Knowledge Base Category -

The first possible cases of a vaping related illness were reported to the CDC on August 1st, 2019. In response to reports of illness, the CDC, FDA, State and Local Health Departments, Clinical and Public Health Partners have been actively investigating a multi-state outbreak of lung injury associated with use of e-cigarettes, or vaping, products. The vaping related illness has been named EVALI (E-cigarette, or Vaping, Product Use-Associated Lung Injury). Information for the Public, Health Care Providers, and Health Departments is available on the CDC webpage Outbreak of Lung Injury Associated with E-Cigarette Use, or Vaping.

CDC Weekly EVALI Updates

Currently information about EVALI is being updated on this CDC webpage every Thursday. The following table recaps information made available over the last three weeks:

‍

• What the CDC Knows: About Patient Exposure
• All EVALI patients have reported history of using e-cigarette, or vaping, products.
• THC is present in most of the samples tested by the FDA to date, and most patients report a history of using THC-containing products.
• Findings suggest products containing THC, particularly when obtained off the street or informal sources, are linked to the most cases and play a major role in the outbreak.

• What the CDC Does Not Know:
• The FDA and CDC has not identified the cause(s) of lung injuries in these 1,479 cases. The only commonality is patient’s reporting e-cigarettes, or vaping, products.
• No one compound or ingredient has emerged as the cause of these illnesses.
• The specific chemical exposure(s) causing lung injuries associated with e-cigarette product use, or vaping, remains unknown.

• What the CDC is Recommending You Should NOT do:
• Use e-cigarette, or vaping, products containing THC.
• Buy any e-cigarette, or vaping, products off the street – particularly those containing THC
• Modify or add any substances to e-cigarettes, or vaping, products that are not intended by the manufacturer, including products purchased through retail establishments.

• What the CDC is Recommending You Should do:
• The CDC recommends considering refraining from use of all e-cigarette and vaping products. If you do not choose to refrain from use, they go on to advise careful monitoring of yourself for symptoms and to see a healthcare provider immediately if you develop the following symptoms that have been reported in this outbreak:
• Cough, shortness of breath, or chest pain,
• Nausea, vomiting, abdominal pain or diarrhea,
• Fever, chills, or weight loss.

Update: Interim Guidance for Health Care Providers Evaluating and Caring for Patients with Suspected EVALI

On October 17th, a Clinician Outreach and Communication Activity (COCA) Webinar was held to discuss what the CDC has learned to date about EVALI and explain their updated interim guidance for healthcare providers. Following is a list of commonalties related to EVALI shared during the webinar:  

Common Clinical Characteristics of Patients as of October 3, 2019:

• 95% of patients initially experienced respiratory symptoms (e.g., cough, chest pain, and shortness of breath).
• 77% of patients had gastrointestinal (GI) symptoms (e.g., abdominal pain, nausea, vomiting and diarrhea). Note, GI symptoms preceded respiratory symptoms in some patients.
• 85% of patients had symptoms accompanied by constitutional symptoms (e.g., fever, chills, and weight loss).
• Vital Signs in cases of EVALI reported to the CDC included:
• 55% had tachycardia (HR>100 beats/min),
• 45% had tachypnea (respiratory rate >20 breaths/min), and
• 57% has an O2 saturation <95% at rest on room air.
• Pulmonary findings in cases of EVALI reported to the CDC were that on auscultation the exam has been unremarkable, even among patients with severe lung injury.
• Specialized Care
• 47% of patients admitted to ICU, and
• 22% required endotracheal intubation and mechanical ventilation.

EVALI Official Coding Guidelines

On October 17, 2019, the CDC released a supplement to the ICD-10-CM Official Coding Guidelines. This supplement:

• Provides guidance related to the 2019 health care encounters and deaths related to EVALI.
• Is intended to be used in conjunction with current ICD-10-CM classifications and the ICD-10-CM Official Guidelines for Coding and Reporting effective October 1, 2019.
• May not represent all possible reasons for health care encounters related to e-cigarette, or vaping, product use.

The introduction to the supplement highlights that this guidance is consistent with what is currently known about this disease and will be updated as new clinical information becomes available. Further, clinical scenarios described in the General Guidance “may not represent all possible reasons for health care encounters that  may be related to e-cigarette, or vaping, product use.”

General guidance focuses on scenarios related to the following:  

• Lung-related complications
• For patients with documented EVALI, assign the code for the specific condition. (i.e. ICD-10-CM code J680.0, (Bronchitis and pneumonitis due to chemicals, gases, fumes and vapors; includes chemical pneumonitis), and
• For patients with acute lung injury but without further documentation identifying a specific condition (pneumonitis, bronchitis), assign code: J68.9, Unspecified respiratory condition due to chemicals, gases, fumes, and vapors.
• Poisoning and toxicity,
• Substance use, abuse, and dependence, and
• Signs and Symptoms.

As mentioned previously, this guidance is consistent with current clinical knowledge. With the CDC posting weekly updates, there is a high probability there will be changes to the guidance in the future.

One way to keep up with any changes is to frequent the CDC webpage Outbreak of Lung Injury Associated with E-Cigarette Use, or Vaping.  Also, for those of you reading this in Alabama, the Alabama Department of Public Health (ADPH) has a page dedicated to Vapes and E-Cigs that includes

Vape-Related Pulmonary Illnesses Alabama specific statistics.

The Discharge Planning Conditions of Participation (CoPs) Final Rule was published September 30, 2019. A recent Wednesday@One included an article where MMP shared highlights from the Final Rule.

Overall, CMS seemed to have listened to the 299 comments to the Proposed Rule and subsequently several of the proposals were not finalized.

CMS indicates in the Final Rule that they believe the proposals finalized will empower patients to be active participants in the discharge planning process. One way of empowering the patient is through the finalized proposal requiring hospitals to assist patients, their families, or their caregivers/support persons in selecting a Post-Acute Care (PAC) provider by using and sharing data on quality measures and resource use measures, that includes, but is not limited to, the following PAC providers:

• Home Health Agencies (HHAs),
• Skilled Nursing Facilities (SNFs),
• Inpatient Rehabilitation Facilities (IRFs), and
• Long Term Care Hospitals (LTCHs).

This article recaps several of the expectations CMS noted in the final rule regarding the provision of Quality Data and highlights the Compare websites.

CMS Expectations for providing Quality Measure Data

Following is a list of expectations CMS provided in the Final Rule regarding sharing Quality Measure Data. With that said, keep in mind that CMS also indicated more than once in the Final Rule that they will be providing sub-regulatory guidance after the Final Rule is published.

• Hospitals will have to ensure the PAC data on quality measures and data or resource use measures is relevant and applicable to the patient’s goals of care and treatment preferences,
• CMS expects hospitals to document in the medical record that the PAC data on quality and resource use measures was shared with the patient and used to assist the patient during the discharge planning process,
• CMS expects providers to make reasonable efforts to use the quality and resource use measure data that are currently available to them until all measures stipulated in the IMPACT Act are finalized and publicly reported.
• CMS indicates providers should use data available at the IRF Compare, HH Compare, Nursing Home Compare, and Long-Term Care Hospital Compare websites to assist patients as they choose a PAC provider that aligns with the patient’s goals and treatment preferences, and would expect providers to document all efforts regarding this requirement in the patient’s medical record.
• CMS notes additional explanations, resources, instructions and help on how to use the Compare Websites are available on the following pertinent websites:

• https://www.medicare.gov/inpatientrehabilitationfacilitycompare/.
• https://www.medicare.gov/homehealthcompare/search.html.
• https://www.medicare.gov/nursinghomecompare/search.html.
• https://www.medicare.gov/longtermcarehospitalcompare/.

• CMS believes providers have the ability and knowledge to interpret and discuss the publicly available data at the most basic levels. CMS does not expect providers to give overly detailed and complex analyses of the data as this may only confuse patients and/or caregivers. They also do not expect providers to attempt to provide patients and their caregivers with data that do not exist regarding PAC facilities.
• CMS does expect providers to answer questions to the best of their ability regarding the data.
• CMS encourages providers to refer to www.medicare.gov for additional resources and help and to consult the sub-regulatory interpretive guidance that will be available after publication of the final rule.
• Providers can use additional available information to assist patients as they select a PAC provider, so long as the information presented aligns with the patient’s goals of care and treatment preferences. The IMPACT Act in no way limits providers’ ability to augment the information provided to patients. All attempts to assist patients should be documented in the medical record.
• CMS believes hospitals, HHAs and CAHs will be in compliance with the Patient Choice requirement if they present objective data on quality and resource use measures specifically applicable to the patient’s goals of care and treatment preferences, taking care to include data on all available PAC providers, and allowing patients and/or their caregivers the freedom to select a PAC provider of their choice.
• Providers must use and share data on quality measures and data on resource use measures that are relevant and applicable to the patient’s goals of care and treatment preferences. While we believe that resource use data can be helpful to all patients, providers can tailor the specific data that are given to patients so that the data are applicable to the patient’s specific medical condition or circumstance. The provider should ensure that the data given to patients aligns with the patient’s ultimate goals of care and treatment preferences.
• For patients enrolled in a Managed Care Organization, the hospital must make the patient aware that the patient or caregiver needs to verify the participation of HHAs or SNFs in their network. If the hospital has information regarding which providers participate in the managed care organization’s network, it must share this information with the patient and must document in the patient’s medical record that the list was presented to the patient. The patient or their caregiver/support persons must be informed of the patient’s freedom to choose among providers and to have their expressed wishes respected, whenever possible. The final component of the retained provision would be the hospital’s disclosure of any financial interest in the referred HHA or SNF. However, this section would be revised to include IRFs and LTCHs.

