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I am so excited about this, that I have to mention it. Cooler weather has finally made its way to the deep South. Now granted, at the time of the writing of this article, this means mid-80’s, but anything beats the sweltering heat of the last few weeks with record-setting temperatures in September and October. In fact, September was the hottest September ever. As the weather cools, so does the temperature of lakes, rivers, the ocean in coastal regions, and even backyard pools. If you plan to go for a swim at this time of year, it is a good idea to test the waters first so you will be prepared for that chilly plunge. Evidently, some Medicare Administrative Contractors (MACs) are “testing the waters” before announcing their Targeted Probe and Educate (TPE) issues. For example, Palmetto GBA, the MAC for Jurisdictions J and M, finally added the topic of DRG 460, Spinal Fusion, to their list of TPE Active Medical Reviews in September although providers in these jurisdictions have been receiving letters for months with the following wording:

“Your organization was selected for review based on Internal Data Analytics. A prepayment review has been initiated to probe a sample of your claims billed with the following DRG 460 code(s): DRG 460 – Spinal Fusion except Cervical without MCC”

One of the major concerns with spinal fusion surgery is that it is not always effective. From the Mayo Clinic website, “Spinal fusion is typically an effective treatment for fractures, deformities or instability in the spine. But study results are more mixed when the cause of the back or neck pain is unclear. In many cases, spinal fusion is no more effective than nonsurgical treatments for nonspecific back pain.” This puts a greater burden on providers in selection of this treatment option and the documentation requirements from Medicare to support this service. The Palmetto Spinal Fusion LCD includes a requirement for, where possible, a documented shared decision making with the patient or patient rep “with the appropriate discussion of anticipated risks and benefits of the procedure.”

The questionable efficacy of spinal fusion over nonsurgical treatments for certain indications also causes Medicare to require conservative treatments be tried and failed or contraindicated before moving on to surgery. Again, from the Palmetto LCD – “The medical record must clearly reflect which conservative treatments the patient has tried or is not a candidate for and why, including medical therapies, physical and exercise therapies and injections.” The problem here for hospital providers is that this information is generally located in the physician’s office record and not always addressed in detail in the hospital H&P. Palmetto also released an article earlier this year that discussed claim denial reasons – “By far the most common reason for denial has been a lack of specific information about conservative care before the surgical intervention. Statements such as: ‘Failed outpatient therapy, admit for spinal fusion’ are simply not sufficient evidence of medical necessity for the admission or the surgery.” The Palmetto article includes suggestions for hospitals and physicians to ensure documentation is complete.

• Hospitals may want to proactively obtain the necessary documentation from the physician office record, radiologic results, therapy treatment notes, therapeutic procedures and other documentation supporting the medical necessity of the surgery. If this documentation is not made part of the hospital record at the time of admission, be sure to have processes in place to gather this information before responding to a data request for records from a Medicare contractor.
• “Practitioners should either create clinically meaningful inpatient records or supply the hospital with relevant documents from their outpatient records.”

Pulling from the Palmetto article and the LCD referenced above, here is a list of the elements that should be included in your documentation.

• History of illness from onset to decision for surgery
• Such as H&P from physician’s office notes, progress notes, documentation of progression of condition
• Prior courses of treatment and results
• Such as previous non-surgical treatment, including, but not limited to physical and/or occupational therapy, joint injections, analgesics, and assistive devices
• Current symptoms and functional limitations
• Such as neurological deficits, upper or lower extremity strength, activity limitations and modification, and pain levels
• Physical exam detailing objective findings supporting history of illness
• Such as patient history and physical exam
• Results of special tests
• Such as diagnostic test results and interpretations, such as MRI

• Shared decision-making
• Such as a physician office note detailing the physician’s discussion with the patient about the risks and benefits of the surgery and documenting the patient’s decision to proceed

MMP reached out to Palmetto to see if there were any additional requirements for the shared decision-making. Palmetto responded that, “It is generally accepted in medicine that patients should be educated about any procedure they are undergoing, and that the patients should provide informed consent for the procedure. Our expectation would be that this general requirement be met for lumbar spinal fusion as it would be met for other invasive procedures.”

