Medicare Program; Request for Information Regarding the Physician Self-Referral Law
Request for information.
CFR Part: "42 CFR Part 411"
RIN Number: "RIN 0938-AT64"
Citation: "83 FR 29524"
Document Number: "CMS-1720-NC"
Page Number: "29524"
"Proposed Rules"
SUMMARY: This request for information seeks input from the public on how to address any undue regulatory impact and burden of the physician self-referral law.
EFFECTIVE DATE: Comment Date: To be assured consideration, comments must be received at one of the addresses provided below, no later than
ADDRESSES: In commenting, refer to file code CMS-1720-NC. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the "Submit a comment" instructions.
2. By regular mail. You may mail written comments to the following address ONLY:
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3. By express or overnight mail. You may send written comments to the following address ONLY:
For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that website to view public comments.
I. Introduction
The Department of
The
II. Background
When enacted in 1989, the physician self-referral law (section 1877 of the Social Security Act), also known as the "
By design, the physician self-referral law is intended to disconnect a physician's health care decision making from his or her financial interests in other health care providers and suppliers. Specifically, the law: (1) Prohibits a physician from making referrals for certain designated health services (DHS) payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship (ownership or compensation), unless an exception applies; and (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payer) for those referred services. The prohibitions are absolute unless the physician's referral is permitted under an enumerated exception. The statute establishes a number of specific exceptions, and grants the Secretary the authority to create regulatory exceptions for financial relationships that do not pose a risk of program or patient abuse. For more information, please refer to the CMS physician self-referral website at https://www.cms.gov/Medicare/Fraud-and-Abuse/PhysicianSelfReferral/index.html?redirect=/PhysicianSelfReferral/.
CMS is aware of the effect the physician self-referral law may have on parties participating or considering participation in integrated delivery models, alternative payment models, and arrangements to incent improvements in outcomes and reductions in cost. The President's Budget for fiscal year (FY) 2019 included a legislative proposal to establish a new exception to the physician self-referral law for arrangements that arise due to participation in alternative payment models. In addition to this legislative proposal, CMS has engaged stakeholders through comment solicitations in several recent rulemakings. In 2017, through the annual payment rules, CMS asked for comments on improvements that can be made to the health care delivery system that reduce unnecessary burdens for clinicians, other providers, and patients and their families. In response, commenters shared additional information regarding the barriers to participation in health care delivery and payment reform efforts, both public and private, as well as the burdens of compliance with the physician self-referral law and our regulations as they exist today. As a result of our review of these comments, and with a goal of reducing regulatory burden and dismantling barriers to value-based care transformation, while also protecting the integrity of the Medicare program, we are requesting additional information in this
III. Request for Information
We are requesting public input on the following areas:
1. Please tell us about either existing or potential arrangements that involve
* The categories/types of parties (for example, the parties are a hospital and physician group with downstream payments to individual physicians in the group).
* Which parties bear risk (and how and to what extent) under the arrangement (for example, per capita payments from a payor are paid to a hospital with downstream payments on a discounted fee schedule to individual physicians; a bundled payment from a payor for all hospital and physician services is split between a hospital and physicians based on a predetermined percentage; hospital-sponsored gainsharing program where participating physicians share in cost savings; physician incentive payments are available for achieving predetermined metrics; etc.).
* The scope of the arrangement (for example, non-Medicare beneficiaries only, Medicare beneficiaries only, or all patients regardless of payor).
* The timeframe of the arrangement (for example, ongoing or for a duration that aligns with a payor-specific initiative).
* Items and services provided under the arrangement and by whom (for example, infrastructure, such as electronic health records technology; physician services; care coordination services; etc.).
* How the arrangement furthers the purpose of the alternative payment model or novel financial arrangement.
* Whether and, if so, how the arrangement mitigates the financial incentives for inappropriate self-referrals, and/or overutilization of items and services, and patient choice.
2. What, if any, additional exceptions to the physician self-referral law are necessary to protect financial arrangements between
* What additional exceptions are necessary to protect accountable care organization models?
* What additional exceptions are necessary to protect bundled payment models?
* What additional exceptions are necessary to protect two-sided risk models in a FFS environment?
* What additional exceptions are necessary to protect other payment models (please explain the nature and design of such models)?
