Knowledge Base Category -
“Typically, repainting needs to occur every few years and before you repaint, you need to strip out the layers of paint from underneath. Otherwise it looks messy! Unfortunately, CMS has been applying new layers of paint without applying this essential step.”
- Seema Verma, the Administrator of the Centers for Medicare and Medicaid Services speaking at the Health Care Payment Learning and Action Network Fall Summit, October 30, 2017
The American Hospital Association (AHA) published the report Assessing the Regulatory Burden on Health Systems, Hospitals and Post-Acute Care Providers to determine the impact of regulatory burden” on hospitals, health systems and post-acute care (PAC) facilities. The purpose of the report is twofold. First, inform policymakers, lawmakers and the public about the administrative impact federal regulatory requirements have on the ability to furnish high-quality patient care. Secondarily, this report seeks to offer a starting point for discussions on implementing meaningful regulatory reform.
The AHA approached this endeavor with a thorough review of the Federal Register and the U.S. Code of Federal Regulations for regulations impacting hospitals and PACs across the following nine domains:
- Quality Reporting,
- New Models of Care/Value-Based Payment (VBP) Models,
- Meaningful Use (MU) of Electronic Health Records (EHRs),
- Hospital Conditions of Participation (CoPs),
- Program Integrity,
- Fraud and Abuse,
- Privacy and Security,
- Post-Acute Care, and
- Billing and Coverage Verification Requirements.
The four agencies described by the AHA as being “the primary drivers of federal regulations impacting these providers” are the Centers for Medicare and Medicaid Services (CMS), the Office of Inspector General (OIG), the Office of Civil Rights (OCR) and the Office of the National Coordinator for Health Information Technology (ONC).
Report Findings by the Numbers
- 629 – The number of mandatory regulatory requirements in effect as of March 2017.
- 341 – The number of hospital related requirements.
- 288 – The number of PAC related requirements.
- $38.6 Billion – The national cost of administrative activities related to regulatory compliance across the 9 domains.
- 59 – The number of FTEs an average-sized hospital (161 beds) dedicates to regulatory compliance. PAC regulations require an additional 8.1 FTEs.
- 4.6 – The number of FTEs an average-sized hospital devotes to quality reporting requirements.
- $706,000 – The annual amount spent by an average-sized hospitals on administrative aspects of quality reporting.
- $760,000 – The annual amount spent by an average-sized hospital to meet Meaningful Use (MU) administrative requirements.
- 63% - The report found that over 63% of compliance costs are dedicated to compliance with documenting CoP adherence and billing and coverage verification processes.
AHA Recommends Immediate Actions
The report lists twelve immediate activities that should be taken by Congress and the Administration to “reduce regulatory burden and enhance care coordination, without negatively impacting patient care.”
Among the recommendations, two specific recommendations would definitely relieve regulatory burden for Hospital Case Managers.
- Modify Medicare CoP to allow hospitals to recommend post-acute care providers, and
- Remove the mandatory free-text field from the Medicare Outpatient Observation Notice (MOON) and eliminate the confusing Second Important Message from Medicare.
In keeping with the purpose to inform policymakers and lawmakers, all of the recommendations were provided by AHA in letters to President Trump, CMS and Congress.
The report ends by noting that regulations are needed to support the safe delivery of care. “However, 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.”
At MMP, we understand the regulatory burden our clients are faced with daily. This is why we publish our weekly e-newsletter and why our mission is Making Health Care Make Sense.
Beth Cobb
According to the Payment Accuracy.gov website “The Improper Payments and Elimination and Recovery Act of 2010 defines an “improper payment” as any payment that should not have been made or that was made in an incorrect amount under statutory, contractual, administrative, or other legally applicable requirements.
Expressed positively, a proper payment has four main attributes: right recipient, right amount, right reason, and right time. A violation of any one of any attributes may result as an “improper payment” if an agency cannot document those conditions. Furthermore, not all “improper payments” are the result of fraudulent actions or represent monetary loss to the government.”
The Comprehensive Error Rate Testing (CERT) Program calculates improper payment rates for the Medicare Fee-for-Service program. This article focuses on the CERT Program and Review Process and findings from the 2017 CERT Report.
CERT Program & Review Process
The CERT Program was implemented by CMS to measure improper payments in the Medicare Fee-for-Service (FFS) Program. For each reporting period, the CERT Program selects a stratified random sample of approximately 50,000 claims submitted to Part A/B Medicare Administrative Contractors (MACs) and Durable Medical Equipment MACs (DMACs).
Medical review professionals perform complex medical reviews to determine whether a claim was paid properly under Medicare coverage, coding and billing rules. This process includes the following steps:
- Claim selection,
- Medical Record Requests,
- Review of claims by medical review professionals to determine whether a claim was paid properly under Medicare coverage, coding and billing rules,
- Assignment of Improper Payment Categories (no documentation, insufficient documentation, medical necessity, incorrect coding and other), and
- Calculation of the Improper Payment Rate.
CMS calculates a national improper payment rate and contractor specific and service specific improper rates from this stratified random sample of claims. As noted on the CMS CERT webpage, “The improper payment rate calculated from this sample is considered to reflect all claims processed by the Medicare FFS program during the report period.”
CMS notes “that the improper payment rate is not a “fraud rate,” but is a measurement of payments that did not meet Medicare requirements. The CERT program cannot label a claim fraudulent.”
In a CMS Introduction to CERT download on the CMS CERT webpage, the following examples are provided specific to each improper payment category.
2017 CERT Report by the Numbers:
Annually, the Department of Health and Human Services (HHS) publishes the improper payment rate in the Agency Financial Report. CMS later publishes more detailed improper payment rate information in the form of the annual Medicare FFS Improper Payments Report and Appendices. CMS published the 2017 Medicare Fee-for-Service Supplemental Improper Payment Data Report on January 8, 2018. This report includes a review of claims submitted from July 1, 2015 through June 30, 2016.
Overall Claims Volume
- 21,120 - The number of claims sampled.
- 14,500 - The number of claims reviewed.
Accuracy & Improper Payment Rates
- 5% - The Percent Accuracy Rate representing $344.68 billion in claims.
- 5% - The Improper Payment Rate representing $36.2 billion in claims.
