Author: hortyspringer

January 23, 2020

Posted on by hortyspringer

QUESTION:  Our hospital is part of a health system. Is there any way we can take advantage of our size and resources to improve our peer review process?

ANSWER:  Yes! Health systems have many options for improving their professional practice evaluation (“PPE”)/peer review processes that aren’t available to individual hospitals. Here are a few examples.

1.  System PPEC

Health systems can create a system Professional Practice Evaluation Committee (“System PPEC”) with representatives from each hospital in the system. The System PPEC could:

(a) serve as a resource for the PPECs of individual system hospitals;

(b) compile triggers for PPE/peer review, OPPE data indicators, and criteria for Informational Letters, and share those with local PPECs for their approval; and

(c) compile and disseminate best practices and lessons learned from each system hospital.

The System PPEC would assist local PPECs, but the local PPEC would remain responsible for all decisions regarding a review.

2.  System Specialty Review Committees

System Specialty Review Committees comprised of specialists from system hospitals could be appointed to review cases upon the request of a system hospital. The PPEC at the entity requesting the review would retain full responsibility for deciding what to do with each case. The System Specialty Review Committee would simply serve as another source of expertise for that PPEC.

System Specialty Review Committees could also monitor aggregate data related to system practitioners and facilities in their specialties and disseminate best practices and lessons learned through the review process.

3.  PPE/Peer Review Clearinghouse Policy

Systems could develop a policy by which central administrative personnel serve as a “clearinghouse” for case review services. System hospitals would notify the clearinghouse of practitioners who have agreed to provide case review services for other system hospitals. A hospital that requires a case review would contact the clearinghouse, which would identify a practitioner who has agreed to provide such services.

4.  PPE/Peer Review Services Agreement Between Facilities

Under this option, one system hospital (the “PPE Services Provider”) could provide PPE/peer review services to another system hospital (the “Requesting Hospital”). The PPE Services Provider and the Requesting Hospital would execute an agreement to describe their respective obligations. The services to be provided by the PPE Services Provider might include case review services, regular participation in meetings of a PPE/peer review committee, and assistance with the FPPE process to confirm practitioner competence.

5.  PPE/Peer Review Services Agreement For Individual Reviewer

Under this option, an individual practitioner who has privileges at one system entity would
provide PPE/peer review services directly to another system entity. Essentially, the practitioner would be serving as an external reviewer for the facility requesting services. The system could develop a template agreement by which these services are provided.

January 16, 2020

Posted on by hortyspringer

QUESTION:        Our Medical Staff Rules and Regulations prohibit physicians and other practitioners from treating themselves, their spouses, and their children at the hospital.  We have been receiving a bit of push-back on this prohibition, particularly because we are located in a somewhat rural area where the selection of specialists can be somewhat limited and, at times, it can be more convenient for family members to schedule and obtain treatment from their own relatives.  Do most hospitals and medical staffs prohibit self-treatment and treatment of family members?  Do most allow exceptions in certain cases?   Do you know whether these prohibitions are just “best practice” recommendations or, alternatively, required by law?

 

ANSWER:        The issue of self-treatment and treatment of close family members comes up from time to time, often after a hospital and its medical staff have received reports of some sort of alleged “abuse” of the hospital’s facilities or services in furtherance of such activities.  For example, it is not uncommon for a hospital and its medical staff leaders to propose restrictions on self-treatment or treatment of family members after learning that a practitioner has been ordering his or her own labs and other diagnostic tests or, a bit less commonly, bringing in family members for “after hours” and undocumented colonoscopies and other diagnostic procedures.

There are a number of reasons that hospitals and their medical staff leaders should consider policymaking in this area.  For one thing, if practitioners are caring for family members without establishing formal patient-physician relationships, performing appropriate histories and examinations, and creating medical records – there could be increased risk of malpractice (and the attendant increased risk of liability).

Aside from the risk that is created when practitioners treat themselves and their family members (due to the informalities in treatment mentioned above, the fact that family members may not feel comfortable revealing full histories to the practitioner, that practitioners may overprescribe to themselves or fail to objectively diagnose themselves or  close family, etc.) – there are other reasons to consider policymaking in this area.

First, a number of states have passed statutes and regulations that specifically prohibit licensed practitioners from treating themselves and certain close relatives.  Accordingly, any hospital or medical staff considering such a policy should first research applicable state law.  Even in states that do not legally prohibit self-treatment or treatment of family members, the Board of Medicine may discourage the practice or have established certain parameters to ensure that any such practice is done safely.  Note the following FAQ from the California Medical Board website:

Can a physician treat and prescribe to family, friends or employees?

