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Medicare Coverage Requirements for Vagus Nerve Stimulation
Published on Jul 24, 2018
20180724

Several years ago, our neighbor gave us a “stick” to plant. He said it was a fig tree. My husband and I were both doubtful this stick would ever become anything, let alone a fig tree. That fig tree is now about 12 feet around and 15 feet high, loaded with beautiful, sweet figs. It is so tall in fact that I have to have a ladder to gather the fruit growing up high. I often however, pick the low-hanging fruit as I pass by the tree. As well as the reality of my fig tree, “low-hanging fruit” is a saying for all easily obtained gains.

CMS quarterly publishes the Provider Compliance Newsletter about common billing errors and other erroneous activities related to Medicare Fee-for-Service (FFS) program. The newsletter provides examples of errors and offers tips on ways to avoid them. Articles identify the types of providers affected by the issues, such as physicians, non-physician practitioners, outpatient hospital, etc. as well as whether the errors were identified by the Comprehensive Error Rate Testing (CERT) program or by the Recovery Auditors (RACs). It is also not unusual for other types of Medicare reviewers, especially the Medicare Administrative Contractors (MACs), to select issues identified by the CERT or RACs for their medical review activities. High-risk issues can be easy “low-hanging fruit” for finding overpayments to recoup.

The July 2018 Medicare Quarterly Provider Compliance Newsletter includes an article related to outpatient hospital services concerning Medicare coverage of vagus nerve stimulation (VNS). This was at one time an issue being reviewed by the Recovery Auditors. Vagus Nerve Stimulation is a pulse generator,

surgically implanted under the skin of the left chest and connected to the left vagus nerve. Electrical signals sent from the battery-powered generator to the vagus nerve via the lead are in turn sent to the brain. VNS is used to treat certain types of epilepsy.

In July 1999, Medicare issued a National Coverage Determination (NCD) allowing coverage of VNS for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed. The coverage is specifically limited to “partial onset” seizures and other types of seizures are not covered. In May 2007, CMS issued an additional non-coverage decision for the use of VNS for patients with resistant depression.

This means VNS is only covered for patients with medically refractory partial onset seizures for whom surgery is not recommended or for whom surgery has failed. If you provide VNS for other types of seizures (not partial onset) or for resistant depression, Medicare will not cover the VNS. Specifically, one of the following diagnosis codes must be reported for Medicare to cover VNS:

  • G40.011 Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable, with status epileptic
  • G40.019 Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable, without status epilepticus
  • G40.111 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, intractable, with status epilepticus
  • G40.119 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with simple partial seizures, intractable, without status epilepticus
  • G40.211 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable, with status epilepticus
  • G40.219 Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable, without status epilepticus

Outpatient hospitals need to have systems in place to verify VNS is being performed for an appropriate, covered indication for their Medicare patients. If VNS is used for non-covered indications, inform the patient with an Advance Beneficiary Notice (ABN) so the patient understands they are financially liable for payment. This will allow your facility to avoid being “low-hanging fruit” for recoupments.

Debbie Rubio

May Medicare Transmittals and Other Updates
Published on May 29, 2018
20180529

MEDICARE TRANSMITTALS

Revisions to the Telehealth Billing Requirements for Distant Site Services

Implements requirements for billing modifier GT for Telehealth Distant Site Services. As of January 1, 2018, the GT modifier is only allowed on institutional claims billed by a Critical Access Hospital (CAH) Method II.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10583.pdf

Implementation of Changes to the Pre-Payment Additional Documentation Request (ADR) Letters for Medical Review

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R2083OTN.pdf

Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10642.pdf

Updates to Publication 100-04, Chapters 1 and 27, to Replace Remittance Advice Remark Code (RARC) MA61 with N382

MACs will use N382 in place of MA61 to communicate reject/denials for patient identifiers (HICN or MBI) in all remittance advices and 835 transactions. However, MACs will continue to use RARC MA61 only when/if communicating rejections/denials related to a missing/incomplete/invalid social security number.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10619.pdf

Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital (LTCH) PPS Extensions per the Advancing Chronic Care, Extenders, and Social Services (ACCESS) Act Included in the Bipartisan Budget Act of 2018

Information and implementation instructions for:

  • Section 50204 – Extension of Increased Inpatient Hospital Payment Adjustment for Certain Low-Volume Hospitals
  • Section 50205 – Extension of the Medicare-Dependent Hospital (MDH) Program
  • Section 51005 – Adjustments to the LTCH Site Neutral Payment Rate

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10547.pdf

Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) – REVISED

The article was revised on May 15, 2018, to clarify that one of the requirements of the SET program is it must be conducted in a hospital outpatient setting or in a physician’s office.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10295.pdf

Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes – July 2018 Update – REVISED

A sentence is added to show that Part B payment for Q9995 includes the clotting factor furnishing fee.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10624.pdf

Intent to Reopen

Provides instructions for contractors to: provide notification of the reopening process and to notify the provider or supplier of their intent to reopen a specific claim when requested documentation is received after a denial of the claim has been made.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R796PI.pdf

Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNmattersArticles/downloads/MM10620.pdf

Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) - July 2018 Update

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNmattersArticles/downloads/MM10644.pdf

 

MEDICARE COVERAGE UPDATES

 International Classification of Diseases, Tenth Revision (ICD-10) and Other Coding Revisions to National Coverage Determinations (NCDs)

CR10622 makes coding and clarifying adjustments to the following NCDs:

  • NCD 110.18 Aprepitant
  • NCD 150.3 Bone Mineral Density Studies
  • NCD 190.11 Prothrombin Time/International Normalized Ratio (PT/INR)
  • NCD 220.6.16 Positron Emission Tomography (PET) for Infection/Inflammation
  • NCD 220.6.17 PET for Solid Tumors
  • NCD 220.13 Percutaneous Image-Guided Breast Biopsy

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNmattersArticles/downloads/MM10622.pdf

 

MEDICARE PRESS RELEASES

CMS Announces Agency’s First Rural Health Strategy

The agency’s first Rural Health Strategy intended to provide a proactive approach on healthcare issues to ensure that the nearly one in five individuals who live in rural America have access to high quality, affordable healthcare.

https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018-Press-releases-items/2018-05-08.html

CMS Unveils Enhanced “Drug Dashboards” to Increase Transparency on Drug Prices

For the first time, the dashboards include year-over-year information on drug pricing and highlight which manufactures have been increasing their prices.

https://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-releases/2018-Press-releases-items/2018-05-15.html

 

