Knowledge Base Category -

Do you ever wonder what your ancestors would think of the modern day advances in technology and medicine? Even in my lifetime, the flip communicator of Star Trek science fiction fame has become a reality. In fact, flip-phones are already out of style and current cell-phones do much more than simply allow communication. Laboratory medicine is no exception to technology advances and scientists are now able to study gene sequences, gene mutations, and other biological markers. This opens a whole new world of laboratory testing and brings about a new subject for Medicare coverage policies.

There are numerous local coverage determinations (LCDs) related to this type of advanced laboratory testing. These policies may reference molecular pathology or molecular diagnostic studies, biomarkers, phenotyping, genomic assays or genetic testing. Palmetto GBA has developed the Molecular Diagnostic Program (MoIDX®) to identify and establish coverage and reimbursement for molecular diagnostic tests. The following Medicare Administrative Contractor (MAC) jurisdictions participate in this program, so these MACs may have more LCDs for biomarkers than non-participating MACs.

• Noridian JE and JF
• Palmetto GBA JM
• WPS J5 and J8
• CGS J15

The Novitas Local Coverage Determination for Biomarkers for Oncology discusses the consideration of medical necessity for biomarkers. “The emergence of personalized laboratory medicine has been characterized by a multitude of testing options which can more precisely pinpoint management needs of individual patients. As a result, the growing compendium of products described as biomarkers requires careful evaluation by both clinicians and laboratorians as to what testing configurations are reasonable and necessary under the Medicare Act. There are a plethora of burgeoning tools, including both gene-based (genomic) and protein-based (proteomic) assay formats, in tandem with more conventional (longstanding) flow cytometric, cytogenetic, etc. biomarkers.” In order to be medically necessary, these tests must have proven clinical validity/utility, be clinically actionable, and be used to assist in the management and/or treatment of the patient. Biomarkers may be used for diagnosis, classification, monitoring, surveillance, prognosis, or prediction of response to a particular therapy.

Below are some of the indications for which biomarkers are utilized. These tests may be performed by specialty laboratories but providers need to be familiar with the LCDs relevant to their MAC jurisdiction if they are performing or billing for this type of testing.

Oncologic Indications

• Molecular Pathology, Molecular Diagnostic Testing, and Biomarkers policies that list numerous genetic/biomarker tests and/or conditions that are covered. (J5, J8, JH, JL, J15, JN, J6, JK, and JN)
• Breast and Ovarian Cancer
• BRCA1 and BRCA2 genetic testing for susceptibility to breast or ovarian cancer is covered when there is a personal history of breast cancer or certain other types of cancer (JN, JE, JF, J15, JM, and JJ)
• OVA-1 is an ovarian cancer blood test that is reported to detect ovarian cancer in a pelvic mass (J6 and JK)
• Several LCDs address tests used to decide breast cancer treatment options, such as Oncotype DX TM, Prosigna test, and Breast Cancer Index℠ (JN, J15, JE, JF, and JM)
• Colorectal Cancer
• Testing for KRAS mutations before using Epidermal Growth Factor Receptor (EGFR) antibodies in the treatment of colorectal cancer (JJ)
• A stepped approach genetic testing for Lynch Syndrome, the most common hereditary cause of colorectal cancer (JN, J15, JE, JF, and JJ)
• NRAS testing for metastatic colorectal cancer (J15, JE, and JF)
• Prostate Cancer
• ConfirmMDx epigenetic assay for prostate cancer (MDxHealth, Irvine, CA) to reduce unnecessary repeat prostate biopsies under certain conditions (J15, JE, and JF)
• To assist in determining treatment options for prostate cancer such as Decipher®, Genomic HealthTMOncotype DX®, or PolarisTM PC Genomic Assay (JE, JF, J15 and JM)
• Non-Small Cell Lung Cancer
• Tests for genomic alterations in tumor specimens for NSCLC to determine if a patient is a candidate for targeted therapy (J6, JK, JE, JF, J15, JM, and JJ)
• Gliomas
• The presence of chromosome 1p/19q deletions in gliomas can assist in tumor differentiation, prognosis and treatment plan. (J15, JM, JE, and JF)
• MGMT promoter methylation status is a strong and independent prognostic factor in patients with newly diagnosed glioblastoma multiforme and can aid in treatment decisions for older patients. (J15, JE, JF, and JM)
• Myeloproliferative Disease
• Provides coverage of a sequential genetic testing approach for the diagnostic workup for myeloproliferative disease (MPD) including polycythemia vera (PV), essential thrombocytopenia (ET), and primary myelofibrosis (PMF). (J15, JE, JF, and JM)