There is no law which specifically prohibits a physician from evaluating, diagnosing, treating, or prescribing controlled substances to a family member, employee or friend. However, the practice is discouraged. There are laws to consider when assessing any prescribing issues which include, but are not limited to: 1) a physician cannot prescribe without an appropriate prior exam and a medical indication for the prescription, and 2) an adequate and accurate medical record relating to the provision of services to the patient and documenting the medical need for the prescription must be created and maintained by the physician. Basically, a physician must follow the same practice/protocol for any patient in which medications are prescribed.

Though the federal Drug Enforcement Administration (DEA) regulations do not include an outright prohibition on self treatment or treatment of family members, they do establish requirements for the prescribing of controlled substances, including that they be issued for a legitimate medical purpose by a practitioner who is acting “in the usual course of his professional practice.”  It is possible, then, that a physician who prescribes a controlled substance for a family member, where the type of prescribing falls outside of his usual course of professional practice, or where the prescribing occurs outside of an established physician-patient relationship, would be engaged in unlawful diversion of controlled substances.  For example, would it be lawful for a surgeon to prescribe Ativan for her mother-in-law’s anxiety?  Though the prescription may be medically indicated, depending on the condition of the mother-in-law, the surgeon could be found to be acting outside the usual course of her surgical practice and the prescription could, in turn, be found to be unlawful.

Aside from looking at legal requirements and prohibitions, also be aware that many medical associations and societies recommend that physicians and other practitioners limit self-treatment and treatment of family members.  While these do not have the force of law, they can provide persuasive guidance for best practice and are worth considering.  For example, the American Medical Association’s Code of Medical Ethics’ Opinion on Physicians Treating Family Members states:

Opinion 8.19 – Self-Treatment or Treatment of Immediate Family Members

Physicians generally should not treat themselves or members of their immediate families. Professional objectivity may be compromised when an immediate family member or the physician is the patient; the physician’s personal feelings may unduly influence his or her professional medical judgment, thereby interfering with the care being delivered. Physicians may fail to probe sensitive areas when taking the medical history or may fail to perform intimate parts of the physical examination. Similarly, patients may feel uncomfortable disclosing sensitive information or undergoing an intimate examination when the physician is an immediate family member. This discomfort is particularly the case when the patient is a minor child, and sensitive or intimate care should especially be avoided for such patients. When treating themselves or immediate family members, physicians may be inclined to treat problems that are beyond their expertise or training. If tensions develop in a physician’s professional relationship with a family member, perhaps as a result of a negative medical outcome, such difficulties may be carried over into the family member’s personal relationship with the physician.

Concerns regarding patient autonomy and informed consent are also relevant when physicians attempt to treat members of their immediate family. Family members may be reluctant to state their preference for another physician or decline a recommendation for fear of offending the physician. In particular, minor children will generally not feel free to refuse care from their parents. Likewise, physicians may feel obligated to provide care to immediate family members even if they feel uncomfortable providing care.

It would not always be inappropriate to undertake self-treatment or treatment of immediate family members. In emergency settings or isolated settings where there is no other qualified physician available, physicians should not hesitate to treat themselves or family members until another physician becomes available. In addition, while physicians should not serve as a primary or regular care provider for immediate family members, there are situations in which routine care is acceptable for short-term, minor problems. Except in emergencies, it is not appropriate for physicians to write prescriptions for controlled substances for themselves or immediate family members.

A number of other organizations/publications have discussed this issue as well:

Finally, note that although Medicare’s reimbursement rules do not appear to have any outright prohibition on self-treatment or treatment of family members, CMS does take the position that services provided by an immediate family member or another individual who is a member of the same household would normally be provided gratuitously, in light of the relationship between the individuals.  In turn, reimbursement for such services is excluded under Parts A and B of Medicare  (see Section 130 of the Medicare Benefits Policy Manual for more details).

With all of this background in mind, what to do?  Well, first of all, work with your legal counsel to research applicable state law.  If your state has an outright prohibition on self-treatment or treatment of certain family members (or specific types of treatments for family members), the decision about what to include in the Rules and Regulations or other policy will be easier – and should closely track the state law (though you can be more restrictive than the state prohibition, if you wish).

