CMS

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 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 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.

July 18, 2019

Posted on by hortyspringer

QUESTION:              If we allow registered dieticians (“RDs”) to order therapeutic diets, do we have to grant them privileges through the Medical Staff?

ANSWER:                 Yes, you do according to CMS.  This is based on a change made in 2014.  Traditionally, CMS restricted the ability to order therapeutic diets to “practitioners responsible for the care of the patient.”  However, in its Final Rule dated May 12, 2014, CMS changed its position on this matter and revised 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.

CMS went on to explain the rationale for this change in the Final Rule as follows:

In order for patients to have access to the timely nutritional care that can be provided by RDs, a hospital must have the regulatory flexibility either to appoint RDs 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.  In either instance, medical staff oversight of RDs and their ordering privileges would be ensured.  Therefore, we proposed revisions to §482.28(b)(1) and (2) that would require that individual patient nutritional needs be met in accordance with recognized dietary practices.  We would make further revisions that would allow for flexibility in this area by requiring that all patient diets, including therapeutic diets, must be ordered by a practitioner responsible for the care of the patient, or by a qualified dietitian or other clinically qualified nutrition professional as authorized by the medical staff and in accordance with State law.  We believe that hospitals that choose to grant these specific ordering privileges to RDs may achieve a higher quality of care for their patients by allowing these professionals to fully and efficiently function as important members of the hospital patient care team in the role for which they were trained.  In the proposed rule, we stated that we believe hospitals would realize significant cost savings in many of the areas affected by nutritional care.

However, not all states allow for this type of flexibility.  For example, in our home state, Section 111.27 of the Pennsylvania Code states that therapeutic diets must be prescribed by a physician.  Accordingly, any hospital that wants to allow RDs to practice in this manner must first obtain an exception from the Pennsylvania Department of Health in order to implement the approach outlined in the new CMS Final Rule.

Also keep in mind that allowing RDs to practice in this way is not required; rather, it is at the discretion of each individual hospital, as explained in a series of responses to comments in the Final Rule:

Comment: Another commenter asked for clarification on whether the proposed requirement only provides a hospital with the option of credentialing and privileging a dietitian.

Response: The requirement, including the revisions we are finalizing here, does not require hospitals to credential and privilege dietitians as a condition of participation, but, as previously stated, allows for it as an option if consistent with State law.

Comment: A few commenters stated that they were concerned about ordering diets for critically ill patients or making specific patients “NPO.” They further state that they would feel comfortable ordering diets only if there was a “‘diet order per dietitian’ order from the doctor.”

Response: As we have stated, the requirement does not require dietitians and nutrition professionals to order diets, but only allows for it as an option if consistent with State law and if a hospital chooses to grant such privileges after considering the recommendations of its medical staff.  An individual dietitian or nutrition professional would then need to apply for these ordering privileges.

May 30, 2019

Posted on by hortyspringer

QUESTION:        We have some advanced practice nurses and physician’s assistants who are lobbying to become members of the Medical Staff.  Some physicians support the idea, but others aren’t so sure.  What are you seeing out there?

ANSWER:             In our experience, most Medical Staffs are composed of physicians, dentists, oral surgeons and, increasingly, podiatrists.  In some states, it is required that others be appointed to the staff, such as psychologists in Ohio.  State laws still vary. For example, in Pennsylvania, a hospital wanting to include podiatrists must seek an exception from the Department of Health, but it is readily granted.

As CMS has amended the Conditions of Participation and Interpretive Guidelines in recent years, the door has been opened:

§482.22(a) Standard: Eligibility and Process for Appointment to Medical Staff

The medical staff must be composed of doctors of medicine or osteopathy. In accordance with State law, including scope-of-practice laws, the medical staff may also include other categories of physicians (as listed at §482.12(c)(1)) and non-physician practitioners who are determined to be eligible for appointment by the governing body.