Non-Oncologic Indications

• Pharmcogenomics
• Genetic testing (CYP2C19, CYP2D6, CYP2C9 and VKORC1) for drug response limited to certain drugs such as Plavix, amitriptyline or nortriptyline for treatment of depressive disorders and tetrabenazine doses greater than 50 mg/day, and warfarin. (J15, JN, J5, J8, JE, JF, and JJ)
• Lipid Biomarkers for Cardiovascular Risk Assessment
• The policies indicate the medical indication(s) for individual lipid biomarkers that may be covered to characterize a given lipid abnormality or disease, to determine a treatment plan or to assist with intensification of therapy. Each individual lipid biomarkers must be specifically ordered and the reason for the test order documented in the patient’s medical record. (J15, JM, JE, JF, J5, and J8)
• Hypercoagulability/Thrombophilia
• Testing for Factor V Leiden (FVL) variants in the F5 gene and F2 G20210A mutations is indicated for pregnant patients who have a history of personal VTE associated with a non-recurrent (transient) risk factor who are not otherwise receiving anticoagulant prophylaxis. (J5, J8, J15, JM, JE, and JF)
• RBC Phenotyping
• Medicare will cover pretransfusion molecular testing using the HEA BeadChip™ assay to prevent the development of alloantibodies or when identification of antibodies is difficult for specific reasons. (J15, JE, JF, JM and JJ)
• HLA-B*15:02 Genotype Testing
• Patients of Asian and Oceanian ancestry with the HLA-B*1502 had an increased risk to develop severe, sometimes lethal diseases of the skin and mucous membrane when exposed to carbamazepine, phenytoin or fosphenytoin. (J15, JE, JF, and JM)
• Refractory Depression
• Limited coverage for the GeneSight® Psychotropic gene panel ordered by licensed psychiatrists and neuropsychiatrists contemplating an alteration in neuropsychiatric medication for patients diagnosed with major depressive disorder (MDD) who are suffering with refractory moderate to severe depression after at least one prior neuropsychiatric medication failure.

(J15, JE, and JF)

As you can see, the uses of genetic testing are many and varied and will only expand over time as clinical studies demonstrate the efficacy of new tests. This means you will see more and more LCDs related to these types of tests – watch for these in our monthly updates of coverage policies.

Influenza Vaccine Payment Allowances - Annual Update for 2016-2017 Season

• Transmittal 3611, Change Request 9758, MLN Matters Article MM9758
• Issued 9/9/2016, Effective 8/1/2016, Implementation by 11/1/2016
• Affects physicians and other providers submitting claims to Medicare Administrative Contractors (MACs) for influenza vaccines provided to Medicare beneficiaries.

Summary of Changes: Provides the availability of payment allowances for the following seasonal influenza virus vaccines.

Coding Revisions to National Coverage Determination (NCDs)

• Transmittal 1708, Change Request 9751, MLN Matters Article MM9751
• Issued 8/19/2016, Effective 1/1/2017, Implementation 1/3/2017
• Affects physicians and other providers submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

Summary of Changes: The 9th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs).

October 2016 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• Transmittal 3602, Change Request 9768, MLN Matters Article MM9768
• Issued 8/26/2016, Effective 10/1/2016, Implementation 10/3/2016
• Affects providers and suppliers who submit claims to Medicare Administrative Contractors (MACs), including Home Health and Hospice (HH&H) MACs, for services provided to Medicare beneficiaries and which are paid under the Outpatient Prospective Payment System (OPPS)..

