American Urological Association Issues Comment on Medicare Program: Modernizing, Clarifying Physician Self-Referral Regulations

WASHINGTON, Jan. 23 -- Christopher M. Gonzalez, chair of public policy council at the American Urological Association, Linthicum Heights, Maryland, has issued a public comment on the Centers for Medicare and Medicaid Services's proposed rule entitled "Medicare Program: Modernizing and Clarifying the Physician Self-Referral Regulations". The comment was written on Dec. 31, 2019, and posted on Jan. 15, 2020:

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The American Urological Association (AUA) is a globally-engaged organization with more than 22,000 members practicing in more than 100 countries. Our members represent the world's largest collection of expertise and insight into the treatment of urologic disease. Of the total AUA membership, more than 15,000 are based in the United States and represent urologists in all practice settings. Our members provide invaluable support to the urologic community by fostering the highest standards of urologic care through education, research and the formulation of health policy. The AUA welcomes the opportunity to submit comments to the Centers for Medicare & Medicaid Services (CMS) in response to Modernizing and Clarifying the Physician Self-Referral Regulations published in the Federal Register on October 17, 2019 (84 Fed. Reg. 55766). We appreciate CMS' efforts to increase flexibility under the physician self-referral prohibition (Stark law) for participation in coordinated care and value-based efforts. As discussed below, challenges remain for the industry as a whole to understand and potentially implement the proposed value-based changes, and particularly for specialist physicians to identify their role in participating in these efforts.

General Comments

As our payment systems transition away from fee-for-service reimbursement and more towards innovative payment models that encourage coordination in the management of patients and reward value-based efforts, the Stark law presents challenges for those who want to contribute to these goals. Although providers are encouraged to enter into arrangements that support value-based care, there has been uncertainty surrounding ways to accomplish this while remaining compliant with the Stark law, the Anti-Kickback Statute (AKS), and the exceptions to the beneficiary inducements civil monetary penalty (CMP) law.

It is clear that CMS has reviewed and considered the comments received in response to its Request for Information Regarding the Physician Self-Referral Law (RFI) (83 Fed. Reg. 29524). While CMS has undertaken efforts to address the challenges that physicians face in identifying ways to participate in value-based efforts while remaining in compliance with the Stark law, the path forward remains unclear. With the proposals from CMS as well as those published by the Office of Inspector General, HHS (OIG), physicians have had to consult legal counsel and dedicate time and resources to understanding these new rules. The needed resources for implementation are even greater due to the similar, though different, proposals that CMS and OIG have issued. As noted further in our comments below, we urge CMS and OIG to collaborate and standardize the terminology and requirements of applicable safe harbors and exceptions in any subsequent final rules issued.

We appreciate the overall cooperation between CMS and the OIG in developing the proposed rules to date. It is apparent that as our health care system continues to evolve, there will be challenges with new models and their interaction with the fraud and abuse laws. Though we note that CMS has requested detailed responses regarding many of its proposals, the AUA is not able at this time to offer the requested level of specificity for many inquiries posed. This is a result of several factors: the limited opportunities for specialists, such as urologists, to participate in innovative payment models to date; the lack of experience due to the limited opportunities; and the complexity of the proposals issued by CMS and the OIG.

AUA is hopeful that physician specialty practices will have increased opportunities to participate in innovative models that contribute to cost savings and value-based care. Many of the existing models are effectively closed to physician specialists as the models require participants to manage a patient population's full spectrum of care in a manner that is inconsistent with specialty practice. We have noted that the waivers of health care fraud and abuse laws issued for CMS-sponsored programs have focused on hospitals, health systems and primary care. As a result, many private practice physicians have been limited in their options to contribute to the goals of care coordination, quality improvement and resource conservation outside of formal advanced payment models. Our hope is that with increased awareness of the limitations present in the current system, CMS and OIG will continue to develop opportunities for physicians in all care settings, including private specialty practices.

