December 12, 2019

QUESTION:        What is a “curbside consultation” and will providing such expose a physician to liability?

 

ANSWER:            A “curbside consultation” is an informal consultation in which a treating physician or practitioner seeks informal information or advice about patient care or the answer to an academic question from a colleague and the colleague provides it.  These consultations are usually based on the treating practitioner’s presentation of the case or posing direct questions.  The colleague doesn’t see the patient or review the chart, nor is he or she paid for the consultation.

Although it would seem the risk for liability would be low as the consulting physician is not technically the treating physician, this varies state by state and usually depends on the extent to which each state considers a consultation to amount to creation of a physician-patient relationship.  The majority of states have ruled that consultants, whether informal or formal, are not liable if they do not personally examine the patient.  However, there are exceptions, and in some states, courts have found that consultations may amount to “directing the care” of a patient and thus imposed liability on those consultants.  Therefore, it is important to review the law and cases within your state to determine if these types of consultations or similar informal consultations expose a physician to potential liability.

December 5, 2019

QUESTION:        Our hospital recently received a request from a former Medical Staff member for a complete copy of his credentials and peer review files.  The files are thick – he had a fair number of clinical and behavioral concerns while on our staff.  Are we required to provide the copies as requested?

 

ANSWER:           State law needs to be reviewed.  However, in most states, hospitals are not required to provide former Medical Staff members (or even current members) copies of their credentials and peer review files.  (In contrast, state law often does require that employees be granted access to personnel files maintained by Human Resources.)

Assuming state law is silent, the next question is whether the hospital has a policy addressing such requests.  Naturally, if a policy exists, it should be followed.

If there is no such policy, the hospital should consider how such requests from former Medical Staff members for copies have been handled in the past.  While a hospital is not bound by the past and is always free to adopt new procedures, it should be careful to avoid allegations that individuals are being treated differently for a discriminatory reason.

The best practice, of course, is to adopt a policy that governs Medical Staff members’ access to their credentialing and peer review files.  For existing Medical Staff members, the policy might describe the rules for accessing “routine” and “sensitive” documents, with sensitive documents receiving special protection (for example, names of those who raised a concern will be redacted).  For former Medical Staff members, the policy could state simply that copies will not be provided, but that the hospital will provide information upon request to other hospitals as directed by the former Medical Staff member for credentialing and peer review purposes.

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 14, 2019

QUESTION:        Is there any way to ensure that practitioners at our hospital keep patients within the community and don’t unnecessarily transfer them to other facilities for the practitioners’ convenience or profit, without going through all of the rigamarole of summarily suspending the physician and then revoking his appointment and privileges, as in the Patel case that is featured in the “NEW CASES” section of this week’s Health Law Express?

ANSWER:            Yes!  Hospital and medical staff leaders can use a number of strategies to help ensure that patients who present to the hospital for treatment do not end up being unnecessarily transferred away to other organizations and/or other communities.  Most organizations’ Medical Staff Bylaws or Credentials Policy includes, as a threshold eligibility criterion for Medical Staff appointment, that an individual live and/or maintain an office within a certain geographic distance of the hospital.  The intent of such requirements is to ensure that practitioners are routinely available to respond to their patients when needed and to participate in medical staff affairs.  Further, it helps to ensure that follow-up, outpatient services are available to patients within the community.

Note that some organizations choose to have a general geographic distance requirement for medical staff membership (e.g., “within 30 miles” or “within 30 minutes driving”) and to also have specialty-specific requirements for those specialties where patient needs may be more urgent or demanding.  For example, it is not uncommon for there to be more stringent geographic requirements (e.g., “within 10 miles” for trauma).  Further, some organizations impose a loose requirement for general medical staff appointment (e.g., “within 50 miles”) but require individuals within certain specialties to be closer to the hospital when serving on call for the emergency department.

In the end, each organization has to choose how to define its geographic requirements, based on the unique nature of the community and the services offered by the hospital’s practitioners.  There’s not a “right” or “wrong” answer with respect to that.  So long as the Bylaws and/or Credentials Policy are appropriately drafted, an individual who fails to meet the geographic distance requirement need not have an application for appointment denied but, rather, can simply be told that he or she has been deemed ineligible to have an application  processed and considered.  Further, so long as those documents call for automatic relinquishment of appointment and privileges when an individual fails to satisfy any eligibility criteria, an individual whose status changes during the course of an appointment term could simply be informed of his or her automatic relinquishment, rather than the Medical Executive Committee and Hospital having to go through the motions (and possible hearing, appeal, and litigation) associated with revocation of appointment and privileges.