Find & Compare Doctors, Hospitals & Other Providers

The following “Compare” webpages are available at www.medicare.gov:

• Hospitals,
• Nursing Homes,
• Home Health Services,
• Dialysis Facilities,
• Long-term Care Hospitals,
• Inpatient Rehabilitation Facilities,
• Doctors & Other Health Professionals, and
• Hospice Compare
  

Navigating the Compare Website:

• First go to the www.medicare.gov website.
• Next, click the box with a picture of binoculars and the text “Find Care: Search all providers & facilities” below the binoculars.
• You will now be on the webpage with links to each of the “Compare” webpages.
• Click the type of post-acute care you are searching for.
• At each of the “Compare” webpages, the first thing you will be asked to do is to enter at a minimum the location where you are searching for post-acute providers.
• This will take you to a page with a list of Providers. You can select up to three Providers to compare at time.

All of the Compare webpages are easy to navigate, even for someone like me who typed my college papers on a Brother typewriter and have learned all I know about computers through on the job training. To provide insight into what is available let’s take a closer look at the Home Health Compare webpage.

Home Health Compare

After searching a specific location you will be taken to the page with a list of Providers. Once on this page you can see star ratings, compare up to three Providers, modify your search and learn more about the Quality of Patient Care and Patient Survey Summary star ratings.

Quality of Patient Care Star Rating

Agencies are rated between 1 and 5 showing how they compare to other home health agencies on performance measures. The ratings are based on 8 quality measure that give a general overview of performance. CMS does note that “since the star rating ranks all agencies from lowest to highest, some agencies will be ranked below others even though they’re providing good quality care.”

Home Health quality measures are divided into the following categories:

• Managing daily activities
• Managing pain and treating symptoms
• Preventing harm
• Preventing unplanned hospital care
• Payment and value of care.

Patient Survey Summary Star Rating

CMS utilizes the HHCAHPS (Home Health Consumer Assessment of Healthcare Providers & Systems) to rate agencies. As with the quality of patient care ratings, the more stars indicates better quality care. CMS provides the following important things to remember as you compare agencies:

• “The patient experience star ratings are based on the information on quality of care that is reported on Home Health Compare. Not all home health agencies will be represented on the web site.
• Home Health Compare displays home health agency performance on certain important measures of quality care. Specifically the web site displays the quality of patient care data and patient survey results (which reflect the patient experience of care).
• Positive results on patient experience of care measures are one aspect of the quality of home health care. Other information may be important to you, like how often an agency initiated patient care in a timely manner, that isn't included in HHCAHPS star ratings.

The HHCAHPS star ratings compare home health agencies to each other. A 1-star rating doesn't mean that you'll get poor care from a home health agency. It means that home health agencies that got 2 or more stars performed better on this particular measure of patient experience of care. For this reason, we suggest that you use the star rating along with other quality information when making decisions about choosing a home health agency.”

Comparing Agencies enables you to see general information about the provider (address, phone number, and services provided) and granular detail about the quality measures and the HHCAHPS that make up an agencies star rating. At this level agencies can be compared to up to two other agencies at a time, the state and national average.

While we wait for the promised sub-regulatory guidance, I encourage you to take the time to become familiar with all of the Compare webpages.

For long time readers, you probably know that fall is my favorite season. How can it not be? By this time in October the college football season is in full swing, yards have been decorated for the Halloween season, and the Thanksgiving and Christmas seasons are just around the corner. Unfortunately, this time of year also brings the flu season.

Here in Alabama, part of the state is already experiencing significant influenza disease activity. Meaning, it’s also the season to get vaccinated.  At the national level, according to the CDC’s FluView Report, as of the week ending October 19th, seasonal influenza remains low in the United States. Regardless of how prevalent the flu may be where you live, you can add to the list of seasons, the “it’s time to get your vaccination season.”

It is also time to make sure Medicare beneficiaries get their annual vaccine. To help get you started, CMS provided the following information in the October 17, 2019 edition of the mlnconnects Newsletter:

Protect Your Patients from Influenza this Season

The Centers for Disease Control and Prevention (CDC) recommends annual influenza vaccination for everyone 6 months and older. Influenza is a serious health threat, especially to vulnerable populations like people 65 and older, who are at high risk for hospitalization and developing serious complications. Vaccinate by the end of October – to help protect your patients, your staff, and yourself.

Medicare Part B covers:

• Influenza virus vaccine once per influenza season

• Additional influenza vaccines if medically necessary

For More Information:

• Medicare Preventive Services Educational Tool

• Influenza Resources for Health Care Professionals MLN Matters Article
• Influenza Vaccine Payment Allowances MLN Matters Article
• CDC Influenza website
• CDC Information for Health Professionals webpage
• CDC Fight Flu Toolkit webpage
• CDC Make a Strong Flu Vaccine Recommendation webpage

In the spirit of celebrating seasons, I wish each and every one of you a “Happy Fall Ya’ll.”

As the first half of the school year winds down, it takes me back to filling spiral notebooks full of class notes, hours of studying, and final exams. Similar to exam results reflecting how well you learned the material taught, the Comprehensive Error Rate Testing (CERT) program performs audits to see how well Medicare Administrative Contractors (MACs) have followed Medicare coverage, coding, and payment rates to adjudicate claims.

Audit findings are used to calculate a Medicare Fee-for-Service (FFS) program improper payment rate. “The CERT program considers any claim that was paid when it should have been denied or paid at another amount (including both overpayments and underpayments) to be an improper payment.”

CERT Audit Approach

Annually, the CERT program reviews a “statistically valid stratified random sample of Medicare FFS claims to determine if they were paid properly.” Specifically, the CERT reviews Part A claims excluding hospital Inpatient Prospective Payment System (IPPS), Part A Hospital IPPS claims, Part B claims (i.e. physician, laboratory, and ambulance services); and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS).

If documentation does not support that the rules were met, a claim is counted as a total or partial improper payment. Once an improper payment is identified the error is categorized into one of the following five major categories:

• No Documentation,
• Insufficient Documentation,
• Medical Necessity,
• Incorrect Coding, or
• Other.

Fiscal Year 2019 Estimated Improper Payment Rates

In mid-November, CMS published a CMS.gov Fact Sheet detailing the estimated improper payment rates for CMS Programs for Fiscal Year (FY) 2019. Approximately 50,000 claims were sampled and included claims submitted from July 1, 2017 through June 30, 2018. The following tables highlights an improper payment rate compare of FY 2018 to FY 2019.

CMS reminds the reader in the Fact Sheet that improper payment rates are not necessarily indicative of or are measures of fraud. Instead, improper payments are payments that did not meet statutory, regulatory, administrative, or other legally applicable requirements and may be overpayments or underpayments.”

CMS Initiatives Contributing to Decrease in Improper Payment Rate

CMS attributes the decreased improper payment rate and payments to reductions in Home Health, Other Medicare Part B services and DMEPOS claims. 

Specific actions taken to reduce improper payments includes:

• Policy clarification and Targeted Probe and Educate for Home Health agencies,
• Other Medicare Part B Services: Clarification and simplification of documentation requirements under the Patients-Over-Paperwork initiative for other Medicare Part B services, and
• “Various corrective actions” for DMEPOS.

You can learn more about the FY 2019 CERT findings in the Department of Health and Human Services FY 2019 Agency Financial Report at https://www.hhs.gov/sites/default/files/fy2019-hhs-agency-financial-report.pdf on pages 200 through 210 of the report.  

To learn more about the CERT visit AdvanceMed’s CERT Provider Documentation Information website at https://certprovider.admedcorp.com/Home/About.

For this newsletter, I often write articles about other articles. I expect the quality and worth of the articles I write are judged by our readers, and likewise, I have an opinion on the worth of the articles I reference. Therefore, I have to applaud Palmetto GBA on their article on Therapeutic Exercise. This is one of the most comprehensive yet concise explanations of the requirements for therapy services I have seen. I will note some of the major points in my discussion below, but I encourage anyone who has a vested interest in this topic to read Palmetto’s article. In fact, I recommend you print and/or save it electronically for future reference. I know I will.

One of the main reasons for Medicare denials of therapy services is the lack of medical necessity. The Palmetto article breaks this down to 4 points and then discusses each of the requirements in more detail. 

“Medical necessity — four main requirements

• Presence of a disabling condition
• Individualized treatment
• Expectation that the beneficiary will benefit from therapy
• Requires skilled care”

Presence of a disabling condition

It seems obvious that the patient must have an injury, post-surgical limitations, or a medical condition that requires therapy. The issue is that there must be documentation beyond simply stating the medical problem. Documenting the patient has a sprained ankle, is post-surgical from a rotator cuff repair, or had a stroke is not enough. The therapist performing the evaluation needs to include the functional deficits the patient has and how these affect the patient’s ability to perform activities of daily living (ADLs). For example, following a shoulder injury or surgery, the patient could have pain, swelling, weakness, and limited range of motion that results in an inability to perform dressing and self-care independently. I like to think of documenting times 3 –

1. the medical condition, such as post-surgical repair of torn rotator cuff,
2. the symptoms and deficits, such as pain, swelling, weakness, and limited range of motion (be sure to include objective measures), and
3. the activity limitations and participation restrictions in the patient’s daily life, such as patient is unable to reach up to wash hair, dress independently and perform house-keeping chores.

