CMS

August 11, 2022

Posted on by Courtney Patterson

QUESTION:
Our state Department of Health informed us that we are required to have cameras installed in our chemotherapy unit so that patients receiving treatment can be observed via a monitor at the nurses’ station. Since we will be recording patient care activity, do we need to post signs stating that cameras are in use?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY HALA MOUZAFFAR:
CMS’s Interpretive Guidelines to the Medicare COPs regarding physical privacy indicate that “audio/video monitoring (does not include recording) of patients in medical surgical or intensive-care type units would not be considered violating the patient’s privacy, as long as there exists a clinical need, the patient/patient’s representative is aware of the monitoring,” and the monitors or speakers are not visible or audible to visitors or the public.  However, “video recording of patients undergoing medical treatment requires the consent of the patient or his/her representative.”

If the hospital is only monitoring the patients via video and not creating a recording, the patients and their representatives only need to be “aware of the monitoring.” In that case, signs would satisfy the requirement and be an appropriate way to inform them that monitoring is occurring.  On the other hand, if a true “recording” will be made, then a more formal consent would be required by CMS.

It is also important to check state law in these circumstances, as most states have their own laws that govern audio and video recordings that could be applicable.

February 3, 2022

Posted on by Courtney Patterson

QUESTION:
What’s all this I hear about “appropriate use criteria” that Medicare will use to determine payment for outpatient imaging?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
The Protecting Access to Medicare Act of 2014 (a/k/a “PAMA”) established a new program to increase the rate of appropriate advanced diagnostic imaging services provided to Medicare beneficiaries.  Examples of such advanced imaging services include:  CT, PET and MRI scans.  Under this program, at the time a practitioner orders an advanced diagnostic imaging service for a Medicare beneficiary, he/she, or clinical staff acting under his/her direction, will be required to consult a qualified Clinical Decision Support Mechanism.  CDSMs are electronic portals through which appropriate use criteria can be accessed.

The program won’t go into effect until January 1, 2023 or the January 1 after the current public health emergency ends, whichever is later.  And it only applies to services in a physician’s office, hospital outpatient department (including the emergency department), an ambulatory surgical center or an independent diagnostic testing facility and whose claims are paid under the physician fee schedule, hospital outpatient prospective payment system or ambulatory surgical center payment system.  So (at least for now) it does NOT apply in critical access hospitals.

For more information, check out the CMS website.

November 18, 2021

Posted on by Courtney Patterson

QUESTION:
Our hospital has more than 100 employees.  Do we have to comply with both the OSHA vaccine mandate and the one issued by CMS?

OUR ANSWER FROM HORTYSPRINGER ATTORNEY DAN MULHOLLAND:
OSHA has issued two different Emergency Temporary Standards (“ETS”) that are the source of some confusion.  The first was issued on June 21, 2021.  It required that covered health care employers must develop and implement a COVID-19 plan to identify and control COVID-19 hazards in the workplace and implement requirements to reduce transmission of COVID-19 in their workplaces related to the following:  patient screening and management, standard and transmission-based precautions, personal protective equipment (facemasks, respirators), controls for aerosol-generating procedures, physical distancing of at least six feet when feasible, physical barriers, cleaning and disinfection, ventilation, health screening and medical management, training, anti-retaliation, recordkeeping, and reporting.  The June OSHA ETS encouraged but did not require vaccination by requiring employers to provide reasonable time and paid leave for employee vaccinations and any side effects.

In early November, OSHA issued a second emergency temporary standard requiring worker vaccinations for any employers (not just health care employers) with 100 or more employees or weekly testing for those who remain unvaccinated without an eligible exemption.  This ETS that was enjoined by the 5th Circuit Court of Appeals this past Friday, and the 5th Circuit  ordered that OSHA take no steps to implement or enforce the ETS until further court order.  CMS said it worked closely with OSHA to ensure that the November regulations of both agencies were complementary.

The FAQs issued with the CMS rule on November 5 contained the following guidance:

Q. Which rule is a given health care facility expected to follow – the CMS Omnibus Staff Vaccination Rule, the Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors, the OSHA COVID-19 Healthcare Emergency Temporary Standard, or the upcoming (or new) OSHA Emergency Temporary Standard?

