Tag Archives: drugs

Enforcement Trend: Patient Assistance Programs

binoculars-clipart-as1859Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance programs. Patient assistance programs also have been the subject of recent Congressional inquiries related generally to the increasing price of certain prescription drugs.

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Filed under Corporate Compliance, Government Enforcement

Medicare Part B Demo Declared Dead

On Thursday, the Center for Medicare & Medicaid Services (CMS) announced that it would not move forward with its controversial Medicare Part B Payment Model  (Part B Demo).  The Part B Demo had come under heavy fire from industry groups, some patient organizations, providers and a bipartisan collection of policymakers in Congress. Continue reading

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Filed under Coverage and Reimbursement, Government Pricing, Health Care, Medicare, Uncategorized

No More Paper PIs? FDA Issues Proposed Rule on Electronic Distribution of Prescribing Information

Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human prescription drugs, including biological products (the “Proposed Rule”).  Currently, although manufacturers often voluntarily make their product PIs available electronically, they are required to distribute the PI in paper form on or within the package from which a prescription drug or biological product is dispensed.  However, under the Proposed Rule, manufacturers would be prohibited from distributing the PIs in paper form, except under limited circumstances. The Proposed Rule is expected to be published in the Federal Register on December 18, 2014, and written or electronic comments from the public will be accepted until 90 days after the date of Federal Register publication (expected to be March 18, 2015).

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Filed under Compliance, FDA, Sales & Marketing

HHS OIG Hands Out 2015 Work Plan For Halloween

On Friday October 31, 2014, the U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) released its annual “Work Plan” for fiscal year 2015.  The Work Plan is a compilation of the OIG’s plans for new and ongoing reviews and activities (including audits, evaluations, and certain legal and investigative initiatives) with respect to HHS programs and operations, for 2015 (and beyond).  The OIG summarized its FY2015 plans as follows:

“In FY 2015 and beyond, we will continue to focus on emerging payment, eligibility, management, and IT systems security vulnerabilities in health care reform programs, such as the health insurance marketplaces. OIG plans to add to its portfolio of work on care quality and access in Medicare and Medicaid, as well as on public health and human services programs. OIG’s examination of the appropriateness of Medicare and Medicaid payments will continue, with possible additional work on the efficiency and effectiveness of payment policies and practices in inpatient and outpatient settings, for prescription drugs, and in managed care. Other areas under consideration for new work include, for example, the integrity of the food, drug, and medical device supply chains; the security of electronic data; the use and exchange of health information technology; and emergency preparedness and response efforts.”

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Filed under 340B, Corporate Compliance, DHHS OIG, FDA, Fraud and Abuse, Government Enforcement, Government Pricing, Health Care, Health Reform, Medicaid, Medicare, OIG Guidance, Part D, The Affordable Care Act

OIG Blesses Tiered Rebate Arrangement

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently determined that a proposed tiered rebate program would not constitute grounds for sanctions under the federal health care program anti-kickback statute (42 U.S.C. § 1320a-7b(b)(7)), or the civil monetary penalty provision of the Social Security Act (42 U.S.C. § 1320a-7a(a)(7)). In Advisory Opinion 13-07 (issued June 24, 1013, and posted on July 1, 2013), the OIG evaluated a discount program in which rebate tiers would be reached based on the combination of purchases of both federally reimbursable products and non-federally reimbursable surgical supplies and devices (the “Surgical Products”). The proposed rebate tiers would be determined based on a customer’s total annual purchases of Surgical Products, regardless of whether those Surgical Products were reimbursable by federal health care programs such as Medicare and Medicaid. The OIG determined that the proposed arrangement would fit within the “discount safe harbor” to the federal health care anti-kickback statute, based on a number of factors. Accordingly, the OIG determined that it would not seek to impose sanctions.

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Filed under DHHS OIG, Fraud and Abuse