The Palmetto articles states, “Per the LCD, include one of the following: weakness, contracture, stiffness secondary to spasm, spasticity, decreased joint range of motion, gait problem, balance and/or coordination deficits, abnormal posture, muscle imbalance (pain is not listed, but it is acceptable as pain typically can cause several of the above conditions).”

Individualized treatment

This is the Plan of Care (POC) where the therapist selects the types of exercises, amount, frequency, and duration of treatment tailored to the specific patient’s needs and abilities. In listing the goals, the therapist can tie the types of exercises chosen to the patient’s activity limitations or participation restrictions identified. For example, therapeutic exercises may be performed to increase strength and improve range of motion to allow the patient to be able to perform self-care activities independently.

Again, from the Palmetto article – “Per the LCDs, goals should address the following: patient needing to improve mobility, flexibility, strengthening, coordination, control of extremities, dexterity, range of motion, or endurance as part of activities of daily living training, or reeducation.”

Expectation that the beneficiary will benefit from therapy

If you do not think it would benefit the patient, you should not be doing it. The goals included in the POC should address your expectations of the benefits the patient will have from the therapy. The progress reports as the patient participates in therapy will hopefully reflect the benefits the therapist expected from the therapy treatment. These should include objective measures, such as measures of the patient’s range of motion or strength, and subjective observations and patient reports of improvements in their abilities to perform ADLs. Not all patients respond as expected – if a patient is not benefiting from therapy, the therapist may modify the plan or discontinue therapy.

Notice that this says the beneficiary should “benefit” from therapy, not “improve” from therapy. That is an important distinction since all patients may not be able to improve, but therapy is needed to prevent or slow further decline in functional status. This is acceptable for Medicare coverage, but the expectation and outcomes should be clearly documented.

Requires skilled care

The treatments provided to the patient must require the skills of a therapist or therapy assistant under the direction of a therapist. If the services could be provided by someone without the skills of a therapist, then the services do not meet Medicare’s requirements for skilled care. Skills may include providing instructions on proper exercise form, direction to the patient during exercises, providing assistance, ensuring the safety of the patient during the performance of treatment, and/or monitoring the patient medically. The requirement for skilled care is addressed in the evaluation, plan of care, and in the daily treatment notes, where the therapist might document cueing the patient, instruction in proper form, or stand-by assist for patient safety, for example. The Palmetto article points out “Keywords in documentation to support use of skilled care (are) educate, education, corrected, instruct, instruction, trained, directed, reassessed, medical monitoring.”

As long as patients are benefiting from therapy and continue to require skilled care, documentation in the record must indicate the patient’s progression and the continuing need for the skills of the therapist. Once a patient is able to perform exercises independently or with non-skilled assistance, therapy services are no longer covered by Medicare. Patients may continue with a home or gym exercise program on their own.

The Palmetto article goes on to discuss all the different types of required therapy documents and what needs to be included in each – evaluation, plan of care, certification/recertification, progress reports, and treatment notes. Medical necessity is whether the patient needs therapy, but therapy documentation provides the support for that medical necessity in addition to supporting the services provided. That is a big job for words on a page. And Medicare will be judging the quality and worth of that writing.

Even though Case Management Week is not for two weeks (October 13 – 19, 2019), the release of the Discharge Planning Conditions of Participation (CoP) Final Rule is a reason for an early celebration as evidenced by the following quote from CMS in the Final Rule.

“We believe that these final discharge planning requirements for hospitals, including LTCHs, IRFs, HHAs, and CAHs will improve transitions of care, increase a patient’s ability to access their health care information in a timely manner, and complement and align with efforts to improve interoperability across the care continuum. We also believe that these final requirements, which we discuss in further detail in subsequent sections of this final rule, are less burdensome than our initial proposed discharge planning requirements. In addition, we continue to believe in the importance of person-centered care during the discharge planning process.”

• Medicare and Medicaid Programs; Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies, and Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement to Patient Care Final Rule
  

Regulatory Background

• December 13, 1994: Original publication date for the hospital discharge planning requirements at §482.43.
• Improving Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act) mandated modifications to the discharge planning or discharge summary CoPs.
• May 17, 2013: CMS released updates to Appendix A of the State Operations Manual providing revised interpretive guidelines for the Discharge Planning CoPs. Notably, this revision included “blue boxes” that CMS indicated displayed “successful practices currently found throughout the industry in the area of care transitions.”
• October 29, 2015: CMS announced proposed revisions to the discharge planning requirements for hospitals, including long-term care hospitals (LTCHs), Inpatient Rehabilitation Facilities (IRFs), Critical Access Hospitals (CAHs), and Home Health (HH) agencies.
• November 2, 2018: CMS published an Extension of Timeline for Publication of Final Rule, citing “the complexity of the rule and scope of public comments” as warranting the extension. This extended publication of a final rule to November 3, 2019.
• Thursday September 26, 2019: CMS released the Final Rule which was published in the Federal Register September 30, 2019.

Key Highlights from the Final Rule

The Final Rule as published in the Federal Register is forty-nine pages long with the first twenty-eight pages detailing the final requirements for hospitals. For key stakeholders involved in discharge planning, it will be important to read the entire document. For everyone else, the rest of this article highlights hospital requirements in the form of questions and answers. Note, most answers in this article reflect CMS statements verbatim from the final rule with the exception of this first question regarding when the rule will be effective.

Question: When will the regulations in the final rule be effective?

Answer: The day after Thanksgiving on Black Friday November 29, 2019.

Question: How will beneficiaries benefit from this Final Rule?

Answer: CMS notes the following in the Final Rule Summary:

• This Rule empowers patients to be active participants in the discharge planning process, and
• Implements requirements giving patients and their families access to information that will help them to make informed decisions about their post-acute care, while addressing their goals of care and treatment preferences, which may ultimately reduce their change of being re-hospitalized.

Question: Who do the Final Hospital Discharge Planning Requirements apply to?

Answer: The final requirements apply to the following:

• Short-term acute care hospitals (including their IPPS-excluded rehabilitation or psychiatric units),
• Psychiatric Hospitals, Long Term Care Hospitals (LTCHs),
• Rehabilitation Hospitals,
• Children’s hospitals, and
• Cancer hospitals
• Distinct part psychiatric and rehabilitation units in Critical Access Hospitals (CAHs)

Question: Will the final requirements replace the current psychiatric hospital requirements?

Answer: Although these discharge planning requirements apply to psychiatric hospitals, there are several additional currently existing discharge planning requirements specific to psychiatric hospitals that are not affected by the discharge planning requirements discussed in this rule. Thus, psychiatric hospitals will still be required to meet the additional special provisions, special medical record requirements, and special staff requirements set out at §§ 482.60, 482.61, and 482.62.

Inpatient psychiatric units located in a hospital, (as opposed to psychiatric hospitals) are specialized units within a larger hospital or CAH. Inpatient psychiatric units must meet the hospital CoP requirements for the hospitals in which they are located. However, they are not required to meet the CoPs specific to psychiatric hospitals set out at §§ 482.60, 482.61, and 482.62. Therefore, these discharge planning requirements apply to inpatient psychiatric units located within a hospital or a CAH.

Question: Are hospitals required to include a patient’s DME needs in a patient’s discharge instructions?

Answer: In response to a comment CMS indicated that, we agree that considering a patient’s DME needs when planning for a patient’s post-hospital care is a best practice. While we are not mandating that providers include information on a patient’s DME needs in the patient’s discharge instructions at this time, we encourage providers to do so where appropriate.

Question: How will compliance with the Final Rule be monitored?

Answer: As with all CoPs, compliance with these requirements will be monitored by CMS, State Survey Agencies (SAs), and national accrediting organizations (AOs) through surveys.

Question: Does CMS plan to provide sub-regulatory guidance focused on how to implement the final rule?

Answer: CMS has indicated that they will provide sub-regulatory interpretive guidance after the publication of this final rule, which will provide further clarification for implementing the final discharge planning requirements.

Question: Will providers be required to give a copy of the discharge plan to caregivers?

Answer: While we are not requiring providers to give a copy of the discharge plan to caregivers, patients can request a copy of their medical record, including the discharge plan, from the hospital, in their requested form and format, as required by newly revised § 482.13(d)(2) (as discussed below), and the hospital must comply with the patient’s access request as required by the HIPAA Privacy Rule at 45 CFR 164.524. Similar requirements exist for HHAs and CAHs as well.

Question: Who are the specific “Practitioners” and/or “Qualified Personnel” that can provide a list of Post-Acute Care (PAC) Providers to a patient?

Answer: Our use of the broad term “practitioner” encompasses all practitioners, including non-physician practitioners, which may be operating within a hospital. Providers may utilize the appropriate practitioners that they believe will effectively conduct a patient’s discharge planning process. For those reasons, the discharge planning CoPs do not include requirements specific to individual practitioner categories.

