Today the Department of Health and Human Services, Office of the Inspector General (“OIG”) published a proposed rule to amend 42 C.F.R. § 1001.952.  If adopted, it would revise certain safe harbors to the anti-kickback statute and add safe harbors providing new protections.  In proposing to modifying the safe harbors, the OIG’s goal, consistent with statute, is to “protect beneficial arrangements that enhance the efficient and effective delivery of health care and promote the best interests of patients, while also protecting the federal health care programs and beneficiaries from undue risk of harm associated with referral payments.” 79 Fed. Reg. 59719 (October 3, 2014).

The proposed rule includes:

  • A technical correction to the existing safe harbor for referral services;
  • Protection for 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;
  • Protection for certain remuneration between Medicare Advantage organizations and federally qualified health centers;
  • Protection for discounts by manufacturers on drugs to beneficiaries under the Medicare Coverage Gap Discount Program; and
  • Protection for free or discounted local transportation services that meet specified criteria.

In addition, the proposed rule proposes to amend the definition of “remuneration” in the Civil Monetary Penalty (“CMP”) regulations at 42 C.F.R. § 1003 by excluding the following:

  • 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 for financially needy individuals; and
  • Copayment waivers for the first fill of generic drugs.

The proposed rule also purports to codify the gainsharing provision of the CMP rule set forth in section 1128A(b) of the Social Security Act and seeks comments on specific areas of concern, including the following:

  • “Should a hospital’s decision to standardize certain items (e.g., surgical instruments, medical devices, or drugs) be deemed to constitute reducing or limiting care?”
  • “Should a hospital’s decision to rely on protocols based on objective quality metrics for certain procedures ever  be deemed to constitute reducing or limiting care (e.g., protocols calling for discontinuance of a prophylactic antibiotic after a specific period of time)?  Should hospitals deciding to compensate physicians in connection with the use of such protocols be required to maintain quality-monitoring procedures to ensure that these protocols do not, even inadvertently, involve reductions in care?”
  • “Should a hospital desiring to standardize items or processes as part of a gainsharing program be required to establish certain thresholds based on historical experience or clinical protocols, beyond which participating physicians could not share in cost savings (i.e., change beyond the relevant threshold would be deemed to constitute reducing or limiting services)?”

Comments to the proposed rule are due by December 2, 2014.