June 18, 2020

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QUESTION:        Does our Utilization Review Committee have to be a Medical Staff committee, or can it be a Hospital committee?

ANSWER:           In our experience, some hospitals do have a utilization review committee set up as a Medical Staff committee, but many do not.  There is no explicit regulatory requirement or accreditation standard obligating a hospital to have a Medical Staff utilization review committee.  For example, the Centers for Medicare & Medicaid Services (“CMS”) Conditions of Participation for Hospitals require hospitals to have a utilization review plan and a utilization review committee.  The committee, per the Conditions of Participation, has to be a “staff committee of the institution” with at least two physicians as members.  The requirement can be satisfied by “a group outside the institution” such as one established by local medical societies.  CMS includes the utilization review requirements in the Conditions of Participation in a separate section from the medical staff requirements.  The Medical Staff sections of the Conditions of Participation do not even mention utilization review.  Even though the Conditions of Participation note that a utilization review committee has to be a “staff committee,”  this is different from a “medical staff committee.” CMS knows how to signify when something falls under the purview of the medical staff and the fact that CMS left out “medical staff” when describing the requirements for the utilization review committee is significant.  Furthermore, the Conditions of Participation state that the committee has to be a committee of the “institution,” which signifies “hospital” as opposed to Medical Staff.  The fact that the utilization review committee requirement can be satisfied by a “group outside the institution” (that would not be a medical staff committee) also demonstrates that it does not need a medical staff committee.  Keep in mind that if you decide to have the utilization review committee as a hospital committee, we recommend that you confirm that your state does not require that the committee be a medical staff committee.

That being said, we are aware of at least one client who received feedback from the CMS Survey & Certification Group, Division of Acute Care Services that the utilization review committee “must be a committee or subcommittee of the medical staff.”  Nonetheless, this feedback, as noted above, is not consistent with the Conditions of Participation and we are not aware of CMS citing any hospital for having a Hospital utilization review committee.  It is also not consistent with current practice of many hospitals whose utilization review committees are multi-disciplinary hospital committees with membership comprised of both practitioners and administrative personnel such as directors of coordinated care, billing staff, and internal audit staff.

June 11, 2020

QUESTION: In response to COVID-19, we recently relocated a hospital provider-based department to a patient’s home.  What information do we need to provide to the CMS Regional Office?

ANSWER: For the duration of the COVID-19 public health emergency, CMS has expanded its extraordinary circumstances relocation exception policy.  According to its April 30, 2020 Final Interim Rule, CMS will permit hospitals to relocate excepted off-campus and on-campus provider-based departments (“PBD”) to off-campus locations.  This includes the ability to expand or relocate a department into a patient’s home.

A hospital that relocates its PBD off-campus must submit a relocation request by email to its CMS Regional Office providing notice and details of its relocation efforts. Specifically, the hospital’s request should include the following information:

  1. The hospital’s CMS Certification Number (“CCN”)
  1. The address of the current PBD
  1. The address of the relocated PBD
  1. The date on which the hospital began furnishing services at the new PBD
  1. A brief justification for the relocation and the role of the relocation in the hospital’s response to COVID-19
  1. An attestation that the relocation is not inconsistent with their state’s emergency preparedness/pandemic plan

Note that a hospital’s justification for relocation should explain why the new PBD location is an appropriate location to furnish outpatient services. In an effort to preserve patient confidentiality, however, the hospital should refrain from referencing patient names of diagnoses in its submissions.

A hospital that relocates a PBD to an off-campus location, such as a patient’s home, will have 120 days from the date on which they began furnishing and billing for services at the relocated site to submit notification to CMS.  In addition, hospitals may include multiple relocation notifications in one e-mail, so long as each submission falls within the 120-day requirement.

May 14, 2020

QUESTION:  We run an acute care hospital.  In order to prevent the spread of COVID-19, we have allowed some of our practitioners to provide services to Medicare beneficiaries via telehealth.  These Medicare beneficiaries are receiving services in their homes that they would normally receive in the hospital’s outpatient department.  What does the recent interim final rule from CMS say about the practitioner’s ability to bill for this sort of arrangement?

 

ANSWER:  Effective March 1, 2020, when a practitioner who ordinarily practices in a hospital outpatient department furnishes a telehealth service to a patient who is located at home, they may submit a professional claim with the place of service code indicating that the service was furnished in the hospital’s outpatient department.  Medicare will then pay the practitioner under the Physician Fee Schedule at the facility rate (as though the service had been provided in the hospital’s outpatient department).

