The HHS Office of Inspector General finalized a rule that amends anti-kickback statutes and gives providers more flexibility to improve access and quality of care.
The rule would includes protections for free or discounted local transportation services, waivers that subsidize drug costs for low income patients and waivers of cost-sharing for emergency use of state or municipality-owned ambulance services.
Providers have asked for more opportunities to collaborate and promote new methods of value-based care without concern of violating the Stark Law, which prohibits doctors from referring Medicare patients for designated health services at a facility where the doctor has a financial relationship.
The final rule acknowledges that concern. “The transition from volume to value-based and patient-centered care requires new and changing business relationships among healthcare providers,” the rule reads.
The American Hospital Association asked for changes to the safe harbor regulations in a letter to President-elect Donald Trump that detailed a list of preferred policy changes.
The safe harbor exception for local transportation would apply only to “established patients,” although that can include a new patient who initiated contact with a provider to seek services. It covers 25 miles in urban settings and 50 miles in rural settings.
The rule also defines eligible entities for local transportation to include home health agencies, pharmacies and laboratories. The entity must bear the costs of the transportation without shifting costs to any payer or other provider or supplier. Air, luxury and ambulance-level transportation are not protected.
The transportation services cannot be publicly marketed and those traveling cannot be subject to marketing of healthcare items or services during the trip.
The proposed rule would protect a pharmacy waiving Medicare Part D cost-sharing as long as the waiver is not advertised, the pharmacy does not routinely waive or reduce the cost-sharing and the pharmacy determined the beneficiary is in financial need.