Summary of Changes: This Recurring Update Notification describes changes to and billing instructions for various payment policies implemented in the October 2016 OPPS update.

Claim Status Category and Claim Status Codes Update

• Transmittal 3599, Change Request 9680, MLN Matters Article MM9680
• Issued 8/26/2016, Effective 1/1/2017, Implementation 1/3/2017
• Affects physicians, providers, and suppliers who submit claims to Medicare Administrative Contractors (MACs), including Durable Medical Equipment (DME) MACs, and Home Health & Hospice (HH&H) MACs for services provided to Medicare beneficiaries.

Summary of Changes: Updates, as needed, the Claim Status and Claim Status Category Codes used for the Accredited Standards Committee (ASC) X12 276/277 Health Care Claim Status Request and Response and ASC X12 277 Health Care Claim Acknowledgment transactions.

Annual Clotting Factor Furnishing Fee Update 2017

• Transmittal 3607, Change Request 9759, MLN Matters Article MM9759
• Issued 8/26/2016, Effective 1/1/2017, Implementation 1/3/2017
• Affects physicians and other providers billing Medicare Administrative Contractors (MACs) for services related to the administration of clotting factors provided to Medicare beneficiaries.

Summary of Changes: This annually recurring CR announces the update to the Clotting Factor Furnishing Fee.

JW Modifier: Drug /Biological Amount Discarded/Not Administered To Any Patient - Frequently Asked Question

• Issued 8/26/2016, Effective 1/1/2017,FAQs
• Affects Providers and suppliers submitting claims for Part B drugs.

Summary of Changes: An FAQ document concerning use of the JW modifier

End of Temporary Suspension of the BFCC-QIO Short Stay Reviews

• Inpatient Hospital Reviews
• Effective 9/12/2016
• Affects acute care inpatient hospitals, long-term care hospitals, and inpatient psychiatric facilities.

Summary of Changes: BFCC-QIOs will resume initial patient status reviews of short stays to determine the appropriateness of Part A payment for short stay hospital claims.

Medicare Fee for Service National Recovery Audit Program   (April 1, 2016 – June 30, 2016) Quarterly Newsletter              

• Recovery Auditor 3rd Qtr 2016 Newsletter

Summary of Changes: Overpayment and underpayment correction amounts for each RA region and the top issue per region.

Notification of Final Rule Published- Emergency Preparedness

• Survey-and-Cert-Letter-16-38
• Issued 9/8/2016, Effective 11/16/2017
• Affects Medicare and Medicaid Participating Providers and Suppliers.

Summary of Changes: The Emergency Preparedness Rule outlines the requirements for all providers and suppliers in regards to planning, preparing and training for emergency situations.

TRANSMITTALS

October 2016 Integrated Outpatient Code Editor (I/OCE) Specifications Version 17.3

• Transmittal 3591, Change Request 9754, MLN Matters Article MM9754
• Issued 8-12-16, Effective 10-1-16, Implementation 10-3-16
• Affects providers who submit claims to Medicare Administrative Contractors MACs), including Home Health and Hospices (HH+H) MACs, for services provided to Medicare beneficiaries.

Summary of Changes: Quarterly update of the I/OCE. All institutional outpatient claims (which includes non-OPPS hospital claims) are routed through a single integrated OCE to apply claims processing edits.

Medicare Part B Clinical Laboratory Fee Schedule: Guidance to Laboratories for Collecting and Reporting Data for the Private Payor Rate-Based Payment System

• MLN Matters Article SE1619
• Issued 8-8-16
• Affects Medicare Part B clinical laboratories who submit claims to Medicare Administrative Contractors (MACs) for services furnished to Medicare beneficiaries.