The interim final rule contains further details about the hospital’s ability to bill for its services.  To access the interim final rule, click here.  For a general overview of recent Medicare telehealth developments, click here.

February 13, 2020

QUESTION:            We are revising our Medical Staff Bylaws and a question has come up about whether we could add a “years of service” exemption that let’s physicians opt-out of their ED call obligations if they have been on the Medical Staff for more than 20 years. Is this okay under EMTALA?

ANSWER:            It is. CMS recognized the practice of giving age or year’s of service based exemptions in the 2003 Preamble to the updated EMTALA Regulations, stating:

“We understand that some hospitals exempt senior medical staff physicians from being on call. This exemption is typically written into the hospital’s medical staff bylaws or the hospital’s rules and regulations, and recognizes a physician’s active years of service (for example, 20 or more years) or age (for example, 60 years of age or older), or a combination of both. We wish to clarify that providing such exemptions to members of hospitals’ medical staff does not necessarily violate EMTALA. On the contrary, we believe that a hospital is responsible for maintaining an on-call list in a manner that best meets the needs of its patients as long as the exemption does not affect patient care adversely. Thus, CMS allows hospitals flexibility in the utilization of their emergency personnel.” (Emphasis added).

Obviously, the highlighted language indicates that while such exemptions are permissible under EMTALA, the exemptions cannot interfere with a hospital’s ability to maintain adequate on-call services.

Therefore, we recommend the MEC approve any request for such an exemption, since allowing an exemption to take effect automatically could create EMTALA problems, depending on the number of remaining physicians in the specialty.  Furthermore, we also recommend including language that states the MEC can require a physician who was previously given an exemption to return to the call schedule (on a temporary or permanent basis) if the needs of the Hospital change.

January 9, 2020

QUESTION:        Why can’t someone come up with a straightforward definition of what it means for a physician’s compensation to vary with, or take into account, the volume or value of the physician’s referrals to a hospital?

ANSWER:          Good question.  CMS is trying, but the federal courts continue to make this analysis much more complicated than Congress intended when it adopted the Stark Law.

Some courts have mistakenly held that if a physician is employed by a hospital in a hospital-based service, and is paid on an RVU basis, then since the more professional services that the physician personally performs, the more referrals they will make to the hospital and as a result, the physician’s compensation varies or takes into account the physician’s referrals to the hospital.

This is incorrect and is part of the reason that the Third Circuit had to reissue its decision in U.S. ex rel. Bookwalter v. UPMC (discussed in this week’s HLE).

CMS has apparently heard these concerns.  On October 17, 2019, CMS published proposed Stark regulations that will provide clear, helpful guidance on this and many other aspects of the Stark Law if they are adopted in final form as proposed.

As CMS has repeatedly stated, the requirement that compensation not vary with or take into account the volume or value of physician referrals, which appears in a number of statutory or regulatory exceptions, should be uniformly interpreted wherever it appears.  Such uniform interpretation is essential.  However, as pointed out in the Preamble to the Proposed Regulation, some courts have interpreted the volume or value standard to consider the subjective intent of the parties, rather than applying an objective “bright line” test as Congress intended, making compliance with the statute much more difficult and uncertain than intended by the statute.

CMS wants to address this confusion by proposing a much clearer definition of the volume or value standard in the regulations.  CMS has stated that this vital term should be interpreted to mean that the volume or value standard will be violated only if the amount paid to the physician or the amount due from the physician (i.e., a rental payment) will increase or decrease in correlation to the referrals that the physician makes to the hospital.

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CMS then gave the following examples of the types of compensation arrangements that will violate the Stark Law.

To illustrate, assume a physician leases medical office space from a hospital.  Assume also that the rental charges are $5000 per month and the arrangement provides that the monthly rental charges will be reduced by $5 for each diagnostic test ordered by the physician and furnished in one of the hospital’s outpatient departments.  Under proposed § 411.354(d)(6)(i), the compensation (that is, the rental charges) would take into account the volume or value of the physician’s referrals to the hospital.  The mathematical formula that illustrates the rental charges paid by the physician to the hospital would be:  Compensation = $5000 – ($5 x the number of designated health services referrals).  The policy at § 411.354(d)(6)(ii)(A) with respect to when compensation from a physician (or immediate family member of the physician) to an entity takes into account other business generated would operate in the same manner.