MEDICARE EDUCATIONAL RESOURCES

Palmetto JM Provider Contact Center (PCC) Frequently Asked Questions (FAQs): January 2018 - April 30, 2018

https://www.palmettogba.com/palmetto/providers.nsf/ls/JM%20Part%20A"AYKQC62336?opendocument&utm_source=J11AL&utm_campaign=JMALs&utm_medium=email

MLN Fact Sheet Complying with Medicare Signature Requirements

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/Signature_Requirements_Fact_Sheet_ICN905364.pdf

Targeted Probe and Educate Video

https://my.happify.com/hd/why-gratitude-is-the-best-gift-we-can-give-our-children/?et=e2e969ce-70c2-474e-873b-a6e3fb839cf1

 

MEDICARE RULES

 Hospital IPPS and LTC 2019 FY Proposed Rule

The proposed rule proposes updates to Medicare payment policies and rates under the Inpatient Prospective Payment System (IPPS) and the Long-Term Care Hospital (LTCH) Prospective Payment System (PPS). Also includes proposal concerning Quality Programs, EHR Incentive Programs, Cost-Reporting and Physician Claim Certifications.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-08705.pdf

Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities (SNF) Proposed Rule for FY 2019, SNF Value-Based Purchasing Program, and SNF Quality Reporting Program

This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2019.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-09015.pdf

Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2019

This proposed rule would update the prospective payment rates for inpatient rehabilitation facilities (IRFs) for federal fiscal year (FY) 2019.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-08961.pdf

FY 2019 Inpatient Psychiatric Facilities Prospective Payment System and Quality Reporting Updates for Fiscal Year Beginning October 1, 2018 (FY 2019)

This proposed rule would update the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs), which include psychiatric hospitals and excluded psychiatric units of an acute care hospital or critical access hospital.

https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-09069.pdf

 

OTHER MEDICARE UPDATES

Kepro Case Review Connections, Acute Care Edition, Spring 2018

A quarterly e-newsletter from your Beneficiary and Family Centered Care Quality Improvement Organization (BFCC-QIO).

https://www.keproqio.com/providers/spring-2018-acute-newsletter/

Trump Administration Releases Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs

https://www.hhs.gov/about/news/2018/05/11/trump-administration-releases-blueprint-lower-drug-prices-and-reduce-out-pocket-costs.html

April Medicare Transmittals and Other Updates
Published on Apr 24, 2018
20180424

MEDICARE TRANSMITTALS

Adjustments to Qualified Medicare Beneficiary (QMB) Claims Processed Under CR 9911

Directs MACs to mass adjust QMB claims impacted by CR9911.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10494.pdf

April 2018 Integrated Outpatient Code Editor (I/OCE) Specifications Version 19.1 – REVISED

Revised to correct the status indicator for the drug code J0606 from SI=G to SI=K.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10514.pdf

April 2018 Update of the Hospital Outpatient Prospective Payment System (OPPS) - REVISED

Updated the number of drugs and biologicals with OPPS pass-through status effective April 1, 2018, from twelve to eleven and removed HCPCS code J0606, Injection, etelcalcetide, 0.1 mg, from Table 5, Attachment A in the CR since its status indicator remains "K" for the April update.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10515.pdf

Claims Processing Actions to Implement Certain Provisions of the Bipartisan Budget Act of 2018

Provides direction to MACs to reprocess claims related to several provisions of the Bipartisan Budget Act of 2018, specifically the Ambulance add-on payment provisions, the Work Geographic Practice Cost Index (GPCI) Floor, the 3% Home Health (HH) Rural Add-on Payment, and the repeal of outpatient therapy caps with requirement to submit the KX modifier for services in excess of the prior cap amounts.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10531.pdf

Institutional Billing for No Cost Items

Provides clarification of the billing instructions specific to drugs provided at no cost when claims processing edits prevent drug administration charges from being billed when the claim does not contain a covered/billable drug charge.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10521.pdf

New Waived Tests

New Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the Food and Drug Administration (FDA).
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10586.pdf

Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) – REVISED

Clarifies that the SET program must be provided in a physician’s office (Place of Service code 11).
NOTE:  MMP contacted CMS and was informed another revision of this CR would be forthcoming.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10295.pdf

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 24.2 Effective July 1, 2018

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10593.pdf

Change in Type of Service (TOS) for Current Procedural Terminology (CPT) Code 77067

Corrects the TOS indicator assigned to CPT code 77067 – Screening Mammography to “1” instead of “4” to allow screening mammography claims to be billed without referring physician information on the claim, consistent with Medicare’s coverage policy for screening mammograms.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10607.pdf

Notice of New Interest Rate for Medicare Overpayments and Underpayments - 3rd Qtr Notification for FY 2018

Medicare contractors shall implement an interest rate of 10.25 percent effective April 17, 2018 for Medicare overpayments and underpayments.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R303FM.pdf

Internet Only Manual Update to Pub 100-04, Chapter 16, Section 40.8 - Date of Service Policy

Updates the Date of Service (DOS) Policy for Clinical Laboratory and Pathology Specimens
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4000CP.pdf

Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes – July 2018 Update

Quarterly update of drug/biological HCPCS codes.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNmattersArticles/downloads/MM10624.pdf

 

MEDICARE SPECIAL EDITION ARTICLES

Prohibition Billing Dually Eligible Individuals Enrolled in the Qualified Medicare Beneficiary (QMB) Program - REVISED

Updates information about the Remittance Advice (RA) and Medicare Summary Notice (MSN) for all Medicare Fee-For-Service (FFS) QMB claims and includes new statistics on the number of beneficiaries enrolled in QMB.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1128.pdf

Proper Coding for Specimen Validity Testing Billed in Combination with Drug Testing

Reminds laboratories and other providers performing validity testing on urine specimens utilized for drug testing not to separately bill the validity testing.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE18001.pdf

 

MEDICARE COVERAGE UPDATES

Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R4)

Evidence is sufficient to conclude that magnetic resonance imaging (MRI) for Medicare beneficiaries with an implanted pacemaker (PM), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), or cardiac resynchronization therapy defibrillator (CRT-D) is reasonable and necessary. Will modify current NCD to eliminate the collection of additional information under the Coverage with Evidence Development paradigm.
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=289&TimeFrame=7&DocType=All&bc=AgAAYAAAQAAA&

 

OTHER MEDICARE UPDATES

New Proposed RAC Review Topics – April 2018

April 2018 proposed topics include:

  • Exact Duplicate Claims
  • Implantable Automatic Defibrillators
  • Group 3 Support Surfaces
  • Percutaneous Implantation of Neurostimulator Electrode Array

https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Recovery-Audit-Program/Provider-Resources.html

March Patients Over Paperwork Newsletter

https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/Downloads/MarchPoPNewsletter032618.pdf

New OIG Compliance Resource Portal

OIG launches new compliance resource portal that provides links to handy resources for the public that can help ensure that you are in compliance with Federal health care laws.
https://oig.hhs.gov/compliance/compliance-resource-portal/

Palmetto GBA and Observation Services
Published on Apr 17, 2018
20180417

“Observation care services are covered only when provided by the order of a physician or another individual authorized by state licensure law and hospital staff bylaws to admit patients to the hospital or to order outpatient tests. These services must be deemed reasonable and necessary to be covered by Medicare. Please share with appropriate staff.”

