Tag Archives: compliance

Health System Free Transportation Program Does Not Warrant Sanctions, Says OIG

The Office of Inspector General (OIG) recently issued Advisory Opinion 15-13, addressing whether an integrated health system (Health System) was at risk for administrative sanctions under the federal anti-kickback statute or civil monetary penalty law for offering free shuttle services to patients. The OIG concluded that the proposed transportation arrangement presents minimal risk of fraud … Continue Reading

OIG Emphasizes Proactive Enforcement of Privacy Rule and Monitoring of Repeat Offenders

The Office of Inspector General’s (OIG) recently released Privacy Standards report assessed the Office for Civil Rights’ (OCR) oversight of covered entities’ compliance with the Privacy Rule as well as the extent to which Medicare Part B providers are aware of HIPAA privacy standards. To that end, the OIG found that Part B providers fell … Continue Reading

D.C. District Court Deals Blow to HHS 340B Program Interpretive Rule

Court says Congress has the power to make the change that HHS attempted with its Interpretive Rule, and thus it should be left to the legislative branch. A lawsuit challenging the Interpretive Rule, filed by the Pharmaceutical Research and Manufacturers of America (PhRMA) in October 2014, was recently vacated in favor of PhRMA by the … Continue Reading

HIPAA Fine Underscores OCR’s Focus on Physician Group Compliance

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) recently announced a $750,000 fine and resolution agreement, including a Corrective Action Plan (CAP), for Cancer Care Group, P.C. (CCG), a private organization made up of 18 physicians. The CCG investigation and resolution demonstrates that OCR does not exempt even modest-size physician … Continue Reading

340B Guidance: Eight Key Points Covered Entities Should Consider

On August 27, 2015, the Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), released the 340B Drug Pricing Program Omnibus Guidance (Guidance). Referred to as “proposed” guidance by HRSA, the Guidance is intended to clarify a multitude of issues for the thousands of registered covered … Continue Reading

Kane and the “60-Day Rule”: The Unforgiving World of Medicare and Medicaid Overpayments

The Southern District of New York has spoken on one of the first issues to confront those seeking compliance with the new “60-day rule” under the Affordable Care Act (ACA), and it does not bode well for defendant hospitals and providers. On August 3, 2015, the district court in Kane v. Healthfirst, Inc., issued its … Continue Reading

Proposed Rule Aims to Refine Stark Regulations and Clarify “Incident To”

On July 15, 2015, the Centers for Medicare and Medicaid Services (CMS) published the calendar year (CY) 2016 Physician Fee Schedule Proposed Rule. In addition to updating several traditional Part B payment policies, the proposed rule contains significant changes to the physician self-referral regulations (Stark regulations) and the Medicare “incident to” coverage rule. The comment … Continue Reading

Proposed 340B Rule Would Impose Penalties for Overcharging, Plus Other Charges

A recently-released proposed rule would impose civil monetary penalties on drug manufacturers that intentionally overcharge healthcare providers for medications purchased under the 340B Discount Drug Program. The proposed rule, if adopted, could open the door to significant financial penalties for manufacturers, even if it is the manufacturer’s wholesaler or other business partner that overcharges the … Continue Reading

HHS OIG Creates New Taskforce to Pursue Civil Monetary Penalties and Exclusions

If you have any questions concerning this article, please contact: B. Scott McBride at smcbride@bakerlaw.com or 713.646.1390; Greg Saikin at gsaikin@bakerlaw.com or 713.646.1399 from our Healthcare Investigation and Enforcement team; John J. Carney at jcarney@bakerlaw.com or 212.589.4255; George A. Stamboulidis at gstamboulidis@bakerlaw.com or 212.589.4211 from our White Collar Defense and Corporate Investigations team; or Hilary … Continue Reading

OIG Advisory Opinion 15-07: An Indicator of Clinical Trial Copayment Change?

“You scratch my back, I scratch yours” arrangements are common in business transactions. These agreements are risky in the healthcare space, however, with the potential to implicate civil and criminal sanctions. Whether involving a patient, provider, or industry, the government closely scrutinizes quid pro quo arrangements when the government foots the bill. Clinical trial sponsors … Continue Reading

OIG Fraud Alert Cautions Against Sham Medical Director Arrangements

The HHS OIG recently issued a brief fraud alert (Fraud Alert) reminding physicians that inappropriate compensation arrangements may lead to enforcement actions under the federal anti-kickback statute and Civil Monetary Penalties Law. Although not mentioned in the Fraud Alert, improper compensation arrangements also raise issues under the federal self-referral law known as the Stark Law. … Continue Reading