The proposals to revise existing exceptions and the proposal of new exceptions demonstrates CMS' efforts to facilitate compliance with the Stark law while continuing to enforce needed safeguards to protect the Medicare program and its beneficiaries from the risk of harm. It is refreshing to read that CMS has gained perspective on the real-life application of the Stark law in contrast to the abusive arrangements the law was intended to prevent. CMS has gained much of this perspective from its review of over 1,100 submission to the CMS Voluntary Self-Referral Disclosure Protocol (SRDP) in the last nine years revealing arrangements that violated the physician self-referral law but posed no real risk of Medicare program or patient abuse. The clarifications provided to the signature and writing requirements in Sec. 411.354(e) and the proposed creation of a new exception for limited remuneration to a physician at Sec. 411.357(z) offer hope that CMS is aware of the challenges of complying with a complex strict liability statute and acknowledges that errors occur that do not rise to the level of conduct the Stark law was meant to prevent.

Facilitating the Transition to Value-Based Care and Fostering Care Coordination

The proposed rule contains new exceptions at Sec. 411.357(aa) as well as definitions for the key terms included in the new exceptions to the Stark Law. The three proposed exceptions to the Stark Law for value-based arrangements include (i) value-based arrangements involving "full financial risk"; (ii) value-based arrangements with meaningful downside risk to the physician; and (iii) a broad exception for value-based arrangements that do not involve full financial risk or downside risk to the physician. In drafting these proposals, CMS focused on the characteristics of the arrangement and the level of financial risk undertaken by the parties to the arrangement or the value-based enterprise of which they are participants. The proposed exceptions range in the level of risk undertaken by participants and pairs this with the safeguards that CMS believes will pose no risk of program or patient abuse. In analyzing the proposed exceptions and requirements of each one, the AUA believes some of the uncertainty surrounding value-based arrangements has impacted the complexity and uncertainty of the proposed exceptions. Because there is not one format for value-based arrangements, CMS has proposed more than one format for exceptions that could apply.

Although the options of several exceptions for value-based arrangements is an effort to offer flexibility, this also has resulted in confusion. The proposed exceptions require new terms that CMS and the industry are endeavoring to understand and determine if they are workable in the most beneficial value-based arrangements for beneficiaries and those who provide care to them. While we realize that it is important to balance innovation with program integrity, we hope that the final rules will offer clarity and perhaps greater simplicity in applying the Stark law exceptions to value-based arrangements going forward.

Value-Based Proposals

CMS has proposed new exceptions that provide options for value-based arrangements that consider the types of remuneration protected (in-kind and monetary), the level of financial risk assumed by the parties, and the types of safeguards included as elements of the exception. In reviewing these proposed exceptions, the AUA notes some overarching comments to highlight: the exceptions should not be limited to nonmonetary remuneration only; the terminology between the Stark law exceptions and the AKS safe harbors should be consistent; and the flexibility in the exceptions as drafted is appreciated but may require additional guidance and clarification as their interaction with value-based arrangements evolve.

Full Financial Risk (Proposed Sec. 411.357(aa)(1))

The proposed exception for value-based arrangements involving full financial risk would protect remuneration paid during the six-month window before the value-based enterprise is contractually obligated to be at full-financial risk. As has been acknowledged in previous waivers issued for fraud and abuse laws under specific CMS value-based programs, participants to these arrangements need time to establish the arrangements. In the proposed rule, CMS balances the need to protect start-up arrangements with its program integrity concerns and reasoned that the six-month period would enable the value-based enterprise to prepare for full financial risk, and could be used to implement a shared information technology (IT) resource across the value-based enterprise. The same time frame is also included for the meaningful risk exception. However, the AUA does not believe that this time period is sufficient. As many value-based arrangements are novel, there is a learning curve involved and many steps that need to be taken to implement such arrangements - distribution of clinical resources, implementation of IT items and services, and development of care design plans are critical elements to the success of value based projects, regardless of the level of risk involved. We ask CMS to consider a longer preparation period for the applicable exceptions and to ensure readiness to engage in the value-based model. A longer preparation period of at least twelve months to implement the preparation activities needed would contribute to a more successful value-based arrangement with any level of risk.