Hospital providers may want to “test the waters” themselves by proactively reviewing their own records to see if the documentation is sufficient to support the medical necessity and other requirements of an admission for spinal fusion surgery. First, educate yourself on the requirements by reviewing your MAC’s LCD and coverage articles and any other education resources from your MAC for documentation tips and suggestions. If you need more information, check out the websites of other MACs and look for articles on-line – just be careful that your sources are credible. Secondly, perform some reviews of records to determine if all the necessary documentation is present. These reviews can be done by internal staff (maybe Compliance) or by a trusted external consultant. Finally, if shortcomings are identified in the reviews, institute processes and procedures and educate those involved on what is needed for complete and compliant documentation.

Q:

Does Medicare Part B cover tetanus vaccinations?

A:

Yes, but not as a preventive service. Tetanus vaccinations are eligible for Medicare Part B coverage when they are directly related to the treatment of an injury or direct exposure to a disease or condition. Claims including tetanus vaccinations must include the proper procedure and diagnosis codes to support the medical necessity for the vaccination. According to a recent article by First Coast, the Medicare Administrative Contractor (MAC) for Jurisdiction N, “Claims must be coded to the highest level of specificity, with related documentation supporting what’s been billed (i.e., specific body part where injury occurred). If no appropriate diagnosis code is present, First Coast will deny the claim as not medically necessary.” The article goes on to list a few examples of ICD-10-CM codes identifying injuries that Medicare allows for tetanus vaccinations.

The First Coast article also explains that routine tetanus vaccination services are not covered by Medicare. “If you are billing for a routine tetanus vaccination, it is recommended to append the GY modifier. This modifier is defined via the Healthcare Common Procedure Coding System as identifying an ‘Item or service statutorily excluded’ or ‘Does not meet the definition of any Medicare benefit.’ Lines with this modifier are thereby submitted as non-covered and will be denied.”

Medicare does cover some routine vaccinations:

• Influenza Virus Vaccine is covered once a flu season. A physician’s order is not required for a patient to obtain a flu shot.
• Pneumococcal Pneumonia Vaccine – CDC recommends pneumococcal vaccination (PCV13 or Prevnar13®, and PPSV23 or Pneumovax23®) for all adults 65 years or older:
• Give a dose of PCV13 to adults 65 years or older who have not previously received a dose. Then administer a dose of PPSV23 at least 1 year later.
• If the patient already received one or more doses of PPSV23, give the dose of PCV13 at least 1 year after they received the most recent dose of PPSV23.
• Medicare covers both of these vaccines and a physician’s order is not required.
• Hepatitis B Vaccine – Medicare provides coverage under Part B for hepatitis B vaccine and its administration, furnished to a Medicare beneficiary who is at high or intermediate risk of contracting hepatitis B.

Refer to Section 50.4.4.2 – Immunizations of Chapter 15 of the Medicare Benefit Policy Manual for more information on routine immunizations.

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.

Q:

Are there any updates for rehabilitative therapy services’ threshold amounts for the coming year?

A:

Yes. MLN Matters Article MM11532 updates the annual per-beneficiary incurred expenses amounts now called the KX modifier thresholds and related policy for CY 2020. These thresholds were previously known as “therapy caps.” For CY 2020, the KX modifier threshold amounts are:

1. $2,080 for Physical Therapy (PT) and Speech-Language Pathology (SLP) services combined, and
2. $2,080 for Occupational Therapy (OT) services.

Providers can track a patient’s year-to-date therapy amounts on Medicare eligibility screens. The KX modifier must be appended to therapy services’ line-items on the claim for medically necessary therapy services above the threshold amounts. The medical necessity of services beyond the threshold amount must be justified by appropriate documentation in the medical record. Services provided beyond the threshold that are not billed with the KX modifier will be denied with Claim Adjustment Reason Code 119 - Benefit maximum for this time period or occurrence has been reached.

There is also a therapy threshold related to the targeted medical review process, now known as the Medical Record (MR) threshold amount. This threshold remains at $3,000 for PT and SLP combined and a separate $3,000 for OT for CY 2020. Not all therapy services exceeding the $3,000 thresholds will be reviewed. CMS will analyze data to select claims exceeding this threshold for review.

