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Delaware Health Law Blog

New Requirements for Delaware Free Standing Surgical Centers

On November 1, the Delaware Department of Health and Social Services (“DHSS”) promulgated new regulations governing the licensure and operation of free standing surgical centers (“FSSCs”), more commonly referred to as ambulatory surgery centers. The comprehensive regulatory changes became effective November 11 and raise a number of new issues for owners and potential investors of FSSCs.

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HHS Office of Inspector General Fraud and Abuse Focus: FY 2015 Work Plan

Each year, the Office of Inspector General (“OIG”) at the Department of Health and Human Services announces the agency’s new and continuing initiatives to combat health care fraud and abuse. The annual OIG Work Plan helps health care providers understand new, and some recurring, areas that the OIG believes are key in the fight to protect the federal fisc. We have previously discussed such key initiatives to help Delaware providers identify and focus on potential areas of compliance risk before issues arise.

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With CMPs for Employing Excluded Individuals on the Rise, Providers Should Review Their Exclusion Check Policies

Over the past three months the Office of Inspector General of the U.S. Department of Health and Human Services (“OIG”) has imposed civil monetary penalties (“CMP”) on 13 health care providers who employed individuals excluded from participating in Medicare and Medicaid. Most of these CMPs (10) were imposed on health care providers who self-reported the issue to the OIG, which likely explains the rise in these types of matters. The CMPs ranged from $10,000 imposed against a surgery center to $1.9 million levied against a diagnostic laboratory and imaging company.

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HIPAA Compliance: Two Things to do Going Forward

Since the publication over 20 months ago of the HIPAA Final Omnibus Rule, there has been no shortage of recommendations and advice to health care providers from trade organizations, industry consultants, attorneys and the Office of Civil Rights of the U.S. Department of Health & Human Services (“OCR”) about the steps providers should take in order to achieve HIPAA compliance. Last week marked a final deadline for Omnibus Rule compliance—September 23, 2014, was the date by which covered entities were required to update their agreements with business associates to include certain provisions required under the Rule.

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Physician Supervision Requirements under CMS Regulations – False Claims Act Cases on the Rise

In 2013, the Department of Justice collected over $3.8 billion in qui tam and non-qui tam settlements and judgments under the False Claims Act (“FCA”). Of the total amount collected, $2.7 billion, or 70% were in cases in which the Department of Health and Human Services (“HHS”) was the primary client agency. In comparison, cases from the Department of Defense represented just 1% of the total collections. Surprisingly, the total numbers for 2013 were actually slightly lower than 2012 numbers. In 2012, total collections were $4.9 billion, with HHS cases representing $3.1 billion, or 63%.

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The Medicare Appeal Conundrum

We have previously discussed in a number of forums the success achieved by providers in appealing Medicare claim audits and denials to the Administrative Law Judge (“ALJ”) level of the statutory appeal process. Because of the success in overturning claim decisions, more and more providers have exercised their rights to appeal claim determinations or audits resulting in alleged overpayments. The number of appeal requests submitted to the Office of Medicare Hearings and Appeals (“OMHA”) increased from approximately 1,250 per week in 2012 to 15,000 per week in 2014. This incredible increase has caused a log jam, where the average processing time for an appeal request is now 464 days and providers are awaiting ALJ hearings in over 1 million appeals.

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Delaware Facilities that Perform Invasive Medical Procedures: Prepare for Enforcement

Back in February, the Delaware Department of Health and Social Services published a final rule setting forth standards for never before regulated Delaware health care facilities: medical and dental offices.

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Delaware Office of Controlled Substances Issues Emergency Regulation Restricting Prescriptions of Extended Release Hydrocodone

On June 18, 2014, the Office of Controlled Substances issued an emergency regulation imposing a number of conditions on prescribing extended release hydrocodone that is manufactured without an abuse deterrent formulation (ADF).  The move is apparently Delaware’s reaction to the FDA’s approval last year of Zohydro ER, which approval has prompted concern among members of […]

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Medication Diversion as Abuse in Facilities

On February 14, Governor Markell signed into law House Bill No. 154, amending Titles 16 and 24 of the Delaware Code, as another action to help curb prescription drug abuse and diversion in Delaware. The law creates a new criminal offense and imposes penalties for diverting prescription drugs from a patient in a facility. More specifically, the law includes in the definition of “abuse” medication diversion “by knowingly, or intentionally, interrupting, obstructing, or altering the delivery or administration, of a prescription drug to a patient or resident” so long as the drug was prescribed or ordered by a healthcare provider for the patient or resident and where the diversion occurred without a prescription or order of a healthcare provider.

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The 2014 OIG Work Plan as a Guide to Fraud and Abuse Focus Areas

After a delay of several months, the Department of Health and Human Services, Office of Inspector General (“OIG”) released its Fiscal Year 2014 Work plan on January 31, 2014. After combing through Work Plan, we noticed new areas of OIG focus, which it believes may be ripe for fraud, waste, and abuse. The Delaware healthcare community—from physician practices to institutional providers—can stand to gain a great deal of insight by understanding the OIG’s focus and trends for the new year. Most importantly, the Work Plan can help providers identify potential areas of compliance risk before an issue arises. We have identified a few key OIG initiatives below.

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