Value-based Arrangements with Meaningful Downside Risk to the Physician (Sec. 411.357(aa)(2)) The second exception proposed by CMS applies to value-based arrangements under which the physician is at meaningful downside financial risk for failure to achieve the value-based purposes of the value-based enterprise during the entire term of the arrangement. In comparing the proposals from CMS with the applicable OIG safe harbor proposals, the AUA has considered the interaction between the Stark law and AKS for potential arrangements. This comparison highlights the different terminology and requirements used in the proposed regulations by the agencies. Physicians and entities are expending resources to understand the proposed rules and had hoped for as much consistency between the two rules as possible. With different definitions and standards to achieve for seemingly similar exceptions and safe harbors, the burden to the industry is increased as there are two sets of standards to meet for protection from the harsh consequences of these laws. CMS' proposal for meaningful downside risk arrangements and the OIG's proposed safe harbor for substantial downside risk arrangements would both protect in-kind and monetary remuneration between a value-based enterprise and its participants. The AUA supports the inclusion of both monetary and in-kind remuneration. However, the mechanisms to determine what it means to share "meaningfully" in downside risk each have different definitions. The OIG proposes that a VBE participant meaningfully shares in the VBE's financial risk if the payment it receives: puts the VBE participant at risk for 8% of the VBE's total risk under the payor agreement (e.g., an 8% withhold, recoupment payment, or shared losses payment); is a partial or fully capitated payment (excluding the prospective payment systems for acute inpatient hospitals, home health agencies, hospice, etc.); or is protected by the corresponding Stark Law exception if the VBE participant is a physician.

In reviewing the CMS proposal, a physician is at meaningful financial risk if he or she is responsible for at least 25% of the value of the remuneration available under the value-based arrangement, or is financially responsible on a prospective basis for the cost of all or a defined set of patient care items and services covered by the applicable payor for the target patient population for a specified period of time. For this element of the exception to be met the physician would be required to assume meaningful financial risk for the duration of the arrangement. It is unclear why these threshold numbers were established at different reference points, 8% for OIG but 25% for CMS and we encourage CMS to consider aligning the risk level at the OIG's proposed 8% as this is a reasonable level of risk as these arrangements are developed.

Not only do the proposals include different risk level requirements, the way that risk is determined varies between the exceptions and the safe harbors. This is another area that should align in the final rules so that the same methodology can be used for both the Stark law and the AKS.

An area where we request clarification relates to the assumption of downside financial risk. We agree with CMS that participants in value-based arrangements may assume certain types of risk other than downside financial risk for items and services furnished to a target patient population (e.g., upside risk, clinical risk, operational risk, contractual risk, or investment risk). In order to understand the application of the proposed exceptions, the AUA requests guidance addressing what downside risk really means when engaging participants in value-based activities. An example that has been discussed is that of bonus pools for participants. Some financial arrangements include a potential bonus pool that the participants can earn if certain metrics are achieved, possibly related to a value-based purpose such as improving the quality of care for a target patient population in a quantifiable manner or appropriately reducing the costs to, or growth in expenditures of, payors without reducing the quality of care for a target patient population. If the participant does not meet the established metrics, the bonus is not earned.

We ask for clarification on whether CMS views the potential to earn the bonus as a downside risk. To the participants themselves this is very much considered a downside risk especially when the incentive is not earned due to not achieving the required metrics. The potential bonus is considered part of the potential aggregate compensation to be paid to the participant and if that bonus is withheld the participant is subject to the downside risk of entering the compensation arrangement. This is an example of where clear guidance from CMS in applying the proposed exceptions and definitions to practical, real-world scenarios will provide additional clarity going forward if the proposals are finalized.

CMS-Sponsored Models

Surprisingly, CMS did not include a proposed exception that would clearly apply to CMS-sponsored models, while the OIG included such a safe harbor at proposed Sec. 1001.952(ii) that is intended to protect care delivery and payment arrangements as well as beneficiary incentives pursuant to certain CMS-sponsored models. OIG defines the term "CMS-sponsored models" as payment models and initiatives being tested by CMS through the Innovation Center and the Medicare Shared Savings Program (under sections 1115A and 1899 of the Act, respectively). Although many of the CMS-sponsored models in place currently do not support the participation of specialist physicians, the AUA sees value in this proposed safe harbor and correlating Stark law exception.