  • Source: Palmetto GBA JJ April 10, 2018 Daily Newsletter

Palmetto GBA, the Jurisdiction J (JJ) Medicare Administrative Contractor (MAC) included the above statement in their April 10, 2018 Daily Newsletter. The reminder also included a link to an article about Observation Care on the Palmetto GBA website.

Given that Palmetto GBA started the conversation, MMP would also like to make appropriate staff aware of the fact that there is a new JJ Outpatient Observation Bed/Room Services (L34552) Local Coverage Determination (LCD). This article will walk you through LCD L34552.

LCD Coverage Indications, Limitations and/or Medical Necessity

Observation Services: What it is?

  • “Observation services are defined as the use of a bed and periodic monitoring by a hospital's nursing or other ancillary staff, which are reasonable and necessary to evaluate an outpatient's condition to determine the need for possible inpatient admission.”
  • “The services may be considered covered only when provided under a physician's order (or under the order of another person who is authorized by state statute and the hospital's bylaws to admit patients or order outpatient testing).”
  • “Outpatient observation services must be patient specific and not part of the facilities standard operating procedure or protocol for a given diagnosis or service. Observation services, generally, do not exceed 24 hours.”

Observation Services: What it is not?

  • “Outpatient observation services are not to be used as a substitute for medically necessary inpatient admissions. Outpatient observation services are not to be used for the convenience of the hospital, its physicians, patients, or patient's families, or while awaiting placement to another health care facility.”

Documentation Palmetto expects to find in the Medical Record

LCD L34552 includes the following five elements that need to be included in the medical record when a patient is receiving Observation Services:

  1. “The attending physician's order including “clock time” for the observation service or “clock time” can be noted in the nursing admission notes/observation unit notes outlining the patient’s condition and treatment.
  1. Observation time which begins at the clock time documented in the patient’s medical record, and which coincides with the time the patient is placed in a bed for the purpose of initiating observation care in accordance with a physician’s order.
  1. The ending time for observation occurs either when the patient is discharged from the hospital or is admitted as an inpatient. The time when a patient is “discharged” from observation status is the clock time when all clinical or medical interventions have been completed, including any necessary follow-up care furnished by hospital staff and physicians that may take place after a physician has ordered that the patient be released or admitted as an inpatient. However, observation care does not include time spent by the patient in the hospital subsequent to the conclusion of therapeutic, clinical, or medical interventions, such as time spent waiting for transportation to go home.
  1. The beneficiary is under the care of a physician during the period of observation as documented in the medical record by admission, discharge, and appropriate progress notes.
  1. Risk stratification criteria (such as intensity of service and severity of illness) were used in considering potential benefits of observation care.”

Observation Services Triggering Medical Review

Tucked between the Coverage Indications, Limitations and/or Medical Necessity and the Categories of Observation Services is to me one of the most important sentences in this LCD: 

“Observation claims exceeding 48 hours may be subject to medical review.”

So why 48 hours, in the related Observation Care article mentioned previously? Palmetto notes that CMS has indicated that “In the majority of cases, the decision whether to discharge a patient from the hospital following resolution of the reason for the observation care or to admit the patient as an inpatient can be made in less than 48 hours, usually in less than 24 hours. In only rare and exceptional cases do reasonable and necessary outpatient observation services span more than 48 hours.”

Additionally, with the implementation of the 2-Midnight Rule effective October 1, 2013, outpatient observation services spanning greater than 48 hours should be closely followed to convert to Inpatient when appropriate or work with the Physician to determine why he/she believes the patient is continuing to require observation care.

 

Outpatient Observation Services Categorized

The LCD indicates that outpatient observation services fall into one of three categories.

  1. Diagnostic Testing

Under this category, for scheduled invasive outpatient diagnostic tests, routine preparation and immediate recovery after the test is not considered to be an observation service. If further monitoring is required as a result of a significant adverse reaction from the test then outpatient observation services may be reasonable and necessary.

“Observation services begin at that point in time when the reaction occurred and would end when it is determined whether or not the patient required inpatient admission. Medical review decisions will be based on the documentation in the patient’s medical record.”

  1. Outpatient Therapeutic Services

“Observation status does not apply when a beneficiary is treated as an outpatient for the administration of blood only and receives no other medical treatment. The use of the hospital facilities is inherent in the administration of the blood and is included in the payment for administration.

When the patient has been scheduled for ongoing therapeutic services as a result of a known medical condition, a period of time is often required to evaluate the response to that service. This period of evaluation is an appropriate component of the therapeutic service and is not considered an observation service.

The observation service begins at that point in time when a significant adverse reaction occurred that is above and beyond the usual and expected response to the service.”

  1. Patient Evaluation
    “When a patient arrives at the facility with an unstable medical condition (generally via the Emergency Department), observation services may be reasonable and necessary to evaluate the medical condition to determine the need for a possible admission to the hospital as an inpatient.

    An unstable medical condition can be defined as:
    · variance from generally accepted normal laboratory values; and
    · clinical signs and symptoms present that are above or below those of normal range (for the patient) and are such that further monitoring and evaluation is needed. Changes in the patient's status or condition are anticipated and immediate medical intervention may be required.

    Documentation in the patient's medical record must support the medical necessity of the observation service.

 

Inpatient Status Changed to Observation Status is a No Go without Condition Code 44

While this LCD does not mention Condition Code 44, it does include the following statement:
“Upon internal review performed before the claim was initially submitted and upon the hospital determining that the services did not meet its inpatient criteria, an inpatient status may not be automatically changed to observation status. An observation stay must adhere to the criteria as described in the “Coverage Indications, Limitations and/or Medical Necessity” section of this LCD.”

Documentation Requirements

When reading an LCD I often jump to the end where you find the “Documentation Requirements” detailing what the MAC expects to find when reviewing a record for medical necessity of the services provided. Specific to this LCD, “documentation must be legible, relevant and sufficient to justify the services billed. The documentation for Outpatient Observation must include:

  1. The attending physician's order including “clock time” for the observation service or “clock time” can be noted in the nursing admission notes/observation unit notes outlining the patient’s condition and treatment.
  2. The physician's admission/progress note which clearly indicates the patient's condition, signs and symptoms that necessitate the observation stay.
  3. Supporting ancillary reports such as laboratory and diagnostic test reports.