Common Causes of Improper Payments
- 1% - Insufficient Documentation
- 5% - Medical Necessity
- 1% - Incorrect Coding
- 7% - No Documentation
- 6% - Other
“0 or 1 Day” LOS Claims Continued Outlier
The CERT Program has reported Projected Improper Payments by Length of Stay (LOS) since the 2014 Report. While the Improper Payment Rate has dropped for “0 or 1 day” LOS claims, this group of claims continues to have the highest improper payment rate.
“0 or 1 Day” Audit Focus
The FY 2016 Office of Inspector (OIG) Work Plan included the issue of Hospital’s use of outpatient and inpatient stays under Medicare’s two-midnight rule (OEI; 02-15-00020). In December 2016, the OIG released the report, Vulnerabilities Remain Under Medicare's 2-Midnight Hospital Policy. This study was based on hospital claims and did not include a medical review. More specifically, the OIG considered inpatient claims lasting 2 midnights or longer as being “appropriate” and claims lasting less than 2 midnights to be “potentially inappropriate.”
One recommendation made to CMS by the OIG was to “conduct routine analysis of hospital billing and target for review the hospitals with high or increasing numbers of short inpatient stays that are potentially inappropriate under the 2-midnight policy.” CMS agreed and noted that its Quality Improvement Organizations are currently conducting short stay patient status reviews for the appropriateness of Part A payment.
Short Stays for Chest Pain: New LCD for Jurisdiction J
The OIG report identified chest pain as one of the most common reasons for a short inpatient stay to be “potentially inappropriate.”
Hopefully, you are aware that the MAC for Jurisdiction J Part A transitioned from Cahaba GBA to Palmetto GBA this past Monday January 29th. What you may not know is that Palmetto GBA has a One Day Stays for Chest Pain Local Coverage Determination (LCD L34551) that became active the same day. This guidance will be used by the BFCC-QIO (KEPRO) for Alabama, Georgia and Tennessee when reviewing short stay claims for chest pain.
Compliance with Short Stays
Have you tracked your short stay volume overall, by MS-DRG or Physician over time? Do you know if your hospital is an outlier? Where can you look to find these answers?
PEPPER
One resource available to hospitals is the Short-Term Acute Care PEPPER (Program for Evaluating Payment Patterns Electronic Report). The PEPPER is made available to hospitals on a quarterly basis and compares your hospital to your state, MAC Jurisdiction and the nation. One-day Stays for Medical and Surgical MS-DRGs are two of the “Target Areas” at risk for improper payments included in this report.
The PEPPER provides the following suggested interventions for high One-day Stays Hospitals:
“This could indicate that there are unnecessary admissions related to inappropriate use of admission screening criteria or outpatient observation. A sample of same- and/or one-day stay cases should be reviewed to determine if inpatient admission was necessary or if care could have been provided more efficiently on an outpatient basis (e.g., outpatient observation). Hospitals may generate data profiles to identify same- and/or one-day stays sorted by DRG, physician or admission source to assist in identification of any patterns related to same- and/or one-day stays. Hospitals may also wish to identify whether patients admitted for same- and/or one- day stays were treated in outpatient, outpatient observation or the emergency department for one or more nights prior to the inpatient admission. Hospitals should not review same- and/or one- day stays that are associated with procedures designated by CMS as “inpatient only.”
RealTime Medicare Data
Another source that can help assist you is our sister company, RealTime Medicare Data (RTMD). RTMD collects over 800 million Medicare claims annually from 23 states and the District of Columbia, and allows for searching of over 7 billion historical claims. In response to the “Two-Midnight” Policy, RTMD has available in their suite of Inpatient Hospital reports a One Day Stay Report. To give you a true picture of your “at risk” volume, this report excludes claims with a discharge status for Expired (20), left against medical advice (07), hospice (50 & 51) and /or were transferred to another Acute care facility (02). This report enables a hospital to view one day stay paid claims data by DRG and Physician to direct where audits should be focused. For further information on all that RTMD has to offer you can visit their website at www.rtmd.org.
To learn more about the CERT visit AdvanceMed’s CERT Provider Documentation Information website at https://certprovider.admedcorp.com/Home/About.
Beth Cobb
Medicare Transmittals
Clinical Laboratory Fee Schedule – Medicare Travel Allowance Fees for Collection of Specimens
Revises the payment of travel allowances when billed on a per mileage basis using Health Care Common Procedure Coding System (HCPCS) code P9603 and when billed on a flat-rate basis using HCPCS code P9604 for Calendar Year (CY) 2018.
Changes to the Laboratory National Coverage Determination (NCD) Edit Software for April 2018
Changes in the April 2018 quarterly release of the edit module for clinical diagnostic laboratory services.
New Waived Tests
New Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the Food and Drug Administration.
Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits
The new Healthcare Common Procedure Coding System (HCPCS) codes for 2018 that are subject to and excluded from Clinical Laboratory Improvement Amendments (CLIA) edits.
Notice of New Interest Rate for Medicare Overpayments and Underpayments - 2nd Qtr Notification for FY 2018
Medicare contractors shall implement an interest rate of 10.625 percent effective January 19, 2018 for Medicare overpayments and underpayments.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R297FM.pdf
ICD-10 and Other Coding Revisions to National Coverage Determinations (NCDs)
Replaces Transmittal 1975. A maintenance update of ICD-10 conversions and other coding updates specific to National Coverage Determinations (NCDs).
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R2005OTN.pdf
Medicare Special Edition Articles
Proper Use of Modifier 59 – REVISED
Revised on January 3, 2018, to conform with the latest Modifier 59 article on the NCCI website.
Medically Unlikely Edits (MUE) and Bilateral Surgical Procedures
Inform providers that Medically Unlikely Edits (MUEs) may render certain claim lines for bilateral surgical procedures unpayable.
Medicare Coverage Updates
Proposed Decision Memo for Magnetic Resonance Imaging (MRI)
Proposing to modify the national coverage determination to eliminate the collection of additional information under the Coverage with Evidence Development.
Rules and Regulations
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Correction
This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on December 14, 2017 entitled ‘‘Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs.’’
https://www.gpo.gov/fdsys/pkg/FR-2017-12-27/pdf/2017-27949.pdf
State Survey Memorandums
Texting of Patient Information among Healthcare Providers
Memorandum clarifies 1) Texting patient information among members of the health care team is permissible if accomplished through a secure platform; 2) Texting of patient orders is prohibited regardless of the platform utilized; 3) Computerized Provider Order Entry (CPOE) is the preferred method of order entry by a provider.