Finally, with respect to employed physicians, many organizations require (either in the employment contract or in separate employment policies) that services to be provided within the employer’s facilities unless certain, enumerated circumstances apply (e.g., the patient’s best interest requires transfer to another facility with more specialized capabilities, the patient’s health insurer insists, the patient requests transfer).

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 24, 2019

QUESTION:        We are in the process of negotiating with insurers to conduct “delegated credentialing.”  We would like to use our Medical Staff Credentials Policy to perform delegated credentialing, but during a pre-delegation audit, the insurer informed us that our Policy does not comply with accreditation standards.  Why is that and what do we need to do?

ANSWER:          By way of background, we are seeing significant interest from hospitals in pursuing delegated credentialing with insurers.  Delegated credentialing means that the hospital performs the credentialing that insurers are required to do before accepting individual providers for participation with the insurers’ plans.  Since the hospital is conducting the credentialing for the insurer, the regulatory requirements and accreditation standards that control are those to which the insurer is subject.  The majority of these requirements and standards come from the Medicare Managed Care Manual, state Medicaid rules (if the insurer has Medicaid managed care plans), and insurer accreditation entities such as NCQA and URAC.

For the most part, these credentialing requirements and standards overlap with those for hospitals.  However, there are a few differences that need to be addressed if you plan to use your Medical Staff documents for delegated credentialing.  For example, the URAC accreditation requirements instruct that the Credentials Committee is tasked with making a “final determination” on applications.  This can be a sticking point for insurers accredited by URAC and which are delegating credentialing to a hospital using its Medical Staff policies for delegated credentialing.  The reason for this is because the Medicare Conditions of Participation and hospital accreditation entities, such as the Joint Commission, require the hospital’s board to make final decisions on applications for appointment and clinical privileges.

Nonetheless, this is not a difficult fix and you have a couple of options.  The first is to adopt a Credentials Procedures Manual that works in conjunction with your Medical Staff Credentials Policy.  You want to be sure that you note in this Manual that the procedures specified are designed to comply with, and for use in, the delegated credentialing process.  A second option is to add an appendix to your Medical Staff Credentials Policy, which includes all the provisions needed to comply with the regulatory requirements and accreditation standards for insurers.  For example, with respect to the “final determination” issue noted above, the appendix could instruct as follows: “For purposes of delegated credentialing and reporting practitioner effective dates to third-party payors, the date that the Credentials Committee, or chairperson of the Credentials Committee (for those applications that meet the criteria outlined in the Credentials Policy for “clean applications”), approves the practitioner’s credentialing will be used as the practitioner’s effective date.”

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

* * * * *

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.

October 3, 2019

QUESTION:        Are two Critical Access Hospitals (“CAHs”) allowed to unify their medical staffs?

ANSWER:          No. Moreover, as CMS made clear in analyzing the comments it received to the proposed regulations related to unified QAPI and infection control programs in the final version published on September 30, 2019, there are other limits: “One commenter requested that CMS include ‘affiliate’ and CAHs in the unified and integrated QAPI and infection control requirements.”  CMS responded:

A CAH must be separately evaluated for its compliance with the CAH CoPs (found at 42 CFR part 485, subpart F), which would not include the requirements included in this section of the rule since these are hospital CoPs. It would not be possible to evaluate the CAH’s compliance as part of an evaluation of a hospital’s compliance.  However, this does not preclude a multi-hospital system’s single governing body from also serving as the CAH’s governing body, so long as the governing body clearly identifies the policies and decisions that are applicable to the CAH.  84 Fed. Reg. at 51742.

However, CMS stated that it encourages CAHs to “work with other hospitals or CAHs in their network (if available) for pharmaceutical support” (among other resources) in dealing with the revised antibiotic stewardship requirements.  84 Fed. Reg. at 51783.

The regulations pertaining to CAHs are just a small part of the entire set of regulations.

Join Charlie Chulack and Joshua Hodges for a special audio conference entitled:

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

October 29, 2019
1:00 to 2:30 pm (ET)

They will discuss the key points in these new regulations, particularly those that affect Medical Staff Rules & Regulations and policies, and revisions you should think about now.

And stay tuned for another special audio conference coming in 2020 on Medical Staff basics for Critical Access Hospitals.