If your state is silent on the issue, this is a matter that should be carefully considered and discussed, weighing patients’ best interests and the practicality of an outright prohibition on self-treatment or treatment of family, given your geographic location (or other relevant factors, such as those related to ready availability of services in the area).

For educational purposes, we provide the following, sample language.  It reflects the type of language that is fairly common, in our experience, in areas where state law is silent about these matters.  To that end, note that most hospitals and medical staffs seem to agree with the professional societies and associations, erring toward fairly tight limitations on self-treatment and treatment of family members, due to the increased risks:

Self-Treatment and Treatment of Family Members, COLLEAGUES, and co-workers

(1)        Self-Treatment:

(a)       Practitioners are strongly discouraged from treating themselves, except in an emergency situation or where no viable alternative treatment is available.

(b)       Practitioners should never write prescriptions for controlled substances for themselves.

(2)        Treatment of Immediate Family Members, Colleagues, and Co-Workers:

(a)        Generally, practitioners should refrain from the following activities in the Hospital:

(1)       admitting or consulting on immediate family members (i.e., spouse, natural or adoptive parent, child, or sibling, step-parent, step-child, or step-sibling, parent-in-law, child-in-law, or sibling-in-law, grandparent, grandchild, spouse of a grandparent, spouse of a grandchild, step-child, or anyone residing in the same household as the practitioner); or

(2)       being involved in the care of an immediate family member with complex or potentially serious symptoms or diagnoses or in situations that raise ethical concerns.

When considering these guidelines, factors such as the availability of other Practitioners to provide the needed care, patient acuity, and the patient’s right to direct his/her own medical care should also be considered.

(b)       Practitioners should never write prescriptions for controlled substances for family members.

(c)        As it relates to colleagues and co-workers in the Hospital, practitioners should refrain from:

(1)       treating any individual without first performing an appropriate assessment and creating a proper medical record; or 

(2)       writing a prescription for any individual in the absence of a formal practitioner-patient relationship.

January 9, 2020

Posted on by hortyspringer

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.

* * *

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.

* * *

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.

December 19, 2019

Posted on by hortyspringer

QUESTION:        We have nine hospitals in our system.  We are not ready to have a unified medical staff (and maybe never will be) but we need to find a way to have more uniformity in our documents and decision-making.  Do you have any suggestions?

 

ANSWER:            There is no single right answer to the question of whether medical staffs within a system should form a unified staff.  Although CMS changed the rules in 2014 and allowed hospitals with separate CMS Certification Numbers (CCN) to have a unified medical staff, unification may not be the best choice for your system.  It is important, however, for medical staffs within a system to strive for uniformity and consistency in their documents and decision-making.  Take it from us, it is a problem when one hospital in a system decides to deny reappointment or imposes a precautionary suspension and the physician shifts his practice to a sister hospital.  Fortunately, there are ways to avoid that disaster short of unification of the medical staff.

Most systems we work with have started with a uniform application form and uniform peer reference forms.  This helps ensure that each hospital in the system is asking the same questions and getting the same responses both from the applicant and from the peer references.

Many systems have gone to the next step and created a credentialing verification organization to gather and verify information that is then forwarded to the physicians and other practitioners involved in the credentialing process.  This helps to ensure that each medical staff has the same primary source information to use in making credentialing recommendations.

As a next step, many systems have developed a system credentials policy.  This helps to standardize the standards and the key credentialing processes.  Each medical staff will then have the same threshold eligibility criteria for appointment, the same way of dealing with misrepresentations and omissions, and the same investigation and hearing processes.  This approach can also be taken for other key documents such as the professionalism policy, health policy and peer review policy.

Once your standards are aligned, you might next want to consider the development of key medical staff committees that would function at a system level.  Many systems have done this with the credentials committee.  Representatives from each medical staff typically serve on the system credentials committee.  This helps ensure that the same people are applying the same standards.  This should drastically reduce variation in recommendations at least at appointment and reappointment.

Good language in your credentials policy can also address those situations where one medical staff in your system has developed a performance improvement plan, commenced an investigation, or recommended revocation of appointment and privileges.  The key is to have language which allows these actions to be effective at all hospitals in the system without having to redo all the hard work that has already been done but, at the same time, to allow some discretion when a different outcome would be warranted by the facts.

December 12, 2019

Posted on by hortyspringer

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

Posted on by hortyspringer

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

Posted on by hortyspringer

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

Posted on by hortyspringer

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 was 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

Posted on by hortyspringer

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

Posted on by hortyspringer

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.