Summary of Changes: This guidance includes clarifications for determining whether a laboratory meets the requirements to be an “applicable laboratory,” the applicable information (that is, private payor rate data) that must be collected and reported to the Centers for Medicare & Medicaid Services (CMS), the entity responsible for reporting applicable information to CMS, the data collection and reporting periods, and the schedule for implementing the new CLFS

Coding Revisions to National Coverage Determination (NCDs)

• Transmittal 1708, Change Request 9751, Transmittal 1708
• Issued 8-19-16, Effective 1-1-17 unless otherwise noted, Implementation 1-3-17

Summary of Changes: The 9th quarterly maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs)

 

OTHER UPDATES

2017 ICD-10-CM and ICD-10-PCS 2017 Guidelines

• ICD-10-CM Guidelines are available on the CDC and CMS Websites http://www.cdc.gov/nchs/icd/icd10cm.htm and https://www.cms.gov/Medicare/Coding/ICD10/2017-ICD-10-CM-and-GEMs.html
• ICD-10-PCS Guidelines on CMS Website https://www.cms.gov/Medicare/Coding/ICD10/2017-ICD-10-PCS-and-GEMs.html

Summary of Changes: To easily identify what is new for the October 1, 2016 start date for the CMS 2017 Fiscal Year, narrative changes appear in bold text. The ICD-10-CM Preface for 2017 found on the CDC website indicates that “ICD-10-CM is the United States’ clinical modification of the World Health Organization’s ICD-10. The term “clinical” is used to emphasize the modification’s intent: to serve as a useful tool in the area of classification of morbidity data for indexing of health records, medical care review, and ambulatory and other health care programs, as well as for basic health statistics. To describe the clinical picture of the patient the codes must be more precise than those needed only for statistical groupings and trend analysis.”

Updates to the Clarifying Questions and Answers Related to the July 6, 2015, CMS/AMA Joint Announcement and Guidance Regarding ICD-10 Flexibilities for Physicians

• Questions & Answers pdf
• Released August 18, 2016

Summary of Changes: The ICD-1 flexibilities are set to expire October 1, 2016. Providers should already be coding to the highest level of specificity. The flexibilities were “solely for the purpose of contractors performing medical review so that they would not deny claims solely for the specificity of the ICD-10 code as long as there is no evidence of fraud.”

Did your mom ever tell you or did you ever tell your own children, “Because I said so!”? That may or may not have worked to accomplish the desired behavior depending on the pre-existing dynamics of the parent-child relationship. CMS encounters the same problem when dealing with the provider community. Sometimes providers follow the rules, sometimes they have never heard of the rules, sometimes they ignore the rules and sometimes they deliberately disobey. This is why where there are Medicare coverage policies, Medicare medical review audits will likely follow. Such is the case for Spinal Cord Stimulators.

Medicare has a National Coverage Determination (NCD) for Electrical Nerve Stimulators (NCD 160.7) which addresses Spinal Cord (Dorsal Cord) Stimulation. The following conditions must be met in order for Medicare to make payment for these services:

• The implantation of the stimulator is used only as a late resort (if not a last resort) for patients with chronic intractable pain;
• Other treatment modalities (pharmacological, surgical, physical, or psychological therapies) have been tried and did not prove satisfactory, or are judged to be unsuitable or contraindicated for the given patient;
• Patients have undergone careful screening, evaluation and diagnosis by a multidisciplinary team prior to implantation. (Such screening must include psychological, as well as physical evaluation);
• All the facilities, equipment, and professional and support personnel required for the proper diagnosis, treatment training, and follow up of the patient must be available; and
• Demonstration of pain relief with a temporarily implanted electrode precedes permanent implantation.

In addition to the NCD, several Medicare Administrative Contractors (MACs) also have Local Coverage Determinations that address this procedure.

As stated above, a medical review audit often follows coverage policies. The Medicare Supplemental Medical Review Contractor (SMRC) recently published their findings for Project Y3P167 – Spinal Cord Stimulator (SCS) Services. The review looked at claims that contained CPT codes 63650 (Percutaneous implantation of neurostimulator electrode array), 63655 (Laminectomy for implantation of neurostimulator electrode plate/paddle), and 63685 (Insertion or replacement of spinal neurostimulator pulse generator or receiver). There was a 72% denial rate for this review, with 26% of claims denied for lack of record submission and 46% denied for failing to meet Medicare’s coverage requirements. According to the report, “The main reason for claim denials following medical review was the provider’s failure to provide documentation of a psychiatric evaluation/screening as required by NCD 160.7.”

