Personal Services and Management Contracts Safe Harbor

(4) Specifies that a first-level contractor may not require payment in any form, directly or indirectly, of a federal health program for items or services covered by the Agreement, except in: (2) If the cost-sharing amounts are owed by a person who is responsible for services subsidized under a provision of the Public Health Services Act or under Titles V or XIX of the Act to a State. A qualified health centre or other health centre has a qualified care facility under a subsidy program under the Public Health Services Act or under Title V of the Act, the health centre or institution may reduce or waive cost-sharing amounts for items or services for which payment may be made in whole or in part through a federal health program. 4. Unless both parties belong to the same common practice within the meaning of point (p) of this Section, the only exchange of value between the parties shall be the remuneration received by the parties directly from the third-party payers or the patient who compensates the parties for the services they have each provided to the patient. (C) Includes and specifies the amount of all goods, goods, services, donations or loans to be made available to the Health Centre by the person or organization. As described in our customer alert issued on December 10, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Office of the Inspector General (OIG) of the Department of Health and Human Services have released two long-awaited final rules that modernize and amend the regulations of the Stark Act and the Anti-Bribery Act (AKS). The final arrangement includes many changes, including the long-awaited changes to personal services and management contracts that are secured under the AKS. This warning concerns significant changes to AKS` personal services and Safe Harbor management contracts to provide greater flexibility for payment agreements in value-based models. Under the results-based safe harbor, an agent is any person who has an agreement to provide services to or on behalf of the principal, with the exception of a bona fide employee of the principal. In particular, this safe haven excludes payments made to (i) a pharmaceutical manufacturer, distributor or wholesaler, (ii) a pharmaceutical service manager, (iii) a laboratory company, (iv) a dispensing pharmacy, (v) a manufacturer of a medical device or care, (vi) a distributor or wholesaler of medical devices, and (vii) a legal or natural person selling or leasing EMR, prostheses, orthotics or supplies, which are covered by a federal health program. (6) The services provided under the Contract do not include advising or promoting any business agreement or other activity that violates state or federal laws.

(5) Neither the recipient nor the practice of the recipient (or any natural or legal person associated with it) makes the receipt of goods or services or the quantity or nature of the goods or services a condition of the business relationship with the donor. 6. Neither the eligibility of a beneficiary for the goods or services nor the amount or nature of the goods or services shall be determined in a manner that takes into account the volume or value of recommendations or other transactions generated between the parties. 1. The UCIT has entered into a written agreement with each person or entity to whom goods or services are provided: safe harbours shall set specific conditions which, if met, shall ensure that the entities concerned will not be prosecuted or sanctioned for the safe harbour eligible agreement. However, Safe Harbor protection is only granted to regulations that meet exactly all the conditions set out in the Safe Harbor. 4. For goods or services of the type that can be used for any patient, regardless of payer status, the donor must not restrict or take steps to restrict the recipient`s right or ability to use the goods or services for a patient.

The Safe Harbor requires the parties to regularly monitor and evaluate performance under the agreement, including the impact of the outcome-based payment agreement on the quality of patient care. The Parties shall regularly assess benchmarks and remuneration and, if necessary, revise them to ensure that remuneration is consistent with fair value. In addition, agreement must be measured using clinical outcome measures that: (i) are selected based on clinical evidence or credible medical support, and (ii) are benchmarks used to quantify the improvement in the quality of patient care or a significant reduction in costs or growth in payer expenses, while maintaining or maintaining the quality of care for the patient. improve. A signed written agreement is required and must describe the types of services to be provided under the outcome-based payment agreement, clinical evidence or credible medical support on which the selection of the outcome measure is based, as well as the timeline by which the parties regularly monitor and evaluate the outcome measures. Monitoring and evaluation may be carried out at least once a year or at least once in the case of value-based agreements with a maturity of less than one year. iii) Covers all electronic prescribing items and services to be provided by the donor (or related parties). This requirement is met if all separate agreements between the donor (and affiliated parties) and the recipient include each other by reference or if they create a reference to a master list of agreements that is maintained and updated centrally and that is available to the Secretary for review upon request. The main list should be kept up to date in order to preserve the historical documents of the agreements. (9) The payment or exchange of value shall not directly or indirectly benefit any person (other than the physician hired) or any entity capable of making or influencing referrals to the entity that provides hiring payments or services of items or services payable by a federal health program.

This comment is part of a series of nine comments on recently finalized exemptions to the Stark Act and the anti-bribery law, as well as safe havens to remove regulatory barriers to supply coordination. (v) All ancillary services to federal health program recipients provided to the entity must be directly and fully related to the primary procedures performed by the entity, and none may be billed separately to Medicare or other federal health programs. Health Care Plan means an entity that provides or arranges for the provision of items or services to members under an agreement with contractual health care providers or provides insurance coverage for the provision of such items and services for a premium or fee if that entity: In terms of results-based payments, of personal services and management contracts now Can offer compensation agreements that include results-based payment models, i.e. payments or payment reductions, in order to achieve or not successfully achieve a measure of results, . B such as the number of emergency room visits. . . .

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