The OIG proposed this safe harbor to offer more certainty and timely protection for value-based arrangements related to models that have already been approved by CMS. To date, the protection for arrangements in these models was issued on a model by model basis for each program in the form of waivers that applied only to that CMS-sponsored model if certain conditions were met. If this safe harbor is finalized, it would protect remuneration between and among parties to arrangements under CMS-sponsored models and remuneration in the form of incentives and supports provided by model participants to patients covered by the model. The assurance that parties would have in entering value-based arrangements related to these models would likely increase participation.

As noted previously, not many specialist physicians currently participate in the existing CMS-sponsored models due to a focus on primary care. The AUA hopes that this fact changes, and that CMS continues to develop new models that look to incorporate opportunities for all physicians, regardless of specialty or site of service, to contribute to the goals of coordinated care. As new models are implemented, the AUA believes having a safe harbor in place for CMS-sponsored models will facilitate participation in these efforts and we hope that our members will be able to take advantage of such a safe harbor.

The clear parameters of the proposed safe harbor for CMS-sponsored models provides a level of clarity that is desired for all of these innovative arrangements being developed. The fact that the proposed safe harbor protects models that CMS has approved under the AKS but CMS does not have a corresponding proposal for a similar exception to the Stark law is challenging. It is unclear why OIG and CMS differ on this point in the proposals. If these arrangements qualify for a CMS-sponsored model safe harbor under an AKS analysis, yet a full Stark analysis must be completed for compliance with an applicable exception as CMS discusses in the proposed rule, the benefit of the explicit safe harbor is less beneficial. The participants have to meet the requirements of the model, which qualifies for AKS protection, but then have to also perform a Stark analysis for each arrangement. The uncertainty surrounding any analysis under these laws is reason for concern due to the potential liabilities incurred if the analysis is incorrect. This is an area of the proposals from OIG and CMS where the AUA asks that the agencies work together to finalize a CMS-sponsored model safe harbor and correlating Stark law exception for clarity and assurance to those model participants, or those considering participation.

Fundamental Terminology and Requirements

The Volume or Value Standard and the Other Business Generated Standard (Sec. 411.354(d)(5) &(6)) Due to uncertainty that has arisen surrounding the application of the volume or value standard of the Stark law for certain compensation arrangements between physicians and hospitals, the AUA appreciates CMS' proposed clarification regarding this standard. It would be beneficial for CMS to formalize in regulatory text a definition that makes clear that with respect to employed physicians, or those providing services under a personal services arrangement, a productivity bonus will not take into account the volume or value of the physician's referrals solely because corresponding hospital services (that is, DHS) are billed each time the physician personally performs a service. More than preamble guidance is needed for this issue because, as CMS discussed in the preamble to the proposed rule, this analysis has come under attack in United States ex rel. Drakeford v. Tuomey Healthcare System, Inc., as well as more recent enforcement activity that has caused concern within the industry. We agree that any future definition is merely a clarification being provided to formalize CMS' existing view of this issue and does not represent a change to past analysis of this standard.

Group Practices (Sec. 411.352)

Special Rules for Profit Shares and Productivity Bonuses (Sec. 411.352(i)) - Distribution of Revenue Related to Participation in a Value-Based Enterprise

CMS offers a helpful addition to the group practice requirements under the Stark law to provide clarity for those physicians participating in value-based efforts and how funds can be distributed to them in a group practice in compliance with the Stark law. CMS proposes to add to Sec. 411.352(i)(3) a deeming provision related to the distribution of profits from DHS that are directly attributable to a physician's participation in a value-based enterprise. CMS has proposed to clarify that when such profits are distributed to the participating physician, they would be deemed not to directly take into account the volume or value of the physician's referrals. Permitting a group practice to distribute directly to a physician in the group the profits from DHS furnished by the group that are derived from the physician's participation in a value-based enterprise, including profits from DHS referred by the physician, and clarification that such remuneration would be deemed not to directly take into account the volume or value of the physician's referrals is needed. This is a change that supports the development of opportunities for physicians in group practices to contribute in a meaningful way to value-based efforts.

