CMS

August 30, 2018

Posted on by hortyspringer

QUESTION:        What is the latest formal regulatory guidance from the government on how hospitals are to structure a gainsharing program or a compensation arrangement with physicians who assist a hospital with the hospital’s Value Based Purchasing Program (“VBP”)?

ANSWER:            Currently, there is none – this is why the responses to the June 25, 2018 CMS Request for Information on the Stark Law and the OIG’s August 27, 2018 Request for Information that is described in this week’s “Government at Work” are so important.

Both OIG and CMS have referenced the HHS “Regulatory Sprint to Coordinated Care.”  Both OIG and CMS have recognized that the Fraud and Abuse Laws that are within their jurisdiction (the Stark Law in CMS’s case and the Anti-Kickback Statute and Civil Money Penalty Law (the “CMP”) in OIG’s case) can create real or perceived barriers to achieving clinical and financial integration between hospitals and physicians.  What is unfortunate is that in the past neither CMS nor OIG has shown much of a willingness to address those barriers to hospital-physician integration efforts.

As we pointed out to CMS (and also intend to inform OIG), if removing unnecessary governmental obstacles to care coordination is a key priority for HHS, then the planned HHS “Regulatory Sprint to Coordinated Care” will not get off the starting line without significant revisions to the regulations implementing the Stark Law, the Anti-Kickback Statute and the CMP, which are well within the respective discretion of CMS and OIG to implement.

For example, hospitals need immediate guidance concerning the ability of a hospital to compensate physicians who assist the hospital under Medicare’s VBP.  It is difficult, if not impossible, for a hospital to achieve the desired goals under the VBP without physician input and cooperation.  However, the fair market value of that input and cooperation is difficult to determine and hourly payment rates are often not reflective of the fair market value of the services actually being provided to the hospital by the physicians.

Hospitals need to be assured that utilizing a payment methodology that is based, in whole or in part, on the amount of the payment that the hospital receives under the VBP due to the services provided by the physicians will satisfy an exception to the Physician Self-Referral Law and will not violate the Anti-Kickback Statute or the CMP.

In addition, since 2001, the OIG has provided Compliance Program and Advisory Opinion Guidance on gainsharing arrangements.  (See, OIG Supplemental Compliance Program Guidance for Hospitals, 70 Fed. Reg. 4858, 4869-70 (Jan. 31, 2005); e.g., OIG Advisory Opinions 01-01 (Jan. 11, 2001); 05-01 (Feb. 4, 2005); 05-02, 05-03, 05-04 (Feb. 17, 2005); 05-05, 05-06 (Feb. 25, 2005); 06-22 (Nov. 16, 2006); 07-21, 07-22 (Jan. 14, 2008); 17-09 (Jan. 5, 2018).  However, no safe harbor exists for gainsharing arrangements.

CMS issued a proposed regulation, Incentive Payment and Shared Savings Programs, on July 7, 2008 (to be codified at 42 C.F.R. § 411.357(x)).  However, that proposed regulation did not adequately address VBP and  differed significantly from OIG’s gainsharing guidance.  Rather than publish a final regulation, CMS asked for public comment on 55 aspects of the proposed regulation.  73 Fed. Reg. 69,725, 69,795-98 (Nov. 19, 2008).  Unfortunately, to date, CMS has failed to issue any type of formal (or informal) guidance on the application of the Stark Law to gainsharing or other shared savings programs.

The OIG should turn its gainsharing, compliance and advisory opinion guidance into a safe harbor.  While we would prefer a new Stark gainsharing exception, a new Stark exception may not necessary so long as CMS states unambiguously that a hospital that complies with that OIG gainsharing safe harbor will satisfy the personal services exception to the Physician Self-Referral Law.

CMS and OIG should also propose additional, consistent guidance that will address VBP and other shared savings programs.  Such a position would be consistent with the position taken by CMS and the OIG in adopting parallel Stark exceptions and anti-kickback safe harbors for providing financial assistance to physicians implementing electronic prescribing and electronic health records (See 42 C.F.R. § 411.357(v)-(w); 42 C.F.R. § 1001.952(x)-(y)) and would provide practical guidance that hospitals and physicians could use to achieve clinical and financial integration.