The regulations text, as written, does not explicitly state who must provide the list of PAC providers to the patient or their representative. In addition, the regulation text does not prohibit hospitals from including any qualified personnel it chooses in this part of the discharge planning process. Typically, the list of PAC providers is given to patients or their representative by a social worker or registered nurse (who is a case manager). The hospital must identify in its discharge planning policy the qualified personnel who will be involved in the discharge planning process and must execute their discharge planning process in accordance with their policies.

Question: What Quality Measure Data should be provided to the patient?

Answer: We proposed and finalized without modification, to require that hospitals assist patients, their families, or their caregivers/support persons in selecting a PAC provider by using and sharing data that includes, but is not limited to HHA, SNF, IRF, or LTCH data on quality measures and data on resource use measures. Furthermore, the hospital would have to ensure that the PAC data on quality measures and data on resource use measures is relevant and applicable to the patient’s goals of care and treatment preferences. We would also expect the hospital to document in the medical record that the PAAC data on quality measures and resource use measures were shared with the patient and used to assist the patient during the discharge planning process.

Section 1899B(i) of the Act requires that PAC providers, hospitals and CAHs take into account quality, resource use, and other measures in the discharge planning process. We understand that commenters had concerns about using appropriate data that would be comparable to the data that would be gathered and provided in accordance with the requirements of the IMPACT Act…We therefore expect providers to make reasonable efforts to use the quality and resource use measure data that are currently available to them until all of the measures stipulated in the IMPACT Act are finalized and publicly reported. Additional explanations, resources, instructions, and help on how to use the IRF Compare, HH Compare, Nursing Home Compare, and Long-Term Care Hospital Compare websites are currently available on the following pertinent websites:

• https://www.medicare.gov/inpatientrehabilitationfacilitycompare/.
• https://www.medicare.gov/homehealthcompare/search.html.
• https://www.medicare.gov/nursinghomecompare/search.html.
• https://www.medicare.gov/longtermcarehospitalcompare/.

While the data from these sources are not available in “real time,” the data are posted as soon as feasible. Providers should use these data sources to assist patients as they choose a PAC provider that aligns with the patient’s goals of care and treatment preferences, and we would also expect providers to document all efforts regarding this requirement in the patient’s medical record.

Question: What is CMS’ expectation regarding interpreting and discussing quality data with the patient, family, or caregiver/support person?

Answer: We believe that providers have the ability and knowledge to interpret and discuss the publicly available data on quality and resource use measures at the most basic levels. We note that we do not expect providers to give overly detailed and complex analyses of the quality and resource use data, which may only serve to confuse patients and/or their caregivers, nor do we expect providers to attempt to provide patients and their caregivers with data that do not exist regarding PAC facilities. We expect providers to put forth their best effort to answer patient questions regarding the data. We also encourage providers to refer to www.medicare.gov for additional resources and help. Further information regarding specific measures mandated by the IMPACT Act will be available in forthcoming regulations. Finally, we also encourage providers to consult the sub-regulatory interpretive guidance that will be available after publication of the final rule.

Question: Can a hospital use other sources of PAC provider quality data?

Answer: Providers can use additional available information to assist patients as they select a PAC provider, so long as the information presented aligns with the patient’s goals of care and treatment preferences. The IMPACT Act in no way limits providers’ ability to augment the information provided to patients. All attempts to assist patients should be documented in the medical record.

Furthermore, these discharge planning requirements do not prohibit providers from giving patients information regarding coverage of a selected PAC by the patient’s insurance or specifics on out of pocket costs for PAC providers. Providers may give this information to patients if they choose. However, we do not expect providers to have definitive knowledge of the terms of a patient’s insurance coverage or eligibility for postacute care, or for Medicaid coverage, but we encourage providers to be generally aware of the patient’s insurance status. We do not believe that it is appropriate to mandate such a requirement here, as these CoPs provide basic requirements for the discharge planning process.

Question: What is CMS guidance regarding “Patient Choice” and patient steering?

Answer: We understand the commenter’s concerns regarding patient steering. However, we believe compliance with the revised CoP and the fraud and abuse laws, including the physician self-referral law and Federal anti-kickback statute, is achievable.

We believe that hospitals, HHAs and CAHs will be in compliance with this requirement if they present objective data on quality and resource use measures specifically applicable to the patient’s goals of care and treatment preferences, taking care to include data on all available PAC providers, and allowing patients and/or their caregivers the freedom to select a PAC provider of their choice.

Providers will have to document all such interactions in the medical record. In addition, we expect hospitals to comply with the requirements in § 482.43(c) and inform the patient and/or the patient’s representative of their freedom to choose among participating Medicare providers and suppliers of post-discharge services, while not specifying or otherwise limiting the qualified providers or suppliers that are available to the patient.

Question: How does CMS plan to monitor for compliance with “Patient Choice”?

Answer: We remind providers that compliance with these requirements will be assessed through on-site surveys by CMS, SAs, and AOs and that purposeful patient steering (that is, directing patients and/or their caregivers to PAC providers that do not align with the patient’s goals of care and treatment preferences) could lead to a determination of provider noncompliance with the requirements in this rule. We also note that physician self-referral violations may result in imposition of penalties set out under section 1877(g) of the Act.

Question: Can hospitals tailor the data on quality measures and data on resource use measures to the individual patient?

Answer: Providers must use and share data on quality measures and data on resource use measures that are relevant and applicable to the patient’s goals of care and treatment preferences. While we believe that resource use data can be helpful to all patients, providers can tailor the specific data that are given to patients so that the data are applicable to the patient’s specific medical condition or circumstance. The provider should ensure that the data given to patients aligns with the patient’s ultimate goals of care and treatment preferences.

Question: Please clarify the protocols that providers would be expected to follow if a patient refused to agree to be discharged to a PAC facility chosen on the basis of the supplied quality data and/or family preferences, especially when no other safe options exist in the area.

Answer: We expect hospitals, HHAs, and CAHs to document the patient’s refusal in the medical records and continue to make reasonable efforts to work with the patient and/or the patient’s caregiver to find appropriate substitutions. However, we note that Medicare and Medicaid participating facilities are surveyed regularly to assure quality, and we believe that Medicare facilities in good standing can be trusted to provide services safely.

Question: How often should a hospital assess their discharge planning process?

Answer: While we are not establishing a specific timeframe requirement in order to preserve flexibility for hospitals and CAHs, we would recommend that a hospital or CAH to do its periodic review every 2 years at a minimum. In addition, hospitals and CAHs would still have the flexibility to perform this review more frequently than every 2 years if they wish to do so.

We therefore are finalizing a provision at § 482.43(a)(7) (as originally proposed at § 482.43(c)(10)) that would require a hospital (or a CAH) to assess its discharge planning process on a regular basis, which would include ongoing, periodic review of a representative sample of discharge plans, including those patients who were readmitted within 30 days of a previous admission, to ensure that the plans are responsive to patient post-discharge needs.

Question: Did CMS finalize the proposal to require the discharge planning process to certain categories of outpatients, including but not limited to patients receiving observation services?

Answer: No, CMS did not finalize this proposal and noted in the final rule that “we agree with commenters that the requirement needs to be scaled back in its scope and applicability to a more flexible requirement. We also agree that the proposed requirement could potentially have the unintended consequence of shifting hospital resources away from those patients most in need of a discharge plan.”

Question: What is the finalized discharge planning process for hospitals?

Answer: After consideration of the comments we received on the proposed rule, we are revising proposed § 482.43(b), to be finalized as § 482.43(a) introductory text and (a)(2), to require that the hospital’s discharge planning process identify, at an early stage of hospitalization, those patients who are likely to suffer adverse health consequences upon discharge in the absence of adequate discharge planning, and must provide a discharge planning evaluation for those patients so identified, as well as for other patients upon the request of the patient, patient’s representative, or patient’s physician. A discharge planning evaluation must include an evaluation of a patient’s likely need for appropriate post-hospital services, including, but not limited to, hospice care services, post-hospital extended care services, and home health services; such evaluation must also determine the availability of those services.

Question: Who is required to coordinate the discharge needs evaluation and development of a discharge plan for a patient?

Answer: Any discharge planning evaluation or discharge plan required under this paragraph must be developed by, or under the supervision of, a registered nurse, social worker, or other appropriately qualified personnel.

Question: It was proposed that hospitals must begin to identify anticipated discharge needs for each applicable patients within 24 hours after admission or registration, and the discharge planning process is completed prior to discharge home or transfer to another facility and without unduly delaying the patient’s discharge or transfer. If the patient’s stay was less than 24 hours, the discharge needs would be identified prior to the patient’s discharge home or transfer to another facility. Was this finalized?

Answer: The identification of needs within 24 hours Proposal was removed from the final rule. CMS did finalize modifying 482.43(a) to state that the hospital must identify at an early stage of hospitalization all patients who are likely to surer adverse health consequences upon discharge if there is no adequate discharge planning. The hospital must provide a discharge planning evaluation for those patients so identified as well as for other patients upon the request of the patient, the patient’s representative, or patient’s physician.

Question: How often must a hospital re-evaluate the discharge planning process?

Answer: CMS finalized that a hospital’s discharge planning process must require regular re-evaluation of the patient’s condition to identify changes that require modification of the discharge plan. The discharge plan must be updated, as needed, to reflect these changes.

Question: What must be included in a discharge planning evaluation?

