HHS proposes new safe harbors

The U.S. Department of Health and Human Services has proposed a rule that would amend the safe harbors to the anti-kickback statute and the civil monetary penalty rules under the authority of the Office of Inspector General.

The 94-page proposed rule, if adopted would add new safe harbors and codify civil monetary provisions for gain sharing. It also would amend the definition of remuneration in the existing civil monetary regulations to provide for additional exceptions.

The anti-kickback statute provides criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration in order to induce or reward the referral of business reimbursable under Federal health care programs.

It was published on the Federal Register on Oct. 3 and comments can be submitted by clicking here by no later than 5 p.m. Eastern Standard Time on December 2, 2014.

The proposal would make the following changes:

• Create a technical correction to the existing safe harbor for referral services
• Protect certain cost-sharing waivers, including pharmacy waivers of cost-sharing for financially needy Medicare Part D beneficiaries; and waivers of cost-sharing for emergency ambulance services furnished by state- or municipality-owned ambulance services
• Add protections for certain remuneration between Medicare Advantage organizations and federally qualified health centers
• Add protections for discounts by manufacturers on drugs furnished to beneficiaries under the Medicare Coverage Gap Discount Program
• Add protection for free or discounted local transportation services that meet specified criteria

As for remuneration, the proposal seeks to: amend the definition of “remuneration” in the CMP regulations at 42 CFR 1003 by adding certain statutory exceptions for:
• Copayment reductions for certain hospital outpatient department services
• Certain remuneration that poses a low risk of harm and promotes access to care
• Coupons, rebates, or other retailer reward programs that meet specified requirements
• Certain remuneration to financially needy individuals
• Copayment waivers for the first fill of generic drugs

Over the years, the OIG has revised these regulations in an effort to strike a balance between protecting provider arrangements and protecting against fraud and abuse. The takeaway from these latest proposed revisions is that more flexibility could be on the way, which could result in allowing providers to offer services to patients in government programs such as Medicare and Medicaid, without fear of prosecution.

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The Health Law Offices of Anthony C. Vitale