Justice to Target Corporations and C-Suite Executives in the Healthcare Industry

On Thursday, May 14, 2015, at a meeting of the American Bar Association’s Healthcare Fraud Section, Leslie Caldwell, the Assistant Attorney General for the Department of Justice (DOJ) Criminal Division, declared stamping out healthcare “fraud and holding those who commit this fraud accountable are core missions of the Criminal Division and the Justice Department.” In … Continue Reading

FDA Finalizes Guidance Documents on Biosimilars

Six years after legislation was adopted creating a new pathway for the approval of biological products that are biosimilar to existing FDA-approved biologics, the Food and Drug Administration (FDA) continues to issue guidance to clarify its interpretation of the law. The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) created an abbreviated licensure … Continue Reading

OIG Provides Additional Compliance Guidance for Healthcare Governing Boards

On April 20, 2015, the HHS Office of Inspector General (HHS OIG), in collaboration with the American Health Lawyers Association (AHLA), the Association of Healthcare Internal Auditors (AHIA), and the Health Care Compliance Association (HCCA), released a guidance document on compliance for healthcare governing boards, attorneys, compliance officers, and internal auditors. The insight provided by the … Continue Reading

OMB Reviewing HRSA Proposed Rule For Civil Monetary Penalties And Ceiling Price Regulations For 340B Drug Discount Program

The agency that oversees the 340B Drug Discount Program (340B program) is seeking review by the White House Office of Management and Budget (OMB) of a proposed rule that would use civil monetary penalties to enforce ceiling price regulations. The Rule, proposed by the Health Resources and Services Administration (HRSA), rule seeks to enforce the … Continue Reading

FDA Issues Draft Memorandum of Understanding for 503A Drug Compounding

Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate distribution of prescription compounded drugs—a Draft Memorandum of Understanding (MOU) between the FDA and each of the 50 states. As previously discussed, … Continue Reading

FDA Guidance Documents Change Compounding Landscape

Almost a year and a half after adoption of the Drug Quality and Security Act (DQSA) in November 2013, which revised federal oversight of drug compounding, the Food and Drug Administration (FDA) continues to roll out guidance documents detailing its view on assorted issues concerning implementation of the statute. The FDA’s most recent offering is … Continue Reading

Now’s the Time to Comment on the FDA’s New Draft Documents on Compounding Policy

The U.S. Food and Drug Administration (FDA) has released five new draft documents related to drug compounding and repackaging by “outsourcing facilities,” state-licensed pharmacies, federal facilities and other healthcare entities. These documents are the latest in a series of policy guidance, including the documents released in July 2014 and December 2014, issued as part of the … Continue Reading

OIG Advisory Opinion Sheds Light on Preventive Care Exception

The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently issued an advisory opinion approving an arrangement whereby a licensed entity providing services under a state program for at-risk mothers and children (State Program) would provide diapers and play yards to program participants who are Medicaid beneficiaries. The advisory opinion … Continue Reading

New Guidance for 503B Outsourcing Facilities

Three guidance documents recently issued by the Food and Drug Administration (FDA) provide greater clarity for certain entities that compound sterile drugs. The new guidance addresses registration requirements, fees and drug reporting requirements for those entities registered as outsourcing facilities under Section 503B of the Federal Food, Drug and Cosmetic Act (FFDCA). Congress amended the … Continue Reading

HRSA Withdraws Proposed “Mega Rule” for 340B Drug Pricing Program

The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services (HHS), has withdrawn a proposed omnibus rule, referred to as the “mega rule,” for the 340B Drug Pricing Program. The mega rule was expected to cover contract pharmacy compliance and eligibility criteria for patients, hospitals and off-campus … Continue Reading

Medical Information More Valuable to Hackers Than Credit Card Numbers

In light of the recently reported large healthcare data breaches that have resulted in the potential theft of the personal information of millions of patients, the FBI warned healthcare providers yet again of the dangers of cyber attacks. Healthcare providers, already sensitive to the need for increased patient data protection in response to the 2013 … Continue Reading

Implications on Pharmacies of Recent OIG Advisory Opinion on Per-Fill Fees

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently issued an advisory opinion regarding a proposed arrangement by a specialty pharmacy (Requestor) to pay local pharmacies a per-fill fee for the provision of support services in connection with patient referrals to the specialty pharmacy. OIG found that this per-fill fee … Continue Reading

Hospital’s Failure to Abate Patient and Visitor Violence Against Employees Results in OSHA Penalty

Hospitals, remarkably, are one of the most hazardous places to work. According to the U.S. Bureau of Labor Statistics, hospital workers have an estimated rate of 8.3 assaults per 10,000 workers compared to an estimated 2 assaults per 10,000 workers in the overall work environment. With this background in mind, the Occupational Safety and Health … Continue Reading
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