Answer: A discharge planning evaluation must include an evaluation of a patient’s likely need for appropriate post-hospital services, including, but not limited to, hospice care services, post-hospital extended care services, and home health services, and non-health care services and community based care providers, and must also determine the availability of the appropriate services as well as of the patient’s access to those services.

Question: How should hospitals involve the patient and his or her care giver in the discharge planning process?

Answer: The discharge planning evaluation must be included in the patient’s medical record for use in establishing an appropriate discharge plan and the results of the evaluation must be discussed with the patient (or the patient’s representative).

Hospitals must have an effective discharge planning process that focuses on the patient’s goals and preferences and includes the patient and his or her caregivers/support person(s) as active partners in the discharge planning for post-discharge care. The discharge planning process and the discharge plan must be consistent with the patient’s goals for care and his or her treatment preferences, ensure an effective transition of the patient from hospital to post-discharge care, and reduce the factors leading to preventable hospital readmissions. These requirements are included in the introductory paragraph at § 482.43.

Similarly, we understand that situations may arise where patients may be uncooperative or may refuse to participate in the discharge planning process. We also expect hospitals and CAHs to document the patient’s refusal to participate in the discharge planning process, and that such attempts to incorporate the patient and/or the patient’s caregiver in the discharge planning process were made, in the medical record.

Question: CMS proposed an extensive list of minimum elements (i.e. demographics, advance directives, functional status assessment) that would need to be provided when a patient transfers to another health care facility. Was this proposal finalized?

Answer: While we are not requiring an extensive list of items as originally proposed, we still expect facilities to send certain necessary medical information that is critical to the care of the patient and pertinent to the patient’s specific medical status at the time of discharge. We also believe facilities should have discretion to send the most relevant information within the required necessary medical information, consistent with “clinical relevance” as defined in the Medicare and Medicaid Electronic Health Record Incentive Program final rule (80 FR 62761, October 16, 2015) (“2015 Meaningful Use Rule”). Other important and pertinent information that should be conveyed at discharge or transfer would be current diagnoses (including any behavioral health issues of mental health and substance abuse), laboratory results (including Clostridium difficile and multi-drug resistant organism status, as well as any antibiotic susceptibility testing, as applicable), and patient functional status, to name just a few broad areas of medical information that we believe are critical to patient care.

Question: What did CMS propose regarding the Requirements for Post-Acute Care Services and was it finalized?

Answer: We proposed to further clarify that the PAC providers mentioned in the IMPACT Act, specifically LTCHs and IRFs (rehabilitation hospitals and rehabilitation units of hospitals and CAHs), would also be subject to the proposed revision to the hospital CoPs in order to provide consistency with the IMPACT Act. We proposed that for patients who are enrolled in Managed Care Organizations (MCOs), the hospital must make the patient aware that the patient or caregiver needs to verify the participation of HHAs or SNFs in their network. If the hospital has information regarding which providers participate in the managed care organization’s network, it must share this information with the patient and must document in the patient’s medical record that the list was presented to the patient. The patient or their caregiver/support persons must be informed of the patient’s freedom to choose among providers and to have their expressed wishes respected, whenever possible. The final component of the retained provision would be the hospital’s disclosure of any financial interest in the referred HHA or SNF. However, this section would be revised to include IRFs and LTCHs.

After consideration of the comments, CMS finalized this proposal without modification.

Question: What is CMS’ expectation regarding providing PAC lists?

Answer: We would allow a hospital the flexibility to implement the requirement to present its list of HHAs, SNFs, IRFs, or LTCHs in a manner that is most efficient and least burdensome in its particular setting. For HHA, SNF, and dialysis services, a hospital can access a list from the CMS Web site, at http://www.medicare.gov, or develop and maintain its own list of HHAs and SNFs. We expect that providers have the most current list of providers that is available to them at the time. When the patient requires home health services, the CMS Web site list can be accessed based on the geographic area in which the patient resides. When the patient requires post hospital extended care services, the CMS Web site list would be accessed based on the geographic area requested by the patient. Or, in the rare instance when a hospital does not have Internet access, the hospital can call 1–800–MEDICARE (1–800–633–4227) to request a printout of a list of HHAs or SNFs in the desired geographic area… We expect discharge planning to facilitate patient choice in any post hospital extended care services, even though the statute does not require a specific list beyond HHAs, SNFs, IRFs, and LTCHs. The proposed requirement at § 482.43(f)(2) is also important because it requires the hospital, as part of the discharge planning process, to inform the patient or the patient’s representative of their freedom to choose among participating Medicare providers and suppliers of post discharge services and must, when possible, respect the patient’s or the patient’s representative’s goals of care and treatment preferences, as well as other preferences they express. The hospital must not specify or otherwise limit the qualified providers or suppliers that are available to the patient. We do encourage hospitals to provide any information regarding PAC providers that provide services that meet the needs of the patient. Hospitals must not develop preferred lists of providers. If the hospital has information regarding a PAC provider’s specialized services, we encourage that this information be provided to the patient as well as any culturally specific needs that the PAC providers are able to address (for example, the patient’s foreign language needs, and their cultural dietary needs or restrictions).

Question: Should a hospital be required to document the actual list of post-acute care referrals presented to the patient as a means for surveyors to determine the adequacy of the post-discharge options presented to the patient?

Answer: We agree with the need to ensure that surveyors appropriately determine that hospitals are providing patients referred to HHAs, SNFs, IRFs, or LTCHs a list of providers that contains appropriate and sufficient options in accordance with this requirement. We think it is important to allow hospitals the flexibility to determine the manner in which they document in the patient’s medical record that the list of PAC providers was presented to the patient or to the patient’s representative. We expect that surveyors will ask to see this documentation as part of the survey process.

Question: What do hospitals need to do to prepare for implementation of the final rule?

Answer: Hospitals will need to review their current policies and procedures and update them so that they comply with the modified requirements, which will be a one-time burden on each hospital.

Note, this article is limited to requirements for hospitals as defined earlier in the article. It does not cover the Home Health Agency or Critical Access Hospital portions of the final rule.

MMP will be watching and alert our readers when CMS publishes sub-regulatory guidance.

To date, Palmetto GBA has posted twenty-three DRG and procedure specific articles on their CERT Topics webpage (JJ Part A CERT General Information or JM Part A CERT General Information). As September comes to a close and in honor of Atrial Fibrillation Awareness Month, today we highlight two recent additions to this growing list of articles.

DRGs 273 & 274: Percutaneous Intra-cardiac Procedure with MCC and without MCC respectively

Left Atrial Appendage Closure (LAAC) procedures are performed as a stroke prevention measure in certain patients with atrial fibrillation. National Coverage Determination (NCD) 20.34 outlines the indications for CMS to consider this procedure to be a medically necessary service.

The CERT denials of inpatient claims for LAAC article highlights the following reasons for denials:

• Missing documentation to support the need for the LAAC procedure. Reminder, CMS covers this procedure for patients with non-valvular atrial fibrillation.
• The submitted medical records were missing evidence of a formal shared decision making interaction with an independent non-interventional physician using an evidence-based decision tool on oral anticoagulation in patients with non-ventricular atrial fibrillation prior to LAAC.

DRG 266: Endovascular Cardiac Valve Replacement with MCC

Transcatheter Aortic Valve Repair (TAVR) procedures are performed to treat symptomatic aortic valve stenosis. NCD 20.32 outlines the indications for CMS to consider this procedure to be a medically necessary service.

The CERT denials of inpatient claims for TAVR article highlights the following two reasons for denials:

• Missing documentation to support the need for the TAVR procedure. Note, this procedure is used for the treatment of aortic stenosis when furnished according to the Food and Drug Administration (FDA) - approved indications.
• The submitted medical records were missing evidence that two cardiac surgeons had independently examined the patient face-to-face and evaluated the patient’s suitability for open aortic valve replacement (AVR) surgery. Both surgeons must document the rationale for their clinical judgment and that the rationale was available to the heart team.

Note: The requirement has changed from two cardiac surgeons independently examining the patient to a cardiac surgeon and an interventional cardiologist with the release of the June 2019 Decision Memo (CAG-00430R).

To date, out of the twenty-three articles, only Psychoses (DRG 885) and Renal Failure (DRG 682) have come under scrutiny in the Targeted Probe and Educate (TPE) Program. While not officially on the list, we have heard from a client that they have received requests for Spinal Fusion records. DRG 460 Spinal Fusion was one of the first of these articles posted. As a reminder to providers in one of the two Palmetto jurisdictions, Palmetto finalized Local Coverage Determination (LCD): Lumbar Spinal Fusion (L37848) this year that is effective for services performed on or after 05/06/2019. 

MMP will continue to follow Palmetto’s websites for any future articles.

What is Structural Heart Disease?

In recent years, we have seen several of our clients expand their Cardiology Services into the field of Structural Heart. So, what exactly is structural heart disease? In my quest for understanding, I found several different definitions of structural heart disease, the two most pertinent to the focus of this article are from the Journal of American College of Cardiology and the Cardiovascular Research Foundation.

“The term “structural heart disease” entered the adult cardiology lexicon in 1999 and currently encompasses the base of knowledge and competencies surrounding noncoronary cardiac procedures such as transcatheter aortic valve replacement (TAVR), percutaneous mitral repair, and left atrial appendage exclusion.”

