
I. INTRODUCTION
The long-awaited "Phase II" rule implementing the Stark II law was published in the Federal Register of March 26, 2004. Vol. 69 Fed. Reg. pages 16053 to 16146 ( the "Phase II rule"). The rule is published as an "interim final" rule, with an effective date of July 26, 2004. Much of the March 26th issuance is simply a republication of the Phase I rule from January of 2001, and those provisions that are unchanged have already been in effect for three years. Much of the rest is either derived from the original Stark I rule published in 1995, and applicable then only to clinical lab services, or was previewed in the proposed Stark II rule in 1998, before the rulemaking was split into two phases. So what is genuinely new, and what are the implications for physicians and the health service providers with which they have financial and referral relationships?
First, the good news. For the first time since Stark was enacted in 1989-that's right, it has been 15 years-the industry has the full regulatory picture. In addition, CMS has for the most part added new flexibility and favorable interpretations to issues that were either more rigidly addressed in Phase I or ambiguous based on the underlying statute. As a result, the things physicians can do under Stark probably vastly outnumber the things they can not do.
Next, the bad news. By trying to accommodate more and more arrangements, and provide specificity where it did not exist before, the regulatory picture has gone from complicated and ambiguous to mind-numbingly complex. The rule itself runs twenty pages in length -probably 20,000 words or more, and the preamble to the rule in which CMS tries to explain all this and provide additional clarification is four times as long again. So trying to understand the full scope and complete ramifications of all this is not for the faint hearted. Further, despite this level of detail, some of the specificity is illusory. To give just two examples: (1) many of the exceptions are conditioned on an arrangement not violating the federal anti-kickback law, an intent-based statute where bright line answers are often not available; and (2) most of the exceptions depend on an arrangement meeting a "fair market value" test which generally must be applied on a case by case basis to the particular facts of the arrangement, and the "market" in which it operates.
More bad news. Despite having been on the books for 15 years, the Stark law has rarely been enforced by the government. The lack of a fully developed regulatory scheme has to explain this lack of enforcement, at least in part. Now that Phase II is here, will enforcement be far behind?
This memo is not a restatement of the entire Phase II rule. Rather, we have tried to highlight the major new material and provide some initial commentary on its significance relative to the previous Phase I rule or the underlying statute. In addition to the comments which follow, Phase II includes dozens of other "tweaks" to provide additional flexibility or clarity that generally are more technical or editorial than substantive. For guidance concerning other aspects of the rule and its applicability to particular arrangements, please contact any attorney at the Firm at 202-466-6550. For general information concerning this memorandum, please contact one of its authors -- Bob Saner, Mark Fitzgerald, Barbara Straub Williams or Becky Burke at the same number.
Because this rule is "interim final", CMS will be accepting comments on it until June 24, 2004. While we suspect there is some aspect of this subject that has not already been addressed after 15 years, we doubt that CMS plans to make more major policy changes in response to comments received in this round.
II. MAJOR GROUP PRACTICE ISSUES
In Office Ancillary Services Exception
The "in office" exception, on which most physicians and groups depend for the routine provision of ancillaries through the practice, remains largely intact from the Phase I rule. Two of its three elements (the performance test and the billing test) remain essentially the same. The third, the site of service test, has two compliance alternatives: the "same building" test for either solos or groups, and for groups only, the" centralized building" test. While the latter is unchanged from Phase I, the former is now more complicated but generally more accommodating.
For a designated health service ("DHS") to be considered furnished in the "same building" as the practice, one of the following must apply:
NOTE: For purposes of the "same building" test, the group need only provide some services unrelated to DHS, not "substantial" services.
NOTE ALSO: While the "centralized building" test remains the same (owned or leased by the group 24/7) CMS has changed another aspect of the rule to permit groups to purchase DHS from mobile providers that they do not own or lease 24/7, as long as they are billed without mark-up under Medicare's purchased diagnostic services rule.