A.  If a Medicare- or Medicaid-certified provider or supplier falls under the requirements of CMS’s Omnibus Staff Vaccination Rule, it should look to those requirements first. Health care facilities are generally subject to new federal vaccination requirements based on primacy.  If facilities participate in and are certified under the Medicare and Medicaid programs and are regulated by the CMS health and safety standards known as the Conditions of Participation 11 (CoPs), Conditions for Coverage (CfCs), and Requirements for Participation, then they are expected to abide by the requirements established in the CMS Omnibus Staff Vaccination Rule.  This rule takes priority above other federal vaccination requirements.  CMS’s oversight and enforcement will exclusively monitor and address compliance for the provisions outlined in the CMS Omnibus Staff Vaccination Rule, while also continuing to monitor for proper infection control procedures as established under previous regulations.  The OSHA COVID-19 Employer Emergency Temporary Standard (for facilities with greater than 100 employees) applies to employers that are not subject to the preceding two regulations.  Facilities should review the inclusion criterion for these regulations and comply with all applicable requirements.

Hospitals that participate in Medicare subject to the CMS’s Omnibus Staff Vaccination Rule which amended the Conditions of participation, so per this FAQ guidance hospitals are NOT subject to the November ETS which requires weekly testing for those who remain unvaccinated without an eligible exemption.  Therefore, testing is not an alternative for staff who have not been exempted from the CMS vax requirement to comply with the rule.

On the other hand, while testing is not a substitute for vaccinations under the CMS rule, hospitals are allowed to require testing of unvaccinated/exempt workforce members as a mitigation measure.  The CMS FAQs say:  “In granting such exemptions or accommodations, employers must ensure that they minimize the risk of transmission of COVID19 to at-risk individuals, in keeping with their obligation to protect the health and safety of patients” but this does not require testing.

CMS explained in the preamble to the regulation:  “we considered requiring daily or weekly testing of unvaccinated individuals.  We have reviewed scientific evidence on testing and found that vaccination is a more effective infection control measure.  As such, we chose not to require such testing for now but welcome comment.  Of course, nothing prevents a provider from exercising testing precautions voluntarily in addition to vaccination.”  86 Fed. Reg. 61614.

However, the September 2020 CMS emergency rule that established new requirements for Long Term Care facilities (nursing homes) to test facility residents and staff for COVID-19 is still in effect.  The new FAQs say:  “CMS expects continued compliance with this requirement.”

If you have a quick question about this, e-mail Dan Mulholland at dmulholland@hortyspringer.com

Also, listen to HortySpringer’s latest podcast on the CMS vaccine mandate here.

August 19, 2021

Posted on by Courtney Patterson

QUESTION:
“Sometimes people who come to our ED simply leave without telling anyone if they have to wait any length of time. Are we on the hook for an EMTALA violation when that occurs?”

ANSWER:
Generally, you are not.  EDs are busy places and individuals may have to wait for care behind others based on priority and other factors.  Some individuals may decide to leave and seek care elsewhere.  That, in and of itself, is not an EMTALA violation.  However, there are several instances where CMS has cited hospitals for “coercing” an individual to seek treatment at another facility.  This type of activity – whether done directly by telling the individual they would be better off going somewhere else, or indirectly by routinely keeping people in the ED waiting so long that they get frustrated and leave– could create risk for the hospital.

However, assuming those types of activities are not in play, the best thing to do when an individual leaves the ED without being seen is to document the individual’s departure as soon as it is discovered and keep any other documentation that may have been created based on any interactions with the individual before he or she left.

August 5, 2021

Posted on by Courtney Patterson

QUESTION:
“Can you provide a quick guide to the Stark Value-Based Exceptions?”

ANSWER:
While these Rules are difficult to summarize and the devil is in the details, the following is a summary of the Stark Value-Based Rules that became effective on January 19, 2021:

A Value-Based Arrangement is intended to compensate the physician Value‑Based Participants of a Value Based Enterprise for achieving the Value‑Based Purposes of the Value-Based Activity for a Target Patient Population, rather than basing that payment on the items or services furnished by the physicians.

CMS stated in the Preamble to the January 19, 2021 Rules that the anticipated benefits from the Value-Based Rules are to:  improve care coordination for patients; reduce cost to payers and patients from poorly coordinated, duplicative care; improve quality of care and outcomes; achieve substantial reduction in Stark Law compliance costs; and reduce administrative complexity and related waste.

Whether the Value-Based Rules will achieve any or all of these benefits remains to be seen.  What is clear is that the Value-Based Rules have requirements that are significantly different from the requirements in fee-for-service arrangements that were governed by the Stark Rules that have been previously in effect.  The Value-Based Rules have different requirements depending on the level of financial risk assumed by the physician Value-Based Participants.