Medicare Press Releases
New Payment Model
CMS’s Center for Medicare and Medicaid Innovation (Innovation Center) announced the launch of a new voluntary bundled payment model called Bundled Payments for Care Improvement Advanced (BPCI Advanced).
Medicare Educational Resources
Medicare Quarterly Provider Compliance Newsletter – January 2018
Topics include Advanced Care Planning and proper use of modifier 59 for physicians and non-physician practitioners
Major Joint Replacement (Hip or Knee) MLN Booklet
Due to the high volume of major joint replacement claims, CMS has had multiple auditing entities, including the Recovery Auditors, Comprehensive Error Rate Testing (CERT) Contractors, and Medicare Administrative Contractors (MACs) review claims for these MS-DRGs. Their findings have demonstrated very high paid claim error rates among both hospital and professional claims associated with major joint replacement surgery.
Total Knee Procedures (CPT 27447) were removed from the Medicare Inpatient Only List Effective January 1, 2018. CMS also finalized prohibiting RAC “reviews for patient status for TKA procedures performed in the inpatient setting for a period of 2 years to allow time and experience for these procedures under this setting.” However, these procedures remain “fair game” for review for medical necessity of the surgical procedure regardless of patient status.
CMS’s January 11, 2018 edition of MLN Connects included a new Medicare Learning Network (MLN) publication titled Major Joint Replacement (Hip or Knee) Booklet (ICN 909065). This booklet provides guidance on how to document medical necessity; ensure a complete and accurate medical record; key points for billing codes; and aids to correct billing.
CMS Focuses on Major Joint Replacement or Reattachment
Before the “how to,” it is important to understand “why” the focus on Major Joint Replacements.
Major Joint Replacement or Reattachment (MS-DRGs 469 and 470) are high volume, high cost procedures for Medicare. CMS has had Recovery Auditors, Comprehensive Error Rate Testing (CERT) Contractors, and Medicare Administrative Contractors (MACs) review claims for these MS-DRGs. “Their findings have demonstrated very high paid claim error rates among both hospital and professional claims associated with major joint replacement surgery.”
MS-DRG 470 is consistently the top surgical MS-DRG by volume for hospitals. To illustrate the volume and cost, the following table details the Jurisdiction J (JJ) MAC paid claims data for MS-DRG 470 for dates of service from July 1, 2016 through June 30, 2017.
Document Medical Necessity
CMS notes that “to avoid denial of claims…the medical records should contain enough detailed information to support the determination that major joint replacement surgery was reasonable and necessary for the patient. Progress notes should consist of more than just conclusive statements. Therefore, the medical record of the joint replacement surgical patient must specifically document a complete description of the patient’s historical and clinical findings.”
The Patient’s Medical Record
The following information should be included in a patient’s Medical Record to support that surgery was reasonable and necessary for the patient.
Patient History
The history should include information such as:
- A description of pain (onset, duration, character, aggravating, and relieving factors),
- Any limitations of specific Activities of ADLs (e.g., unable to climb steps),
- Safety issues (e.g. any falls),
- Contraindications to non-surgical treatments,
- Failed non-surgical treatments (e.g., NSAIDs, weight loss, intra-articular injections).
Physical Exam
Detailed objective findings of the joint examination should be included in the physical exam. Examples of findings include:
- Any deformity,
- Range of motion limitations,
- Crepitus,
- Effusions,
- Tenderness, and
- Gait description.
Investigations
The medical record should include the results of any applicable tests (i.e. plain radiographs and pre-operative imaging studies).
The Patient’s Hospital Record
Pre-operatively, the record should include documentation of the specific condition necessitating surgery such as osteoarthritis (mild, moderate, severe), avascular necrosis of the knee, or fractures).
Post-Operatively, the record should include the operative report (including observed pathology), daily progress notes for an inpatient, the discharge plan and discharge orders.
The booklet goes on to provide examples of a medical record that may result in a denied claim and a claim with more detail and support of medical necessity. CMS also provides a link to MLN SE1236 - Documenting Medical Necessity for Major Joint Replacement (https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/se1236.pdf) as a resource for providing guidance on documenting medical necessity for major joint replacement procedures.
MMP encourages you to carefully read the MLN Booklet and MLN SE1236 and share this information with your surgeons as CMS notes that “both physicians and hospitals are responsible for ensuring a complete and accurate record.”
Beth Cobb
If your life is not hectic, I want to know where you live and how you manage that! In today’s busy world, as most of us balance numerous responsibilities at work and at home, we have to be able to multi-task. It is a great feeling to be able to accomplish several things with one action. This article about Medicare coverage updates addresses multiple lessons to learn from one LCD.
Effective December 7, 2017, First Coast Service Options, the Medicare Administrative Contractor (MAC) for Jurisdiction N (JN) has a new LCD for Wound Care (L37166). As usual, with new LCDs, there is also an accompanying Article that reviews the comments received from the provider community in regards to the draft LCD and First Coast’s responses to those comments. Here are the lessons to be learned from the First Coast Wound Care LCD and Article:
- Requirements for coverage of wound care services
- Documentation necessary to support coverage of wound care services
- Importance of commenting on draft policies
- Importance of reading LCD comments
Coverage Requirements
The LCD is lengthy and contains a lot of detailed information. This is a summary of some of the coverage highlights, so providers affected by this LCD should read it carefully for a complete understanding. Other than for palliative care covered in specific circumstances, Medicare coverage for wound care is contingent upon evidence that the wound is improving. Wound care must also include all applicable adjunctive measures as part of comprehensive wound management in order to be medically reasonable and necessary. Debridement is not covered when the wound is without devitalized, fibrotic, nonviable tissue, infection, necrosis, foreign matter, or if the wound has pink to red granulated tissue.
Also per the First Coast LCD, “the following services are considered to be not reasonable and necessary wound debridement services:
- Removal of necrotic tissue by cleansing or dry-to-dry or wet-to-dry dressing.
- Washing bacterial or fungal debris from lesions.
- Removal of secretions and coagulation serum from normal skin surrounding an ulcer.
- Dressing of small or superficial lesions.
- Paring or cutting of corns or non-plantar calluses.