Hospitals that provide this service should evaluate their practices and documentation to make sure Medicare’s requirements for payment are being met. Why? Because Medicare said so! 

Medicare news over the past month includes some coverage updates, ICD-10 coding updates, and clarification articles on substance abuse services and prolonged infusions.

Transmittals

Clarification of Inpatient Psychiatric Facilities (IPF) Requirements for Certification, Recertification and Delayed/Lapsed Certification and Recertification

• Transmittals 223 and 98, Change Request 9522, MLN Matters Article MM9522
• Issued May 13, 2016, Effective August 15, 2016, Implementation August 15, 2016
• Affects physicians and other specified providers submitting claims to Medicare Administrative Contractors (MACs) to certify and recertify the medical necessity of inpatient psychiatric services provided to Medicare beneficiaries.

Summary of Changes: This Change Request is to clarify physician certification, recertification and delayed//lapsed certification and recertification with respect to IPF services in Medicare Benefit Policy Manual, Chapter 2, §30.2.1.

Coding Revisions to National Coverage Determinations (NCDs)

• Transmittal 1665, Change Request 9631, MLN Matters Article MM9631
• Issued May 13, 2016, Effective October 1 2016, Implementation October 3, 2016
• Affects physicians and other providers submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

Summary of Changes: This change request (CR) is the 7th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs).

Update to Internet-Only-Manual Publication 100-04, Chapter 18, Section 30.6

• Transmittal 222, Change Request 9606,MLN Matters Article MM9606
• Issued May 13,, 2016; Effective: June 14, 2016; Implementation Date June 14, 2016
• Affects physicians, providers, and suppliers submitting claims to Medicare Administrative Contractors (MACs) for cervical cancer screening services provided to Medicare beneficiaries.

Summary of Changes: This change request replaces ICD-10 diagnosis code Z12.92 with ICD-10 diagnosis code Z12.72 for coverage of cervical cancer screening in Pub. 100-04, chapter 18, section 30.6. In addition, section 30.6 is revised and updated for clarity.

Coding Revisions to National Coverage Determinations

• Transmittal 1658, Change Request 9540,MLN Matters Article MM9540
• Issued April 29, 2016; Effective July 1, 2016; Implementation Date July 5, 2016
• Affects physicians, providers, and suppliers who submit claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries

Summary of Changes: Transmittal 1630, dated February 26, 2016, is being rescinded and replaced by Transmittal 1658 to (1) remove duplicate spreadsheet NCD210.3, (2) add missing spreadsheet NCD20.33, (3) add B/MAC to requirement 3 at request of WPS/B, (4) rename the spreadsheet titles, and, (5) provide a link to the attached spreadsheets for more efficient ease of reference and accessibility. All other information remains the same.

Percutaneous Left Atrial Appendage Closure (LAAC)

• Transmittals 3515 and 192; Change Request 9638, MLN Matters Article MM9638
• Issued May 6, 2016; Effective February 8, 2016; Implementation Date October 3,, 2016
• Affects physicians, other providers, and suppliers submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

Summary of Changes: The purpose of this Change Request (CR) is to inform contractors that the Centers for Medicare & Medicaid Services (CMS) issued a National Coverage Determination (NCD) covering Percutaneous Left Atrial Appendage Closure ( LAAC) through Coverage with Evidence Development (CED) when LAAC is furnished in patients with Non-Valvular Atrial Fibrillation (NVAF) and according to an FDA approved indication for percutaneous LAAC with an FDA-approved device.

Shared Savings Program (SSP) Accountable Care Organization (ACO) Qualifying Stay Edits

• Transmittal 1660, Change Request 9568, MLN Matters Article MM9568
• Issued May 6, 2016; Effective January 1, 2017; Implementation Date January 3, 2017
• Affects Hospitals and Skilled Nursing Facilities (SNFs) working with Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program (SSP) and submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

Summary of Changes: This CR is to allow the processing of Skilled Nursing Facility (SNF) claims without having to meet the 3-day hospital stay requirement for a select number of facilities that have a relationship with a Shared Savings Program (SSP) ACO.

