Question Of The Week

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.

October 24, 2019

Posted on by hortyspringer

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

Posted on by hortyspringer

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 29, 2019
1:00 pm to 2:30 pm (ET)
Faculty:  Charles J. Chulack and Joshua A. Hodges

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October 10, 2019

Posted on by hortyspringer

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

Posted on by hortyspringer

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.

September 26, 2019

Posted on by hortyspringer

QUESTION:        Do the Medicare Secondary Payor rules apply to our freestanding ambulatory surgery center?

 

ANSWER:          Yes, they do.  All Medicare-participating providers are required to file claims with Medicare using billing information obtained from the beneficiary to whom the item or service is furnished and all entities seeking payment for any item or service furnished under Part B are to complete, on the basis of information obtained from the individual to whom the item or service is furnished, the portion of the claim form relating to the availability of other health insurance.  Thus, any providers (including ASCs) that bill Medicare for services rendered to Medicare beneficiaries (other than Medicare Advantage Plan members) must determine whether or not Medicare is the primary payor for those services.  This must be accomplished by asking Medicare beneficiaries, or their representatives, questions concerning the beneficiary’s MSP status.  If the provider fails to file correct and accurate claims with Medicare, and a mistaken payment situation is later found to exist, Medicare can recover its conditional or mistaken payments.  All providers are required to retain the information about secondary payors for 10 years.  The only difference between hospitals and other providers like ASCs is that hospitals are subject to regular audits by the MAC whereas other providers are not.

September 19, 2019

Posted on by hortyspringer

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QUESTION:        What is the significance of the CMS “Pathways to Success” program for ACOs in the Medicare Shared Savings Program?

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ANSWER:            At the end of 2018, the Centers for Medicare & Medicaid Services (“CMS”) redesigned the Medicare Shared Savings Program.  Although the Medicare Shared Savings Program had been in operation since 2012, it had failed to generate the kinds of cost savings that CMS hoped to manifest.  “Pathways to Success” was intended to accelerate the process of transitioning Accountable Care Organizations (“ACOs”) to performance-based risk models.

Among other things, the Pathways to Success program implemented certain kinds of “risk tracks” that offer different mixtures of risk and reward.  Each risk track balances factors such as the potential for financial rewards (in the form of shared savings), the risk of financial penalties (in the form of shared losses), and the opportunity to qualify as an Advanced Alternative Payment Model (which provides certain benefits for individuals subject to the MIPS program).

There are many different variables that govern an ACO’s performance and opportunities under the Shared Savings Program, which means that a full discussion of the program details falls well outside the scope of this article.  The key takeaway to understand is that Pathways to Success was designed to accelerate ACOs to take on higher levels of financial risk and responsibility.  This is yet another example of the ongoing federal effort to promote population health while simultaneously combating the growth of health care expenditures.

To learn more about the Medicare Shared Savings Program, click here.

 

September 12, 2019

Posted on by hortyspringer

QUESTION:        Our Bylaws state that all of the members of the Active Staff are required to provide call coverage for our ED.  Assuming that we only have two neurosurgeons who are able to cover the ED each month, does this mean they must take 15 days of call each?  Our physician leaders are telling us that this is a tremendous burden, but we do not want to violate EMTALA.

 

ANSWER:            A tough question, made even tougher by the fact that CMS has provided very little guidance on the reasonableness of hospital call schedules.  In fact, it has even denounced a common “rule of thumb” that many hospitals have decided to follow over the years.

We are referring to the “rule of three” approach, which is based on prior, informal guidance from CMS that said if there were three physicians in a particular clinical specialty on a medical staff, the hospital had the obligation to provide emergency services on a 24/7/365 basis for that specialty.  This has been extrapolated to mean that, in a specialty with fewer than three physicians (like in the question above), each physician should provide 10 days/month of call coverage.

But before you start revisiting your own On-Call Policy requirements, keep in mind that CMS never put this rule in writing and now denies it ever existed.  Instead, it uses a rather nebulous “all relevant” factors test to evaluate the reasonableness of a hospital’s call schedule.  This means that each hospital should consider factors like the number of physicians available to take call, other demands on these physicians, frequency of emergency cases in that specialty, etc. to determine its on-call schedule.

