Category Archives: Compliance

Deadline Looms for Pharmaceutical Manufacturers and Distributors to Comply with New Expanded Access Program Reporting Requirements

Certain pharmaceutical manufacturers and distributors of an investigational drug under an investigational new drug (IND) application must make their policies for evaluating and responding to requests under an expanded access program “public and readily available” by the end of this week pursuant to section 3032 of the 21st Century Cures Act (Cures). Cures, which became effective on December 13, 2016, provided a deadline for making the policies available on the later of: (i) 60 days after the enactment of Cures, or (ii) the first initiation of a phase 2 or phase 3 study with respect to the investigational drug. Therefore, the 60-day deadline expires on Saturday, February 11, 2017, for those manufacturers and distributors who are already conducting a phase 2 or 3 study under an IND. Continue reading

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Filed under Clinical Trials, Compliance, FDA

OIG Releases Criteria for Implementing Exclusion Authority

On April 18, 2016, the Health and Human Services Office of Inspector General (OIG) released updated guidance related to the criteria it may use for evaluating its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act. This guidance replaces guidance previously released by the OIG in 1997. All of the OIG’s special advisory bulletins and guidance documents related to its exclusion authority can be found here.

The OIG stated that in determining where a person or entity falls on the “compliance risk spectrum”, thereby determining whether exclusion should be pursued, the OIG will consider the following four risk areas:

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Filed under Compliance, DHHS OIG, Fraud and Abuse, Government Enforcement, OIG Guidance

Final Medicaid Drug Rebate Program AMP Rule: Some Technical Highlights

We reported yesterday that the Centers for Medicare & Medicaid Services (CMS) Final Average Manufacturer Price (AMP) Rule (the “Final Rule”) was released and will be published in the Federal Register on February 1.  If you are still reading, despite the fact that we included “Technical Highlights” in today’s title, we will assume a certain level of familiarity with the Medicaid Drug Rebate Program in our discussion below.  However, although the issues addressed in the Final Rule are technical, the business implications are very real, and the Final Rule is significant to all manufacturers with marketed drug products participating in the Medicaid Drug Rebate Program (or who hope to participate someday).

Those of you who have been anxiously awaiting a final AMP rule for years now will be pleased to learn that some long-standing questions raised by CMS’s controversial 2012 proposed AMP rule have been answered (and, of course, some new questions have been raised).  Some highlights of the Final Rule, in no particular order:

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Filed under 340B, Compliance, Corporate Compliance, Coverage and Reimbursement, Fraud and Abuse, Government Pricing, Health Care, Health Reform, Medicaid, The Affordable Care Act

“Common Rule” Overhaul Proposed – Intended to Modernize Human Research Subject Protections

On September 2, 2015, sixteen federal agencies and departments jointly issued a Notice of Proposed Rulemaking (“the NPRM”), designed to “modernize, strengthen, and make more effective” the so-called “Common Rule”.  The Common Rule is a uniform federal policy for the Protection of Human Subjects, originally issued in 1991. The U.S. agencies and departments adopting the Common Rule generally agree to the same set of basic protections to be applicable to human subject research activities they will conduct or support, but adopt such protections within their own applicable regulations. The NPRM is expected to appear in the September 8, 2015, issue of the Federal Register, and to be open for public comment through December 7, 2015.

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Filed under Clinical Trials, Compliance, FDA, Health Care

HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 27, 2015

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the Federal Register (the “Proposed Rule”).  The 340B Drug Discount Program is the program by which drug and biologic manufacturers are generally required to offer their products at potentially steeply discounted prices to certain purchasers, generally “safety net” entities such as certain hospitals (called “covered entities”).  Public comments on the Proposed Rule will be accepted by HRSA until October 27, 2015.  Pharmaceutical and hospital industry stakeholders are encouraged to review the proposals carefully to evaluate whether there are areas of particular concern. Continue reading

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Filed under 340B, Compliance, Coverage and Reimbursement, Government Pricing, Health Care

Key Takeaways from Government Enforcement Panel at ACI Sunshine Conference

Today, representatives from the United States Attorney’s Office for the Northern District of Georgia, United States Attorney’s Office for the District of New Jersey, and Medicaid Fraud Control Unit (MFCU) for the Office of the Attorney General of New York spoke to industry participants at the ACI 7th Advanced Forum on Sunshine Act, Open Payments, and Aggregate Spend Compliance. The robust dialogue included several key takeaways that health care entities should note:

Data Mining. As we previously discussed here, the government uses data mining and other analytics to assist in evaluating and developing cases, such as matters brought to the government’s attention by a qui tam relator or in connection with the review of a particular industry. Although the MFCU teams are prohibited from proactive data mining not associated with a particular matter or investigation plan, federal investigators are encouraged to use the data to proactively identify potential fraud and abuse. According to the panelists, the government has used claims data for data mining and analytics for some time, which will play “an even greater role” in investigations moving forward. Similarly, use of the Open Payments data will continue to increase as the offices become more skilled at working with this data.

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Filed under Compliance, Federal Transparency, Fraud and Abuse, Government Enforcement

OIG Issues Fraud Alert re: Physician Compensation Arrangements

The U.S. Health and Human Services Office of Inspector General (OIG) released a Fraud Alert today titled Physician Compensation Arrangements May Result in Significant Liability. The OIG directs health care professionals (HCPs) to carefully evaluate compensation arrangements, including medical directorships and office staff arrangements, to confirm that (i) the compensation represents fair market value (FMV) for bona fide services; (ii) the FMV payment does not take into consideration the HCP’s past or future volume or value of referrals to Federal health care programs; and (iii) the services will actually be provided. The Fraud Alert directs HCPs to the OIG’s Compliance Program Guidance for Individual and Small Group Physician Practices and A Roadmap for New Physicians: Avoiding Medicare and Medicaid Fraud and Abuse for more information for additional information.

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Filed under Compliance, Fraud and Abuse, OIG Guidance