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As another example, assume that a physician leases medical office space from a hospital and the rental charges are as follows:  $2000 per month if the physician is in the top 25 percent of admitting physicians at the hospital (measured by the gross charges per inpatient admission); $2500 per month if the physician  is in the second quartile of admitting physicians on the hospital’s medical staff (measured by the gross charges per inpatient admission); and $3500 per month if the physician is in the bottom half of admitting physicians at the hospital (measured by the gross charges per inpatient admission).  Under our proposed additional approach to the volume or value standard and other business generated standard, the compensation (that is, the rental charges) would be determined in a manner that takes into account the value of the physician’s referrals and other business generated for the hospital.

These proposed amendments to the Stark Volume or Value Standard, as well as the proposed definition of fair market value and commercial reasonableness (which recognized that it does not violate the law to lose money on a physician’s practice and that published salary surveys are to be used as benchmarks only), will make compliance with the Stark Law much more straightforward.  These proposed regulations also provided valuable guidance on value-based arrangements and recognize that the fair market value of the physician’s input and cooperation with a value-based enterprise is generally not reflected in the hourly payment rates for the services actually performed by the physician.

The comment period for these proposed regulations ended on December 31, 2019.  We have urged CMS to issue the proposed regulations in final form without delay so that providers and the federal courts can begin to take advantage of this guidance.

If you want to learn more about value-based compensation, these regulations or the proposed Safe Harbor regulations that were issued on the same day, join Dan and Henry in Chicago on April 23-25 for the Hospital Physician Contracts Clinic.

November 21, 2019

QUESTION:        We need to employ physicians in order to provide the care needed by our patients.  The main reasons that private practice is no longer a viable option for many physicians are the ever increasing costs of operating a practice (especially malpractice insurance and EHR costs) while professional reimbursement keeps decreasing.  However for the same reasons, we rarely break even on a physician practice.  Does anyone in the government understand this or do they assume that we overpay physicians to get their referrals?

ANSWER:          Unfortunately, many courts do not understand your dilemma.  Some courts seem to take the position that a hospital paying a physician more than the physician generates in professional fees is evidence of unreasonable compensation that violates the Stark Law.

However, help is on the way.  In the October 19, 2019, proposed Stark Regulations, CMS has provided an excellent description of the analysis that should be followed when assessing whether the compensation paid to a physician violates the Stark Law.

For the first time, CMS has included a definition of the term “commercially reasonable” that specifically states that an arrangement may be commercially reasonable even if “it does not result in a profit for one or more of the parties.”  CMS has also substantially revised the definition of “fair market value” and has made it clear that in order to violate the “volume or value” standard there must be a direct correlation between the physician referrals and the amount to be paid to the physician.

CMS also stated that salary surveys are to be treated as benchmarks, not the last word on physician compensation and even provided easy to understand examples such as the following in order to make this point crystal clear:

By way of example, assume a hospital is engaged in negotiations to employ an orthopedic surgeon.  Independent salary surveys indicate that compensation of $450,000 per year would be appropriate for an orthopedic surgeon in the geographic location of the hospital.  However, the orthopedic surgeon with whom the hospital is negotiating is one of the top orthopedic surgeons in the entire country and is highly sought after by professional athletes with knee injuries due to his specialized techniques and success rate.  Thus, although the employee compensation of a hypothetical orthopedic surgeon may be $450,000 per year, this particular physician commands a significantly higher salary and the general market value (or market value) of the transaction may, therefore, be well above $450,000.  The statute requires that the compensation is the value in an arm’s length transaction, but that value must also be consistent with the general market value (or market value) of the subject transaction.  In this example, compensation substantially above $450,000 per year may be fair market value.

The proposed rules also provide much needed guidance on value-based arrangements.

The comment period will end on December 31, 2019.  We hope that CMS will finalize these proposed regulations as soon as possible after that date and that the federal courts begin to adopt CMS’s analysis.

November 7, 2019

QUESTION:        Did CMS recently change its regulations on supervision of physician assistants?

 

ANSWER:          Yes.  CMS recently issued a final rule that revised its regulations on physician supervision.  This rule explains that CMS will largely defer to state law and state scope of practice rules for issues involving supervision of physician assistants (“PAs”).  In situations where there is no state law governing physician supervision of PA services, CMS will look for documentation of the PA’s scope of practice and the working relationships the PA has with supervising physicians (when furnishing professional services).

Crucially, you will need to check your state law to verify whether these changes will have a significant impact on your organization.

October 31, 2019

QUESTION:        I thought I saw something recently about the Stark and Safe Harbor Regulations being changed?  Did I hallucinate after eating too much Halloween candy?