- Incision and drainage of abscess including paronychia, trimming or debridement of mycotic nails, avulsion of nail plates, acne surgery, or destruction of warts.
- Removal of non-tissue integrated fibrin exudates, crusts, or other materials from a wound without removal of tissue does not meet the definition of any debridement code and may not be reported as such.”
Documentation Requirements
Documentation has the same disclaimer as coverage – providers must read the entire LCD to understand all of the documentation requirements. Some key points to remember concerning documentation are that the documentation should include:
- The current status of the wound,
- A plan of care containing treatment goals and physician follow-up,
- Complicating factors for wound healing and the measures taken to control the complicating factors,
- An operative note or procedure note for the debridement services that among other requirements, describes the wound size and characteristics, the medical necessity for debridement, the level of tissue debrided, the material removed, the instrument used, goals and response to treatment, and follow-up instructions, and
- Evidence of the wound’s progress toward healing.
Commenting on Draft Policies
Medicare requires MACs provide a minimum comment period of 45 calendar days for draft LCDs and an additional 45-day notice period after final revisions based on the comments received before an LCD becomes effective. The comment period allows providers and the medical community to express their concerns and suggestions about the proposed LCD.
The benefit of reviewing and commenting on draft policies is twofold. Most importantly, the MAC may agree with your comments and revise the policy. Secondly, even if no changes are made, you become familiar with the policy and are better prepared when it is finalized. It is not unusual for the MAC to make revisions to a draft LCD based on comments. The following clarifications or revisions were some of the ones made by First Coast in response to the comments:
- Clarification is provided on judicious use and efficacy of wet-to-dry and dry-to-dry dressings.
- The limitations addressing ulcers which may arise after paring or cutting of corns or non-plantar calluses as not reasonable and necessary wound debridement services have been removed from the finalized LCD.
- Photographic documentation for wounds has been amended to suggestions for best practices in wound care. (instead of a requirement)
- The final LCD was amended to remove the reference about podiatrists.
- After consideration, some of the conditions which were referred to as dermatologic have been amended or removed.
Read LCD Comments
Do you ever read a coverage policy and wonder “what were they thinking?” The LCD Comments Article gives hints, at least on the issues addressed, as to what the MAC was thinking regarding the policy decisions. Here are a few examples from the First Coast Wound Care LCD Comments Article demonstrating this:
- The Contractor also recognizes studies show disposable Negative Pressure Wound Therapy (NPWT) may be just as effective as the traditional NPWT, and it has been determined that there will be access to coverage for NPWT utilizing durable medical equipment or non-durable medical equipment in appropriately selected patients.
- Concerning the establishment of an appropriate non-skilled maintenance program: Medicare coverage is defined by reasonable and necessary criteria per Social Security Act section 1862 (a) 1(A). This statement is an expectation; it does not preclude a skilled maintenance program or palliative wound care when reasonable and necessary.
- Concerning the addition of biofilm or bioburden to Covered Indications for debridement: The contractor agrees that this statement is incorrect. There are active wound care management CPT® codes that reference removal of biofilm and may be reported for such debridement. Please reference CPT® and coding guidelines.
- Concerning frequency limitations for debridement of muscle/fascia or bone: Debridement codes involving fascia or bone would be expected to lessen over a period of time as the wound heals. Data analysis illustrates that a minority of beneficiaries receiving wound care actually receive more than five debridements involving muscle/fascia or bone in a rolling 360-day period. Debridements of an unusually prolonged or excessive number should be accompanied by meticulous documentation illustrating that the service is both medical necessary and reasonable.
Once again, I remind everyone in the JN jurisdiction to read the complete LCD for all information about coverage and documentation requirements. I also encourage reading the Comments Article for additional understanding of the MAC’s reasoning on certain points. For our readers in other jurisdictions, this would be a good time to review the wound care LCD that applies to your hospital. There are always lessons to be learned.
Debbie Rubio
I love a beautiful sunset, especially those where low level clouds in the western sky catch the rays of the waning sun and light up the sky with an orangish, pinkish, reddish glow. It always brings to mind a saying I learned as a child – “red sky at night, sailors delight; red sky at morning, sailors take warning.” For providers approved to participate in a study and bill Medicare for NaF-18 PET scans for bone metastasis, there is a warning for the upcoming sunset of NCD 200.6.19.
Although Medicare generally does not cover experimental or investigational items and services, the National Coverage Determination (NCD) Coverage with Evidence Development (CED) process allows Medicare coverage for some items and services on the condition they are furnished in the context of approved clinical studies or with the collection of additional clinical data. CMS performs an initial review of medical literature to determine if CED coverage is appropriate with the expectation the studies conducted under a CED NCD will produce evidence that will lead to revisions of Medicare coverage policies. The CED process allows patients earlier access to innovative technology while ensuring patient safeguards. CED NCDs usually list the specific questions CMS expects the study or data collection to answer.
In February 2010, CMS approved coverage of NaF-18 Positron Emission Tomography (PET) to identify bone metastasis of cancer under the CED process. Specifically, under NCD 220.6.19, Medicare covers “NaF-18 PET imaging when the beneficiary’s treating physician determines that the NaF-18 PET study is needed to inform the initial antitumor treatment strategy or to guide subsequent antitumor treatment strategy after the completion of initial treatment, and when the beneficiary is enrolled in, and the NaF-18 PET provider is participating in, (a specified) type of prospective clinical study.” Medicare expected the clinical studies to answer the following questions:
Does the addition of NaF-18 PET imaging lead to:
- A change in patient management to more appropriate palliative care; or
- A change in patient management to more appropriate curative care; or
- Improved quality of life; or
- Improved survival?
In 2015, the National Oncologic PET Registry (NOPR), which is the approved study for NaF-18 PET, asked CMS to reconsider NCD 220.6.19, end the CED data collection requirements, and authorize national coverage of NaF-18 PET for bone metastasis of all oncologic indications. On December 15, 2015, CMS issued a Decision Memo that did not end the CED data collection requirements for NaF-18 PET, but extended coverage under the CED process for an additional 24 months. This means the current NCD and Medicare coverage for NaF-18 PET (under CED) will sunset on December 14, 2017. NOPR has sent notices concerning the expiration of this NCD to the participating facilities and also has an announcement on their website, but I was unable to locate any information on Medicare’s websites concerning this.
