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iii. Arrangements for Patient Engagement ad Support to Improve Quality, Health Outcomes and Efficiency safe harbor, to protect a provider’s furnishing of certain patient engagement tools and support to patients to improve quality, healthoutcomes and efficiency in value-based arrangements.
iv. CMS-Sponsored Models Arrangements and Patient Incentives safe harbor, to protect remuneration provided in connection with CMS-sponsored payment models.
v. Cybersecurity Technology and Related Services safe harbor, to protect non- monetary donations of cybersecurity technology and services that are necessary and used predominantly to implement, maintain, or reestablish effective cybersecurity.
2. Amended Safe harbors.
a. Personal Services and Management Contracts:
i. Removed a requirement to have a set schedule and the exact per-time period charges associated with part-time, periodic or sporadic arrangements. This was one of the main differences between the provisions of this safe harbor and the corresponding exception to Stark Act. Notably, this change was not implemented in the Space Rental and Equipment Rental safe harbors.
ii. Added protections for certain clinical outcomes-based payments.
iii. Replaced a requirement for having the aggregate compensation for the term of the arrangement being set in advance, with a requirement for having a methodology for determining the compensation over the term of the arrangement. This is now also consistent with the corresponding exception to Stark Act.
b. ACO Beneficiary Incentive Programs statutory safe harbor – added a new exception in the definition of “remuneration” for incentive payments made by an ACO to an assigned beneficiary under a beneficiary incentive program.
c. Warranties – revised the definition of “warranty” and protection for bundled warranties for one or more items and related services.
d. Local Transportation – expanded mileage limits for rural areas from 50 to 75 miles, and created an exception to the mileage requirements for
patients being transported to their residence after being discharged from an inpatient facility or released from a hospital after being placed in observation status for at least 24 hours.
e. Electronic Health Records Items and Services – updated the provision regarding interoperabili- ty, and removed the sunset date.
Stark Act
The Stark Act provides, in pertinent part, that if a physician (or an immediate family member of such physician) has a financial relationship with an entity, then the physician may not make a referral to the entity for the furnishing of designated health services (“DHS”), and the entity may not present or cause to be presented a claim or bill to any individual, third party payor, or other entity for any designated health services furnished pursuant to a prohibited referral.
1. New Definitions.
a. Commercially Reasonable – means that a particular arrangement furthers a legitimate business purpose of the parties to the arrangement and is sensible, considering the characteristics of the parties, including their size, type, scope, and specialty; an arrangement may be commercially reasonable even if it does not result in profit for one or more of the parties.
b. Cybersecurity
c. Interoperability
d. Target patient population, Value-based activity, Value-based arrangement and VBE participant, all of which are related to the new value-based exceptions.
2. Amended Definitions.
a. Group Practice – to clarify the profit share
and productivity bonus provisions (the scope of which remains substantially the same), but adding a provision that allows profits from DHS that are directly attributable to a physician’s participation in a value- based enterprise to be distributed to the participating physician.
Note, this change will become effective January 1, 2022.
b. DHS – to exclude services furnished to inpatients by a hospital if the furnishing of the service does not increase the amount of Medicare’s payment to the hospital under the Acute Care Hospital Inpatient, Inpatient Rehabilitation Facility, Inpatients Psychiatric Facility or Long-Term Care Hospital prospective payment systems.
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