ANSWER:          Well, you may have been hallucinating, but it wasn’t about the Stark and Safe Harbor Regulations.  On October 9, 2019, CMS issued a proposed rule to modernize and clarify the Stark regulations and, at the same time, the OIG published proposed amendments to the Anti-Kickback Safe Harbor regulations.  Comments will be accepted through December 31, 2019.

The proposed amendments to the Stark regulations would:

  • create new, permanent exceptions to the Stark Law for value-based arrangements;
  • solicit comments about the role of price transparency in the context of the Stark Law and whether to require cost-of-care information at the point of a referral for an item or service;
  • provide additional guidance on several key requirements that must often be met in order for physicians and healthcare providers to comply with the Stark Law, including how to determine if compensation is at fair market value;
  • provide guidance on a wide range of other technical compliance issues; and
  • propose a new Stark exception for donations of certain cybersecurity technology.

The revisions proposed by the OIG to the Anti-Kickback safe harbors apply to certain coordinated care and associated value-based arrangements between or among clinicians, providers, suppliers, and others and add protections under the anti-kickback statute and civil monetary penalty (“CMP”) law that prohibit inducements offered to patients for certain patient engagement and support arrangements to improve quality of care, health outcomes, and efficiency of care.

The proposed rule would add a new safe harbor for donations of cybersecurity technology and amend the existing safe harbors for electronic health records (“EHR”) arrangements, warranties, local transportation, and personal services and management contracts.  The proposed rule would also add a new safe harbor related to beneficiary incentives under the Medicare Shared Savings Program and a new CMP exception for certain telehealth technologies offered to patients receiving in-home dialysis.

Do you want to know more?  HortySpringer partners Henry Casale and Dan Mulholland went over these proposals in detail earlier this month in a Special Audio Conference and told everyone what they should be doing right now to get ready for them.  You can order a recording of that audio conference here.

October 17, 2019

QUESTION:        A few years ago, CMS proposed a rule that would have required hospitals to send a copy of the discharge instructions and the discharge summary to practitioners responsible for the patient’s follow-up care.  Specifically, the proposed rule attached a 48-hour deadline to this requirement, with an exception for pending test results (which would have been due within 24 hours after becoming available).  Was the 48-hour deadline ever finalized?

ANSWER:          No, CMS ultimately decided not to impose this 48-hour deadline.  At the end of September, the agency published a final rule explaining its rationale.  CMS received numerous comments that supported the idea of requiring hospitals to send a copy of the discharge instructions and discharge summary to the practitioners responsible for the follow-up care, so long as those practitioners were known and had been clearly identified.  However, most of the commentators expressed concern about the idea of a 48-hour time frame.  In the Federal Register, CMS explained that it found these concerns convincing.  Specifically, it acknowledged that the 48-hour deadline would not be reasonable or appropriate for all situations.  It therefore eliminated that specific time frame requirement and instead gave hospitals discretion on when to send this information.

However, CMS did finalize a requirement for hospitals to “discharge the patient, and transfer or refer the patient where applicable, along with all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences.”  This does place certain obligations on the hospital (and discharging practitioners) to ensure that necessary medical information is ready to be sent at the time of discharge.

To hear more on this topic and other recent CMS changes, tune in to our upcoming audio conference:

“Patients Over Paperwork”? The New CMS Rules and Their Impact on Your Patients and Policies

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October 10, 2019

QUESTION:        The five medical staffs in our system are thinking about unifying.  Are there any particular steps we need to follow and any changes we need to make to our bylaws?

 

ANSWER:          In May 2014, CMS revised the Medicare Conditions of Participation to allow a multi-hospital system to have a unified and integrated Medical Staff.  There are several steps that must be taken in the integration process.  First, the system must ensure that there is nothing in the state hospital licensing statutes or regulations that would prohibit the medical staffs of separately licensed hospitals from integrating into a single staff.

Second, the Board (and there must be a single Board) must document in writing its decision to use  a unified medical staff model.  This decision would be conditioned on acceptance by the hospitals’ medical staffs to opt-in to an integrated medical staff model.

Third, the medical staff of each of the hospitals must take a separate vote to opt in or opt out of the unified medical staff.  The vote at each hospital must be governed by the respective medical staff bylaws in effect at the time.  Only voting members of the medical staff who hold privileges to practice on site at the hospital may participate in the vote.

Fourth, the unified medical staff will also want to adopt new medical staff bylaws and related policies.  The new bylaws should take into account the unique circumstances of each hospital, including any significant differences in the patient populations and the clinical services that are offered at each hospital.

Importantly, the new bylaws must also include a process by which the voting members of the medical staff who exercise clinical privileges at the hospital may vote to opt out of the unified medical staff in the future.