Group Practice Definition
In general, the "in office" exception only works for MDs in group practices if the group also meets Stark's definition of a bona fide group practice. The major elements of that definition are unchanged in the Phase II rule, but certain aspects are tweaked and clarified, including the following:
Note: CMS has reiterated its earlier guidance that "incident to" services can be included in productivity bonuses under the compensation tests in the group practice definition. But once again, it has used the word "services" without specifically mentioning "items," and despite tremendous interest in the question, does not specifically state that "incident to" drugs administered by someone in the office other than the physician may or may not be directly factored into productivity bonuses.
III. KEYS TO UNDERSTANDING COMPENSATION EXCEPTIONS
Special Rules on Compensation
Many Stark law exceptions depend on compensation being "set in advance," not taking into account "the volume or value of referrals," and not taking into account "other business generated between the parties." Like the Phase I rule, Phase II includes several "deeming" provisions concerning these requirements.
Set in Advance
One of the most controversial aspects of Phase I was the uncertain status of percentage-based contracts. The rule said they were not considered "set in advance" but this aspect of the rule was repeatedly deferred. Phase II settles the issue by deeming percentage formulas to be set in advance as long as the formula is established up front and does not vary based on volume changes during the term of the arrangement.
Volume or Value of Referrals
Phase II clarifies that "per-click" arrangements as well as other per unit or per time payments will be deemed not to take into account the volume or value of referrals if priced at fair market value, and if the pricing does not change in response to volume during the term of the arrangement.
Other Business Generated
Phase II clarifies that personally performed services of a referring physician are not "other business generated" for the DHS provider, consistent with the exclusion of personally performed or provided services from the rule's definition of what constitutes a referral.
Directed Referrals
Phase I permitted employers and entities with which physicians contract to condition compensation arrangements on requirements to refer to a particular DHS provider or network if certain safeguards were included (patient preference, insurer selection of provider, and medical judgment as to best interests of the patient). Phase II retains these provisions while adding two new safeguards:
Safe Harbor for Hourly Rate Compensation
A principle underpinning much of the Stark law is that compensation arrangements between DHS entities and physicians must be at fair market value, but previous Stark rules provided only general criteria for determining fair market value. Phase II retains the general criteria, and adds to the definition a safe harbor for services personally performed by physicians if the hourly rate of compensation conforms with either of the following:
For purposes of the salary survey option, annual income data is to be divided by 2000 hours to produce an hourly rate. Where the surveys do not include the relevant specialty, the survey data for general practice is to be used.
Direct vs. Indirect Compensation, and the Indirect Compensation Exception
The statute and prior rules are clear in providing that compensation relationships may be either direct or indirect. The Phase I rule defined indirect compensation relationships, and provided a new regulatory exception for certain indirect compensation arrangements. Phase II retains both the definition and the exception with only technical changes to the two provisions. However, the Phase II commentary makes explicit a number of interpretations that were only implicit, if that, in Phase I, including the following:
NOTE: The clarification of indirect compensation arrangements simplifies the analysis of many financial relationships in as much as the indirect compensation exception provides "one stop shopping." Unfortunately, because the exception depends on kickback law compliance, it will not produce comparable certainty.
IV. OTHER RELEVANT COMPENSATION EXCEPTIONS
Employment
The employment exception was not in the Phase I rule, and was among those anxiously awaited. However, the Phase II approach is minimalist, following closely the statutory language and the old Stark I rule from 1995. The Phase II preamble does provide some new guidance on specific situations, including:
Personal Services
This exception also follows the statute and old Stark I rule closely, but other aspects of Phase II, particularly the special deeming rules discussed above, make it more user-friendly. Phase II also clarifies the following:
Fair Market Value
This exception, crafted by CMS as part of Phase I, remains substantively the same in Phase II. As with the personal services exception, it is enhanced by the special deeming rules, particularly the allowance of percentage formulas and "per click" arrangements.