I reached out to Medicare and have received confirmation that this is indeed correct. For dates of service on and after December 15, 2017, Medicare will no longer cover NaF-18 PET scans to identify bone metastasis of cancer. There have not been any published studies that conclusively answer the study questions. Medicare denials will likely be based on the presence of HCPCS code A9580 (Sodium fluoride F-18, diagnostic, per study dose, up to 30 millicuries) on the claim.
It is likely CMS will receive another request for reconsideration of this policy from NOPR or other stakeholders. Be on the lookout for further guidance from CMS in the future as to whether they will reinstate coverage of NaF-18 PET to identify bone metastasis of cancer under CED, cover the service outright without CED, or continue to not cover the service at all. Until that time, providers take warning – this sunset isn’t pretty since it takes away your Medicare reimbursement for NaF-18 PET.
Debbie Rubio
Ambulance Inflation Factor for CY 2018 and Productivity Adjustment
The Calendar Year (CY) 2018 Ambulance Inflation Factor (AIF) for determining the payment limit for ambulance services is 1.1 percent.
Correction to Prevent Payment on Inpatient Information Only Claims for Beneficiaries Enrolled in Medicare Advantage Plans
Sets system edits to zero out payment on inpatient information only claims billed with condition codes 04 and 30 for Investigational Device Exemption (IDE) Studies and Clinical Studies Approved Under Coverage with Evidence Development (CED).
New Common Working File (CWF) Medicare Secondary Payer (MSP) Type for Liability Medicare Set-Aside Arrangements (LMSAs) and No-Fault Medicare Set- Aside Arrangements (NFMSAs) - RESCINDED
Clarifying Signature Requirements
Medicare requires that services provided/ordered/certified be authenticated by the persons responsible for the care of the beneficiary in accordance with Medicare’s policies. Claim denials shall be limited to those instances in which signatures that are required by Medicare policies are flawed or missing.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R751PI.pdf
Clinical Laboratory Improvement Amendments of 1988 (CLIA); Fecal Occult Blood (FOB) Testing
Clarifies CLIA regulations that the waived test categorization applies only to non- automated fecal occult blood tests.
https://www.gpo.gov/fdsys/pkg/FR-2017-10-20/pdf/2017-22813.pdf
Calculating Interim Rates for Graduate Medical Education (GME) Payments to New Teaching Hospitals – REVISED
Re-issued to revise several policy statements and to address how to handle certain impacted claims.
New Common Working File (CWF) Medicare Secondary Payer (MSP) Type for Liability Medicare Set-Aside Arrangements (LMSAs) and No-Fault Medicare Set-Aside Arrangements (NFMSAs) – REPLACED
Removes provider education requirements from original transmittal.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R1954OTN.pdf
Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs Final Rule
Revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2018.
https://www.gpo.gov/fdsys/pkg/FR-2017-11-13/pdf/2017-23932.pdf
Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018
Addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to update payment systems to reflect changes in medical practice and the relative value of services, as well as changes in the statute. In addition, this final rule includes policies necessary to begin offering the expanded Medicare Diabetes Prevention Program model.
https://www.gpo.gov/fdsys/pkg/FR-2017-11-15/pdf/2017-23953.pdf
Implementation of the Award for the Jurisdiction Part A and Part B Medicare Administrative Contractor (JJ A/B MAC)
Announces CMS has awarded the JJ A/B MAC contract for the administration of the Part A and Part B Medicare fee-for-service claims in the states of Alabama (AL), Georgia (GA) and Tennessee (TN) to Palmetto GBA LLC.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R1960OTN.pdf
Update to Pub 100-04, Chapter -18 Preventive and Screening Services -Screening for Lung Cancer with Low Dose Computed Tomography (LDCT)
Adds ICD-10 diagnosis codes: F17.210 (Nicotine dependence, cigarettes, uncomplicated), F17.211 (Nicotine dependence, cigarettes, in remission), F17.213 (Nicotine dependence, cigarettes, with withdrawal), F17.218 (Nicotine dependence, cigarettes, with other nicotine-induced disorders), or F17.219 (Nicotine dependence, cigarettes, with unspecified nicotine-induced disorders), for LDCT coverage.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R3901CP.pdf
Billing Requirements for Ophthalmic Bevacizumab
Clarifies HCPCS code for billing ophthalmic bevacizumab.
Notification of the 2018 Dollar Amount in Controversy Required to Sustain Appeal Rights for an Administrative Law Judge (ALJ) Hearing or Federal District Court Review
ALJ hearing requests amount for 2018 will remain at $160. Federal District Court appeals amount will increase to $1,600 for 2018.
Accepting Payment from Patients with a Medicare Set-Aside Arrangement
Explains what a MSA is and explains why it is appropriate to accept payment from a patient that has a funded MSA.
CMS Hospital Value-Based Purchasing Program Results for Fiscal Year 2018
Fact Sheet describing VBP program and updates. Estimates the total amount available for value-based incentive payments for FY 2018 discharges will be approximately $1.9 billion.
Additional Appeals Settlement Option
CMS will make available an additional settlement option for providers and suppliers (appellants) with appeals pending at the Office of Medicare Hearings and Appeals (OMHA) and the Medicare Appeals Council (the Council) at the Departmental Appeals Board.
ICD-10 and Other Coding Revisions to National Coverage Determinations (NCDs)
NCD coding changes the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
CMS Posts RAC Review Topics
CMS has begun to post a list of review topics that have been proposed, but not yet approved, for RACs to review. These topics will be listed, on a monthly basis, on the Provider Resources page.
Partial Settlement of 2-Midnight Policy Court Cases
Provides instructions to Medicare Administrative Contractors (MACs) on how to ensure hospitals receive additional payments due to a partial settlement agreement regarding the 0.2 percent downward adjustment beginning in Fiscal Year ("FY") 2014.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2017Downloads/R1969OTN.pdf
New Waived Tests
New Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the Food and Drug Administration (FDA).
Annual Update of HCPCS Codes Used for Home Health Consolidated Billing Enforcement
Provides the 2018 annual update to the list of Healthcare Common Procedure Coding System (HCPCS) codes used by Medicare systems to enforce consolidated billing of home health services.
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.
Claim Status Category Codes and Claim Status Codes Update
MAC and shared systems changes will be made as necessary as part of a routine release to reflect applicable changes such as retirement of previously used codes or newly created codes.