Legible documentation in the medical record must clearly support the medical necessity and reasonableness of the observation services. The documentation should clearly state the method of assessment during observation and, if necessary, treatment in order to determine if the patient should be admitted or may be safely discharged.”

Key Takeaways for Providers

The three major points Providers need to be mindful of when internally reviewing outpatient claims where the beneficiary was receiving observation services are: 

  • To support medical necessity of an outpatient stay receiving observation services, the medical record should include the following elements:
  1. A timed order for observation services,
  2. Physician documentation indicating a patient’s condition, signs and symptoms necessitating observation services.
  3. All ancillary reports supporting the patient evaluation (i.e. labs and diagnostic test results).
  • An inpatient status may not automatically be changed to an “observation stay.” If the patient was still in house at the time this determination was made you would need to follow Condition Code 44 guidance. You can access further guidance specific to Condition Code 44 in MLN Matters Article SE0622.
  • “Observation claims exceeding 48 hours may be subject to medical review.” Make patients receiving observation services a priority for your Utilization Review staff.

Beth Cobb

New Credential Requirements for Hospital Sleep Centers
Published on Apr 10, 2018
20180410

What do you have on your bedside table - an alarm clock, a lamp, perhaps a good book to lull you to sleep? A new addition to many bedside tables over the past few decades is a C-PAP (continuous positive airway pressure) machine for the treatment of sleep apnea. In recent years, the incidence of sleep apnea and C-PAP usage in the United States has increased significantly, likely due in part to the obesity epidemic, increased sleep testing, and the coming of age of the more health-conscious baby boomers. Sleep apnea is not to be taken lightly – the cost in health effects, productivity, and healthcare dollars is staggering.  Some fascinating information on these topics from an internet search include:

American Academy of Sleep Medicine (AASM) 2014 Article

  • Sleep apnea afflicts at least 25 million adults in the U.S., according to the National Healthy Sleep Awareness Project. It is now estimated that 26 percent of adults between the ages of 30 and 70 years have sleep apnea.
  • Obstructive sleep apnea increases the risk of high blood pressure, heart disease, Type 2 diabetes, stroke and depression.

AASM 2018 Article

  • More than 37% of workers (are) sleep-deprived (contributing to) cognitive declines, heightened safety risks and increased economic costs.
  • According to the National Safety Council (NSC), sleepy workers are estimated to cost employers $136 billion a year in health-related lost productivity.
  • About 13% of work injuries are attributable to sleep deprivation.
  • The National Transportation Safety Board (NTSB) estimates that fatigue has been a contributing factor in 20 percent of its (driving-related) investigations over the last two decades.

Wiley Online Library "The Laryngoscope" 2017 Article

  • In 2014, 845,569 sleep studies were completed by 1.4% of Medicare beneficiaries for a total of $189 million.
  • Since 2010, the number of studies performed has increased by 9.1%.

Sleep Review Journal 2017 Article

  • The sleep testing services market is expected to be valued at $8,395.7 million by the end of 2021, reflecting a compound annual growth rate of 12.9% during the forecast period (2016–2021), according to a report by Persistence Market Research.
  • The growth of the North America sleep services market is driven by favorable reimbursement policies and high awareness of sleep disease.

Another recent trend related to sleep apnea and sleep testing is the change in credentialing requirements by some Medicare Administrative Contractors (MACs) for hospital-based sleep centers. Prior to the recent changes almost all MACs required sleep testing centers to be certified by the American Academy of Sleep Medicine (AASM), The Joint Commission (formerly known as JCAHO), or Accreditation Commission for Health Care, Inc. (ACHC).  Accreditation by either the Joint Commission Hospital or Ambulatory Care Accreditation programs was acceptable for hospital-based sleep centers. If the Joint Commission survey of the general hospital accreditation included the hospital-based sleep lab, an additional accreditation was not needed.

Things began to change in 2017 when 3 MACs, Wisconsin Physician Services (WPS), CGS, and Noridian changed their sleep lab certification requirements so that Joint Commission’s Hospital Accreditation was no longer sufficient to meet the credentialing requirements for a hospital sleep center. The new/revised Local Coverage Determinations (LCDs) require certification by the Joint Commission’s Ambulatory Care Accreditation Program or one of the other approved accreditors (AASM and ACHC). Although the WPS, CGS, and Noridian policies were effective in February, March and June of 2017 respectively, they all issued clarification statements allowing 90 days from the date of the statement to apply for accreditation and 1 year to obtain an accreditation award. This means the accreditation due date for WPS is May 12, 2018; for CGS, May 11, 2018; and June 22, 2018 for Noridian. Hospitals can elect to have all their ambulatory services accredited through the Joint Commission’s Ambulatory Care Accreditation Program or just specifically sleep services only.  You can find more information in a Joint Commission Fact Sheet.

In March 2018, Palmetto GBA followed suit and sleep facilities in the Palmetto Jurisdictions J and M must have sleep-specific accreditation to be eligible for coverage. Palmetto is allowing a much shorter time frame for sleep centers to comply. Here is an excerpt from a future effective Palmetto Article that explains the new requirements and the timeline for compliance.

As noted above in section 1, outpatient sleep centers affiliated with a hospital which is currently accredited by The Joint Commission (formerly JCAHO) through the hospital’s accreditation will now be required to obtain separate ambulatory care accreditation for the sleep center if ambulatory services accreditation for the sleep center is not currently in place. This accreditation must be obtained by October 1, 2018 in order to continue to render services to Medicare beneficiaries and submit claims to Palmetto GBA.”

This could be bad news for hospitals – if your sleep center is not accredited by The Joint Commission’s Ambulatory Care Accreditation Program or one of the other approved accreditors (AASM and ACHC), your claims for services rendered past the above noted MAC-imposed deadlines may be denied. Enough to make hospital administrators, finance, and sleep lab managers toss and turn and lose sleep.

Facility accreditation is not the only credentialing requirement for sleep centers. Sleep centers must be under the supervision or direction of a physician who meets certain certification requirements. And there are also requirements for the credentials and training of sleep technologists and technicians. Hospital offering sleep testing should carefully review the requirements of their Medicare contractors and other payers. Here is a list of the various coverage policies for sleep testing /polysomnography of the MACs.

