The U.S. Department of Health and Human Services (HHS) announced today the release of two long-awaited proposed rules to “modernize and clarify” federal laws relevant to value-based and patient coordinated care programs. As previously discussed, these proposed rules are part of HHS’ Regulatory Sprint to Coordinated Care and arise from requests for information (RFI) issued by HHS in mid-2018.

The first proposed rule, “Revisions to the Safe Harbors Under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements” (AKS/CMP Proposed Rule), would, if finalized, make a number of changes to the Anti-Kickback Statute (AKS) and beneficiary inducement provisions of the Civil Monetary Penalties Law (CMP). These changes would include the addition of several new AKS safe harbors:

  • Care Coordination Arrangements to Improve Quality, Health Outcomes, and Efficiency (§ 1001.952(ee));
  • Value-Based Arrangements With Substantial Downside Financial Risk (§ 1001.952(ff));
  • Value-Based Arrangements With Full Financial Risk (§ 1001.952(gg))
  • Certain tools and supports furnished under patient engagement and support
    arrangements to improve quality, health outcomes, and efficiency (1001.952(hh));
  • Certain remuneration provided in connection with a CMS-sponsored
    model (§ 1001.952(ii))
  • Cybersecurity Technology and Services (§ 1001.952(jj)

The AKS/CMP Proposed Rule also would make material changes to current AKS safe harbors, including:

  • Revise the Electronic Health Records Items and Services safe harbor (§ 1001.952(y)) to add protections for certain related cybersecurity technology and update provisions regarding interoperability.
  • Revise the Personal Services and Management Contracts safe harbor(§ 1001.952(d)) to add flexibility with respect to outcomes-based payments and part-time arrangements.
  • Revise the Warranties safe harbor (§ 1001.952(g)) to revise the definition of “warranty” and provide protection for certain bundled warranties.
  • Revise the Local Transportation safe harbor (§ 1001.952(bb)) to modify mileage limits for rural areas and transportation for patients discharged from inpatient
    facilities.
  • Codification of the statutory exception to the definition of “remuneration” related to ACO Beneficiary Incentive Programs for the Medicare Shared Savings Program (§ 1001.952(kk))

The AKS/CMP Proposed Rule also would make changes to the beneficiary inducement provisions of the CMP Law by revising the definition of “remuneration” to incorporate a new statutory exception related to “telehealth technologies” furnished to certain in-home dialysis patients.

For more information regarding the AKS/CMP Proposed Rule, read the OIG Fact Sheet.

The second proposed rule, “Modernizing and Clarifying the Physician Self-Referral” (Stark Proposed Rule), would, if finalized, provide several new exceptions to the Stark Law, including for Limited Remuneration to a Physician (§411.357(z)) and Cybersecurity Technology and Related Services (§411.357(bb)), and amend the current EHR exception (§411.357(w)). The Stark Proposed Rule also would introduce several new definitions for value-based activity, value-based arrangement, value-based enterprise, value-based purpose, VBE participant, and target patient population in order to implement these exceptions.

For more information regarding the Stark Proposed Rule, read the CMS Fact Sheet.

Health care and life sciences companies should carefully review and consider the AKS/CMP Proposed Rule and Stark Proposed Rule relevant to their business. Comments to both proposed rules are being accepted until late December. Cooley will continue to review and monitor activity related to these proposed rules.

Posted by Sarah K. diFrancesca