Answer: We share the interest of commentators in protecting patients from selective selection, provision of medically unnecessary care, hesitation in care, patient control and any inappropriate violation of the patient-physician relationship. As a result, we have put in place safeguards in each of the three value-based safe havens related to these issues. We did not propose any transparency or patient notification requirements in the OIG`s proposed value-based safe harbor rule, as we felt it could impose an unreasonable administrative burden on providers, and we do not include such a condition in this final rule. Medical personnel, as in the Self-Referral Act, are exempt from anti-bribery laws [(see Article 1001.952(i) of the Regulation]] Although existing safety rules may protect many supply coordination agreements, the comments we received in response to the OIG indicated that the existing safe harbour rules are not sufficient to protect the range of care coordination agreements envisaged by the sprint. regulatory. For example, apart from employment, there is no safe haven for staff or the sharing of infrastructure at prices below market value. As such, value-based refuges will protect a wider range of supply coordination agreements than is currently possible under existing safety harbours. Referring to the commenter suggesting that a pre-implementation assessment of safe havens was warranted, we sought comments on the expected approach for the development of Start Printed rules page 77692 in the RFI and sought comments on certain safe havens, an exception and relevant considerations in the rule proposed by the OIG. We do not believe that further evaluation is needed to inform the publication of this final rule; Indeed, further formal assessment could delay regulatory flexibilities to facilitate innovative value-based care and care coordination arrangements. Answer: With this final rule, we have tried to find the right balance between the strategic objectives of the regulatory sprint and the need to protect both patients and federal health programs. We refuse to adopt the specific recommendations of commentators regarding a possible step-by-step approach or the regular publication of related reports, but we note that as part of our oversight mission, we may conduct future reviews of value-based agreements in federal health programs. We have put in place strong protections in value-based shelters to address the concerns of commentators. We note that under the significant downside and total risk exemptions, we offer greater flexibility when the parties assume the required financial downside risk.
Others who are unwilling or unwilling to take risks, or who are only willing or willing to take risks below the level required for significant financial downside risk or the Safe Harbor agreement on full financial risk, may turn to Safe Harbor due diligence coordination agreements that do not require risk-taking. Structure arrangements so that they fit into another safe harbor that may apply or make arrangements that are not protected by a safe harbor, as structuring a safe harbor compliance agreement is voluntary. Of course, the AKS applies to both sides of the bribery settlement. Therefore, its prohibitions also apply to the company that offers or pays these parties to generate healthcare business. This independent diagnostic testing facility (IDTF) offered remote monitoring services under exclusive supplier agreements with physicians and hospitals. He paid $1.35 million to settle allegations that he had paid illegal bribes to suppliers. MedNet aggressively marketed the financial benefit of “Split Bill Medicare and Fee for Service for Private Payors” to physicians. This was done to get doctors to use MedNet`s cardiac monitoring services, as it was more cost-effective for the provider than using the services of MedNet`s competitor. Comment: While supporting the proposed definition of “value-based society,” several commentators have called on the OIG and CMS to align all changes with the final definition of “VBE.” According to the commenter, identical definitions would allow stakeholders to focus more on providing value-based care, as they would not have to navigate different legal frameworks under the Federal Bribery Act and the Physician Self-Referral Act. Certain financial relationships between the audiologist or speech-language pathologist and the physician are protected (i.e., “safe”) as long as the rules outlined in the Safe Harbor regulations are followed. Response: Based on these comments, we have endeavoured, during this final rule, to provide additional clarifications and examples of key terms and concepts.
Parties may also use the OIG`s notice procedure to obtain legal advice on the application of the OIG`s fraud and abuse powers to a particular agreement. With respect to the call for better alignment with Medicare`s shared savings program, we note that in developing value-based safe havens, we have relied on our experience with waivers granted for Medicare`s shared savings program, but we do not believe that an adjustment to the waiver terms would be appropriate for a number of reasons. First, CMS provides programmatic oversight of the Medicare shared savings program, which it would not offer to all value-based businesses under this final rule. In addition, the exemptions apply to certain remuneration linked to an alternative payment model, while the safe havens concluded in this final rule apply to a wider range of value-based supply-based agreements. Finally, as explained in more detail below, all individuals and entities can be VBE participants, while participation in the Medicare Shared Savings Program is more limited. Parties participating in CMS-sponsored models may wish to see the new safe haven for these models under paragraph 1001.952(ii), which is closely aligned with the requirements of the model and takes into account the CMS`s oversight of these models and the Medicare Shared Savings Program. In general, most commentators strongly supported the proposed security rules and the need for regulatory reform of safe harbors and exemptions from the definition of compensation as part of the CMP`s “incentives to beneficiaries”. While the majority of commentators recommended various revisions to the proposed Safe Harbor offerings to increase regulatory flexibility, some commentators acknowledged that increased regulatory flexibility could increase the risk of harm from fraud and abuse, and recommended revisions to add or strengthen safeguards in the Safe Harbor proposals.