Question Of The Week

August 13, 2020

Posted on by hortyspringer

QUESTION:          Are you aware of anything new on the Proposed Stark Rules and Anti-Kickback Safe Harbors?  If they are adopted now, is there anything that could affect those rules from going into effect?

 

ANSWER:           The answer to both of your questions is yes.

You are referring to the proposed regulations to the Stark Law and the proposed safe harbor regulations to the Medicare Anti-Kickback Statute that were proposed on October 17, 2019.  The notice and comment period for these rules ended on December 31, 2019 (click the links below to read our comments on these rules).

Comments on Proposed Safe Harbor Regulations (File Code OIG-0936-AA10P)

Comments on Proposed Regulations to the Physician Self-Referral Law (File Code CMS-1720-P)

Supplement to Comments on Proposed Regulations to the Physician Self-Referral Law (File Code CMS-1720-P)

While the rules have not been published in final form, according to a July 21, 2020 posting by the Office of Management and Budget, those regulations are under review by OMB and it is our understanding that these rules remain a high priority for CMS.

The proposed rules provide practical, realistic guidance for compliance with both the Stark law and the Medicare Anti-Kickback Statute.  It is our hope that both sets of regulations are published in final form in much the same form as proposed.

But here is where life gets complicated.  Due to a provision in a little known law called the Congressional Review Act (“CRA”) and the upcoming Presidential, House and Senate elections, publication of those rules in final form at this late date in the Trump administration may not be enough for them to remain in effect.

The CRA was enacted in 1996.  The provision in the CRA to keep an eye on is the section of the CRA that applies to regulations that are published within 60 legislative days of the end of a presidential term (which has long passed).

The CRA requires regulatory agencies to submit their rules, regulations, and guidance documents to Congress before they can officially take effect.  Congress has 60 legislative days to review a rule.  If Congress does nothing, then the rule takes effect.  However, if a simple majority in the House and the Senate (filibuster rules do not apply) do not like the rule/regulation/guidance, they can issue a “resolution of disapproval.”  Once the “resolution of disapproval has passed, unless it is vetoed by the President, the rule/regulation/guidance document is dead.

It is important to note that as a practical matter, the CRA will only be relevant if there is a change in the President, the Democrats hold the House and the Democrats flip the senate.  If that does not occur, then it will be virtually impossible to get the votes necessary for the CRA to apply.

Prior to the Trump Administration, the CRA was only used once.  However, after President Trump was elected and the Republicans held a majority in the House and Senate, the CRA was used 14 times to invalidate Obama/Biden Administration enacted rules.  It will be interesting to see if the Democrats will do the same if they are given the chance and whether the Stark rules and/or the Safe Harbor regulations will be a victim of the CRA.

August 6, 2020

Posted on by hortyspringer

QUESTION:        I heard that CMS has proposed to extend some of the new telehealth flexibilities.  Can you provide a little more information on this?

ANSWER:            On Tuesday morning, the Centers for Medicare & Medicaid Services (“CMS”) submitted a proposed rule regarding revisions to payment policies under the Physician Fee Schedule.  This proposed rule is available for public inspection in the Federal Register and is scheduled for publication on August 17th, 2020.  The proposed rule addresses a wide range of topics.  Among other things, CMS has proposed adding certain services to the Medicare Telehealth Services list permanently and has suggested that certain flexibilities will remain in place through the calendar year in which the public health emergency ends.  Furthermore, CMS has expressed a willingness to solicit and use input from practitioners to determine whether further permanent changes should be made to the Medicare telehealth services list.

In the proposed rule, CMS noted that it had received a significant number of requests to add physical therapy, occupational therapy, and speech-language pathology services to the Medicare telehealth services list permanently.  The agency explained that even though there are waivers in effect during the current public health emergency, its authority would be limited to some degree by statute.

CMS also reiterated its policy that telehealth rules do not apply when the beneficiary and the practitioner are in the same location, even if audio-visual technology assists in furnishing a service.  This was done in response to a number of questions about whether services should be reported as telehealth when the individual physician or practitioner furnishing the services is in the same location as the beneficiary.

In addition, CMS addressed questions about payment for audio-only telehealth services.  The agency explained that it was also limited in this area by statutory requirements relating to telehealth services (which typically require an interactive telecommunications system that includes two-way, audio-visual communication technology).  The agency noted its willingness to explore other potential improvements, and invited comment on certain kinds of telephone-only check in services.

Notably, this is only a brief overview of some of the changes included in the proposal.  It is important to emphasize that these policies are not yet finalized and may change significantly in the following weeks.  Nevertheless, the proposed rule does indicate that the agency is focusing its attention on making certain telehealth flexibilities permanent, to the extent its authority will allow.  For a fact sheet that discusses the proposed rule, click here.  To review the full proposed rule, click here.