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Interpretive Guidelines §482.22(a) The hospital’s governing body has the responsibility, consistent with State law, including scope-of-practice laws, to determine which types/categories of physicians and, if it so chooses, non-physician practitioners or other licensed healthcare professionals (collectively referred to in this guidance as “practitioners”) may be privileged to provide care to hospital patients.  All practitioners who require privileges in order to furnish care to hospital patients must be evaluated under the hospital’s medical staff privileging system before the hospital’s governing body may grant them privileges.  All practitioners granted medical staff privileges must function under the bylaws, regulations and rules of the hospital’s medical staff.  The privileges granted to an individual practitioner must be consistent with State scope-of-practice laws.

CMS provided the following statement in 2014:

For Information Only – Not Required/Not to be Cited

CMS expects that all practitioners granted privileges are also appointed as members of the medical staff.  However, if State law limits the composition of the hospital’s medical staff to certain categories of practitioners, e.g., only physician practitioners, there is nothing in the CoPs that prohibits hospitals and their medical staffs from establishing certain practice privileges for those specific categories of non-physician practitioners excluded from medical staff membership under State law, or from granting those privileges to individual practitioners in those categories, as long as such privileges are recommended by the medical staff, approved by the governing body, and in accordance with State law.  (79 FR 27114-27115, May 12, 2014)

Today, it is becoming more common for a category to be added to the Bylaws for Advanced Practice Clinicians, and APCs may serve on committees with vote.

Join Barbara Blackmond and Josh Hodges for the next Grand Rounds audio conference on June 4, “Q&A on Advanced Practice Clinicians,” where they will discuss practical issues, including credentialing, privileging, peer review, collaborative practice in states allowing independent practice for some APCs, the role in emergency call, hearing rights and emerging issues, such as the role of APCs in admission, discharge, and  consults.

 

January 24, 2019

Posted on by hortyspringer

QUESTION:        Is there anything new on physician retention arrangements?

 

ANSWER:            Unfortunately, no.  However, we have asked both the OIG and CMS to consider updating their respective positions on physician retention arrangements in response to the OIG’s and CMS’s requests for information on whether the Antikickback Statute and/or the Stark Law are creating barriers to improving quality care and achieving clinical and/or financial integration.

We urged CMS to consider changes to its exception for physician retention arrangements, 42 C.F.R. § 411.357(t), that will permit any hospital, regardless of its location, to use this exception and not limit this exception to instances where there is a firm, written recruitment offer.

There is no rational basis or business justification to continue to limit this exception to hospitals that are located in a rural area or HPSA (42 C.F.R. § 411.357(t)(3)(i)(A)) or where the physician’s patients reside in a medically underserved area or are members of a medically underserved population (42 C.F.R. § 411.357(t)(3)(i)(B)).

In our experience, hospitals, regardless of their location, would benefit from the ability to assist a physician in an existing independent practice to remain independent.  We are aware of clients that have been approached by a group of physicians who want to remain independent.  However, between the charity care they provide, their Medicaid patient population, and the amounts that were being paid to the physicians by Medicaid, Medicare and other third-party payors for their professional services, the group could not generate a sufficient amount of professional reimbursement to allow the group to compensate the physicians at a reasonable fair market rate and precluded the group from expanding the practice even though there was a need for additional physician services.

The hospital could have employed the physicians.  However, the physicians preferred to remain independent and the hospital determined that it would lose more money if the hospital employed the physicians than it would if the hospital provided a guarantee-like payment that would allow the physicians to remain independent.  While such a compensation arrangement might be able to be structured to comply with the Anti-Kickback Statute, there is no safe harbor that will protect such a retention arrangement.  Of greater concern is that currently there is no exception to the Stark Law that would permit this type of retention assistance in most hospitals.

One of the other problems with the Stark retention exception is that a hospital must wait until a physician has a written offer from a third party before it can offer retention assistance.  42 C.F.R. §411.357(t)(2).  By the time a physician has such a firm, written offer, he/she has often decided to leave the area and the permitted retention benefit is of little practical benefit.  We urged CMS to change the exception so that any hospital will be permitted to be proactive and has the ability to offer retention assistance to independent practicing physicians as long as the hospital has a good faith belief that the community served by the hospital would benefit from retention assistance, the amount of the financial assistance is reasonable, and the compensation arrangement complies with the other requirements set forth in this exception.

