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HHS Proposes to Revise Discount Safe Harbor Protections for Drug Rebates

On January 31, 2019, the Department of Health and Human Services (HHS) released a notice of proposed rulemaking (the Proposed Rule) as part of ongoing administration drug pricing reform efforts. The Proposed Rule would modify a regulatory provision that had previously protected certain pharmaceutical manufacturer rebates from criminal prosecution and financial penalties under the federal Anti-Kickback Statute. Specifically, the Proposed Rule would exclude from “safe harbor” protection rebates and other discounts on prescription pharmaceutical products offered by pharmaceutical manufacturers to Medicare Part D plan sponsors or Medicaid Managed Care Organizations (MCOs), unless the price reduction is required by law (such as rebates required under the Medicaid Drug Rebate Program). The proposed exclusion would apply to rebates offered directly to Part D plan sponsors and Medicaid MCOs, as well as those negotiated by or paid through a pharmacy benefit manager...

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OIG Seeks Comments on Anti-Kickback Statute and Beneficiary Inducements as Part of its Regulatory Sprint to Coordinated Care

On August 24, 2018, the Office of Inspector General (OIG), Department of Health and Human Services (HHS) published a request for information, seeking input from the public on potential new safe harbors to the Anti-Kickback Statute and exceptions to the beneficiary inducement prohibition in the Civil Monetary Penalty (CMP) Law to remove impediments to care coordination and value-based care. The broad scope of the laws involved and the wide-ranging nature of OIG’s request underscore the potential significance of anticipated regulatory reforms for virtually every healthcare stakeholder. The request for information follows a similar request by the Centers for Medicare and Medicaid Services (CMS) published on June 25, 2018, regarding the physician self-referral law, commonly known as the Stark Law. Both of these requests are part of HHS’s “Regulatory Sprint to Coordinated Care,” which is being spearheaded by the Deputy Secretary as an effort to address regulatory...

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OIG Issues Alert About Information Blocking, Warning Providers Who Share Software

Amid bipartisan concerns in Congress and multiple U.S. Department of Health and Human Services (HHS) agencies about health “information blocking,” the HHS Office of Inspector General (OIG) recently issued an alert reminding the health care industry that health information blocking can impact whether an arrangement satisfies the electronic health record (EHR) items and services safe harbor (42 C.F.R. § 1001.952) (EHR Safe Harbor) under the federal Anti-Kickback Statute (AKS) (42 U.S.C. § 1320a-7b(b)). The EHR Safe Harbor permits certain health care providers and other donors to pay up to 85 percent of the cost of EHR technology provided to a physician practice or other referral source if the arrangement meets all EHR Safe Harbor elements.  The third element of the EHR Safe Harbor requires that “The donor (or any person on the donor’s behalf) does not take any action to limit or restrict the use, compatibility, or interoperability of the items or services with...

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Medigap Insurer’s Discounts to Hospitals and Premium Credits to Patients Approved by OIG

In advisory opinion (15-03) earlier this month, the U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) found that a Medigap insurer’s arrangement allowing discounts on deductibles at certain preferred hospitals  – with a portion of the resulting savings going to the insurer’s policyholders  – would not result in penalties under the Anti-Kickback Statute (AKS) or Civil Monetary Penalties (CMP) Law prohibition on inducements to beneficiaries, because the likelihood of fraud and abuse under the proposal is minimal. The requestor was an offeror of Medigap insurance, a supplemental insurance policy sold by private companies to pay some costs that Medicare does not cover. For its Medigap plans, the insurer proposed an arrangement with certain network hospitals through a preferred provider organization (PPO) where the PPO hospitals would provide discounts of up to 100 percent of the Part A inpatient deductibles, for which the...

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