MAC Jurisdiction States Policy ID #
CGS J15 Kentucky, Ohio L36902
First Coast JN Florida L33405
NGS JK Connecticut, New York, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont A53019
J6 Illinois, Minnesota, Wisconsin
Noridian JE California, Hawaii, Nevada L36861
JF Alaska, Idaho, Oregon, Washington, Arizona, Montana, North Dakota, South Dakota, Utah, Wyoming L34040
Novitas JH Colorado, New Mexico, Oklahoma, Texas, Arkansas, Louisiana, Mississippi L35050
JL Delaware, DC, Maryland, New Jersey, Pennsylvania
Palmetto JJ Alabama, Georgia, Tennessee L36593
JM South Carolina, Virginia, West Virginia, North Carolina
WPS J5 Iowa, Kansas, Missouri, Nebraska, Other  L36839
J8 Indiana, Michigan

Debbie Rubio

Coverage Policies for IMRT
Published on Mar 13, 2018
20180313

When I provided patient care years ago, we had a young patient whose mother was overbearing, demanding, and well-informed. As difficult as it was to deal with this parent, due to the child’s age and mental capacity, she needed a healthcare advocate. In recent years, I have had to be such an advocate for my parents’ healthcare. Thankfully it is much easier to be well-informed these days than it was years ago for that mother. Television ads promote a drug for everything, Facebook includes posts on numerous medical technologies such as TAVR and IMRT, and the internet allows research of any condition and any treatment. This is good and bad – knowledgeable and educated patients can make wiser healthcare decisions, but overzealous and ill-advised patients may make demands that are not the best choice for their healthcare. In today’s environment, I can easily envision a patient demanding of their oncologist, “I want some of that IMRT.”

Intensity Modulated Radiation Therapy (IMRT) is not for everyone. Healthcare providers have to keep up with the latest treatment protocols and the coverage requirements of numerous payers.  With the transition of the Jurisdiction J MAC from Cahaba to Palmetto, Palmetto elected to adopt the Cahaba Local Coverage Determination (LCD) for IMRT for both jurisdictions JJ and JM. Palmetto JM had not previously had a coverage policy for IMRT. This policy became effective on January 29, 2018. Several other MACs also have policies addressing the coverage of IMRT.

IMRT is generally reserved for treatment of tumors when adjacent structures need to be protected from the radiation dose or to deliver higher doses than commonly used. There are certain types of tumors that due to their location, shape, or dose requirements support the use of IMRT.  The LCDs describe the specific circumstances and types of tumors for which IMRT may be indicated. Some LCDs also include limitations where the use of IMRT is not supported, such as clinical urgency, palliative treatments, motion concerns, or “where IMRT does not offer an advantage over conventional or three-dimensional conformal radiation therapy techniques that deliver good clinical outcomes and low toxicity.”

There are also documentation requirements in the LCDs for IMRT.  The rationale of the advantage of IMRT versus the use of other radiation therapy methods must be documented in the medical record. In addition to this rationale, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures, there are documentation requirements specific to IMRT.  For example, the Palmetto LCD indicates the following components must be included:

  • Prescription defining the goals and requirements of the treatment plan, including the specific dose constraints for the target(s) and nearby critical structures
  • Signed and dated IMRT inverse plan that meets prescribed dose constraints
  • Target verification methodology including documentation of the clinical treatment volume (CTV) and the planning target volume (PTV), immobilization and patient positioning, and means of dose verification
  • Documentation of fluence distributions re-computed in a phantom or an equivalent methodology
  • Documentation that accounts for structures moving in and out of high and low dose regions created by respiration
  • Documentation for clinical treatment planning (77261-77263) should evidence the criteria are met which are outlined in “The ASTRO/ACR Guide to Radiation Oncology Coding 2015”

Note: This is not a complete list or descriptions of all the Palmetto LCD documentation requirements. Please see the Palmetto IMRT LCD or your MAC’s LCD for complete documentation requirements. 

 

As you can see, just the partial requirements for IMRT treatment and documentation are daunting. It is good that patients are more involved in their healthcare choices, but hopefully they will understand the complexity of treatment decisions and defer to their physician’s judgement.

Debbie Rubio

February Medicare Transmittals and Other Updates
Published on Feb 27, 2018
20180227

MEDICARE TRANSMITTALS

Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - April 2018 Update

The April 2018 updates of specific biosimilar biological product HCPCS code, modifiers used with these biosimilar biologic products and an autologous cellular immunotherapy treatment.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10454.pdf

E/M Service Documentation Provided By Students (Manual Update)

Allows the teaching physician to verify in the medical record any student documentation of components of E/M services, rather than re-documenting the work.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10412.pdf

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 24.1, Effective April 1, 2018

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10472.pdf

Medicare Fee-for-Service Recovery Audit Program Additional Documentation Limits for Medicare Institutional Providers (i.e. Facilities)

New ADR limits for the Recovery Audit Program.

https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Recovery-Audit-Program/Downloads/Institutional-Provider-Facilities-ADR-Limits.pdf

Diagnosis Code Update for Add-on Payments for Blood Clotting Factor Administered to Hemophilia Inpatients

Updates to diagnosis codes required in order to allow add-on payments under the Inpatient Prospective Payment System (IPPS) for blood clotting factor administered to hemophilia inpatients.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10474.pdf

Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

Changes in the April 2018 quarterly update to the Clinical Laboratory Fee Schedule (CLFS).

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10445.pdf

Replacement of Mammography HCPCS Codes, Waiver of Coinsurance and Deductible for Preventive and Other Services, and Addition of Anesthesia and Prolonged Preventive Services – REVISED

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10181.pdf

Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits – REVISED

Revised to add HCPCS code G0475 as a code that is subject to CLIA edits effective, April 13, 2015.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10446.pdf

Modifications to the Implementation of the Paperwork (PWK) Segment of the Electronic Submission of Medical Documentation (esMD) System

Enables MACs to receive unsolicited documentation (also known as paperwork (PWK)) via the Electronic Submission of Medical Documentation (esMD) system.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10397.pdf

Update to the Medicare Physician Fee Schedule Database (MPFSDB) - April 2018 Update

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10488.pdf

Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update

Updates the Remittance Advice Remark Codes (RARC) and Claims Adjustment Reason Code (CARC) lists and instructs Medicare Shared System Maintainers (SSMs) to update Medicare Remit Easy Print (MREP) and PC Print.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10489.pdf

ICD-10 and Other Coding Revisions to National Coverage Determinations (NCDs)

A maintenance update of the International Classification of Diseases, Tenth Revision (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.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10473.pdf

 

MEDICARE COVERAGE UPDATES

Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)

Effective May 25, 2017, new NCD to cover Supervised Exercise Therapy (SET) for beneficiaries with Intermittent Claudication (IC) for the treatment of symptomatic Peripheral Artery Disease (PAD).

