Knowledge Base Category -
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
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
March Patients Over Paperwork Newsletter
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/
“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:
- “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.
- 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.
- 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.
- 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.
- 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.
- 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.”
- 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.”
- 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:
- 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.
- The physician's admission/progress note which clearly indicates the patient's condition, signs and symptoms that necessitate the observation stay.
- 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:
- A timed order for observation services,
- Physician documentation indicating a patient’s condition, signs and symptoms necessitating observation services.
- 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
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.
- 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.
Debbie Rubio
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
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.
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.
Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 24.1, Effective April 1, 2018
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.
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.
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).
Replacement of Mammography HCPCS Codes, Waiver of Coinsurance and Deductible for Preventive and Other Services, and Addition of Anesthesia and Prolonged Preventive Services – REVISED
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.
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.
Update to the Medicare Physician Fee Schedule Database (MPFSDB) - April 2018 Update
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.
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.
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).
Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)
Changes to the ICD NCD from the 2005 reconsideration.
OTHER MEDICARE UPDATES
Medicare Fee-for-Service Recovery Audit Program Additional Documentation Limits for Medicare Institutional Providers (i.e. Facilities)
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.
MEDICARE EDUCATIONAL RESOURCES
Transition to New Medicare Numbers and Cards FACTSHEET
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.
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.
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
“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
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
“Courage doesn’t happen when you have all the answers. It happens when you are ready to face the questions you have been avoiding your whole life.”
- Shannon L. Alder,
Last fall the American Hospital Association’s (AHA) released a Report detailing regulatory burden placed on hospitals, health systems and post-acute care (PAC) facilities. The report ended by noting “the outsized growth of staff and resources devoted to regulatory and compliance-related functions illustrates that a step back is needed: federal agencies should review and streamline requirements to reduce overhead cost of health care and allow providers to focus on their mission of caring for patients.”
You can read about the report in a related MMP article or by viewing a related AHA Infographic. It seems that CMS listened. This article focuses on how CMS is responding.
Patients over Paperwork
On October 26, 2017, CMS launched the “Patients over Paperwork” initiative. Through this initiative CMS has “established an internal process to evaluate and streamline regulations with a goal to reduce unnecessary burden, to increase efficiencies, and to improve the beneficiary experience.”
CMS is keeping stakeholders informed through Patients over Paperwork Newsletters and the development of a Patients over Paperwork CMS webpage.
December 2017 Newsletter
In this inaugural edition, CMS noted that they have the following three aims for this initiative:
- Increase the number of satisfied customers – clinicians, institutional providers, health plans, etc. engaged through direct and indirect outreach;
- Decrease the hours and dollars clinicians and providers spend on CMS-mandated compliance; and
- Increase the proportion of tasks that CMS customers can do in a completely digital way.
CMS went on to outline how this initiative will work including having a Steering Committee, Customer Centered Workgroups, Journey Mapping, conducting listening sessions, reducing burden through rule making, and sub-regulatory changes.
January 2018 Newsletter
The second edition highlighted what CMS has been doing to reduce regulations, streamline requirements and improve clarity of guidance. Key efforts are presented in a “You Said” and “We Heard You” format and discusses the following areas of concern:
- Quality Measures,
- Quality Payment Program (QPP) (5522-FC),
- Appropriate Use Criteria for Advanced Diagnostic Imaging,
- Documentation Review,
- Quality and Safety Oversight,
- Promote Affordability for Consumers,
- States,
Specific to Documentation Review, there is a clarification related to Signature Requirements and Medical Review of Inpatient Rehabilitation Facility (IRF) Claims highlighted in the newsletter.
Clarified Signature Requirements
“Before: CMS contractors occasionally denied claims when a nurse initialed a medication administration log instead of including a full signature.
After: CMS clarified guidance in the Program Integrity Manual, such that providers ultimately responsible for the beneficiary’s care must sign the medical record; however, claims won’t be denied if a support care provider (such as a nurse documenting chemotherapy) doesn’t sign part of the record.
To Learn More, Visit: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R751PI.pdf”
Clarified Medical Review of Inpatient Rehabilitation Facility (IRF) Claims
“You Said: IRF claims are denied even though patients need and could benefit from an inpatient rehabilitation program.
We Heard You: CMS clarified guidance to its contractors, requiring them to use clinical review judgment to determine medical necessity of the intensive rehabilitation therapy program based on the individual facts and circumstances of the case, and not based on any threshold of therapy time.
To Learn More, Visit: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE17036.pdf”
E/M Service Documentation Provided by Students (Manual Update)
Currently, a medical student may document review of systems (ROS) and/or past, family, and/or social history (PFSH)
While technically not credited as part of the Patients over Paperwork Initiative, a change to E/M service documentation provided by students is definitely in keeping with the Patients over Paperwork aims of increasing the number of satisfied customers (clinicians) and decreasing the hours clinicians spend on CMS-mandated compliance.
