up to 138% of the federal poverty line is completely funded with federal money. However, federal funding rates will decline beginning in 2017 (Federal funding rates will not fall below 90% of costs). 
 U.S. Department of Health & Human Services, HHS Secretary Sylvia M. Burwell Applauds Louisiana Medicaid Expansion Under the Affordable Care Act, (May 31, 2016).
Written by: Catherine Moore
The Office for Civil Rights (OCR) recently announced two separate settlements with a hospital and a physician practice that highlight the importance of having HIPAA business associate agreements. Each of these HIPAA settlements were based on the failure to have a HIPAA business associate agreement in place with a third party that a hospital and a physician practice had disclosed patient’s healthcare information to perform certain administrative services. In each case, the third party recipients of patient electronic healthcare information committed or contributed to a breach under the HIPAA Privacy Rule. Continue reading
On April 19, 2016, the United States Supreme Court heard oral argument in Universal Health Services, Inc. vs. United States and Massachusetts ex. rel. Escobar. In Escobar, the Court will decide for the first time whether to embrace the theory of “implied certification” under the Federal False Claims Act (“FCA”), 31 U.S.C. §§3729-3733. Under that theory, a health services provider that requests payment from the Government for providing services while knowing, but not disclosing, that the services failed to meet requirements that were material to payment is deemed to have presented a false or fraudulent claim under the FCA. In other words, the theory states that the provider impliedly certifies that the billed for services meet the applicable requirements merely by submitting the claim for payment. Most Federal circuits which have considered the theory have adopted it in one form or another. Continue reading
This week, the OCR announced another HIPAA settlement based on a provider’s failure to have a Business Associate Agreement in place before disclosing PHI to a third party business vendor.
OCR had initiated an investigation of Raleigh Orthopaedic Clinic, P.A. of North Carolina following receipt of a breach report which revealed a release of protected health information (PHI) without first having a business associate agreement (BAA) in place. Continue reading