The Trump Administration is proposing an overhaul of the law against self-referral, known as the Stark Law.The goal is to boost the adoption of value-based care, promote coordinated patient care and foster improved quality, better health outcomes, and improved efficiency. The administration’s plan is to create “safe harbors” where the Stark Law no longer applies.Keep in mind that this is only a proposal at this point, and that any changes will go through the typical rulemaking process, including a public comment period that will close in about 75 days.HHS’s Office of the Inspector General identified 10 proposed safe harbors in the Stark Law. See the slideshow below to find out what they are:
Patient Engagement
A proposed new safe harbor for certain tools and supports furnished to patients to improve quality, health outcomes, and efficiency.
CMS-Sponsored Models
A proposed new safe harbor for certain remuneration provided in connection with a CMS-sponsored model (as defined in the proposed rule), which should reduce the need for separate and distinct fraud and abuse waivers for new CMS-sponsored models.
Cybersecurity Technology and Services
A proposed new safe harbor for donations of cybersecurity technology and services.
EHR Items and Services
Proposed modifications to the existing safe harbor for electronic health records items and services to add protections for certain related cybersecurity technology, to update provisions regarding interoperability, and to remove the sunset date.
Outcomes-Based Payments and Part-Time Arrangements
Proposed modifications to the existing safe harbor for personal services and management contracts to add flexibility with respect to outcomes-based payments and part-time arrangements.
Warranties
Proposed modifications to the existing safe harbor for warranties to revise the definition of “warranty” and provide protection for bundled warranties for one or more items and related services.
Local Transportation
Proposed modifications to the existing safe harbor for local transportation to expand and modify mileage limits for rural areas and for transportation for patients discharged from inpatient facilities.
Accountable Care Organization (ACO) Beneficiary Incentive Programs
Codification of the statutory exception to the definition of “remuneration” related to ACO Beneficiary Incentive Programs for the Medicare Shared Savings Program.
Telehealth for In-Home Dialysis
A proposed amendment to the definition of “remuneration” in the rules interpreting and incorporating a new exception to the prohibition on beneficiary inducements for “telehealth technologies” furnished to certain in-home dialysis patients.
Value-Based Arrangements
Three proposed new safe harbors for certain remuneration exchanged between or among eligible participants in a value-based arrangement that fosters better coordinated and managed patient care:
• Care coordination arrangements to improve quality, health outcomes, and efficiency;
• Value-based arrangements with substantial downside financial risk; and
• Value-based arrangements with full financial risk.
These proposed safe harbors vary by the types of remuneration protected, level of financial risk assumed by the parties, and types of safeguards included as safe harbor conditions.