Recalibrating Scope and Application of Regulations

Decoupling the Physician Self-Referral Law from the Federal Anti-Kickback Statute and Federal and State Laws or Regulations Governing Billing or Claims Submission

CMS proposes to remove the requirement in the Stark law compensation arrangement exceptions that the arrangement not violate the AKS. The AUA agrees that this is an appropriate revision and believes that this will reduce some of the burden in working to ensure compliance with the Stark law. Clearly compliance with the Stark law is not a substitute for complying with the AKS, and thus this requirement is unnecessary. Additionally, eliminating the requirement that arrangements not violate any federal or state billing and claims submission rules as this element of the exceptions is appropriate as well.

Transaction (Sec. 411.357(f))

The isolated financial transaction exception at Sec. 411.357(f) presents a shift in this proposed rulemaking form the other modifications and clarifications proposed by CMS. In addressing this exception, CMS offers a clarification that limits the application of the Stark law rather than applying flexibility to the analysis and application where possible. CMS discusses this clarification as longstanding policy regarding application of the isolated transaction exception, although there are stakeholders who have understood the exception to apply to the very arrangements that CMS is now proposing to specifically exclude from the exception. CMS notes that an isolated transaction will be defined to exclude payments for multiple services provided over an extended period of time, even if there is only a single payment for all the services.

Under the Stark law, where parties to an arrangement discover that they failed to document a services arrangement with a physician in writing, but the services have already been provided, the options have been limited. Without the availability of the personal services or fair market value compensation exceptions because the parties did not have a written arrangement that set the compensation in advance of the services being provided, the parties would often have to disclose these arrangements. However, under certain facts and circumstances, some parties believed they had the option to apply the isolated financial transaction exception to the arrangement. Based on a reading of the plain language of the exception, there is nothing to put the parties on notice that this exception was unavailable. If this revision is finalized, the burden of complying with the Stark law will increase for arrangements that cannot satisfy even the new proposed exception for limited remuneration to a physician at Sec. 411.357(z) but still are likely to be non-abusive arrangements.

Special Rules on Compensation Arrangements (Sec. 411.354(e))

Over the years CMS has offered increased flexibility related to some of the procedural requirements under the Stark law exceptions, particularly related to the writing requirement. The clarifications in the CY 2016 Medicare Physician Fee Schedule Final Rule that the "in writing" requirement is satisfied by the "contemporaneous documents evidencing the course of conduct between the parties involved" and that the signature requirement is satisfied by obtaining the required signatures within 90 consecutive days after the arrangement became noncompliant were helpful updates to the Stark law. However, even as CMS has implemented these revisions to the regulations for these inadvertent errors that occur, the proposed rule discussion acknowledges that stakeholders have submitted numerous compensation arrangements to the SRDP that fully satisfied all the requirements of an applicable exception, including requirements pertaining to fair market value compensation and the volume or value of referrals, except for the writing or signature requirements.

In many cases, parties have disclosed short periods of noncompliance with the Stark Law at the outset of a compensation arrangement because the parties begin performance under the arrangement before including all key terms and conditions of the arrangement in a writing.

The proposed change addressing CMS' policy on temporary noncompliance with the signature as well as the writing requirements of various compensation arrangement exceptions is a welcome modification to the Stark law. Allowing parties to memorialize an arrangement in writing and sign the written documentation within 90 days, as long as the arrangement otherwise meets all the requirements of an applicable exception, poses no risk of program or patient abuse. The AUA appreciates this revision and believes it will be useful in ensuring that those arrangements with physicians that miss the mark on complying with an exception due solely to a delay in a writing or a signature do not result in disclosure submissions to the SRDP.

Clearly the revision to the 90 day time period is very beneficial. The AUA asks CMS to consider a potential extension to permit signatures and a writing to be obtained within 180 days. It is not apparent that any greater risk would exist from the exact same arrangement that continued for longer than the 90 days without a writing or a signature. Because the arrangement would need to satisfy all other elements to an applicable exception for the duration, the risk to the Medicare program is seemingly the same during a 180-day grace period.

We encourage CMS to include regulation text at Sec. 411.354(e) to reflect its policy on electronic signatures and documents by explicitly acknowledging that electronic signatures, including assent transmitted via email, are sufficient to meet the signature requirements of the applicable exceptions. This is a helpful clarification that should be included in the regulations and not only in preamble.