NOTE: Despite requests from commenters, CMS declined to extend this exception to items and services provided by a DHS entity to physicians and groups; it remains limited to items and services provided by physicians and groups to DHS entities.
Isolated Transactions
The Stark I rule and the proposed Stark II rule limited this exception to transactions involving a single payment, and did not recognize installment sales as "isolated". Phase II liberalizes this very slightly by permitting:
Risk Sharing Arrangements
Phase II clarifies that payments by downstream entities may qualify for this exception as long as they relate to health plan enrollees.
Space and Equipment Leases
Phase II makes minor changes to these exceptions:
Physician Recruitment
The exception for physician recruitment was also anxiously anticipated, and the Phase II rule delivers a detailed exception with many strings attached. For recruitments done through existing groups, it may well prove simpler and more flexible to rely on the indirect compensation exception, leaving use of the recruiting exception to subsidies provided directly to new solo practitioners.
Exception provisions include the following:
Retention Payments in Underserved Areas
Phase II adds a new and limited exception for retention payments made by hospitals and FQHCs to physicians already on staff. Requirements include:
Payments by a Physician for Items and Services
The statute contains a broad exception covering payments made by physicians to clinical labs for lab services at any price, and to other DHS entities for items and services at fair market value, with no other strings attached. The Phase II rule follows the 1998 proposal in narrowing this exception so that, except in the lab context, it can only be used if the arrangement in question is not eligible for one of the other compensation exceptions. CMS appears to be telling people to use the fair market value exception, with its other strings attached. Unfortunately, that exception is worded to cover items and services provided by physicians or groups, not to them, so it is not clear what is left, if anything, of this provision of the statute.
Professional Courtesy
Phase II creates a new exception for "professional courtesy," defined as free or discounted health care items or services provided by an entity to a physician, his or her immediate family, or office staff. The giving of professional courtesy will not create a compensation relationship under the Stark law provided certain conditions are met:
Charitable Donations
Phase II also creates a new exception permitting physicians to make charitable donations to DHS entities, provided:
Non-monetary Compensation up to $300
The only change from Phase I in this exception is that the $300 limit will now be indexed to inflation. CMS specifically declined to raise the limit.
Medical Staff Incidental Benefits
CMS has modified the Phase I exception to clarify that
NOTE: The commentary on this exception also has useful clarification with respect to technology and services provided by hospitals that would not be considered remuneration to physicians for purposes of Stark, e.g. transcription services that are limited to hospital records.
Compliance Training Exception
The Phase I exception for compliance training has been broadened in several respects, including:
Kickback Law Safe Harbors
Phase I solicited comments on whether Stark protection should be extended to all arrangements that meet kickback law safe harbors. Phase II declines to do so, but does create two new exceptions for "safe harbored"
Community-wide Health Information Systems
Phase II creates a new compensation exception for IT items and services provided to physicians by hospitals or other entities that
V. EXCEPTIONS RELATED TO OWNERSHIP AND INVESTMENT
Phase II includes a number of exceptions related to physician ownership and investment that were not included in Phase I and have not been updated since the 1995 Stark I rule.
Publicly-traded Securities and Mutual Funds
The statute protects physician ownership of publicly traded securities and mutual funds that meet certain size thresholds. A contentious issue when Stark II was proposed was whether the security interests had to be publicly available at the time of physician acquisition. Phase II liberalizes this exception to require compliance with its provisions at the time the DHS referrals are made, and not the time of original acquisition of the investment interest.
Ownership of Hospitals and Rural Providers
These exceptions have been modified in response to section 507 of last year's Medicare legislation (P.L. 108-173) which included an 18 month moratorium on new physician-owned specialty hospitals in cardiac care, orthopedics or surgery, and also carved those specialty hospitals out from those eligible for the rural provider exception during the moratorium. Certain specialty hospitals "in operation" without significant changes, or "under development," as of November 18, 2003, are grandfathered. Implementation of the grandfather provision is being handled by CMS through non-regulatory guidance, not the Phase II rule. See CMS Transmittal No. 62, March 19, 2004.