July 19, 2018

Posted on by hortyspringer

QUESTION:        We have two physicians in two different specialties, all four of whom have been willing to take emergency call two days each week, but they have announced that they want their employed advanced practice clinicians (“APCs”) to take their call on weekend days; they are no longer willing personally to take any call on weekends.  ED visits are rare in one of those specialties but common in the other.   Does that comply with EMTALA?

ANSWER:            According to CMS, hospitals must have specialty call schedules that meet the needs of patients in the community.  With only two physicians in any specialty, a reasonable call schedule can be developed with arrangements to transfer patients on the days (known in advance) when those specialists are not on call.  CMS will consider “all relevant factors” in determining compliance, and would expect that the call schedule be based on data showing when patients seek care in the ED for the specialties represented on the medical staff.  Are these specialists on call for their own practices on weekends?  That would be a factor to be considered per CMS.  Another hospital to which patients in need of a specialist on a weekend are transferred might report your hospital, leading to an investigation.  The specialists’ refusal to provide any weekend call thus could put the hospital in jeopardy.  CMS allows APCs to participate in the response to call pursuant to policies adopted by a hospital board.  However, CMS does not permit APCs to be listed on the call roster independently (even if they can practice independently in your state). CMS likely would not accept the inclusion of the APCs on the call schedule in lieu of a physician specialist (despite the newer language in the CMS Conditions of Participation and Interpretive Guidelines calling for APCs to have a greater role on the medical staff).  If a patient presents on a weekend in an emergency medical condition, needing the care of the specialist who employs (and supervises/collaborates with) the APC, the physician would be responsible to come in if the ED physician determines that the specialist is needed personally.  (That could be a condition of the grant of privileges.)  It would be best to convene a working group of physician leaders (including an ED physician), the management team, counsel, risk management and at least one Board member to review data showing when patients present to the ED in need of various specialties, and the relative burden among the specialties on the staff. That group can develop a compliant plan.  The risks are significant so it behooves every organization to develop a policy.

Be sure to join Ian Donaldson and Barbara Blackmond for The Complete Course for Medical Staff Leaders!  We cover EMTALA basics, as well as solutions to common dilemmas, in an entertaining way.

May 3, 2018

Posted on by jwilbert

QUESTION:        We’re revisiting our on-call policy and we’re debating whether to set specific rules on physician response times.  Has CMS issued any guidance on this?

ANSWER:            Yes.  CMS advises hospitals to establish detailed, specific guidelines on physician response times.  In particular, CMS has said that a hospital would be “well?advised to establish in its on-call policies and procedures specific guidelines – e.g., the maximum number of minutes that may elapse between receipt of a request and the physician’s appearance for what constitutes a reasonable response time, and to make sure that its on-call physicians and other staff are aware of these time-sensitive requirements.”

This kind of agency guidance is not mandatory, but from a best practice perspective, we would encourage you to craft an on-call policy that follows this advice.  We recommend that you set a bright-line rule for acceptable physician response times.  The rule should be expressed in minutes.

You can carve out well-defined and carefully considered exceptions to the rule (so long as they are otherwise compliant with the law) if you want to allow for more flexibility.  The key is to have clear, detailed, specific guidelines in your policy.

February 22, 2018

Posted on by hortyspringer

QUESTION:        Our hospital is looking for creative ways to reduce the on-call burden for our physicians.  We’d like to find more efficient ways to schedule and structure their time, but we don’t want to sacrifice quality.  We’ve heard that some organizations are moving toward community call.  Does CMS permit this?

ANSWER:             Yes, CMS does permit organizations to adopt so-called “community call” arrangements.  Community call plans can potentially reduce the on-call burden on physicians, can allow hospitals to provide specialty care in a more efficient and reasonable manner, can eliminate the need for duplicative coverage at nearby hospitals, and can increase access to limited resources throughout the region.