Electronic Health Records Items and Services (Sec. 411.357(w))

CMS has offered protection for the donation of interoperable EHR software or information technology and training services beginning in 2006. Over the past thirteen years there have been many changes and advancements in the technology the EHR being provided under the exception. In response to this evolution both CMS and the OIG revised and extended the sunset of the exception and safe harbor multiple times. CMS is now proposing to remove the sunset which the AUA supports. The continued availability of this exception encourages adoption of EHR technology and facilitates the goals of meaningful use and standardizing the electronic capture of information such as patient demographics or clinical orders and results; improving quality at the point of care; and using clinical decision support and patient self-management tools as vehicles to improve the quality, safety and efficiency of treatments.

CMS also discusses the 15-percent cost sharing requirement under the exception. This was originally included by CMS "to encourage prudent and robust electronic health records arrangements, without imposing a prohibitive financial burden on recipients.'' CMS wanted recipients to contribute toward EHR due to the benefits they would likely experience as result of the donation such as a decrease in practice expenses or access to incentive payments related to the adoption of health information technology. As CMS is aware, the 15-percent contribution requirement has proven burdensome to some recipients and sometimes creates a barrier to adoption of EHR. As a result, CMS has asked about several potential revisions to the 15-percent contribution.

The AUA supports the alternative put forth by CMS that would eliminate the 15-percent contribution requirement in this exception for all recipients. The tracking and calculation of this 15-percent requirement can be burdensome. In some smaller practices, the contribution can even limit participation due to financial constraints. If CMS does not finalize the removal of the 15-percent contribution for all recipients, the AUA asks that the requirement is removed for those practices likely to be most challenged by this element - the small and rural practices. This will remove any actual or potential barrier that the contribution requirement poses for these practices and will facilitate better coordination of care for patients in those practices. Even if CMS does not ultimately finalize a removal of the 15-percent contribution requirement based on the first two alternatives, the AUA encourages CMS to eliminate the contribution requirement for updates to previously donated EHR software or technology. The software or technology is already in place and the updates often ensure it continues to function as needed. We ask CMS to revise the contribution requirement in the final rule.

In another consideration of how of EHR technology continues to evolve and the issues that arise, CMS proposes to amend the exception to clarify that certain cybersecurity software and services have always been protected under this exception. The proposed exception modification would include certain cybersecurity software and services that ''protect'' electronic health records. Due to risks of cybersecurity attacks, particularly the number focused on health care entities, the AUA supports the proposed clarification in the EHR exception that it protects software or services that have the predominant purpose of cybersecurity associated with the electronic health records. Inclusion of "cybersecurity software and services, necessary and used predominantly to create, maintain, transmit, receive or protect electronic health records if the identified conditions are met" is a beneficial clarification for donors and recipients of EHR technology.

Providing Flexibility for Nonabusive Business Practices

Limited Remuneration to a Physician (Proposed Sec. 411.357(z))

Based on experience in administering the SRDP, CMS proposes a new exception that provides flexibility by protecting limited remuneration paid to a physician if certain criteria are met. CMS notes that many disclosures involve non-abusive arrangements under which a limited amount of remuneration was paid by an entity to a physician in exchange for the physician's provision of items and services to the entity. In some instances, the arrangements were ongoing service arrangements under which services were furnished sporadically or for a low rate of compensation; in others, services were furnished during a short period of time and the arrangement did not continue past the service period. CMS realizes that although there may be a legitimate need for the services and compensation was fair market value and not determined in any manner that took into account the volume or value of the referrals or other business generated by the physician, the arrangement could not satisfy all requirements of any applicable exception because the compensation was not set in advance of the provision of the services and was not reduced to writing and signed by the parties. These types of violations have often been referred to as "technical" violations that have troubled the industry for years.

The proposed exception at 411.357(z) provides an option for many of these arrangements that could not satisfy each and every element of an exception but really posed no risk of program or patient abuse. The exception does contain certain elements that must be satisfied such as: (1) the arrangement is for items or services actually provided by the physician; (2) the amount of the remuneration to the physician is limited; (3) the arrangement furthers a legitimate business purpose of the parties and is on similar terms and conditions as like arrangements, regardless of whether it results in profit for either or both of the parties; (4) the remuneration is not determined in any manner that takes into account the volume or value of referrals or other business generated by the physician; and (5) the remuneration does not exceed the fair market value for the items or services.