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.

Q:

Is it appropriate to bill Medicare for a therapy evaluation and therapy treatment on the same day of service?

A:

Yes, it is appropriate to bill these services on the same day as long as they are separate and distinct – that means each service is provided separately in its own time period.

Here is wording from Section 220.1.2 A of Chapter 15 of the Medicare Benefit Policy Manual (https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf) - see page 163.

 “Treatment under a Plan.  The evaluation and treatment may occur and are both billable either on the same day or at subsequent visits.  It is appropriate that treatment begins when a plan is established.”

 The therapy evaluation must be done first and a plan of care established. Then it would be appropriate to provide and bill for the treatment. There are usually no CCI edits for these combinations of codes, but check to be sure, and only use a modifier if required.

Q:

What HCPCS code do we report for the drug Khapzory?

A:

For dates of service on or after October 1, 2019, use HCPCS code J0642 for levoleucovorin injection products marketed under the brand name of Khapzory.

According to the KHAPZORYTM website, it is a folate analog indicated for:

• Rescue after high-dose methotrexate therapy in patients with osteosarcoma.
• Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination.
• Treatment of patients with metastatic colorectal cancer in combination with fluorouracil.

Khapzory is the first levoleucovorin product approved by the FDA that contains sodium in its formulation.

Levoleucovorin is also available as the brand name Fusilev (levoleucovorin, calcium) and its generic equivalent (levoleucovorin). These drugs are reported with HCPCS code J0641 effective October 1, 2019. This replaces HCPCS code C9043 as noted in the October OPPS Update. On Monday, September 30, 2019, CMS released a Special Edition of MLN Connects instructing the use of J0642 for the brand Khapzory.

Khapzory and Fusilev are not approved for the treatment of pernicious anemia or megaloblastic anemias.

Providers may want to check payers’ policies concerning the use of these drugs as some payers limit the use of levoleucovorin to when there are shortages of leucovorin, which there currently is. You can check for drug shortages on the FDA website. Also, some payers require providers to use the least costly levoleucovorin product.

Q:

Our hospital sometimes receives automated medical necessity denials related to a National Coverage Determination (NCD). Where can I find a listing of the acceptable ICD-10 diagnosis codes that support medical necessity for services with an NCD?

A:

Although a listing of the covered diagnoses is not available for all NCDs, you can find many of them on CMS’s Medicare Coverage General Information ICD-10.  At the bottom of the page, there is a table, “Links related to ICD-10 NCDs (as of 05/13/2019).” This table contains links to all the transmittals concerning code changes for NCDs “related to ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.”

The easiest way to find code edits for a particular NCD is to do a search for the NCD number on this webpage. Select “Find” from the Menu option or “Control+F,” and enter the NCD number in the search box. If you need to find the current ICD-10 requirements for a service, choose the latest transmittal by date that contains the NCD number you are looking for. If you are looking for the requirements for a certain point in time, select the transmittal that addresses the relevant NCD and is from the last transmittal date prior to the date you are interested in.

Once you select the correct transmittal, find the link in the transmittal to the NCD spreadsheets included with the related Change Request Transmittal (CR). This will open a file with spreadsheets for all the NCDs with revisions at the time of the date of the transmittal. Select the NCD/service you are researching and open the spreadsheet. The spreadsheets have tabs for “ICD Diagnosis,” “ICD Procedures,” and “Rule Description” which contain the expected information. Medicare contractors use these edit tables to control Medicare coverage with automated denials if a required diagnosis is not present on the claim. Being aware of the specific codes required can assist hospitals in being proactive about Medicare coverage with education and the use of Advance Beneficiary Notices (ABNs).

Notice in the title of the table referenced above, that the title includes an “as of” date. For dates after the as of date, I recommend searching the current transmittal listing for the term “NCD” or “ICD-10.” Also sign up for Medicare transmittal updates through Medicare’s Listserv Signup so that you will aware for any changes in these edits and other Medicare information. At the link above, scroll to the bottom right of the page to find a “Receive Email Updates” box where you can enter your email address to receive updates.

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.