This may not be as helpful as a “rule of three” or “rule of five” approach that we still see some hospitals follow, but it is important to recognize CMS does not have a bright line rule that require 24/7/365-day coverage for each specialty, so there is some flexibility.

September 5, 2019

Posted on by hortyspringer

QUESTION:        How do we handle a situation when there is a physician on the Credentials Committee who is married to another physician, and the spouse’s application is up for consideration?

ANSWER:           Every so often we run across physician couples.  In those instances, there may be a situation in which the conflict of interest rules for credentialing or peer review activities are implicated.  For example, imagine that Dr. Wright is appointed to the Medical Staff, is recognized as having good leadership qualities, and is appointed to the Credentials Committee.  Then, his spouse applies for Medical Staff appointment.  The application comes before the Credentials Committee and Dr. Wright is told “You can’t vote on the application” but Dr. Wright insists on voting, because  “I know this applicant better than any other applicant that has been before this committee!”

Well, that may be so, but Dr. Wright can’t vote!  Going back to compliance training and basic conflict of interest rules, Dr. Wright has a conflict of interest regarding his spouse’s application.  He is emotionally involved in the outcome, and probably financially involved too.  Of course, Dr. Wright can provide any relevant information he may have regarding his spouse and can answer any questions the Credentials Committee may have about her.  But, after doing so, it’s prudent for him to leave the Credentials Committee meeting, and not participate in the discussion of his spouse’s credentials or the vote on the application.  Also, the minutes should reflect that he left the meeting, the vote occurring after he left, and his return to the meeting.

August 29, 2019

Posted on by hortyspringer

QUESTION:        Our Credentials Policy says that applicants for Medical Staff appointment and clinical privileges will be interviewed by the department chair, the Credentials Committee, the Medical Executive Committee, the Chief of Staff, the Chief Medical Officer or the Chief Executive Officer.  Is there really any benefit to performing an interview as a part of the credentialing process or should we just eliminate this language from our Policy?

 

ANSWER:            There certainly is some debate about the effectiveness of interviews in predicting future job performance.  However, much of the research indicates that unstructured job interviews are ineffective.  On the other hand, structured interviews are one of the most effective selection techniques.

In structured interviews, applicants are asked to respond to the same set of questions and their answers are rated on a standard scale.  Sounds complicated, right?  Not necessarily.  We understand that the development of a complex, standard scale for rating would involve the participation of experts; however, a common set of straightforward questions that are structured to elicit information about past behavior (as opposed to questions designed to elicit information about how an applicant would respond in a hypothetical situation) and that are relevant to Medical Staff appointment, measured against a simple rating scale, can be useful.  This task shouldn’t be outside of the Credentials Committee’s wheelhouse.

There is always the risk of variability among interviewers, but this could be minimized by having at least two individuals conducting the interview, using the same scale but rating separately, and then comparing notes after the interview to reduce variability in rating.

Like we mentioned earlier, questions about past behavior are key because there is less opportunity for an applicant to provide a response that is not capable of being verified.  Interview questions can also elicit information about whether the applicant’s views and practice style are consistent with the medical staff and hospital’s culture.

For example:

Q:        What attracts you to this hospital/why are you interested in working here?

Q:        Tell us about a time in which a case of yours was reviewed through the peer review process and how you participated/responded.

Q:        Describe a situation in which you were asked to do something beyond your established responsibilities (e.g., service on medical staff committee, fill in a call coverage gap) and tell us how you responded.

Q:        Tell me about a time when you had a conflict with another physician and how you dealt with that conflict.

Q:        What role do you see the nursing staff playing in patient care in the hospital?

If interviewing every applicant simply isn’t an option because of time constraints, interviews should, at the very least, be conducted when there are questions or concerns about the applicant’s qualifications, experience, education, training, or other aspects of his or her practice that have been raised at any time during the review of the application.  Thus, rather than having a strict requirement that all applicants will be interviewed, you can adjust your Policy language to instruct that applicants may be interviewed.