* How (if at all) should a new exception (or exceptions) protect individual
3. What, if any, additional exceptions to the physician self-referral law are necessary to protect financial arrangements that involve integrating and coordinating care outside of an alternative payment model? Specifically, what types of financial arrangements and/or remuneration related to care integration and coordination should be protected and why? How (if at all) should a new exception (or exceptions) protect individual
4. Please share your thoughts on the utility of the current exception at 42 CFR 411.357(n) for risk-sharing arrangements.
5. Please share your thoughts on the utility of the special rule for compensation under a physician incentive plan within the exception at 42 CFR 411.357(d) for personal service arrangements.
6. Please share your thoughts on possible approaches to address the application of the physician self-referral law to financial arrangements among participants in alternative payment models and other novel financial arrangements. Consider the following:
* Would a single exception provide sufficient protection for all types of financial arrangements?
* Would a multifaceted approach that amends existing exceptions and/or establishes new exceptions be preferable?
* Would such a multifaceted approach sufficiently allow parties to identify and satisfy the requirements of one (or more) applicable exceptions in order to protect individual
7. In the context of health care delivery, payment reform, and the physician self-referral law, please share your thoughts on definitions for critical terminology such as--
* Alternative payment model
* Care coordination
* Clinical integration
* Financial integration
* Risk
* Risk-sharing
* Physician incentive program
* Gainsharing
* Health plan
* Health system
* Integrated delivery system
* Enrollee
8. Please identify and suggest definitions for other terminology relevant to the comments requested in this
9. Please share your thoughts on possible approaches to defining "commercial reasonableness" in the context of the exceptions to the physician self-referral law.
10. Please share your thoughts on possible approaches to modifying the definition of "fair market value" consistent with the statute and in the context of the exceptions to the physician self-referral law.
11. Please share your thoughts on when, in the context of the physician self-referral law, compensation should be considered to "take into account the volume or value of referrals" by a physician or "take into account other business generated" between parties to an arrangement. Please share with us, by way of example or otherwise, compensation formulas that do not take into account the volume or value of referrals by a physician or other business generated between parties.
12. Please share your thoughts on when, in the context of alternative payment models and other novel financial arrangements, compensation should be considered to "take into account the volume or value of referrals" by a physician or "take into account other business generated" between parties to an arrangement. Please share with us, by way of example or otherwise, compensation formulas that do not take into account the volume or value of referrals by a physician or other business generated between parties.
13. Please share your thoughts regarding whether and, if so, what barriers exist to qualifying as a "group practice" under the regulations at 42 CFR 411.352.
14. Please share your thoughts on the application and utility of the current exception at 42 CFR 411.357(g) for remuneration unrelated to
15. Please identify any provisions, definitions, and/or exceptions in the regulations at 42 CFR 411.351 through 411.357 for which additional clarification would be useful.
16. Please share your thoughts on the role of transparency in the context of the physician self-referral law. For example, if provided by the referring physician to a beneficiary, would transparency about physician's financial relationships, price transparency, or the availability of other data necessary for informed consumer purchasing (such as data about quality of services provided) reduce or eliminate the harms to the Medicare program and its beneficiaries that the physician self-referral law is intended to address?
17. Please share your thoughts on whether and how CMS could design a model to test whether transparency safeguards other than those currently contained in the physician self-referral law could effectively address the impact of financial self-interest on physician medical decision-making.
18. Please share your thoughts on the compliance costs for regulated entities.
19. Please identify any recent studies assessing the positive or negative effects of the physician self-referral law on the healthcare industry. To the extent publicly available, please provide a copy of the study(ies).
20. Please share your thoughts regarding whether CMS should measure the effectiveness of the physician self-referral law in preventing unnecessary utilization and other forms of program abuse relative to the cost burden on the regulated industry and, if so, how CMS could estimate this.
Respondents are encouraged to provide complete but concise and organized responses, including any relevant data and specific examples. However, respondents are not required to address every issue or respond to every question discussed in this
Please note, this is a request for information only. As previously stated, respondents are encouraged to provide complete but concise responses. This
Responses to this
IV. Collection of Information Requirements
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. However, section III. of this document does contain a general solicitation of comments in the form of a request for information. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically 5 CFR 1320.3(h)(4), this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the
IV. Response to Comments
Because of the large number of public comments we normally receive on
Dated:
Administrator,
[FR Doc. 2018-13529 Filed 6-20-18;
BILLING CODE 4120-01-P
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