CMS permits hospitals to enter into community call plans so long as those plans meet certain defined criteria.  Among other things, the call plan must have a clear delineation of on-call coverage responsibilities (explaining when each participating hospital is responsible for on-call coverage).  It must include a description of the specific geographic area that the plan covers.  Local and regional EMS protocols should include information on the community call arrangements.  In addition, the plan must be annually assessed by each of the participating hospitals.

So long as these criteria (and a handful of others) are met, CMS will generally permit hospitals to engage in the community call arrangement.  CMS has not provided much detail beyond this on what an ideal model should look like — instead, the agency has given hospitals some room to be creative.

The difficulty comes in designing an effective community call plan that is agreeable to all of the participants.   There are a lot of details to consider and resolve.  For example, hospitals may have to reconcile different approaches on paying for call.  In addition, hospitals must be prepared to invest time, effort, money, and personnel in administrating and implementing the call plan.  In some states, the department of health may need to review and approve the call plan.  There are many other topics that should be considered and addressed as well.

October 12, 2017

Posted on by hortyspringer

QUESTION:        Our hospital operates an emergency room and has an inpatient behavioral health unit.  Our emergency room has evaluated a patient with mental illness on numerous occasions, typically on “emergency certificates” under our state law.  In the past, this particular patient has been violent and assaultive toward staff in the emergency room.  Under the Emergency Medical Treatment and Active Labor Act (“EMTALA”), are we permitted to refuse to admit this patient to our behavioral health unit the next time he comes to the emergency room with a psychiatric emergency?

ANSWER:            That’s a very good question, and for any individual hospital, the best answer probably comes from its CMS Regional Office.  Each Regional Office has EMTALA “jurisdiction” over its region.  It is the Regional Office that determines whether there has been an EMTALA violation or not if a complaint is received.

Under EMTALA, the hospital is required to perform a medical screening examination on the patient when he is brought to the emergency room to determine if the patient has an emergency medical condition.  The definition of “emergency medical condition” under EMTALA includes a psychiatric emergency medical condition.

If the patient has a psychiatric emergency medical condition, the EMTALA duty on the hospital is to stabilize that emergency medical condition if the hospital has the capacity and the capability to do so.  Because this hospital has a behavioral health unit, it has the services and resources to stabilize a psychiatric emergency medical condition.  (That’s assuming the behavioral health unit has an available bed.)

Many hospitals do not have forensic units, nor are they staffed to address violent psychiatric patients.  The EMTALA regulations state that a hospital is to provide stabilizing treatment within the capabilities of the staff and facilities available at the hospital.  Thus, there is an EMTALA argument to make that treating a violent psychiatric patient does not come within the capabilities of a hospital’s behavioral health unit.

However, in our discussions with one CMS Regional Office, a representative informed us that the Regional Office expects all behavioral health units to be able to handle a certain level of violence in a psychiatric patient.  If a complaint was ever brought about the rejection of a patient with a psychiatric emergency medical condition, the Regional Office would have its own psychiatrist review and determine whether the violence level of the patient exceeded the behavioral health unit’s capabilities and resources.  If the Regional Office psychiatrist felt that the behavioral health unit could have managed the patient, there would be an EMTALA violation.

Notwithstanding the EMTALA implications of the situation, the most important consideration is the safety of the staff of the hospital and the patient.  A more proactive approach might be useful in which representatives from the hospital (including its security staff) sit down to discuss a method to handle violent patients in general.  The development of this method may be assisted by involving the local police, especially if the circumstances involve a patient or patients who have been assaultive in the past and/or have threatened to assault hospital staff in the future.

This is a very difficult issue, but a well-defined plan or policy that includes input from all those potentially involved would help in understanding the issue, achieving buy-in, complying with the law, and, most importantly, protecting staff and patients.

For more information on this topic, join Susan Lapenta and Phil Zarone on November 7, 2017 for the On-Call and EMTALA Policies audio conference (part of the Horty, Springer & Mattern Grand Rounds audio conference series).

September 21, 2017

Posted on by hortyspringer

QUESTION:        We’re trying to create a standardized job description for surgical assistants.  Are there any uniform standards or best practices we should follow?

