HISTORIC CHANGES TO STARK LAW AND ANTI-KICKBACK STATUTE REGULATIONS BY OIG AND CMS.
CMS has finalized changes to outdated federal regulations, such as the Stark Law, which have saddled health care providers with more administrative costs and impeded the advancement of the health care system toward value-based reimbursement. To know more about these changes and Anti-Kickback Statute Reforms, read along!
CMS has finalized changes to obsolete federal regulations that have saddled health care providers with more administrative costs and impeded the health care system’s move toward value-based reimbursement. Also known as the “Stark Law”, the Physician Self-Referral Law prohibits a physician from making referrals to an entity for certain healthcare services if there is a financial relationship with that entity.
The Stark Law forbids a physician from making referrals for certain healthcare services payable by Medicare if the physician (or an immediate family member) has a financial relationship with the individual rendering the service. In 1989, when the time Stark Law was established, healthcare was paid for primarily on a fee-for-service basis. The law recognized that some physicians could be motivated by financial gains to request services based on their financial self-interest instead of the good of the patient. There are, however, statutory and regulatory exceptions to this rule. Additionally, the Stark Law forbids the entity from filing claims with Medicare for services resulting from a prohibited referral, and Medicare is not to pay if such claims are filed.
Stark Law Final Rule
CMS, through this final rule, tries to ensure that the regulations regarding the Stark Law allow for changes that will help in modernizing the healthcare system. The rule finalizes most of the proposed policies from the notice of proposed rulemaking that was issued in October 2019, which include:
· Minimizing administrative issues that increases costs by redirecting funds budgeted for administrative compliance to patient care.
· Protecting non-abusive, beneficial arrangements that apply irrespective of whether the parties operate in a fee-for-service or value-based payment system — for example, donations of cybersecurity technology that safeguard the integrity of the healthcare environs.
· Finalizing additional guidance on the major requirements of the exceptions to the physician self-referral law to make it easier for physicians and other health care providers to comply with the law.
· Finalizing new, permanent exceptions for value-based arrangements to that will permit physicians and other health care providers to design and enter into value-based arrangements without fear that legitimate activities to coordinate and improve the quality of care for patients and lower costs would violate the physician self-referral law.
OIG’s final rule, and the CMS final rule to the extent the Stark Law is applicable, would facilitate a range of arrangements to improve the coordination and management of patient care and the engagement of patients in their treatment if all applicable regulatory conditions are met, including the following examples:
· To improve patient transitions from one care delivery point to the next, a hospital may wish to provide physician offices with care coordinators that furnish individually tailored case management services for patients requiring post-acute care.
· A hospital may wish to provide support and to reward institutional post-acute providers for achieving outcome measures that effectively and efficiently coordinate care across care settings and reduce hospital readmissions. Such measures would be aligned with a patient’s successful recovery and return to living in the community.
· A primary care physician or other provider may wish to furnish a smart tablet that is capable of two-way, real-time interactive communication between the patient and his or her physician. The patient’s access to a smart tablet could facilitate communication through telehealth and the provision of in-home services.
· A health system furnishes cybersecurity technology to physician practices to reduce harm from cyber threats to all their systems.
AKS Final Rule includes seven new safe harbors, modify four existing safe harbors and codifies one new exception under the Beneficiary Inducements Civil Monetary Penalty (CMP).
The final safe harbor regulations protect:
· Value-Based Arrangements. Three 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:
o Care Coordination Arrangements to Improve Quality, Health Outcomes, and Efficiency;
o Value-Based Arrangements With Substantial Downside Financial; and
o Value-Based Arrangements With Full Financial Risk.
These new safe harbors vary by the type of remuneration protected, level of financial risk assumed by the parties, and safeguards included as safe harbor conditions.
· Patient Engagement and Support. A new safe harbor for certain tools and supports furnished to patients to improve quality, health outcomes, and efficiency.
· CMS-Sponsored Models. A new safe harbor for certain remuneration provided in connection with a CMS-sponsored model.
· Cybersecurity Technology and Services. A new safe harbor for donations of cybersecurity technology and services.
· Electronic Health Records Items and Services. 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. Modifications to the existing safe harbor for personal services and management contracts to add flexibility for certain outcomes-based payments and part-time arrangements.
· Warranties. 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. Modifications to the existing safe harbor for local transportation (§ 1001.952(bb)) to expand and modify mileage limits for rural areas and for transportation for patients discharged from an inpatient facility or released from a hospital after being placed in observation status for at least 24 hours.
· Accountable Care Organization (ACO) Beneficiary Incentive Programs. Codification of the statutory exception to the definition of “remuneration” under the anti-kickback statute related to ACO Beneficiary Incentive Programs for the Medicare Shared Savings Program (§ 1001.952(kk)).
· Telehealth for In-Home Dialysis. An amendment to the definition of “remuneration” in the CMP rules interpreting and incorporating a new statutory exception to the prohibition on beneficiary inducements for “telehealth technologies” furnished to certain in-home dialysis patients.