The Stark exceptions for Value-Based Arrangements went into effect on January 19, 2021 and are found at § 411.357(aa)(1)-(3).  While each Value-Based Exception needs to be considered to determine which will apply,  there are several elements that all of the exceptions have in common: (i) the Value-Based Definitions found at 42 C.F.R. § 411.351; (ii) as the Value-Based Enterprise (“VBE”) and/or VBE participants increase the financial risk assumed, the applicable Stark Value‑Based Exception will allow for increased flexibility; (iii) the traditional definition of Fair Market Value is not required by any of the Stark Value-Based Rules; (iv) the remuneration to the VBE participants cannot constitute an inducement to limit services; (v) the remuneration to the VBE participants cannot be conditioned on the referral of patients who are not part of Target Patient Population; (vi) if remuneration is conditioned on referrals to a particular provider, then the referral arrangement must be in writing, signed by the parties, and must include the three exceptions contained in the Stark directed referral rules; and (vii) records of the compensation methodology used must be retained for six years and provided to HHS upon request.

The Stark Rules then categorize the Value-Based Exceptions based on the level of financial risk assumed with the greatest flexibility provided to a VBE that accepts Full Financial Risk which means the Value-Based Enterprise is responsible on a prospective basis for the cost of all patient care, items and services covered by the applicable payor for each patient in the Target Patient Population for a specified period of time (such as accepting capitation).

The next greatest amount of flexibility is permitted for Value-Based Arrangements with meaningful downside risk to the physicians.  Meaningful Downside Financial Risk requires the physicians to be responsible to repay or forego no less than 10% of the Total Value of the remuneration the physician receives under the Value-Based Arrangement.  Examples of this model provided by CMS in the Preamble to the January 19, 2021 Rules include:  a $50,000 payment, plus $25,000 for Value-Based Activities as long as the entire $25,000 is conditioned on achieving a specified Value-Based Activity for a Target Patient Population; and a $100,000 payment with a $20,000 withhold, so long as the withhold is only payable upon completing the Value-Based Activities for the Target Patient Population.

There is also a Value-Based Exception in which the Physicians are not placed at financial risk.  This is referred to in the regulations as the Value-Based Arrangements Exception, 42 C.F.R.  § 411.357(aa)(3).  This exception protects remuneration paid to the physician participants in the Value-Based Arrangement regardless of whether it is in cash or in kind.  However, due to the fact that the physicians are not at financial risk and are not required to be paid at Fair Market Value, this exception has the most detailed regulatory requirements of any of the Stark Value-Based Rules.

In addition to the terms described above, this exception requires that the Value-Based Arrangement must be set forth in writing that is signed by the parties and describes: (i) the Value‑Based Activities to be undertaken; (ii) how the Value-Based Activities are expected to further the Value‑Based Purposes of the Value-Based Enterprise; (iii) the target patient population; (iv) the type or nature of remuneration; (v) the methodology that is to be used to determine that remuneration; and (vi) the Outcome Measures against which remuneration is assessed.

CMS also requires that at least annually, or at least once if the arrangement is in effect for less than one year, the Outcome Measures must be monitored to determine: (i) whether the parties have provided the Value-Based Activities required by the Value-Based Arrangement; (ii) whether and how the continuation of the Value-Based Activities will further the Value-Based Purposes of the VBE; and (iii) the progress toward the attainment of the Outcome Measures against which the recipient of the remuneration will be assessed.

If this monitoring determines that the Value-Based Activity is not expected to further the Value‑Based Purposes of the VBE, then the VBE has two options in order to maintain compliance with the Stark Law:  (1) terminate the arrangement within 30 consecutive calendar days of the date of completion of the monitoring indicating that the Value-Based Activity was ineffective; or (2) modify the Arrangement to terminate the ineffective Value-Based Activity within 90 consecutive calendar days of completion of the monitoring and, if they choose, replace that Value-Based Activity with a different Value-Based Activity with prospective applicability.

