Federal Register/Vol. 84, No. 201/Thursday, October 17, 2019

55694 Federal Register / Vol. 84, No. 201 / Thursday, October 17, 2019 / Proposed Rules DEPARTMENT OF HEALTH AND recommendations, without unduly I. Executive Summary delaying any final rulemaking. HUMAN SERVICES A. Purpose and Need for Regulatory ADDRESSES: In commenting, please Office of Inspector General Action reference file code OIG–0936–AA10–P. The Secretary of Health and Human Because of staff and resource 42 CFR Parts 1001 and 1003 Services (the Secretary) has identified limitations, we cannot accept comments transforming our healthcare system to RIN 0936–AA10 by facsimile (fax) transmission. one that pays for value as one of the top However, you may submit comments priorities of the Department of Health Medicare and State Healthcare using one of three ways (no duplicates, Programs: Fraud and Abuse; and Human Services (the Department or please): HHS). Unlike the traditional fee-for- Revisions To Safe Harbors Under the 1. Electronically. You may submit Anti-Kickback Statute, and Civil service (FFS) payment system, which electronic comments on this regulation rewards providers for the volume of care Monetary Penalty Rules Regarding to http://www.regulations.gov. Follow Beneficiary Inducements delivered, a value-driven healthcare the ‘‘Submit a comment’’ instructions. system is one that pays for health and AGENCY: Office of Inspector General 2. By regular, express, or overnight outcomes. Delivering better value from (OIG), Department of Health and Human mail. You may send written comments our healthcare system will require the Services (HHS). to the following address: Office of transformation of established practices ACTION: Proposed rule. Inspector General, Department of Health and enhanced collaboration among and Human Services, Attention: OIG– providers and other individuals and SUMMARY: This proposed rule is being 0936–AA10–P, Room 5521, Cohen entities. The purpose of this proposed issued by the Office of Inspector General Building, 330 Independence Avenue rule is to modify existing safe harbors to (OIG) in conjunction with the SW, Washington, DC 20201. the anti-kickback statute and add new Department of Health and Human Please allow sufficient time for mailed safe harbors and a new CMP law Services’ Regulatory Sprint to comments to be received before the exception to remove potential barriers to Coordinated Care. It proposes to add, on close of the comment period. more effective coordination and a prospective basis only after a final rule 3. By hand or courier. If you prefer, management of patient care and is issued, safe harbor protections under you may deliver your written comments delivery of value-based care that the Federal anti-kickback statute for by hand or courier before the close of improves quality of care, health certain coordinated care and associated the comment period to: Office of outcomes, and efficiency. value-based arrangements between or Inspector General, Department of Health Since the enactment in 1972 of the among clinicians, providers, suppliers, and Human Services, Cohen Building, Federal anti-kickback statute, there have and others that squarely meet all safe Room 5521, 330 Independence Avenue been significant changes in the delivery harbor conditions. It also would add SW, Washington, DC 20201. of, and payment for, healthcare items protections under the anti-kickback Because access to the interior of the and services within the Medicare and statute and civil monetary penalty Medicaid programs and for non-Federal (CMP) law that prohibits inducements Cohen Building is not readily available to persons without Federal Government payors and patients. This has included offered to patients for certain patient changes to traditional FFS Medicare engagement and support arrangements identification, commenters are encouraged to schedule their delivery (i.e., Medicare Parts A and B), Medicare to improve quality of care, health Advantage, and states’ Medicaid outcomes, and efficiency of care with one of our staff members at (202) 619–0335. programs. For some time, the delivery that squarely meet all safe Department has worked to align Inspection of Public Comments: All harbor conditions. The proposed rule payment under the Medicare program comments received before the end of the would add a new safe harbor for with the quality of the care provided to comment period will be posted on donations of cybersecurity technology Federal health care program http://www.regulations.gov for public and amend the existing safe harbors for beneficiaries. Laws such as the viewing. Hard copies will also be electronic health records (EHR) Medicare Prescription Drug, available for public inspection at the arrangements, warranties, local Improvement, and Modernization Act of Office of Inspector General, Department