The AUA believes that these are reasonable safeguards for this proposed exception and does not support a limitation of applicability of the exception to items and services that are personally furnished by the physician. We do not believe that any additional protection is achieved by including a condition that the arrangement must not violate the AKS or other Federal or state law or regulation on billing and claim submission and do submit inclusion of such criteria.

Although the AUA sees the value in this proposed exception and appreciates CMS' efforts towards flexibility in this regard, CMS proposes to permit the exception to apply only where the remuneration does not exceed an aggregate of $3,500 per calendar year, which would be adjusted for inflation in the same manner as the annual limit on nonmonetary compensation and the per-instance limit on medical staff incidental benefits. We believe that for the arrangements that will likely fall under this category CMS should reconsider the aggregate limit of $3,500 per calendar year for compensation to a physician under this exception. A higher annual aggregate limit of $10,000 per year for all arrangements with a physician for items and services provided under this exception is more appropriate to cover the typical range of commercially reasonable arrangements for the provision of items and services that a physician might provide to an entity on an infrequent or short-term basis. If the threshold remains at $3,500 per year it is likely that the exception will not benefit as many current "technical" violations as anticipated.

Cybersecurity Technology and Related Services (Sec. 411.357(bb))

The proposed rule contains a new exception to protect donations of certain cybersecurity technology and related services with appropriate safeguards. CMS intends for this proposed exception to help improve the cybersecurity protection in the healthcare industry by removing potential barriers and allowing parties to address the growing threat of cyberattacks that can corrupt systems or prevent access to health records and other information essential to the delivery of health care. This is a helpful proposal that would enable the donation of technology and services that are necessary to limit the harm that can be caused by cybersecurity attacks. Not only businesses impacted by these attacks, but the patients' whose data is impacted can suffer the consequences when proper care cannot be provided due to such an attack. The AUA believes that the availability of an exception to protect these donations will address the needs of donors and recipients.

Because cybersecurity, and the tools needed to fight it, are still developing, a broad exception is helpful. CMS proposes to protect a wide range of services in this exception such as: services associated with developing, installing, and updating cybersecurity software; any kind of cybersecurity training services; any kind of cybersecurity services for business continuity and data recovery services to ensure the recipient's operations can continue during and after a cyberattack; and any services associated with performing a cybersecurity risk assessment or analysis, vulnerability analysis, or penetration test. Because cybersecurity services are usually comprised of multiple elements to provide effective protection, it is likely that donations will consist of several elements and the proposed exception appears to address this.

CMS and OIG Collaboration

While the government and the industry work to understand the future of value-based arrangements, the interaction with the Stark law and AKS cannot be ignored. Although these are separate laws, they so often apply to the same arrangements. Whether the arrangements are focused on value-based goals or not, analysis must be conducted under both the Stark law and AKS. While we appreciate the effort of CMS and the OIG to coordinate, both in the requests for information as well as in the publication of these proposed rules, we hope this teamwork continues through to any final rules published in response to these proposals. Physicians are already navigating a complex web of understanding novel arrangements and analyzing such arrangements under the fraud and abuse laws. The ability to apply consistency between the rules will increase the level of comprehension of and compliance with these laws. As such, AUA asks that CMS and the OIG continue to collaborate with each other for rules that are usable and contribute to the goals of improved care for beneficiaries.

We thank CMS for the opportunity to submit comments in response to the proposed rules. We hope that with the input from the comments, the final rules will provide greater clarity on the new value-based structure for the Stark law so that our members are able to more fully participate in coordinated care and management of patients. If you have any questions regarding our comments, please contact Keith Hawman, Payment Policy Manager at 410-689-4045 or [email protected].

Sincerely,

Christopher M. Gonzalez, MD, MBA

Chair, Public Policy Council

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The proposed rule can be viewed at: https://beta.regulations.gov/document/CMS-2018-0082-0394

TARGETED NEWS SERVICE, Harwood Place, Springfield, Virginia, USA: Myron Struck, editor; 703/304-1897; [email protected]; https://targetednews.com