July 30, 2020

Posted on by hortyspringer

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QUESTION:        We recently received a request, from one of the Physician Assistants in our organization, asking that the Medical Staff Bylaws be amended to allow advanced practice clinicians (Nurse Practitioners, CRNAs, and Physician Assistants) to be members of the Medical Staff and to serve on committees, including the Credentials Committee and the Peer Review Committee.  Can you tell us what you are seeing around the country in these areas?

 

ANSWER:           There has been significant change around the role and responsibilities of advanced practice providers.  We can start with the terms that have been used to describe this group.  In the past, these practitioners were referred to as “physician extenders,” “mid-levels” or “allied health practitioners.”  Now, many organizations use the term “advanced practice professionals” or “advanced practice clinicians.”

Historically, any reference to “physician extenders” or “mid-levels” in the Bylaws was limited to a paragraph or two tucked away at the back of the document.  As the accreditation organizations began to require that these practitioners be credentialed and privileged through the medical staff or related process, many hospitals created parallel policies but still treated allied health practitioners as separate from the Medical Staff.

As advanced practice clinicians have become more integrated into the delivery of care in hospitals and integral to that care, we have seen their roles and responsibilities on the Medical Staff change.  Some Medical Staffs have created an Advanced Practice Clinician Staff that is not a category of the Medical Staff but is included in the Bylaws and addresses the prerogatives and responsibilities of these practitioners.

A small number of Medical Staffs, usually in critical access hospitals, have simply incorporated advanced practice clinicians into their existing Medical Staff categories.  More recently, in Bylaws that we draft, we include an Advanced Practice Clinician Staff as a category of the Medical Staff; however, much like the Courtesy Staff or Consulting Staff, the Advanced Practice Clinician Staff has limited prerogatives and responsibilities.

Another easy step towards inclusion is to allow advanced practice clinicians to be appointed to committees.  This will allow advanced practice clinicians the opportunity to participate in medical staff affairs in a meaningful way and to develop valuable leadership skills.

Since the number of advanced practice clinicians continues to grow, their training continues to evolve,  and their scope of practice continues to expand, creating an Advanced Practice Clinical Committee (staffed by both advanced practice clinicians and physicians) or adding advanced practice clinicians to the Credentials Committee could give your organization a leg up on these challenging issues.

Similarly, since hospitals must evaluate the clinical performance of advanced practice clinicians through the peer review process initially, on an ongoing basis, and when questions are raised, fostering the development of advanced practice clinicians so they can participate in this process makes a lot of sense.  Training advanced practice clinicians to perform case reviews and inviting advanced practice clinicians to serve on the Peer Review Committee are important discussion points.

Some Medical Staffs have decided to include an advanced practice clinician as a member of the Medical Executive Committee (with or without vote).  Identifying the right person to serve in this role is very important and that’s why it may be worth vesting this power in the Chief of Staff or the Medical Executive Committee.

In addition to serving on committees, advanced practice clinicians can be invited to attend department meetings and meetings of the Medical Staff.   In the organizations that we work with, typically, this participation is without the right to vote.

The bottom line is that these are important issues to discuss because they are not going away.  Before you make any changes to your bylaws, however, be sure to check state law.  Some states, like Pennsylvania, limit the Medical Staff to physicians and dentists, unless an exception is granted by the Department of Health.

Additionally, there are some limitations reflected in the CMS Interpretative Guidelines in terms of the Chief of Staff position; this position must be filled by an MD, DO, or, if permitted by State law, “a doctor of dental surgery, dental medicine, or podiatric medicine.”  With respect to the composition of the Medical Executive Committee, the Interpretative Guidelines say that a majority of the members must be MDs or DOs.

July 23, 2020

Posted on by hortyspringer

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QUESTION:        Our hospital recently addressed a HIPAA breach by a hospital employee.  Do we have any obligation to conduct a comprehensive review of that employee’s activities to see if there are any other HIPAA breaches?

 

ANSWER:            HIPAA doesn’t specifically require a hospital to conduct an audit or other type of review to determine if a person who committed one HIPAA breach may have committed other similar (or different) breaches.  However, a hospital’s efforts are important in two ways:

  1. The HIPAA breach notification rule says patients must be notified of a breach within 60 days of when the hospital knows of a breach, or within 60 days of when the hospital would have known of the breach if it had exercised “reasonable diligence.”
  2. HIPAA penalties are based on the action a hospital takes. If a hospital knows of a breach that may be part of a pattern but chooses not to look for other similar breaches, the hospital could be charged with “willful neglect” and penalized more severely.

The federal government has never said whether “reasonable diligence” means that a hospital must go back a certain amount of time or engage in certain types of activities.  Instead, the government has offered the following general guidance:

With respect to those commenters asking for guidance on what it means for a covered entity to be exercising reasonable diligence, we note that the term reasonable diligence, as defined in § 160.401, means the business care and prudence expected from a person seeking to satisfy a legal requirement under similar circumstances.  The determination of whether a person acted with reasonable diligence is generally a factual one, since what is reasonable depends on the circumstances.  Factors to be considered include whether a covered entity or business associate took reasonable steps to learn of breaches and whether there were indications of breaches that a person seeking to satisfy the Rule would have investigated under similar circumstances.  Covered entities and business associates may wish to look to how other covered entities and business associates operating under similar circumstances conduct themselves for a standard of practice.