• Structural Heart Disease, Curt J. Daniels, Michael J. Landzberg, Robert H. Beekman ,Journal of the American College of Cardiology May 2015, 65 (20) 2260-2261; DOI: 10.1016/j.jacc.2014.12.075

The Cardiovascular Research Foundation defines structural heart disease as covering “a wide range of cardiac conditions, including valvular heart disease and defects in the muscular structure of the heart. The disease may be congenital, as well as acquired. As the American population ages, acquired disease, such as calcific (senile) aortic stenosis and mitral regurgitation has increased in importance, with 12% of adults over the age of 75 being diagnosed with the disease. The past two decades have seen a revolution in the treatment of structural heart disease with transcatheter therapies being developed for valve repair and replacement, closure of defects such as ASD (atrial septal defects), and isolation of the left atrial appendage to reduce embolic risk in atrial fibrillation. Patients who previously could only undergo high risk surgical aortic valve replacement or were completely inoperable can now be treated with a transcatheter approach, often with only a one night stay in the hospital.”

Structural Heart Procedures

With an understanding of structural heart disease, the rest of this article focuses on Medicare Fee-for-Service documentation requirements for the three procedures described in the Journal of the American College of Cardiology’s definition of structural heart disease, specifically:

• Left Atrial Appendage Closure (LAAC) or WATCHMAN™ Procedure,
• Transcatheter Aortic Valve Replacement (TAVR), and
• Transcathater Mitral Valve Repair (TMVR) or MitraClip Procedure.

In addition to documentation requirements, there are very specific billing requirements for the claims to be paid. You can read about the billing requirements in the related article in this week’s newsletter.

Left Atrial Appendage Closure “WATCHMAN™”

The FDA approved the WATCHMAN™ closure technology in March of 2015. This procedure is indicated to reduce the risk of thromboembolism from the Left Atrial Appendage in patients with non-valvular atrial fibrillation (NVAF). CMS published the National Coverage Determination (NCD) for Percutaneous Left Atrial Appendage Closure (20.34) with an effective date of February 8, 2016.

Checklist for hospitals performing WATCHMAN™ procedure

• This procedure is on the Medicare Inpatient-Only Procedure (IPO) List
• The patient must have non-valvular atrial fibrillation,
• The patient must have a CHADS2 score ≥ 2 OR CHA2DS2-VASc score ≥3,
• The patient must participate in a formal Shared Decision Making Encounter (SDM) with an independent non-interventional physician using an evidence based decision tool on oral anti-coagulation in patients with non-ventricular atrial fibrillation prior to procedure.
• Documentation of the SDM must be in the medical record.
• The patient must be suitable for short-term Warfarin but deemed unable to take long-term anticoagulation following the conclusion of the SDM encounter.
• The patient must be under the care of Multidisciplinary Team (MDT) of medical professionals.
• The procedure must be performed by an interventional cardiologist, electrophysiologist, or cardiovascular surgeon who meets the criteria outlined in the NCD to perform the procedure.
• The patient must be enrolled in, and the MDT must participate in a prospective, national audited registry.
• Read the NCD carefully and make sure you are following all of Medicare’s requirements.

Transcatheter Aortic Valve Replacement (TAVR)

TAVR is for the treatment of symptomatic aortic valve stenosis where a biprosthetic valve is inserted percutaneously using a catheter and implanted in the orifice of the native aortic valve. CMS published the National Coverage Determination (NCD) Transcatheter Aortic Valve Replacement (TAVR) (20.32) in May 2012. In June of this year, CMS published a Final Decision Memo making updates to the NCD. One significant change was to change the requirement that two cardiac surgeon’s document a face-to-face encounter with the patient prior to the procedure to requiring a cardiac surgeon and an interventional cardiologist. You can read more about the new decision memo in a related MMP article by Debbie Rubio in a July 2019 edition of the Wednesday@One. The following excerpt is from that article:

Checklist for hospitals that perform the TAVR procedure:

• This procedure is on the Medicare IPO List.
• The patient must have symptomatic aortic valve stenosis;
• The patient must be under the care of a heart team and the heart team's interventional cardiologist(s) and cardiac surgeon(s) jointly participate in the intra-operative technical aspects of TAVR;
• The hospital must have the appropriate infrastructure for the procedure;
• Your medical record must contain documentation of the face-to-face patient examinations by a cardiac surgeon and an interventional cardiologist (experienced in the care and treatment of aortic stenosis) evaluating the patient’s suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy;
• Assess your hospital and heart team volumes to be sure you meet the requirements for performing the procedure under the new Decision Memo; and
• Read the new Decision Memo carefully and make sure you are following all of Medicare’s requirements.

Transcatheter Mitral Valve Repair (TMVR) MitraClip

The FDA approved the first TMVR device on October 24, 2013. Abbott Vascular’s MitraClip® was approved “for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.” CMS published the National Coverage Determination (NCD) for Transcatheter Mitral Valve Repair (TMVR) (20.33) with an effective date of August 7, 2014.

On August 14, 2019, at the request of the Society of Thoracic Surgeons (STS), the American College of Cardiology (ACC), the American Association for Thoracic Surgery (AATS), and the Society for Cardiovascular Angiography & Interventions (SCAI), CMS opened a National Coverage Analysis (NCA) Tracking Sheet for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438R). The expected release of a Proposed Decision Memo is February 14, 2020.

The issue identified in the NCA is that currently this procedure is covered for the treatment of degenerative (primary) mitral regurgitation (MR) involving a structural abnormality. However, there are two types of MR and currently this procedure is not covered for the treatment of functional (secondary) MR which is a distinct condition that generally results from left ventricular dysfunction.

Checklist for hospitals that perform the TMVR procedure:

• This procedure is on the Medicare IPO list.
• The ICD-10-CM diagnoses supporting medical necessity for service provided both describe a nonrheumatic condition. Documentation in the medical record must specify if the valve insufficiency is Nonrheumatic or rheumatic as the Second Quarter 2019 Coding Clinic guidance advises that ICD-10-CM assumes aortic and mitral valve disease is rheumatic in nature when it is not described as non-rheumatic.
• Currently, the procedure is approved for the treatment of significant symptomatic degenerative MR.
• The patient must have a face-to-face encounter by a cardiothoracic surgeon experienced in mitral valve surgery and a cardiologist in mitral valve disease. The encounter must evaluate the patient’s suitability for mitral valve surgery and determination of prohibitive risk, and both must have documented their rationale for their clinical judgement in the medical record.
• The patient must be under the care MDT of healthcare professionals.
• Assess your hospital infrastructure and heart team volumes to be sure you meet the requirements for performing this procedure.
• The heart team’s interventional cardiologist or a cardiothoracic surgeon must perform the TMVR.
• Read the NCD carefully and make sure you are following all of Medicare’s requirements.

This article is meant to help providers with a structural heart program perform a self-assessment to validate that your claims support the medical necessity requirements outlined in the NCDs. This article is also meant to be a starting point for those providers considering or in the early stages of a structural heart program become knowledgeable about the CMS medical necessity. Additionally, MMP has developed procedure specific tip sheets. Click here to download the tip sheet for Left Atrial Appendage Closure (LAAC), here for Transcatheter Aortic Valve Replacement (TAVR), and here for Transcatheter Mitral Valve Repair (TMVR).

CMS Administrator Seema Verma is quoted as saying in an April 23rd Press Release that “transformative technologies are coming to the private market, but Medicare’s antiquated payment systems have not contemplated these technologies…I am particularly concerned about cases that have been reported to the agency in which Medicare’s inadequate payment has led hospitals to curtail access to needed therapies. We must continually update our policies in response to the rapid pace of advancement in medical science.”

Over the past two weeks we have covered finalized changes to ICD-10-CM diagnosis code severity designation and MS-DRGs found in the FY 2020 IPPS Final Rule. This week we examine the finalized New Technology Add-On Payments.

Background

Annually, CMS addresses applications for new technology add-on payments in the IPPS proposed rule. They do not make proposals, instead the proposed rule describes any concerns they may have about an applicant meeting the criteria for payment as a new technology and seeks additional information as needed to make a decision in the IPPS final rule. To be eligible for an add-on payment a new technology must meet the following three criteria:

• The medical service or technology must be new;
• The medical service or technology must be costly such that the DRG rate otherwise applicable to discharges involving the medical service or technology is determined to be inadequate; and
• The service or technology must demonstrate a substantial clinical improvement over existing services or technologies.

Once a new technology add-on payment status is granted hospitals are eligible to receive the payment for up to three years.

Increasing Add-On-Payment Amount

For FY 2019, the calculation for add-on payments is based on cost to hospitals for the new medical service or technology. Specifically, Medicare makes an add-on payment equal to the lesser of the following:

• 50% of the costs of the new medical service or technology, or
• 50% of the amount by which the costs of the case exceed the standard DRG payment.

In response to concerns from commenters and stakeholders, CMS agrees “that capping the add-on payment amount at 50 percent could, in some cases, no longer provide a sufficient incentive for the use of the technology.” As such, for discharges on or after October 1, 2019, CMS finalized their proposal to make the add-on payment be equal to the lesser of the following:

• 65% of the costs of the new medical service or technology, or
• 65% of the amount by which the costs of the case exceed the standard DRG payment.