ANSWER:            The most important thing to keep in mind is that surgical assistants may differ dramatically in terms of their education and skill set.  Even the term “surgical assistant” can cover a wide range of different practitioners.

In almost all cases, you will need to grant clinical privileges to surgical assistants.  The Centers for Medicare & Medicaid Services (“CMS”) mandates that hospitals delineate privileges for all practitioners who perform surgical tasks.  This includes practitioners who perform surgical tasks under the supervision of an M.D. or D.O.  (If you are Joint Commission-accredited, you will also need to conduct appropriate professional practice evaluations to confirm competence.)  You will also need to check your state law.  In most states, the surgical assistant profession is not directly regulated.  Others, like Texas, have instituted a licensure process for surgical assistants.

When you are dealing with new applicants for the surgical assistant position, it’s advisable to do some research on their education and training.  Some surgical assistant training programs can be completed within four months.  Others last for two years.  In some programs, almost all of the coursework is taught online and then supplemented by a brief period of hands-on training.  Other programs subject students to an extensive clinical training phase that lasts nearly a year.

If your hospital’s policies and culture allow surgical assistants to play a significant role and to perform significant surgical tasks, it’s advisable to set a high bar in your credentialing and privileging process.  Look for experienced candidates from high-quality programs with extensive, hands-on clinical training.  If the person is certified, inquire about the general requirements for certification.

If you have the resources, consider appointing a task force of interested individuals.  The task force can do research on different educational programs, different kinds of program accreditation, and different types of surgical assistant certification.  The information can then be assembled into a chart for easy comparison.  We also recommend that you seek input from surgeons at neighboring institutions to see whether they have any preferences, recommendations, or cautionary tales to share.  The task force would eventually make a report to your Credentials Committee, Allied Health Professionals Committee, or Committee on Interdisciplinary Practice (as appropriate).

Ultimately, it is important to err on the side of caution.  Although surgical assistants will be supervised by the surgeon, it is important to build in additional safeguards to catch problem applicants before they see a patient.  Strong credentialing and privileging standards will help your surgeons build a team of assistants that they can rely on, and will further strengthen the quality of care at your institution.

September 14, 2017

Posted on by HSMAdmin

QUESTION:        We just discovered that several leases between the hospital and physicians who are active members of our medical staff expired several years ago without being renewed in writing.  We understand that the Stark Law requires a written lease.  Do we have any alternative other than a self-disclosure?

ANSWER:           Yes.  On November 16, 2015, CMS provided some much needed relief from technical violations of the Stark Law such as the one that you have described.

The first thing that you must determine is that a lack of a writing is the only problem that you have.  Therefore, you need to document that each lease complied with the other requirements of the Stark rental of office space exception, especially that at all times the rent that was paid by each physician constituted fair market value, commercially reasonable rent that did not take into account or vary based on any referrals or other business generated by the physicians.

If so, then you should be aware that in the November 16, 2015 Federal Register, CMS stated that it has received numerous submissions similar to your question that related to potential violations caused by the writing requirement, including the “…failure to renew an arrangement that expired on its own terms after at least 1 year.”  80 FR 71314.

CMS then clarified the writing requirement, provided policy guidance, and also provided illustrative examples of the writing requirement, including “checks issued for items, services or rent” (80 FR 71316).  (Emphasis added.)  In all likelihood, each month each physician paid the physician’s rent with a check that was in writing and signed by each physician, and each month the hospital endorsed and deposited those checks.  If the rent was deposited electronically, then the Uniform Electronic Transaction Act will give an electronic transfer of funds the same force and effect as a written check.

Those rent checks/electronic transfers of rent will be found to constitute “contemporaneous documents (that is, documents that are contemporaneous with the arrangement) [that] would permit a reasonable person to verify compliance with the applicable exception at the time that a referral is made” (80 FR 71315) and, as such, satisfied the writing requirement set forth in 42 C.F.R. §411.357(a).

Since this is a policy clarification and not a new regulation, the fact that the leases expired prior to the date of the CMS guidance does not prohibit you from applying this guidance to your situation, even if those expired leases predate that guidance.