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10295.pdf

Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)

Changes to the ICD NCD from the 2005 reconsideration.

https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=288&TimeFrame=7&DocType=All&bc=AgAAYAAAQAAA&

 

OTHER MEDICARE UPDATES

Medicare Fee-for-Service Recovery Audit Program Additional Documentation Limits for Medicare Institutional Providers (i.e. Facilities)

https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Recovery-Audit-Program/Downloads/Institutional-Provider-Facilities-ADR-Limits.pdf

Correction: Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems and Quality Reporting Programs

https://www.gpo.gov/fdsys/pkg/FR-2018-01-31/pdf/C1-2017-27949.pdf

Targeted Probe and Educate (TPE) Website Update

New resources available on the TPE website.

https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/Targeted-Probe-and-EducateTPE.html

 

MEDICARE EDUCATIONAL RESOURCES

Transition to New Medicare Numbers and Cards FACTSHEET

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/TransitiontoNewMedicareNumbersandCards-909365.pdf

Implantable Cardioverter Defibrillator Decision Memo
Published on Feb 27, 2018
20180227
 | Billing 

DECISION

CMS posted a Final Decision Memo on February 15, 2018 for the National Coverage Determination (NCD) for Implantable Automatic Defibrillators (20.4). CMS finalized what they describe as “minimal changes” to the ICD NCD from the 2005 reconsideration. After you have finished reading this article I will leave it to you to decide if you agree with their definition of “minimal changes.”

DECISION SUMMARY OF THE CHANGES

Patient Criteria

  • Add cardiac magnetic resonance imaging (MRI) to the list of diagnostic imaging studies that can evaluate left ventricular ejection fraction (LVEF).
  • Note: Prior approved diagnostic imaging studies included echocardiography, radionuclide (nuclear medicine) imaging, and catheter angiography.
  • Require patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation to have been on optimal medical therapy (OMT) for at least 3 months.
  • Require a patient shared decision making (SDM) interaction prior to ICD implementation for certain patients.
  • Note: This includes all patient’s receiving an ICD for primary prevention.

Additional Patient Criteria

  • Remove the Class IV heart failure requirement for cardiac resynchronization therapy (CRT)

Exceptions to Waiting Periods

  • Add an exception for patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD;
  • Add an exception for patients with an existing ICD and qualifying replacement
  • End the data collection requirement

Evidence

When developing a National Coverage Determination (NCD), CMS in general “evaluates relevant clinical evidence to determine whether or not the evidence is of sufficient quality to support a findings that an item or service falling within a benefit category is reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”

The evidence review primarily focused “on randomized controlled trials that assess the clinical utility of defibrillators compared to optimal medical therapy, and relevant formal Technology Assessments and professional society guidelines. While reading through this part of the Decision Memo, some of the conclusions were reminiscent of statements made when Jack Handy shared “Deep Thoughts” on Saturday Night Live in the 1990’s. The following table highlights four of the studies.

Study Study Aim and Conclusion
Freeman JV1, Wang Y, Curtis JP, et al. Physician procedure volume and complications of cardioverter-defibrillator implantation. Circulation. 2012 Jan 3;125(1):57-64. Aim: Examine the relationship between physician annual ICD implantation volume and in-hospital complications. Conclusion: “Physicians who implant more ICDs have lower rates of procedural complications and in-hospital mortality, independent of hospital procedure volume, physician’s specialty, and ICD type.” Thus, “concentrating ICD implantation in the hands of fewer physicians may improve the clinical outcomes of this increasingly common procedure.”
Curtis JP, Luebbert JJ, Wang Y, et al.  Association of physician certification and outcomes among patients receiving an implantable cardioverter-defibrillator. JAMA. 2009 Apr 22;301(16):1661-70. Aim: Estimate the association of implanting physician certification with in-hospital procedural complication rates following ICD implantation. Conclusion: Overall, implantations by a nonelectrophysiologist were associated with a higher risk of procedural complications and lower likelihood of receiving a CRT-D device when indicated compared with patients whose ICD was implanted by an electrophysiologist.”
Freeman J,Wang Y,Curtis J, et al.  The relation between hospital procedure volume and complications of cardioverter-defibrillator implantation from the implantable cardioverter-defibrillator registry.  J Am Coll Cardiol.2010 Sep 28;56(14):1133-9. Aim: Assess the relationship between hospital ICD implantation volume and procedural complications. Conclusion: “Patients who have an ICD implanted at a high-volume hospital are less likely to have an adverse event associated with the procedure than patients who have an ICD implanted at a low-volume hospital.”
Al-Khatib S,Hellkamp M, Curtis J, et al.  Non–evidence-based ICD implantations in the United States.  JAMA.2011;305(1):43-49. Aim: Determine the number, characteristics, and in-hospital outcomes of patients who receive a non-evidence-based ICD and examine the distribution of these implants by site, physician, specialty, and year of procedure. Conclusion: “A substantial number of ICDs were implanted in patients who were similar to those who either were excluded from major clinical trials of primary prevention ICDs or shown not to benefit from ICD therapy in other trials.  Such patients not only have more comorbidities than patients receiving an evidence-based device, but they are at a higher risk of in-hospital death and any post-procedure complication.”  They also found no clear decrease in the overall number of non–evidence-based ICD implants over time.  Thus the authors conclude that more effort is needed to improve physician adherence to evidence-based practice.

PUBLIC COMMENTS

A significant portion of this Decision Memo was dedicated to detailing public comments received and CMS responses. The following table highlights comments and responses related to the “minimal changes” being made.