78 Fed. Reg. 5566, 5647 (January 25, 2013).

July 16, 2020

Posted on by hortyspringer

QUESTION:        Our newly elected Chief of Staff is currently a department chair at our hospital.  She really likes the department chair position and is good at it.  At the same time, she also wants to fulfill the will of the Active Staff members who elected her to serve as the Chief of Staff.  Can she serve both positions at the same time?

ANSWER:            Serving in two leadership roles in the same hospital is not technically a conflict of interest, so unless there is a provision in the medical staff bylaws stating that an individual cannot serve in both roles, there is likely no technical reason that she cannot serve in both positions.  That said, practically speaking, it may not be the best idea.  Department chairs often have significant duties in terms of performing mentoring efforts and collegial counseling sessions with members of their departments in addition to their obligations to reviewing applicants for appointment and reappointment as well as service on the MEC.  In large clinical departments, these responsibilities can be quite intensive.  The Chief of Staff will generally be intimately involved in the active management of the most significant medical staff issues.  Combine those two sets of responsibilities and it is a lot for one person to do, and to do well.  In our experience, when department chairs or division chiefs are elected to serve as either the Vice Chief of Staff or the Chief of Staff, they have typically resigned the department chair/division chief position that they previously held.

July 9, 2020

Posted on by hortyspringer

QUESTION:        We’ve had some debate over who can order therapeutic diets.  Can you help explain the rules on this issue?

 

ANSWER:            Historically, CMS has restricted the ability to order therapeutic diets to “practitioners responsible for the care of the patient.”  This generally meant physicians.  However, CMS changed its position on this matter in its Final Rule dated May 12, 2014 by revising 42 C.F.R. §482.28(b)(2) to read “All patient diets, including therapeutic diets, must be ordered by a practitioner responsible for the care of the patient, or by a qualified dietician or qualified nutrition professional as authorized by the medical staff and in accordance with State law governing dieticians and nutrition professionals.” (Emphasis added.)

This change came about largely in recognition of the fact that registered dietitians are trained to order patient diets independently, without requiring the approval or supervision of a physician.  In order to give hospitals more flexibility in this area, CMS noted that “[i]n order for patients to have access to the timely nutritional care that can be provided by [registered dieticians], a hospital must have the regulatory flexibility either to appoint [registered dieticians] to the medical staff and grant them specific nutritional ordering privileges or to authorize the ordering privileges without appointment to the medical staff, all through the hospital’s appropriate medical staff rules, regulations, and bylaws.”  This means that in order for a dietician to order patient diets independently, clinical privileges must be granted and monitored by the medical staff.

We have not seen any medical staffs elect to make dieticians full members.  Instead, the most common approach we have seen is to adopt a stand-alone policy that states that any requests for ordering privileges would be processed through the Medical Staff process, while the rest of the dietician’s practice would continue to be monitored through HR.

Of course, your state law may still limit a dietician’s scope of practice, so be aware of any restrictions at the state law level.

July 2, 2020

Posted on by hortyspringer

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QUESTION:        Our hospital received a couple of million dollars from the COVID-19 Provider Relief Fund.  We are in the process of being acquired by a larger health system.  Will we have to send the money back?

ANSWER:            It depends on the form of the acquisition.

HHS recently posted the following on its Provider Relief Fund FAQ Page:

If the transaction is a purchase of the recipient entity (e.g., a purchase of its stock or membership interests), then the Provider Relief Fund recipient may continue to use the funds, regardless of its new owner.  But if the transaction is an asset purchase (whether for some or all of the Provider Relief Fund recipient’s assets), then the original recipient must use the funds for its eligible expenses and lost revenues and return any unused funds to HHS.  In these circumstances, the Provider Relief Fund money does not transfer to the buyer, however, buyers in these circumstances will be eligible to apply for future Provider Relief Fund payments.  If a bankrupt recipient is liquidated, it must similarly use the funds for its eligible expenses and lost revenues and return any unused funds to HHS.

https://www.hhs.gov/coronavirus/cares-act-provider-relief-fund/faqs/index.html#pr-overview

June 25, 2020

Posted on by hortyspringer

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QUESTION:        Is it true that Barbara Blackmond is retiring?

 

ANSWER:           We are sad to say, but it is true.  After practicing at Horty, Springer & Mattern for over forty years, Barb is retiring.  Although, that’s great news for Barb and her family, it’s tough on the rest of us.  Fortunately, Barb was an amazing mentor and teacher.

There is no one quite like BB, but we are ready to carry on the work to which she was dedicated, in service of the clients for whom she was so very fond.  So feel free to call and ask for any of us.  We are delighted to be at your service.

And, best wishes to Barb on her retirement!

*****

June 18, 2020

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

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

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

June 11, 2020

Posted on by hortyspringer

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

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

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

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

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

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