transportation, and personal services 2003 (MMA),1 the Deficit Reduction Act of Health and Human Services, Cohen and management contracts. Further, the of 2005 (DRA),2 and the Medicare proposed rule would add a new safe Building, 330 Independence Avenue Improvements for Patients and harbor pursuant to a statutory change SW, Washington, DC 20201, Monday Providers Act of 2008 (MIPPA) 3 are set forth in the Bipartisan Budget Act of through Friday from 8:30 a.m. to 4 p.m. among statutes that guided the 2018 (Budget Act of 2018) related to To schedule an appointment to view Department’s efforts to move toward beneficiary incentives under the public comments, phone (202) 619– healthcare delivery and payment Medicare Shared Savings Program and a 0335. reform. The Patient Protection and new CMP exception for certain FOR FURTHER INFORMATION CONTACT: Affordable Care Act (ACA) 4 required or telehealth technologies offered to Jillian Sparks or Meredith Williams, encouraged significant changes to the patients receiving in-home dialysis, also (202) 619–0335. Medicare program’s payment systems pursuant to the Budget Act of 2018. SUPPLEMENTARY INFORMATION: and provided the Secretary with broad DATES: To ensure consideration, authority to test and implement models comments must be delivered to the Social Security United States Code to promote reforms, including through address provided below by 5 p.m. on Act citation citation the Center for Medicare and Medicaid December 31, 2019. The 75-day period for public comments being set forth in 1128B, 1128D, 1102, 42 U.S.C. 1320a–7b, 1 Public Law 108–173, 117 Stat. 2066. this proposed rule will serve to protect 1128A. 42 U.S.C. 1320a– 2 Public Law 109–171, 120 Stat. 4. 3 the public’s interest in this rulemaking 7d, 42 U.S.C. Public Law 110–275, 122 Stat. 2494. 1302, 42 U.S.C. 4 Public Law 111–148, 124 Stat. 119, as amended process by allowing for an opportunity 1320a.–7a. by the Health Care and Education Reconciliation for additional input and Act of 2010 (Pub. L. 111–152, 124 Stat. 1029). VerDate Sep<11>2014 20:24 Oct 16, 2019 Jkt 250001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\17OCP2.SGM 17OCP2 Federal Register / Vol. 84, No. 201 / Thursday, October 17, 2019 / Proposed Rules 55695 Innovation (the Innovation Center) • providers’ alignment on end-to-end • safe harbor protection for financial within the Centers for Medicare & treatment (i.e., coordination among arrangements with entities not Medicaid Services (CMS).5 providers along the patient’s full care participating in Innovation Center The Department has identified the journey); models, including commercial and self- broad reach of the Federal anti-kickback • incentives for providers to pay APM arrangements; statute 6 and the CMP law provision coordinate, collaborate, and provide • additional protection for patient prohibiting inducements to patients tools to be more involved in tools and supports, such as in-kind beneficiaries, the ‘‘beneficiary their own care; and items and services to support patient inducements CMP,’’ 7 as well as the • information sharing among compliance with discharge and care Federal physician self-referral law providers, facilities, and other plans, services and supports to address (sometimes known as the Stark law),8 as stakeholders in a manner that facilitates unmet social needs affecting health, and potentially inhibiting beneficial efficient care while preserving and expanded protections under the local transportation safe harbor; arrangements that would advance the protecting patient access to data. • transition to value-based care and In connection with the Regulatory enhanced safe harbor protection for improve the coordination of patient care Sprint, OIG issued a request for transfers of information technology, among providers and across care information (OIG RFI) regarding the data, and cybersecurity tools; • modifications to the current settings in both the Federal health care Federal anti-kickback statute and ‘‘patchwork’’ fraud and abuse waiver programs and commercial sectors. beneficiary inducements CMP on framework for Innovation Center models Industry stakeholders have informed the August 27, 2018.10 CMS published a and the Medicare Shared Savings Department that, because the Request for Information Regarding the Program; and consequences of potential Physician Self-Referral Law in June • a variety of protections for 11 noncompliance with the physician self- 2018 (CMS RFI). In the OIG RFI, we pharmaceutical and medical device referral law and the Federal anti- sought feedback on ways in which we manufacturer arrangements, including kickback statute could be dire, might modify or add new safe harbors broad protections for drug and medical providers, suppliers, and others may be to

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