CMS Responses to Public Comments
Shared Decision Making (SDM) Comment: Disagreement with who must provide SDM and providing the SDM at all “stating informed consent would be sufficient for the patient.” Response: “We believe that a SDM encounter prior to initial ICD implantation is a critical step in empowering patient choice in their treatment plan….the strength of evidence for an ICD benefit is different for different patient populations.   As mentioned in the Analysis section of this decision memo, the joint 2017 guidelines by AHA/ACC/HRS state that “In patients with VA [Ventricular Arrhythmia] or at increased risk for SCD, clinicians should adopt a shared decision-making approach in which treatment decisions are based not only on the best available evidence but also on the patients’ health goals, preferences, and values,” topics that are not typically covered when obtaining informed consent.  The SDM interaction requires the use of an evidence-based tool to ensure topics like the patients’ health goals and preferences are covered before ICD implantation.  We want to ensure that the patient receives more information than the risks and benefits of the procedure.  We also recognize that requiring a SDM encounter with an “independent” physician or non-physician professional could create unnecessary burden, so we have decided to remove the word “independent” from the SDM requirement.  In order to provide flexibility for this requirement, we are indicating that the SDM interaction may occur at a separate visit. Comment: Request for clarification around what is considered an “evidenced-based decision tool.” Response: CMS believes in the importance of an evidenced based tool but they are not specifying the type of tool that is required. They do provide an example of an evidence based decision aid for patients with heart failure who are at risk for sudden cardiac death and are considering an ICD. This tool was funded by the National Institutes on Aging and the Patient-Centered Outcomes Research Institute and can be found at https://patientdecisionaid.org/wp-content/uploads/2017/01/ICD-Infographic-5.23.16.pdf. CMS notes that this tool is based on published clinical research and interviews with patients and includes discussion of the option for future ICD deactivation. Comment: Suggestion that SDM encounter be required for all ICD indications. Response: CMS encourages an SDM encounter for all covered indications. However, they “only require a SDM interaction for certain patient populations to limit the added burden of this interaction.”
Removal of New York Heart Association (NYHA) Class IV Indication for CRT Comment: Request for clarification of what is meant by the statement of removing the NYHA Class IV Indication for CRT and does this signify intent to create a separate coverage decision for CRT. Response: “We believe CRT is a separate therapy and should be evaluated in a distinct determination. Because there is no national coverage criteria for CRT, we have removed this section from the NCD on ICDs. At this time, CMS has not proposed to open a separate NCD on CRT.”
MRI for Evaluating LVEF Comment: Several commenters supported this addition. One suggested including a Cardiac MRI for evaluation of ventricular scarring or infiltration as a finding supporting the indication for an ICD. Response: “There is strong evidence supporting the addition of cardiac MRI to our list of modalities that may be used to evaluate LVEF.  Our focus here is on depressed LVEF as it is an important, trial-based risk factor for SCD in patients who have no history of documented cardiac arrest or life-threatening ventricular tachyarrhythmia.  We recognize that MRI as well as other diagnostic tests may be useful in the clinical work up of such patients, but we are not mandating which tests should be used for which patients, or when in the course of their clinical evaluation.”
Optimal Medical Therapy (OMT) Comment: There was a comment to remove this requirement for Ischemic Dilated Cardiomyopathy. Response: “We believe that the evidence is equivocal on whether patients with ischemic cardiomyopathy and systolic heart failure would benefit from a new requirement for at least 3 months of OMT alone prior to ICD placement, if they otherwise met criteria for an ICD. We thus accept this recommendation to split the ischemic and nonischemic categories, and to apply the 3 month OMT requirement to the nonischemic heart failure population, but not to the ischemic population.”   Comment(s): Several commenters expressed concern about this being a requirement at least 3 months before implantation as this may not be possible for some patients due to not tolerating medications. One commenter suggested the wording “clinicians must have tried for at least three months to optimize medical therapy to the extent tolerated by the patient.” Response: “We understand this concern and appreciate these comments.  OMT must be tailored to the patient.  If a patient cannot tolerate a given medication, then that medication is not optimal medical therapy for that patient.  We also note that the evidence for ICDs is based on chronic stable patients and based on the best available evidence do not believe ICDs should be implanted prior to the completion of three months of OMT for patients with non-ischemic dilated cardiomyopathy whose condition continues to worsen during that time.  Therefore, we are not making any changes to the wording of the OMT requirement.”
Subcutaneous ICD Comment: There was one comment suggesting the NCD specifically address indications for the subcutaneous ICD. Response: “The coverage indications in this NCD apply to subcutaneous ICDs.”
Covered Indications There were several comments specific to the Covered Indications for ICD placement. Following are some of the key Responses provided in the Decision Memo: Response: We are re-wording the phrase “uncontrolled supraventricular tachycardia such as from atrial fibrillation” to “supraventricular tachycardia such as atrial fibrillation with a poorly controlled ventricular rate,” as this clarifies that a patient would not be automatically excluded if they have atrial fibrillation. Response: In response to a suggestion that discontinuing the data collection requirement would eliminate coverage for ICDs for the primary prevention of sudden cardiac death, CMS responded by noting that “ICDs for the primary prevention of sudden cardiac death will be covered under the indication for “patients who have severe ischemic and/or non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation.     Response: In response to a suggestion that “significant, irreversible brain damage” could be too subjective, CMS responded by noting that “the phrase “significant, irreversible brain damage” listed as part of the exclusion criteria is consistent with wording in the 2005 NCD, and with trial exclusion criteria and medical society clinical guidelines. We believe clinicians fully understand that this exclusion, for example, applies to comatose patients in a vegetative state, but may not apply to all patients with persistent speech or motor dysfunction as a result of a prior stroke, but who otherwise meet criteria and are good candidates for ICD placement.  We do not believe patients or clinicians would benefit by more granular definition.”

ANALYSIS

Patient Shared Decision Making

In addition to the example SDM tool for ICDs, CMS notes that a website was also developed “which leads patients step-by[step through some information on ICDs designed to increase patients’ knowledge of their medical condition, the risks and benefits of available treatments and to empower patients to become more involved in the decision-making process. https://patientdecisionaid.org/icd/.

CONSIDERATIONS MOVING FORWARD

Shared Decision Making

There are now 6 covered indications listed in the NCD. All patients receiving an ICD for primary prevention must be provided SDM. “For these patients…a formal shared decision making encounter must occur between the patient and a physician (as defined in Section 1861(r)(1)) or qualified non-physician practitioner (meaning a physician assistant, nurse practitioner, or clinical nurse specialist as defined in §1861(aa)(5)) using an evidence-based decision tool on ICDs prior to initial ICD implantation.  The shared decision making encounter may occur at a separate visit.”

Questions to Consider:

  • Who will be the healthcare provider to provide the SDM encounter?
  • What tool will you utilize?
  • When will this SDM be done? For example, the patient meeting Pacemaker and ICD indications that has been admitted for an AMI, Stent or CABG and placement is advised prior to the patient’s discharge.
  • Since the SDM encounter can occur at a separate visit, what will be your process to make sure this information makes it into the medical record when the patient receives an ICD?

Optimal Medical Therapy

Patients who have severe non-ischemic dilated cardiomyopathy but no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation must have been on optimal medical therapy (OMT) for at least 3 months prior to ICD placement.

Questions to Consider:

  • Who is the healthcare provider providing optimal medical therapy? Is it a patient’s Internal Medicine Doctor, Cardiologist, Electrophysiologist?
  • Similar to SDM, what will be your process to make sure this information makes it into the medical record when the patient receives an ICD?