Stem Cell Transplantation for Multiple Myeloma, Myelofibrosis, Sickle Cell Disease, and Myelodysplastic Syndromes

• Transmittals 3509 and 191, Change Request 9620,MLN Matters Article MM9620
• Issued April 29, 2016; Effective: January 27, 2016; Implementation date October 3, 2016
• Affects physicians and providers submitting stem cell transplantation claims to Medicare Administrative Contractors (MACs) for services to Medicare beneficiaries.

Summary of Changes: Effective for claims with dates of service on and after January 27, 2016, contractors shall be aware that the use of allogeneic HSCT for treatment of Multiple Myeloma, Myelofibrosis, and Sickle Cell Disease is only covered by Medicare if provided in the context of a Medicare-approved clinical study meeting specific criteria under the CED paradigm. This CR also clarifies the ICD-9 and ICD-10 diagnosis codes for allogeneic HSCT for treatment of Myelodysplastic Syndromes in the context of a Medicare-approved, prospective clinical study under the CED paradigm.

Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/ Biological Code Changes - July 2016 Update

• Transmittal 3518; Change Request 9636; MLN Matters Article MM9636
• Issued May 6, 2016; Effective July 1, 2016; Implementation July 5, 2016
• Affects physicians, providers, and suppliers submitting claims to Medicare Administrative Contractors (MACs), including Durable Medical Equipment MACs (DME MACs) and Home Health & Hospice (HH&H) MACs for services provided to Medicare beneficiaries.

Summary of Changes: The HCPCS code set is updated on a quarterly basis. This instruction informs the contractors of updating specific drug/biological HCPCS codes.

JW Modifier: Drug amount discarded/not administered to any patient

• Transmittal 3508; Change Request 9603; MLN Matters Article MM9603
• Issued April 29, 2016; Effective July 1, 2016; Implementation July 5, 2016
• Affects physicians, providers, and suppliers submitting claims to Medicare Administrative Contractors (MACs) for drugs or biologicals administered to Medicare beneficiaries.

Summary of Changes: Effective July 1, 2016, claims for discarded drug or biological amount not administered to any patient, shall be submitted using the JW modifier. Also, effective July 1, 2016, providers must document the discarded drugs or biologicals in patient's medical record. This CR updates the Section 40 - Discarded Drugs and Biologicals of Chapter 17 of the Claims Processing Manual 100-04.

Medicare Coverage of Substance Abuse Services

• MLN Matters Article SE1604
• Issued April 28, 2016
• Affects physicians, other providers, and suppliers who submit claims to Medicare Administrative Contractors (MACs) for substance abuse services provided to Medicare beneficiaries.

Summary of Changes: While there is no distinct Medicare benefit category for substance abuse treatment, such services are covered by Medicare when reasonable and necessary. The Centers for Medicare & Medicaid Services (CMS) provides a full range of services, including those services provided for substance abuse disorders. This article summarizes the available services and provides reference links to other online Medicare information with further details about these services.

Medicare Policy Clarified for Prolonged Drug and Biological Infusions Started Incident to a Physician's Service Using an External Pump

• MLN Matters Article SE1609
• Issued April 25, 2016
• Affects all physicians and hospital outpatient departments submitting claims to Medicare Administrative Contractors (MACs) for prolonged drug and biological infusions started incident to a physician's service using an external pump.

Summary of Changes: Reviews policy for prolonged drug and biological infusions started incident to a physician's service using an external pump. These services cannot be billed on suppliers’ claims to DME MACs.

Other Updates

Recovery Audit Program Update

• May 4, 2016
• CMS has revised the method used to calculate additional documentation request (ADR) limits for Institutional Providers (Facilities). A document describing the new methodology can be found in the “Downloads” section of our Provider Resource

Quality Measure Development Plan

• Posted May 2, 2016
• A strategic framework for clinician quality measurement development to support the new Merit-based Incentive Payment System (MIPS) and advanced alternative payment models (APMs).