Effective January 1, 2018 with an implementation date of March 5, 2018, the Medicare Claims Processing Manual, Chapter 12, Section 100.1.1 has been revised to update the policy on Evaluation and Management (E/M) documentation to allow teaching physicians to verity in the medical record any student documentation of components of E/M services, rather than re-documenting the work.
You can read more about this update in Change Request (CR) 10412 and related MLN Matters article MM10412.
Moving forward MMP plans to follow this initiative, keeping our readers informed about future Patients over Paperwork activities.
Beth Cobb
Regardless of where you stand politically – conservative, liberal, or moderate – you must admit that sometimes a conservative approach is best. This can be true with medical treatments. Medicare coverage policies often require conservative treatments be tried and fail before more aggressive and invasive treatments are covered. There are at least two benefits to this – conservative treatments usually cost less and save Medicare dollars if they are successful and there are fewer medical risks to the patient than with the more invasive procedures. Sometimes Medicare can be slow in following their own advice. Despite years of high-quality research illustrating the effectiveness of supervised exercise therapy (SET) to treat intermittent claudication associated with peripheral vascular disease (PAD), more invasive treatment options (i.e., endovascular revascularization) have continued to increase. This may be due to lack of Medicare coverage and limited access to SET programs. Hopefully this will change with the new Medicare National Coverage Determination (NCD).
On February 7, 2018, MLN Matters Article MM10295 was released explaining the new coverage and claims processing requirements for Supervised Exercise Therapy (SET) for beneficiaries with Intermittent Claudication (IC) for the treatment of symptomatic Peripheral Artery Disease (PAD). Intermittent claudication is aches, cramps, numbness or a sense of fatigue, usually in the calf muscle, during mild exertion, such as exercise or walking, that is relieved by a short period of rest. It is the most common symptom experienced by people with PAD.
Under the new NCD 20.35, Medicare will cover SET for up to 36 sessions over 12 weeks, with the option of coverage for another 36 sessions at the discretion of the Medicare Administrative Contractor(MAC) when the services are reported with the KX modifier, attesting the medically necessary need for additional sessions. SET involves the use of intermittent walking exercise, which alternates periods of walking to moderate-to-maximum claudication, with rest and is recommended as the initial treatment for patients suffering from IC. Coverage is effective for services performed on or after May 25, 2017. Other Medicare requirements for coverage of SET for PAD include:
- Sessions lasting 30-60 minutes, comprising a therapeutic exercise-training program for PAD in patients with claudication
- Be conducted in a hospital outpatient setting, or a physician’s office
- Be delivered by qualified auxiliary personnel necessary to ensure benefits exceed harms, and who are trained in exercise therapy for PAD
- Be under the direct supervision of a physician, physician assistant, or nurse practitioner/clinical nurse specialist who must be trained in both basic and advanced life support techniques,
- Patients must have a face-to-face visit with the physician responsible for PAD treatment to
- Obtain the referral for SET and
- Receive information regarding cardiovascular disease and PAD risk factor reduction, which could include education, counseling, behavioral interventions, and outcome assessments.
Coding
Report SET for symptomatic PAD with CPT code 93668 (Peripheral arterial disease (PAD) rehabilitation, per session) and with one of the following ICD-10 codes for atherosclerosis of extremities with intermittent claudication: I70.211 – right leg; I70.212 – left leg; I70.213 – bilateral legs; I70.218 – other extremity; I70.311 – right leg; I70.312 – left leg; I70.313 – bilateral legs; I70.318 – other extremity; I70.611 – right leg; I70.612 – left leg; I70.613 – bilateral legs; I70.618 – other extremity; I70.711 – right leg; I70.712 – left leg; I70.713 – bilateral legs.
In other coverage news this month, Palmetto GBA announced the coverage Articles unrelated to LCDs that will become effective for the newly transitioned Jurisdiction J on February 26, 2018 (the date the JJ Part B transition occurs; JJ Part A transitioned to Palmetto on January 29, 2018). To see the announcement, including the list of articles, click here. The LCDs for JJ Part A became effective upon their transition on January 29, 2018. Those articles are now listed on the Medicare Coverage Database for Palmetto JJ. You can also see a discussion of the LCDs selected for JJ and JM and a crosswalk here. The crosswalk (link at bottom of the page) includes tabs for Palmetto LCDs that are new for Jurisdiction J and Cahaba policies that were adopted and are new for providers in Jurisdiction M. All the information providers need to know about the LCD changes can be found in the article and the crosswalk.
Debbie Rubio
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