MMP strongly encourages key stakeholders take the time to read the entire Decision Memo.

Beth Cobb

Emergency Room Services
Published on Feb 20, 2018
20180220
 | Billing 

“If you have an apple and I have an apple and we exchange these apples then you and I will still each have one apple. But if you have an idea and I have an idea and we exchange these ideas, then each of us will have two ideas.”

-George Bernard Shaw

Probe & Educate Target: Emergency Room Services

This past November, the Medicare Administrative Contractor (MAC) WPS announced that they would begin reviewing facilities billing emergency room services (CPT codes 99281-99285) as part of the Targeted Probe and Educate (TPE) review process.

The TPE process includes MACs utilizing data analysis to identify:

  • Providers and suppliers who have high claim error rates or unusual billing practices, and
  • Items or services that have high national error rates and are a financial risk to Medicare.

WPS provides the following guidance in the announcement for a successful review of emergency department visits for facility services (Type A Emergency Rooms):

  • The number and type of interventions under the facility charge,
  • The visit record showing the signs/symptoms that support medical necessity for the interventions, and
  • The internal guidelines used to determine the HCPCS equivalent CPT code (99281-99285) for the hospital resources being billed.

WPS is currently the MAC for Jurisdiction 5 (IA, KS, MO, and NE Providers) and Jurisdiction 8 (IN, MI Providers). For those of you in a different MAC Jurisdiction, take note now as in general when one MAC targets a specific service it is not long before other MACs follow suit.

Are you an Outlier?

The question is, how do your E.R. levels codes compare to other facilities? Now, the Program for Evaluating Payment Patterns Electronic Report for short-term acute care hospitals (ST PEPPER) can assist you in analyzing your volume of emergency room services claims and comparing your data to your state, MAC jurisdiction and at the national level.

As of the 4th Quarter of the 2017 CMS IPPS Fiscal Year (July – September 2017), Emergency Department Evaluation and Management Visits (ED E&M) is a new PEPPER Target Area.

Target areas are approved by CMS because they have been identified as prone to improper payments. The Twenty-fourth Edition of the ST PEPPER User’s Guide notes that “concerns with overuse/misuse of higher level E&M codes have been prevalent for several years. The Office of Inspector General identified increasing trends of E&M coding for higher-level services (https://oig.hhs.gov/oei/reports/oei-04-10-00180.pdf ) as well as improper payments associated with E&M coding errors (https://oig.hhs.gov/oei/reports/oei-04-10-00181.pdf).”

PEPPER Recommendations for Outliers?

High Outliers could represent coding and billing errors related to over-coding of CPT code 99285. Appendix 5 of the User’s Guide notes attributes CPT 99285 as when “usually, the presenting problem(s) are of high severity and pose an immediate significant threat to life or physiologic function.” The ST PEPPER recommends reviewing a sample of claims coded to 99285 to validate the code is supported by documentation in the medical record.

Low Outliers could represent coding errors related to under-coding 99285. The ST PEPPER recommends reviewing a sample of claims coded to 99281, 99282, 99283 or 99284 should be reviewed to validate the code level is supported by documentation in the medical record.

Related article about the ST PEPPER: http://www.mmplusinc.com/news-articles/item/pepper-resources-guide-updates.

To learn more about the TPE Review Process visit the CMS TPE webpage at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Medical-Review/Targeted-Probe-and-EducateTPE.html

Beth Cobb

Preventing Medicare Denials of Cardiac Rehab Services
Published on Feb 13, 2018
20180213

Happy Cardiac Rehabilitation Week to all the therapists and specialists who work with patients to improve their cardiac health!  According to the American Heart Association website, cardiac rehab  is a medically supervised program consisting of exercise counseling and training, education for heart-healthy living, and counseling to reduce stress designed to help improve cardiovascular health for patients who have experienced heart attack, heart failure, angioplasty or heart surgery. It is a beneficial program for those who need it and is covered as a Medicare benefit.

However, as with all things Medicare, there are coverage requirements and I often see denials of cardiac rehab services.  One of the main reasons for Medicare denials of cardiac rehab services is the duration of services, specifically denials with Medicare claims denial reason code (CARC) 151 – “Payment adjusted because the payer deems the information submitted does not support this many services.” It is likely some, if not most, of these denials could be prevented with proper billing – application of the KX modifier for services exceeding 36 sessions.

Medicare covers a maximum of two 1-hour cardiac rehab sessions per day for up to 36 sessions over up to 36 weeks, with the option for an additional 36 sessions over an extended period of time if approved by the Medicare contractor. Some patients need those additional sessions and Medicare will pay for these when the cardiac rehab CPT code (93797 or 93798) is appended with a KX modifier.  Medicare considers the KX modifier “an attestation by the provider of the service that documentation is on file verifying that further treatment beyond 36 sessions of CR up to a total of 72 sessions meets the requirements of the medical policy.”  Upon completion of a cardiac rehab program (up to 72 sessions), beneficiaries must experience another indication in order to be eligible for coverage of more cardiac rehabilitation.

Other common reasons for Medicare denials of cardiac rehab services are lack of a covered diagnosis code reported on the claim (generally automated denials) and lack of all the required components of cardiac rehab services (complex denials).  Diagnoses supporting coverage of cardiac rehabilitation services are:

  • An acute myocardial infarction within the preceding 12 months; or
  • A coronary artery bypass surgery; or
  • Current stable angina pectoris; or
  • Heart valve repair or replacement; or
  • Percutaneous transluminal coronary angioplasty (PTCA) or coronary stenting; or
  • A heart or heart-lung transplant; or
  • Stable, chronic heart failure defined as patients with left ventricular ejection fraction of 35% or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least 6 weeks.

If your record is selected for a complex review by Medicare, it must contain documentation supporting the diagnosis reported. Be sure your records contain copies of relevant patient history including intervention procedure reports and documentation of specific heart failure classification and ejection fractions when applicable.

Also upon Medicare complex reviews, the reviewer will be looking for documentation of all the required components of cardiac rehab therapy.  These include:

  • Physician-prescribed exercise each day cardiac rehabilitation items and services are furnished;
  • Cardiac risk factor modification, including education, counseling, and behavioral intervention at least once during the program, tailored to patients’ individual needs;
  • Psychosocial assessment;
  • Outcomes assessment; and
  • An individualized treatment plan detailing how components are utilized for each patient.

For complete information on the billing of cardiac rehab services, see the Medicare Claims Processing Manual, Chapter 32, Section 140.

Again, Happy Cardiac Rehab Week and make sure you are receiving appropriate payment for the wonderful services you provide by documenting and billing correctly.

Debbie Rubio

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