Therapy Cap Values for Calendar Year (CY) 2018
For physical therapy and speech-language pathology combined, the CY 2018 cap is $2,010. For occupational therapy, the CY 2018 cap is $2,010.
New Positron Emission Tomography (PET) Radiopharmaceutical/Tracer Unclassified Codes
CMS has created two new PET radiopharmaceutical unclassified tracer codes that can be used temporarily pending the creation/approval/implementation of permanent CPT codes that would later specifically define their function: A9597 - Positron emission tomography radiopharmaceutical, diagnostic, for tumor identification, not otherwise classified; A9598 – Positron emission tomography radiopharmaceutical, diagnostic, for non-tumor identification, not otherwise classified.
2018 Medicare Parts A & B Premiums and Deductibles
On November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released the 2018 premiums, deductibles, and coinsurance amounts for the Medicare Part A and Part B programs. The standard monthly premium for Medicare Part B enrollees will be $134 for 2018, the same amount as in 2017. The annual deductible for all Medicare Part B beneficiaries will be $183 in 2018, the same annual deductible in 2017. The Medicare Part A annual inpatient hospital deductible that beneficiaries pay when admitted to the hospital will be $1,340 per benefit period in 2018, an increase of $24 from $1,316 in 2017.
https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-11-17.html
Quarterly Update of HCPCS Codes Used for Home Health Consolidated Billing Enforcement
Provides the quarterly update of HCPCS codes used for HH consolidated billing effective April 1, 2018.
Over the past several weeks, our newsletter has focused attention on the transition of the Jurisdiction J (Alabama, Georgia, and Tennessee) Medicare Administrative Contractor (MAC) from Cahaba to Palmetto GBA. For those providers affected by this transition, please pay special attention to this article as you will be required to participate in this program under the Palmetto contract. Special information affecting Jurisdiction J is included at the end of this article.
If you are a regular reader of our Wednesday@One newsletter, you may already know that my original role in healthcare was as a clinical laboratory scientist (CLS) or Medical Technologist (MT). I loved working in the clinical laboratory, but my detail oriented brain also loves my current work with Medicare regulations. In the realm of healthcare compliance, I keep up with the rapid and never-ending changes of Medicare healthcare regulations. Unfortunately, since Compliance is now my focus, I no longer keep up with the also rapid and never-ending changes to laboratory medicine.
Molecular diagnostic testing (MDT) is one area of laboratory advancements that is having a tremendous impact on the practice of medicine overall. Human genomics is reshaping the medical approach to therapy and diagnosis in areas such as inherited genetic diseases, infectious disease, oncology, human leucocyte antigen typing to predict immune function, coagulation, and pharmacogenomics—the genetic prediction of which drugs will work best. As this testing has become more common, healthcare payers have struggled with determining the appropriate coverage and payment for these tests.
Some of the challenges for Medicare related to molecular diagnostic testing were:
- HCPCS and CPT descriptions for these codes describe the pathology and laboratory categories but do not identify a specific test.
- The Clinical Laboratory Fee Schedule pricing methodology does not account for the unique characteristics of these tests.
- Who determines if the tests fall within a Medicare benefit category?
- Some tests have not been assessed for clinical and analytical validity and clinical utility.
Medicare’s solution was the Molecular Diagnostic Services (MolDX) Program, which was developed by Palmetto GBA in 2011 to identify and establish coverage and reimbursement for molecular diagnostic tests. Palmetto GBA currently administers the MolDX Program and all its information.
The program applies to all private, reference, and hospital laboratories that perform molecular diagnostic testing and submit claims to Medicare Part A or Part B. The following molecular diagnostic assays/tests are included in MolDX.
How does the MolDX Program address the above challenges?
The MolDX program performs the following functions, which solve the challenges noted above concerning molecular diagnostic tests:
- Facilitates detailed and unique identification through registration of molecular diagnostics tests to facilitate claims processing and to track utilization.
- Establishes clinical utility expectations
- Completes technical assessments of published test data to determine clinical utility and coverage
- Establishes reimbursement
How does the MolDX Program work?
Obtain a DEX Z-Code
Laboratories must apply for and obtain a unique test identifier for each MDT or LDT (lab developed test) they perform.
Attention Hospitals - You are NOT expected to submit tests to obtain Z-Codes for tests sent to another laboratory to perform. You submit tests to obtain a Z-code only for those tests you perform in-house. However, the MolDX FAQs state it is the responsibility of the billing provider to obtain a DEX Z-Code™ identifier, such as in cases where the performing lab is not in a jurisdiction under the MolDX program. Since reference labs performing genetic testing generally offer services across the nation, most will have already obtained the necessary Z-codes.
These are the steps required for participation in the MolDX program:
- You are required to register your organization in the DEX Diagnostics Exchange if you plan to submit claims for the MolDX codes to MACs participating in the MolDX program (see list of Participating MACs below).
- Providers billing Part A for molecular tests performed by a proprietary or reference laboratory will “Request Sharing” in DEX, from your reference lab, to get access to the Z-Code for billing purposes. You must obtain the DEX Z-CodeTM for the molecular test(s) from the performing laboratory, either directly or through the DEX system.
- Hospital providers billing for molecular services performed by their hospital-based laboratory must register and obtain a unique DEX Z-CodeTM for each molecular test in the MolDX code ranges designated above.
Obtain a Technical Assessment Approval (Coverage Determination)
Once a Z-code is assigned, coverage is determined through a technical assessment (TA). Established FDA-approved tests with proven utility that are performed within labeling indications may not require a technical assessment. A TA is required for molecular assays that are laboratory developed tests (LDT), employ new or novel technology, or have undefined or unproven clinical utility. For these tests, labs/developers must submit a detailed dossier of clinical data to substantiate the test meets Medicare’s requirements for coverage. The Technical Assessment Submission Instructions (M00115) provides the steps to submit a dossier.
All new test services will be denied as noncovered until the test completes the TA process and reasonable and necessary criteria is established. Claims submission for tests in the TA process should be suspended until a final coverage determination is made. Labs should not provide lab tests pending a TA approval until coverage is approved and appropriate billing and coding guidelines are published.
Once a coverage determination has been established, the results will be published to the provider community. A Local Coverage Determination (LCD) or Coverage Article may be developed if the test requires administration of reasonable and necessary limitations.