For advice in connection with specialty hospitals, and particularly the grandfather provisions, contact one of the authors of this memo as soon as possible.
NOTE: Technically, the moratorium is on physician referrals, not physician ownership. If a new specialty hospital fails to qualify for grandfathered status, it is free to open during the moratorium with physician ownership, as long as the owner MDs do not use it.
NOTE ALSO: Specialty hospitals located in Puerto Rico are not subject to the moratorium.
VI. EXCEPTIONS PROTECTING BOTH INVESTMENT AND COMPENSATION RELATIONSHIPS
In addition to the "in-office" exception discussed above, the Phase II rule contains a number of other general exceptions relevant to some physician practices. Two of particular note are discussed below.
A third, the academic medical center exception is the subject of a separate analysis available on request from PPSV. It appears, however, that in virtually all faculty practice plan settings without physician ownership, the indirect compensation exception discussed above will be the simpler way to protect transfers between different components of the AMC system, while the "in-office" and employment exceptions will cover DHS referrals and compensation within the practice plan.
A fourth, the physician services exception, is republished without change from Phase I.
Managed Care Enrollees
Phase II retains this broad exception protecting DHS services provided by entities, contractors and subcontractors to Medicare managed care enrollees, and expands it to cover financial relationships related to Medicaid health plan enrollees.
Intra-Family Rural Referrals
CMS has used its regulatory discretion in Phase II to create another limited exception for rural areas. It protects DHS referrals to family members or entities with which they have a financial relationship if the following criteria are met:
The referring MD or family member must make reasonable inquiry as to the availability of alternate providers within the 25 mile limit.
VII. ODDS AND ENDS
PET Services
Throughout Phase I there has been speculation and concern that CMS would extend the definition of "radiology and certain other imaging services" to nuclear medicine, thus picking up PET as a DHS. While CMS continues to consider the issue, it is not a DHS service in the Phase II rule.
Brachytherapy
Phase I elicited significant pressure on CMS to create a new targeted exception for brachytherapy, effectively removing these services and supplies from the scope of radiation therapy services subject to Stark. CMS declined to so, noting that brachytherapy services and supplies may fit within other existing exceptions depending on the facts of the arrangement.
VIII. COMPLIANCE AND ENFORCEMENT CONSIDERATIONS
Exception for Temporary Noncompliance
An entity which falls out of compliance with the Stark law for reasons beyond its control has up to 90 days to come into compliance, during which period it is not considered to be in violation of the Stark law. To qualify for this exception, the arrangement must have been in compliance for 180 days immediately preceding the date it became non-compliant, and the entity must take prompt steps to rectify the non-compliance. This exception may only be used once every 3 years, and it does not apply at all if the applicable exception is for non-monetary compensation (Section 411.357(k)) or medical staff incidental benefits (Section 411.357(m)).
Reporting Requirements
Phase II significantly eases the reporting burden on physicians and groups. CMS originally proposed that entities (including physician group practices) would be required to report annually on financial relationships with physicians, using an agency form. In addition, reportable financial relationships were broadly defined to include any relationship covered by the Stark law.
The final rule eliminates the annual reporting requirement. Instead, entities must maintain information on their financial relationships with physicians, and make information available on request by the OIG or CMS, including carriers and intermediaries. Entities from which information is requested have at least 30 days to comply with the request, and longer if specified in the request. In addition, entities need not report on excepted ownership interests in publicly-traded securities and mutual funds.
Information required to be submitted on request will be subject to disclosure.
FOR FURTHER INFORMATION, CALL 202-466-6550 AND ASK FOR
Bob Saner
Mark Fitzgerald
Barbara Straub Williams
Rebecca Burke
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