New Technology Add-On Payment for Qualified Infectious Disease Products

CMS received comments and concerns related to antimicrobial resistance and its serious impact on Medicare beneficiaries and public health overall and finalized that for medical products designated as a Qualified Infectious Disease Product (QIDP) by the FDA, “if the costs of a discharge involving a new medical service or technology exceed the full DRG payment…Medicare will make an add-on payment equal to the lesser of (1) 75 percent of the costs of the new medical service or technology; or (2) 75 percent of the amount by which the costs of the case exceed the standard DRG payment.”

CMS Finalizes Proposal to Modernize Payment Policies for Medical Devices Meeting FDA’s Breakthrough Devices Designation

In December 2018 the U.S. Food and Drug Administration (FDA) implemented the Breakthrough Devices Program. At that time, the FDA indicated this “is a voluntary program for certain medical devices and device-led combination products that provides for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions…this program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the Agency’s mission to protect and promote public health.”

CMS finalized the proposal that “for applications received for IPPS new technology add-on payments for FY 2021 and subsequent fiscal years, if a medical device is part of the FDA’s Breakthrough Devices Program and received FDA marketing authorization, such a device would be considered new and not substantially similar to an existing technology for purposes of new technology add-on payment under the IPPS.” CMS also finalized extending this proposal to products designated by the FDA as a QIDP.

Applications for New Technology Add-On Payments for FY 2020

• For FY 2020, CMS proposed to continue 10 of 13 technologies receiving NTAP in FY 2019.
• The remaining 3 of 13 technologies receiving NTAP in FY 2019 were no longer considered “new” and have been discontinued for FY 2020.
• There were 17 new applicants for new technology add-on payment for FY 2020
• Eight of the 17 new applicants discussed in the proposed rule either withdrew their application, did not receive FDA approval by the deadline of July 1 or after evaluation CMS found they did not meet the criteria to be considered a new technology.
• Effective October 1, 2019, there will be 19 New Technologies eligible for Add-On Payments.

CMS estimates the payment amounts for new technology add-on payments in the Final Rule based on the applicant’s estimates. This amount and the estimated number of patients is highlighted in the following table:  

‍For Your Consideration

While the number of patients estimated to receive one of the FY 2020 technologies approved for add-on payments is relatively small, this is an opportunity not to be missed for those hospitals providing the service. Looking at paid claims data in RealTime Medicare Data (RTMD), it appears that not all hospitals are taking advantage of the additional payment opportunity by not including a code for these medical services or technologies on the claim. That said, some questions come to mind for you to think about:

• Is your hospital providing any of these medical services or technology?
• Who needs to be aware of what the new technologies are? (i.e. Physicians, Pharmacy, Coding Professionals, Clinical Documentation Integrity Specialists, Case Managers)
• What process do you have in place to alert your Coding Staff of the need to code the new technologies?

To help you get started, I have put together a document detailing each New Technology including a description of the technology, the ICD-10-PCS code(s) and code description and the maximum new technology add-on payment in FY 2019 and for FY 2020. To download this document, click here.

At least annually, DRG classifications and relative weights are adjusted to reflect changes in treatment patterns, technology, and other factors that may change the relative use of hospital resources. This week is the second article in our series about the 2020 IPPS Final Rule. This week highlights finalized changes to specific MS-DRG Classifications.

Pre-MDC

Extracorporeal Membrane Oxygenation (ECMO)

In FY 2019, three new procedure codes were finalized describing different types of ECMO treatments being used (central and peripheral). However, the codes were not finalized prior to the release of the FY 2019 IPPS Proposed Rule meaning there was no proposed Major Diagnostic Category (MDC), MS-DRG or O.R. vs. Non-O.R. designation made for the new codes.  

Given this unique situation, CMS Clinical Advisors reviewed the predecessor central ECMO code (5A15223) and determined the new peripheral codes should not sequence to Pre-MDC MS-DRG 3 where the central ECMO code is assigned.

Instead the new Peripheral ECMO codes were designated as Non-O.R. Procedures impacting MS-DRG assignment for specific medical MS-DRGs. The following table reflects the differences in ECMO Procedures DRG assignment:

In the FY 2020 IPPS Proposed Rule, stakeholders expressed the following concerns:

• MS-DRG assignment for ECMO should not be based on how the patient is cannulated as most of the cost can be attributed to a patient’s severity of illness,
• There was a lack of opportunity for public comment on the final MS-DRG assignments,
• Patient access to ECMO treatment and programs is now at risk because of inadequate payment, and
• CMS did not appear to have access to enough patient data to evaluate for appropriate MS-DRG assignment.

In the Final Rule CMS finalized the following proposals:

• Reassign the procedure codes describing peripheral ECMO procedures from their current MS-DRG assignments to Pre-MDC MS-DRG 003,
• Maintain the designation of the peripheral ECMO procedures as non-O.R., and
• Make changes to the titles for MS-DRGs 207, 291, 296, and 870 to no longer reflect the ECMO terminology in the title.

Allogenic Bone Marrow Transplant

A request was made to create new MS-DRGs for cases that would identify patients undergoing an allogeneic hematopoietic cell transplant (HCT) procedure according to the donor source (related or unrelated donor source). The requester indicated this would more appropriately recognize the clinical characteristics and cost differences in allogeneic HCT cases.

CMS data analysis of MS-DRG 014 cases reporting HCT related donor source, HCT unrelated donor source and unspecified donor source had comparable average length of stay and average costs. Thus, no proposal was made to create new MS-DRGs.

However, as a result of CMS’ review of procedure codes they proposed and finalized:

• The reassignment of 4 ICD-10-PCS codes for HCT procedures specifying autologous cord blood stem cell as the donor source from MS-DRG 014 to MS-DRGs 016 and 017, and
• Delete 128 clinically invalid codes from the transfusion table describing arterial access as transfusion procedures always use venous access rather than arterial access.

Chimeric Antigen Receptor (CAR) T-Cell Therapy

“Chimeric Antigen Receptor (CAR) T-cell therapy is a cell-based gene therapy in which a patient’s own T-cells are genetically engineered in a laboratory and used to assist in the patient’s treatment to attack certain cancerous cells. Blood is drawn from the patient and the T-cells are separated. The laboratory then utilizes the CAR process to genetically engineer the T-cells, resulting in the addition of a chimeric antigen receptor that will bind to a certain protein on the patient’s cancerous cells. The CAR T-cells are then administered to the patient by infusion.”

Two CAR T-cell therapy drugs received FDA approval in 2017 (KYMRIAH™ manufactured by Novartis Pharmaceuticals Corporation and YESCARTA™ manufactured by Kite Pharma, Inc.). Current ICD-10-PCS procedures codes involving the CAR T-cell therapy drugs includes:

• XW033C3 (Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into peripheral vein, percutaneous approach, new technology group 3), and
• XW043C3 (Introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into central vein, percutaneous approach, new technology group 3).

Both ICD-10-PCS procedure codes became effective October 1, 2017 and are designated as non-O.R. procedures impacting MS–DRG assignment.

In FY 2019 CMS finalized the assignment of these procedure codes to Pre-MDC MS-DRG 016, revise the title of MS-DRG 016 to include “or T-cell immunotherapy,” and Car T-cell therapy was approved for a new technology add-on payment.

In the FY 2020 IPPS Proposed Rule, a request was made to create new MS-DRGs for CAR T-cell therapy. CMS does not believe enough data is available to make a change at this time. However, CMS has finalized the continuation of CAR-T cell therapy being eligible for new technology and add-on payments for FY 2020.

MDC 1: Diseases and Disorders of the Nervous System

Carotid Artery Stent Procedures

Current logic for case assignment to MS-DRGs 034, 035, and 036 (Carotid Artery Stent Procedures with MCC, with CC, and without CC/MCC respectively) “is comprised of two lists of logic that include procedure codes for operating room (O.R.) procedures involving dilation of a carotid artery (common, internal or external) with intraluminal device(s).”

CMS identified 46 ICD-10-PCS procedures codes in the second list that do not describe dilation of a carotid artery with intraluminal device. CMS finalized the proposal to remove these 46 codes from MS-DRGs 034, 035 and 036.

These 46 ICD-10-PCS codes are also assigned to MS-DRGs 037, 038, and 039 (Extracranial Procedures with MCC, with CC, and without CC/MCC, respectively.) Therefore, CMS also examined claims data for this MS-DRG group and finalized their proposals to:

• Remove 96 ICD-10-PCS procedure codes describing dilation of a carotid artery with an intraluminal device from the logic for MS-DRG group 037-038 and 039,
• Reassign 6 ICD-10-PCS procedure codes describing dilation of a carotid artery with an intraluminal device from MS-DRG group 037, 038 and 039 to MS-DRG group 034, 035, and 036,
• Delete 48 procedure codes from MS-DRGs 037, 038, and 039 that include the qualifier term “bifurcation;” and
• Combining all procedure codes identifying a carotid artery stent procedure within MS-DRGs 034, 035, and 036 into one list entitled “Operating Room Procedures” to better reflect the definition of the MS-DRGs.

MDC 4: Diseases and Disorders of the Respiratory System

Pulmonary Embolism

A request was made to reassign the following three ICD-10-CM diagnosis codes for Pulmonary Embolism (PE) with acute core pulmonale from MS-DRG 176 (PE without MCC) to MS-DRG 175 (PE with MCC):

• I26.01 – Septic pulmonary embolism with acute cor pulmonale,
• I26.02 – Saddle embolus of pulmonary artery with acute cor pulmonale, and
• I26.09 – Other pulmonary embolism with acute cor pulmonale.