Report Z-Code on Claim
When the unique test identifier (DEX Z-Code™) is reported in conjunction with the appropriate CPT/HCPCS code on the claim, it allows Medicare to determine the exact test that has been performed, facilitating the process of making pricing and/or coverage determinations. The MolDX Manual provides instructions on the claim line detail fields for reporting the Z-codes.
- Part B providers – Paper claim - Block 19 of the CMS 1500 claim form; electronic claims (837P) - SV101-7 field adjacent to the applicable CPT code.
- Part A providers – Paper claim - block 80 of the UB04 claim form; electronic claims (837I) - line SV202-7.
- Part A providers will need to specify which lines are billed for MolDX and the appropriate DEX Z-Code per line within the remarks section of the claim.
Adjudication
The molecular test is adjudicated in accordance with the MAC’s LCDs and coverage articles.
Palmetto GBA’s “Molecular Diagnostic Tests (MDT)” LCD provides coverage for MDTs and LDTs that are identified as covered in the LCD. Palmetto has also developed and published specific LCDs, and/or coverage articles for some MolDX tests. MDTs and LDTs not identified as covered in an NCD, LCD, or coverage article are not covered. Palmetto GBA will continue to accept and consider requests on excluded genetic tests. You can find a link to Palmetto’s LCDs, as well as list of covered and excluded tests, on Palmetto’s MolDX website.
Participating MACs
Although Palmetto “owns” the MolDX program, several other MACs also participate in the program. These include Noridian JE and JF, CGS J15, and WPS J5 and J8. Each of these MACs have coverage policies and websites dedicated to the MolDX program. If you are a provider in one of these jurisdictions, please check you MACs website for more information. At this time CMS has not determined how MolDX will be expanded.
Jurisdiction J Transition
Medicare Part A and Part B providers in the Palmetto GBA Jurisdiction J will be required to register all molecular tests with the Diagnostics ExchangeTM (DEX), an online test registry. There will be a phase in for Jurisdiction J to allow time for test providers to obtain their Z-codes. We strongly suggest labs and other test providers begin the process now to avoid any claim processing delays once the Z-code is required on the claim, which is currently projected to be no later than claims submitted on or after June 1, 2018 (note this is not Date of Service driven).
Refer to the Steps for Participating in the MolDX Program listed above to determine exactly what actions are needed for JJ providers billing for molecular diagnostic testing. JJ providers should carefully study all the information on the MolDX website and become familiar with Palmetto’s MolDX LCDs. This is a necessary piece of the JJ transition.
Debbie Rubio
“Inpatient only” services are generally, but now always, surgical services that require inpatient care because of the nature of the procedure, the typical underlying physical condition of patients who require the service, or the need for at least 24 hours of postoperative recovery time or monitoring before the patient can be safely discharged.
- Source: Medicare Claims Processing Manual, Chapter 4 – Part B Hospital
CMS released the Calendar Year (CY) 2018 OPPS/ASC Final Rule last Wednesday November 1st. For CY 2018 CMS proposed two changes to the Inpatient Only (IPO) List and had one request for solicitation. This article provides highlights from section IX. Procedures That Will Be Paid Only as Inpatient Procedures section of the Final Rule.
Total Knee Arthroplasty Public Comments
Many commenters believed that appropriately selected patients who are in excellent health, have no or limited medical comorbidities, and have sufficient caregiver support could be successful candidates for outpatient TKA. Following are TKA topic specific comments and how CMS responded.
Patient Selection for Outpatient TKA
Commenters
- Commenters supported the proposal, with “caveats regarding patient safety, including requests that CMS develop, with input from stakeholders, patient selection criteria and risk stratification protocols for TKA to be performed in an outpatient setting.”
- Two orthopedic specialty societies noted their organizations are in the process of developing these patient selection and protocol tools.
CMS Responds
- CMS believes that surgeons, clinical staff, and medical specialty societies performing outpatient TKA procedures possess the specialized clinical knowledge and experience are most suited to create patient selection guidelines. As such, they do not expect to create or endorse specific guidelines or content.
Determining Appropriate Site for Surgery
Commenters
- There were requests that “CMS explicitly state that the surgeon is the final arbiter of the appropriate site for the surgical procedure, that CMS provide an incentive for outpatient and ambulatory settings performing TKA, PHA, and THA to be a part of a registry such as the American Joint Replacement Registry, and CMS confirm that all surgeons will continue to have the option to select the appropriate setting (inpatient or outpatient) for the procedure.”
CMS Responds
- CMS indicates they “continue to believe that the decision regarding the most appropriate care setting for a given surgical procedure is a complex medical judgment made by the physician based on the beneficiary’s individual clinical needs and preferences and on the general coverage rules requiring any procedure be reasonable and necessary.”
- CMS reminds you that removal from the IPO List does not require the procedure to be performed only on an outpatient basis and that the “2-Midnight” rule continues to be in effect and was established to provide guidance on when an inpatient admission would be appropriate for payment under Medicare Part A (inpatient hospital services).
Impact on Medicare Payment Models
Commenters
- Numerous commenters believe this could potentially impact two current Medicare payment models (Bundled Payment Care Initiative (BPCI) and Comprehensive Care for Joint Replacement (CJR) Model). They expressed concern that younger and healthier patients would be more likely to undergo outpatient TKA’s and that TKA patients in the Inpatient setting would be higher risk and/or likely to need additional post-acute care support. This shift could increase average episode payment affecting a hospital’s ability to fall below an episode established target price.
CMS Responds
- Initially, CMS does not expect a significant volume of TKA cases to shift to the hospital outpatient setting as a result of removing this procedure from the IPO List. They do “intend to monitor the overall volume and complexity of TKA cases performed in the hospital outpatient department to determine whether any future refinements of these models are warranted.”
After consideration of public comments CMS finalized their proposal to remove the TKA procedure described by CPT code 27447 from the IPO List beginning in CY 2018 and to assign the procedure to C-APC 5115 with status indicator “J1”.
Moratorium on Recovery Audit Contractor (RAC) TKA reviews
CMS also finalized the proposal to prohibit RAC “reviews for patient status for TKA procedures performed in the inpatient setting for a period of 2 years to allow time and experience for these procedures under this setting.”
Public Requests for “Removal of” or “Additions to” Procedures on IPO List
Request for “Removal”
CMS notes there were requests to remove several additional procedures from the IPO List. The following table includes CPT codes that were requested to be removed.