If the leases expired after January 1, 2016, then you can take advantage of a change to the Stark Rental of Office Space exception that went into effect on January 1, 2016, which provides that the lease will continue to comply with the Stark exception so long as the lease continues to satisfy the other requirements of the exception.  (See 42 C.F.R. §411.357(a)(7).

September 7, 2017

Posted on by hortyspringer

QUESTION:        I heard that CMS is planning to cancel its upcoming episode payment models.  Is this true?

ANSWER:            Yes.  In mid-August, CMS issued a proposed rule that would cancel its upcoming episode payment models (“EPMs”) and cardiac rehabilitation incentive payment model.  The rule also proposed revisions to the existing Comprehensive Care for Joint Replacement model (“CJR program”).  This proposal marks a significant change of course for the agency’s regulatory agenda, given that CMS had previously expressed an intent only to delay these models, not cancel them outright.

The upcoming EPMs would have affected Medicare beneficiaries undergoing services related to acute myocardial infarctions, coronary artery bypass grafts, and surgical hip/femur fracture treatment.  The rule has not been finalized, so the ultimate fate of these payment models remains uncertain.  CMS will continue to accept comments (as part of the standard notice and comment rulemaking process) on this proposal until October 16, 2017.

If the proposed rule is finalized, it will also give hospitals participating in the CJR program a one-time opportunity to exit the program.  This is likely the beginning of a future trend away from mandatory payment models (such as the CJR program) in favor of voluntary value-based payment programs.

We continue to recommend that you build flexibility into your planning processes to account for this uncertainty in CMS’s rulemaking activities.

The proposed rule is available here.

July 13, 2017

Posted on by hortyspringer

QUESTION:        I heard that CMS is planning to introduce new episode payment models.  When will these take effect?

ANSWER:            As many of you know, CMS has spent the past several years trying to move away from traditional fee-for-service medicine.  Some of you are likely already participating in the Comprehensive Care for Joint Replacement model, which provides value-based payment for certain types of lower extremity joint replacement procedures.  CMS has recently finalized new policies to implement three new episode payment models (“EPMs”).  The EPMs will apply to Medicare beneficiaries undergoing services related to acute myocardial infarctions (the “AMI model”), coronary artery bypass grafts (the “CABG model”), and surgical hip/femur fracture treatment (the “SHFFT model”).

In the spring of this year, CMS publicized its intent to delay the effective date of these three EPMs.  CMS explained that it agreed with commentators who had asked for more time to prepare for this new payment structure.  CMS also reasoned that the delay would give the agency more time to make modifications, if necessary.  Consequently, the effective date of the AMI model, CABG model, and SHFFT model has been delayed until January 1, 2018.

In addition to these three EPMs, there will also be a cardiac rehabilitation incentive payment model.  This is designed to reduce hospitalizations and preserve medical resources by encouraging affected beneficiaries to take advantage of cardiac rehabilitation.  CMS reasoned that it would be confusing and operationally challenging to implement this cardiac rehabilitation model in 2017.  For ease of implementation, it delayed the cardiac rehabilitation model to January 1, 2018 as well.

Although CMS has expressed a firm intent to proceed with the planned EPMs and cardiac rehabilitation model, it is possible that the agency will make significant further changes before 2018.  We recommend that you build some flexibility into your planning process to account for this uncertainty.

January 26, 2017

Posted on by hortyspringer

QUESTION:        An applicant for reappointment has requested privileges that he has not performed for many years (and he doesn’t perform them anywhere).  Can we deny the request?

ANSWER:           The D word is not the best answer; why not approach it by developing eligibility criteria for core and special privileges?  A determination of ineligibility is not an adverse professional review action, and so is not reportable.  CMS requires that hospitals consider evidence of current competence in granting and renewing privileges.  What is “current”?  For many procedures and practice areas, there is a recognized correlation between proficiency and performance.  A two-year reappointment cycle is a logical period, except perhaps for procedures that are very rarely done (but it may be vital to maintain privileges for those unusual occasions where a patient can’t be transferred in time to help).

Join us for our Grand Rounds audio conference on Feb. 7 when we address how you can design policies to help handle a number of privileging dilemmas.