While several differences exist between the Stark Value-Based Exceptions and the OIG Value‑Based Safe Harbors that also went into effect on January 19, 2021, this exception is the greatest point of departure from the OIG Value-Based Safe Harbors (42 C.F.R. § 1001.952(ee)-(kk)).  If a physician is not at financial risk, then the OIG Safe Harbors only protect in-kind remuneration.  (As stated above, the Stark exception protects remuneration in the form of cash or in-kind services.)  That said, payments of cash remuneration in a non-risk setting (such as a cost‑sharing arrangement) may be protected by the amended personal services and management contracts and outcomes-based arrangements safe harbor that was added by the January 19, 2021 Safe Harbor Regulations (see 42 C.F.R. § 1001.952(d)(2)).

July 1, 2021

Posted on by Courtney Patterson

QUESTION:   “In reference to the case in this week’s HLE, does EMTALA apply to inpatients?”

ANSWER:      The obligations under EMTALA do not apply to a hospital once a patient is admitted as an inpatient in good faith.

However, the issue in the Harmon case was whether the patient had been formally admitted as an inpatient or simply placed in observation. If it is ultimately determined that the patient had been admitted as an inpatient, then he will no longer have a claim under EMTALA, as the Hospital’s obligation to effectuate an appropriate transfer would have ended prior to his attempt to kill himself by jumping out of the car during the transfer to the other facility.

Conversely, if it is determined the patient was put into observation but not admitted as an inpatient, he will be free to pursue his EMTALA claim. This is because CMS has stated that such action does not end a hospital’s EMTALA obligations. This can be found in the Interpretive Guidelines, which state:

“Individuals who are placed in observation status are not inpatients, even if they occupy a bed overnight. Therefore, placement in an observation status of an individual who came to the hospital’s [emergency department] does not terminate the EMTALA obligations of that hospital or a recipient hospital toward the individual.” (Emphasis added)

TAG A-2411/C-2411, Rev. 191,07-19-19

The court in Harmon cites entries in the patient’s medical record that support both arguments (i.e., that the patient was admitted vs. put into observation), so it declined to make a finding on this factual question at this point in the litigation.

February 11, 2021

Posted on by jwilbert

QUESTION:        I hear that the new Stark regulations have a way that Stark violations can be corrected without penalty.  Is that so?

ANSWER:           Yes, within limits.  CMS has now given hospitals and doctors a new way to correct noncompliance with the Stark law without having to make a self-disclosure.  The regulations, which became effective on January 19, 2021, contain a new regulation at 42 CFR §411.357(h) that allows parties to a compensation arrangement to reconcile all discrepancies while a contract is in effect or up to 90 days after it terminates so long as after the reconciliation the arrangement fully complies with all elements of the applicable exception.

For example:  say a hospital contract with a medical director calls for payment at $140 per hour but the doctor is paid $150 per hour.  If $150 still is within FMV range, all that is necessary is to reflect that in amendment going forward.  If the amount actually paid exceeds fair market value, the contract can be amended to recoup payments in excess of FMV via an offset against amounts due in the future (e.g., a payroll deduction) while the relationship is in effect, but the entire amount of the excess must be recouped within 90 days after the contract ends.

CMS also said that not every error will cause a financial relationship to be out of compliance with Stark nor must every mistake or error be corrected in order to maintain compliance.  Administrative and operational errors that are identified and rectified in a timely manner will not cause a relationship to be out of compliance.  In addition, CMS said that not all transfers of remuneration create compensation arrangements.  Examples include mistaken payments that are never identified, theft, use of office space not in lease, use of equipment beyond the expiration of the lease term or slight deviation from written agreement such as a one-time incorrect rental payment.

This new option is a great alternative to resorting to the Stark self-disclosure protocol.  To learn more about it, stay tuned for an upcoming Health Law Expressions podcast, where Horty Springer attorneys Josh Hodges and Dan Mulholland will discuss this new rule, or e-mail them at jhodges@hortyspringer.com or dmulholland@hortyspringer.com.

 

January 21, 2021

Posted on by hortyspringer

QUESTION:        I’ve heard that the Centers for Medicare & Medicaid Services (“CMS”) has recently begun a new program called “Acute Hospital Care at Home.”  Can you explain more about this?  Is this related to the Hospitals without Walls initiative?

 

ANSWER:          The Acute Care Hospital at Home program builds upon Hospitals without Walls, which provided broad regulatory flexibility to allow hospitals to provide services in locations beyond their existing campus.  After considerable study and research, CMS determined that over 60 different acute conditions could be treated appropriately and safely in home settings with proper monitoring and treatment protocols.