Whether CMS or the OIG listens to these concerns remains to be seen.

January 17, 2019

Posted on by hortyspringer

QUESTION:       We recently learned that the medical board investigated one of our medical staff members after a patient called the hospital to request a copy of her medical records and, while doing so, informed our patient experience liaison that she had filed a complaint with the state board.  A little fact-gathering revealed that the board’s investigation was closed.  The practitioner showed us a letter from the board thanking him for his cooperation and informing him that the board was unable to substantiate the complaint.  What comes next for the hospital?  Do we just make a copy of the letter and put it in the practitioner’s file?  Since he was exonerated, do we even need to do that?

 

ANSWER:           It’s disappointing to learn AFTER THE FACT that one of your doctors has been under investigation by the state board, CMS, or any other government agency.  Many hospital and medical staff leaders may be hesitant to make “a big deal” about a failure to notify in a situation where, as here, the member provides evidence showing that the investigation went nowhere.

But, as usual, how you respond to information about the state board’s investigation of a medical staff member should depend on what your Medical Staff Bylaws and related documents say.  Do they require members to notify you if they are under investigation?  When?  Within a certain time frame?  Is failure to notify excused when the underlying matter has been closed with no “adverse” action by the regulatory body?  Obviously, it does not serve the interest of patient safety to require notification of investigations only after the outcome is known to the member, since such a policy would prevent the hospital and medical staff leadership from taking precautionary steps to protect patients, the hospital, and other practitioners during the pendency of the investigation (if such precautions were determined to be necessary).

At this point, it makes sense to at least obtain a copy of the letter the physician produced to evidence the fact that the investigation was closed.  Note that the closure of an investigation by the board due to lack of substantiating evidence is not equivalent to exoneration.  Therefore, hospital and medical staff leaders should at least consider whether any additional information should be requested from the physician (e.g., correspondence between the physician and/or his attorney and the state board regarding this matter) or directly from the state board.

Provided that the Medical Staff Bylaws or Credentials Policy required the physician to notify you of the investigation earlier, it also makes sense to refer this instance of non-compliance into the professional practice evaluation process for further review under the medical staff’s professional practice evaluation policy (or Credentials Policy or other document outlining peer review procedures).  If the practitioner has a long history of failing to comply with the Bylaws and other requirements of hospital and medical staff policies, then a significant response to this event might be appropriate (e.g., a written reprimand or “last chance” performance improvement plan).  If the practitioner is generally compliant and his or her actions indicate that this was mere oversight or a one-time poor decision (e.g., perhaps a conscious decision not to provide notification, but based on the practitioner’s rational embarrassment about being investigated or based on incorrect legal advice telling him he was not required to report), the response may be less substantial (e.g., a collegial conversation).

In cases such as this, a lot depends on the facts.  But, what we know for sure is that ignoring an incident like this is never the right approach.  Consistent application of and reminder of policies – even when done collegially and without a punitive tone – helps to establish the expectations of the hospital and medical staff.

Finally, one could argue that too much of the lip service that is given to the topic of notification revolves around what’s required and what’s not.  Consider including in your policies and/or guidance documents language making it clear that the hospital and medical staff expect all ambiguities to be resolved in the favor of patient safety.  After all, patient safety is the first priority:

Applicants and practitioners are expected at all times to be forthcoming and truthful with respect to their initial and ongoing qualifications for Medical Staff membership and clinical privileges and any concerns that have been raised regarding the same.  The hospital and medical staff agree that complete information is of the utmost importance to the credentialing and professional practice evaluation processes and, in turn, to patient safety.  To that end, when in doubt about whether disclosure is required, applicants and practitioners are expected to err on the side of making a full disclosure to the Hospital and/or Medical Staff leadership, as set forth in the Medical Staff Bylaws and related hospital and medical staff policies.