The requestor noted with the FY 2019 IPPS Final Rule special logic change where a Principal Diagnosis could no longer be its own CC or MCC this resulted in these three codes being assigned to MS-DRG 176 when no other MCC is present. The requestor stated MS-DRG 176 does not appropriately account for cost and resource utilization associated with these cases.

CMS claims analysis supported the requestor’s statement about cost and resource utilization. CMS has finalized their proposals to:

• Reassign cases reporting diagnosis codes I26.01, I26.02 and I26.09 to MS-DRG 175, and
• Revise the MS-DRG 175 title to “Pulmonary Embolism with MCC or Acute Cor Pulmonale.”

The difference in relative weight (RW) and Geometric Mean Length of Stay (GMLOS) are reflected in the following table.

‍MDC 5: Diseases and Disorders of the Circulatory System

Transcatheter Mitral Valve Repair (TMVR) with Implant

CMS received a request to modify the current MS-DRG assignment for TMVR with implant procedures (MS-DRG 228 and 229: Other Cardiothoracic Procedures with MCC and without MCC, respectively). The requestor believed that TMVR is more similar to the replacement procedures in MS-DRGs 266 and 267 compared to other procedures currently assigned to MS-DRGs 228 and 229 and “noted that both TMVR procedures and endovascular cardiac valve replacements use a percutaneous approach, treat cardiac valves, and use an implanted device for purposes of improving the function of the specified valve.”

In the Proposed Rule CMS indicated “Our clinical advisors continue to believe that transcatheter cardiac valve repair procedures are not the same as a transcatheter (endovascular) cardiac valve replacement.

However, they agree with the requestor and, based on our data analysis, that these procedures are more clinically coherent in that they also describe endovascular cardiac valve interventions with implants and are similar in terms of average length of stay and average costs to cases in MS-DRGs 266 and 267 when compared to other procedures in their current MS-DRG assignment. For these reasons, our clinical advisors agree that we should propose to reassign the endovascular cardiac valve repair procedures (supplement procedures)…to the endovascular cardiac valve replacement MS-DRGs.”

CMS finalized the following proposals:

• Modify the structure of MS-DRGs 266 and 267 by reassigning the procedure codes describing transcatheter cardiac valve repair (supplement) procedure,
• Revise the title of MS-DRG 266 from “Endovascular Cardiac Valve Replacement with MCC” to “Endovascular Cardiac Valve Replacement and Supplement Procedures with MCC,”
• Revise the title of MS-DRG 267 from “Endovascular Cardiac Valve Replacement without MCC” to “Endovascular Cardiac Valve Replacement and Supplement Procedure without MCC,”
• Create two new MS-DRGs with a two-way severity split for the remaining (non-supplement) transcatheter cardiac valves.
• MS-DRG 319 (Other Endovascular Cardiac Valve Procedures with MCC), and
• MS-DRG 320 (Other Endovascular Cardiac Valve Procedures without MCC).

Pacemaker Leads

CMS noted that ICD-10-PCS procedure code 02H60JZ (Insertion of pacemaker lead into right atrium, open approach) was inadvertently omitted from the GROUPER logic for MS-DRGs 260, 261, and 262. They finalized adding this procedure code to the list of Non-O.R. procedures that would impact MS-DRGs 260, 261, and 262 when reported as a stand-alone procedure code.

MDC 8: Diseases and Disorders of the Musculoskeletal System and Connective Tissue

Knee Procedures with Principal Diagnosis of Infection

In FY 2019 ICD-10-CM diagnosis codes M00.9 (Pyogenic arthritis, unspecified) and A54.42 (Gonococcal arthritis) grouped to MS-DRGs 488 and 489 (Knee Procedures without Principal Diagnosis of Infection with and without CC/MCC, respectively) when a knee procedure is reported on the claim.

CMS received a request to add these two codes to the list of principal diagnoses for MS-DRGs 485, 486, 487 (Knee Procedure with Principal Diagnosis of Infection with MCC, with CC, and without CC/MCC, respectively).  

CMS finalized the following:

• Add both codes to the list of principal diagnosis codes for MS-DRGs 485, 486 and 487,
• Add 10 additional ICD-10-CM diagnosis codes specific to the knee and describing an infection; and
• Remove 8 ICD-10-CM diagnosis codes from the list of principal diagnosis for MS-DRG 485, 486 and 487 as they do not describe an infection of the knee.

Scoliosis: Neuromuscular and Secondary Scoliosis and Kyphosis

Requests were made to add ICD-10-CM diagnosis codes describing neuromuscular scoliosis, secondary scoliosis and secondary kyphosis to the list of principal diagnosis codes for MS-DRGs 456, 457, and 458 (Spinal Fusion except Cervical with Spinal Curvature or Malignancy or Infection or Extensive Fusions with MCC, with CC, without CC/MCC, respectively).

CMS finalized their proposals to:

• Add 5 codes describing neuromuscular scoliosis and 8 codes describing secondary scoliosis and secondary kyphosis to the list of principal diagnosis codes for MS-DRGs 456, 457, and 458; and
• Remove 34 ICD-10-CM diagnosis codes describing conditions involving the cervical region from MS-DRGs 456, 457, and 458.

MDC 11: Diseases and Disorders of the Kidney and Urinary Tract

Extracorporeal Shock Wave Lithotripsy (ESWL)

Data analysis revealed a steady decline in inpatient cases reporting urinary stones and an ESWL procedure over the past five years. CMS indicated in the proposed rule that due to an ESWL procedure being a Non-O.R. procedure and the decreased usage of this procedure in the inpatient setting, clinical advisors believe there is no longer a reason to subdivide the MS-DRGs for urinary stones (MS-DRGs 691 &692, and 693 & 694) based on ESWL procedures.

CMS finalized their proposals to:

• Delete MS-DRGs 691 and 692 (Urinary Stones with ESW Lithotripsy with CC/MCC and without CC/MCC respectively); and
• Revise the MS-DRG title for MS-DRGs 693 and 694 from “Urinary Stones without ESW Lithotripsy with MCC” and “without MCC”, respectively to “Urinary Stones with MCC” and “Urinary Stones without MCC.”

MDC 12: Diseases and Disorders of the Male Reproductive System

In FY 2019, four ICD-10-CM diagnosis codes (R93.811, R93.812, R93.813, and R93.819) describing body parts with male anatomy grouped to in MS-DRGs 302 and 303 (Atherosclerosis with MCC and without MCC, respectively) in MDC 5 (Diseases and Disorders of the Circulatory System).

Based on a request and claims data analysis, CMS finalized the reassignment of these four codes from MDC 5 in MS-DRGs 302 and 303 to MS-DRGs 729 and 730 (Other Male Reproductive System Diagnosis with CC/MCC and without CC/MCC, respectively) in MDC 12.

MDC 14: Pregnancy, Childbirth and the Puerperium

Reassignment of Diagnosis Code 099.89 (Other specified Diseases and Conditions complicating pregnancy, childbirth and the puerperium)

CMS finalized their proposal to reclassify ICD-10-CM diagnosis code 099.89 (Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium) from a postpartum condition to an antepartum condition.

Coding logic will now assign a case with an O.R. procedure and this code to MS-DRGs 817, 818, or 819 (Other Antepartum Diagnoses with O.R. Procedure with MCC, with CC, and without CC/MCC, respectively). When no O.R. procedure is reported on the claim, the logic will assign the case to MS-DRGs 831, 832, and 833 (Other Antepartum Diagnoses without O.R. Procedure with MCC, with CC, and without CC/MCC, respectively).

MDC 23: Factors Influencing Health Status and Other Contacts with Health Services

Assignment of Diagnosis Code R93.89 (Abnormal finding on diagnostic imaging of other specified body structures)

There was a request to reassign ICD-10-CM diagnosis code R93.89 from MS-DRGs 302 and 303 (Atherosclerosis with MCC and without MCC, respectively) in the Circulatory MDC 5 to MDC 23.

CMS finalized their proposal to reassign this diagnosis code to MS-DRGs 947 and 948 (Signs and Symptoms with MCC and without MCC, respectively).

Review of Procedure Codes in MS-DRGS 981 through 983 and 987 through 989

Adding Procedures Codes Currently Grouping to MS-DRGS 981 – 983 and 987 – 989 into MDCs

Annually, CMS conducts a review of procedures resulting in assignment to the O.R. and non-extensive O.R. Procedures Unrelated to Principal Diagnosis MS-DRG Groups (981-983 and 987-989). This review is done on the basis of volume, by procedure, to see if it is more appropriate to move a procedure to a surgical MS-DRG for the MDC where the Principal Diagnosis falls.

Several proposals were made and finalized for FY 2020 to move diagnosis and procedure codes back into a specific MDC including:

• Gastrointestinal stromal tumors (GIST),
• Peritoneal dialysis catheter complications codes,
• Bone excision with pressure ulcers codes,
• Lower extremity muscle and tendon excision codes,
• Insertion of feeding device code,
• Basilic vein reposition in chronic kidney disease codes; and
• Colon Resection with Fistula code 0DTN0ZZ.

You can access the Final Rule and related tables on the FY 2020 IPPS Final Rule Home Page.