Note that this is different from more traditional home health services.  Acute Hospital Care at Home is for beneficiaries who require acute inpatient admission to a hospital and who require at least daily rounding by a physician and a medical team monitoring their care needs on an ongoing basis.

In late November, there were six health systems who had received approval for new waivers under the program.  By mid-January, the program had expanded to include 88 hospitals across 24 different states.

To enter the program, hospitals must submit a waiver request to CMS.  There is an abbreviated process available, but most hospitals will be required to submit a detailed waiver request.  As part of this request, the hospital will need to show that it can provide or contract for services such as:

  • Pharmacy
  • Infusion
  • Respiratory Care (including oxygen delivery)
  • Diagnostics (labs, radiology)
  • Monitoring (with at least 2 sets of patient vitals daily)
  • Transportation
  • Food Services (including meal availability as needed by the patient)
  • Durable Medical Equipment
  • Physical, Occupational, and Speech Therapy
  • Social Work and Care Coordination

More information is available on the CMS website, including an FAQ document.  CMS also held a conference call on December 22, 2020, which explained further details of the program (transcript and recording available here).  We expect that more information will be made available in the near future as the program evolves.

November 5, 2020

Posted on by hortyspringer

QUESTION:        I know that the Centers for Medicare and Medicaid Services (“CMS”) have made certain regulatory flexibilities available in response to the public health emergency.  Where is the best place to learn more about these changes?

 

ANSWER:           CMS has made available a large amount of material relating to COVID-19 on its website, but it isn’t always easy to find a specific piece of information (or to know when something’s been recently updated).  Speaking generally, the best starting point for research is the agency’s “Current Emergencies” page, which you can find here.  It’s a bit overwhelming at first, but I would first suggest that you focus on the link that says:  “Get waiver & flexibility information.”  This will take you to a new page that lists “Waivers & flexibilities for health care providers.”  You can skim that list to look for items that may be relevant to your question.  I often scroll down to the “provider-specific fact sheets” when I am beginning my research.

Be careful of relying too heavily on any one document, unless it is crystal clear.  These guidance pages are being updated regularly, and we have encountered numerous situations where the information provided can be misleading or seriously incomplete.  Although it’s not always possible, it’s good if you can locate relevant material from a regulation.

If you have a question about a recent change to a policy, be aware that the agency may not yet have an answer for you.  Under these circumstances, it may be helpful to check this list of CMS podcast transcripts to look for recent updates.  The “CMS Office Hours” calls will often have transcripts that you can search.  (If you have the time, you can also call into one of the agency’s “Office Hours” calls directly.  Agency representatives make themselves available to answer questions related to the Medicare program.)

These online resources can be a helpful way to answer run-of-the-mill questions, but we would encourage you not to rely on them for more important matters.  In those cases, it’s best to seek legal counsel.

September 24, 2020

Posted on by hortyspringer

QUESTION:         May a physician be on-call for more than one hospital at the same time (take “simultaneous call”) or perform elective surgeries while on call?  If so, is that physician required to identify a specific back-up physician who will take calls at our hospital if the original physician is called to another hospital or is in the middle of an elective surgery when called by our hospital?

 

ANSWER:           CMS doesn’t specifically require that another physician be identified to take back-up call if the original on-call physician is performing elective surgery or is taking call at another hospital when the ED needs assistance.  Instead, CMS says that a “back-up plan” must be in place.  Per CMS, “some hospitals may employ the use of ‘jeopardy’ or back-up call schedules,” indicating that other hospitals may choose to not use back-up call schedules.  Here’s the full quote from the EMTALA Interpretive Guidelines (found in Appendix V of the Medicare State Operations Manual):

The [hospital’s] policies and procedures must also ensure that the hospital provides emergency services that meet the needs of an individual with an EMC [Emergency Medical Condition] if the hospital chooses to employ any of the on-call options permitted under the regulations, i.e., community call, simultaneous call, or elective procedures while on-call. In other words, there must be a back-up plan to these optional arrangements. For instance, some hospitals may employ the use of “jeopardy” or back-up call schedules to be used only under extreme circumstances. The hospital must be able to demonstrate that hospital staff is aware of and able to execute the back-up procedures.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_v_emerg.pdf

Of course, a hospital may decide that it’s On-Call Policy will not permit simultaneous call or elective surgeries while on call.  Or, a hospital’s policy may require on-call physicians to identify a specific individual to provide back-up coverage in such cases.  The key is to clearly identify the requirements in the hospital’s On-Call Policy.