Request for “Additions to”
One commenter requested adding CPT 92941 (Percutaneous transluminal revascularization of acute total/subtotal occlusion during acute myocardial infarction, coronary artery or coronary artery bypass graft, and combination of intracoronary stent, arthrectomy and angioplasty, including aspiration thrombectomy when performed, single vessel) to the IPO List because this is an emergent procedure to treat acute myocardial infarction patients.
Codes Finalized for “Removal from” or “Addition to” the IPO List in CY 2018
The following table details the finalized changes to the CY 2018 IPO list.
Should Partial Hip Arthroplasty (PHA) & Total Hip Arthroplasty (THA) be removed from IPO List?
As a reminder, in the CY 2018 OPPS Proposed Rule, CMS requested public comments to several questions related to whether or not PHA (CPT code 27125 (Hemiarthroplasty, hip, partial (e.g., femoral stem prosthesis, bipolar arthroplasty)), and THA, CPT code 27130 (arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft) procedures should be removed from the IPO List.
CMS further sought comment on whether these procedures meet criteria to be added to the ASC Covered Procedures List and how removing these from the IPO List would affect the BPCI and CJR models.
In the Final Rule CMS thanks commenters for their detailed responses and will consider them in future policymaking. So for now, hip procedures remain on the IPO List. Section IX. Procedures That Will Be Paid Only as Inpatient Procedures can be found on pages 657 through 685 of the unpublished Final Rule.
Resources:
Link to unpublished CY 2018 OPPS/ASC Final Rule:
Note: The Final Rule is schedule to be published in the Federal Register on 11/13/2017
Link to CY 2018 OPPS/ASC Final Rule Fact Sheet: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-11-01.html
Beth Cobb
As our readers may have noticed over the last two weeks, we are providing information on the transition of Jurisdiction J from Cahaba GBA as the Medicare Administrative Contractor (MAC) to Palmetto GBA beginning in January and February of 2018. Numerous MMP clients are located in Jurisdiction J, so we believe providing information on the transition is beneficial to our clients and other providers in this Jurisdiction (Alabama, Georgia, and Tennessee). Along these lines, the focus coverage policy for this month is B-type natriuretic peptide (BNP). I selected this policy because Cahaba GBA has been conducting pre-payment medical review of BNP in the outpatient/non-patient laboratory setting for several years with consistent error rates in the range of 99-100%. These denials are mainly due to “the documentation submitted did not support clinical urgency for 83880” which would be expected for acute potential cardiac events.
Since our newsletter is read nation-wide, I do not want to forget our readers in other Jurisdictions. It turns out it is easy to remember almost everyone when discussing coverage of BNP, because 7 of the 8 MACs (9 of 11 Jurisdictions) also have Local Coverage Determinations (LCDs) for BNP. And with only one exception, the indications and limitations for coverage across these policies is consistent. Here is a listing of the various Part A LCDs for BNP (CPT code 83880). You can easily view the specific policies by entering the Document ID # in the Quick Search section of the Medicare Coverage Database webpage.
Although stated somewhat differently between policies, the consensus for coverage of BNP is that it is covered:
- When used in combination with other medical data such as medical history, physical examination, laboratory studies, chest x-ray, and electrocardiography; and
- To distinguish cardiac cause of acute dyspnea from pulmonary or other non-cardiac causes;
- To distinguish decompensated CHF from exacerbated chronic obstructive pulmonary disease (COPD) in a symptomatic patient with combined chronic CHF and COPD (Cahaba’s LCD does not include this indication, although Cahaba has stated in verbal discussion with providers that this would be a covered use of BNP.); or
- As a risk stratification tool (to assess risk of death, myocardial infarction or congestive heart failure) among patients with acute coronary syndrome (myocardial infarction with or without T-wave elevation and unstable angina) when obtained in the first few days after the onset of ischemic symptoms.
Providers also need to be familiar with the ICD-10 diagnosis codes that “support medical necessity.” The list of codes supporting medical necessity varies between LCDs. It is likely the MAC will deny coverage utilizing automated edits when a claim is submitted without a “covered” diagnosis code.
BNP is not covered:
- As a stand-alone test, without being used in conjunction with standard diagnostic tests, medical history and clinical findings;
- For monitoring the efficiency of treatment for CHF and in tailoring the therapy for heart failure;
- For adjustment of therapy in individual patients, or
- As part of cardiovascular risk assessment panels (screening).
Some policies quote the American College of Cardiology/American Heart Association 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult. These guidelines were updated in 2017 and can be viewed on the ACC website. Some physicians argue the new guidelines support a standard of care to monitor and adjust therapy, determine prognosis and establish disease severity in CHF patients followed in an ambulatory setting based on the
“Class I recommendation (Level of Evidence: A) for measurement of B-type natriuretic peptide (BNP) or N-terminal (NT)-proBNP for establishing prognosis or disease severity in chronic HF.”
However the full ACC/AHA article states, “Because of the absence of clear and consistent evidence for improvement in mortality and cardiovascular outcomes (43-62), there are insufficient data to inform specific guideline recommendations related to natriuretic peptide–guided therapy or serial measurements of BNP or NT-proBNP levels for the purpose of reducing hospitalization or deaths in the present document.”
The National Government Services (NGS) LCD for Jurisdictions K and 06 is significantly different, though extremely specific, from the other LCDs by allowing coverage for:
- To establish prognosis or disease severity in chronic CHF when needed to guide therapy,
- To achieve optimal dosing of guideline-directed medical therapy (GDMT) in select clinically euvolemic patients followed in a well-structured heart failure (HF) disease management program,
- To guide therapeutic decision-making in individuals who have amyloidosis.
Laboratory tests are not paid separately for inpatients or for outpatients having other outpatient services, and even when paid the Clinical Lab Fee Schedule payment rate for BNP is around only $46. The Medicare issue with laboratory tests such as BNP is not the payment rate per test, but that millions of lab tests across the nation can add up to large reimbursement amounts for Medicare.
Hospitals need to evaluate whether their physicians are following the Medicare LCD guidelines for their Jurisdiction when ordering BNP testing on outpatients in a setting other than the Emergency Department. Should another MAC besides Cahaba perform audits, what does your hospital have at risk?
Debbie Rubio
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