Extending Participation in the Bundled Payments for Care Improvement Initiative

• Posted April 18, 2016
• Offers the awardees in the Bundled Payments for Care Improvement (BPCI) initiative the opportunity to extend their participation in Models 2, 3 and 4 through September 30, 2018.
• http://innovation.cms.gov/initiatives/bundled-payments

I regret the paper pages of newspapers and books are becoming obsolete in today’s digital age. There was some comfort in holding the pages, smelling the print, and hearing the sound of crinkling paper as you read. Newsprint was important – movies set in the 20’s and 30’s often show the newsboy running through the streets shouting, “Special edition! Special edition! Read all about it!” Now we receive most of our “printed” news on-line or on our smart phones. But thanks to Medicare there are still “special editions.” Most of CMS’s MLN Matters Articles are based on recent transmittals (change request) – these are named based on the change request number beginning with the alpha characters “MM.” CMS also publishes Special Edition (SE) articles, generally to clarify existing regulations.

Two recent SE articles address prolonged drug infusions using an external pump and coverage of substance abuse services.

Prolonged Drug Infusions Via External Pump

On April 25, 2016, CMS released MLN Matters Article SE1609 clarifying Medicare’s policy for prolonged drug and biological infusions started incident to a physician's service using an external pump. There are times when hospitals or physicians’ offices may start an infusion using an external pump in the hospital outpatient or office setting of a drug they purchased, then send the patient home for a portion of the infusion and have the patient return to the clinic/office at the end of the infusion.   In these situations, the drug or biological and the drug/biological administration are billable to the Medicare Administrative Contractor (MAC). Also, payment for the external pump is included in the drug administration payment. The external pump may not be billed separately as Durable Medical Equipment to the DME MAC.   The MAC may direct use of a CPT or HCPCS code for the drug administration service that also accounts for the cost of external pump. This may be an unlisted code if no specific CPT or HCPCS code exists.

Medicare Coverage of Substance Abuse Services

There is not a distinct benefit category for substance abuse services but Medicare will cover medically necessary services for substance abuse as explained in the April 28th MLN Matters Article SE1604. The almost epidemic national opioid abuse make these services extremely important for Medicare beneficiaries. Medicare covers:

• Inpatient Treatment
• Medically necessary inpatient services, associated professional services, and medications (bundled into the inpatient payment).
• Outpatient Treatment
• Professional services such as counseling by an enrolled licensed clinical social worker, psychologist, or psychiatrist.
• Incident-to services of auxiliary personnel in certain settings (such as an outpatient hospital)
• Medications used in an outpatient setting that are not usually self-administered may be covered under Part B if they meet all Part B requirements.
• Note that substance abuse treatment facilities are not recognized by Medicare as an independent provider type. There is no integrated payment for the bundle of services these providers provide (either directly, or incident to a physician’s service).
• Partial Hospitalization Programs (PHP)
• Available in hospital outpatient department or Medicare certified Community Mental Health Center (CMHCs)
• Includes psychotherapy, occupational therapy, some activity therapies, family counseling, patient education/training, diagnostic services, and covered Part B medications.
• Supplier Services
• Suppliers such as physicians (medical doctor or doctor of osteopathy), clinical psychologists, clinical social workers, nurse practitioners, clinical nurse specialists, physician assistants, and certified nurse-midwives may furnish substance abuse treatment services providing the services are reasonable and necessary and fall under their State scope of practice.
• Screening, Brief Intervention, and Referral to Treatment (SBIRT) Services
• Early intervention strategies for individuals with nondependent substance use prior to the need for more extensive or specialized treatment
• Easily used in primary care settings
• Consists of 1) Structured Assessment, 2) Brief Intervention, and 3) Referral to Treatment
• See Medicare's fact sheet, “Screening, Brief Intervention, and Referral to Treatment (SBIRT) Services”
• Drugs Used to Treat Opioid Dependence
• Part D drugs medically necessary for the treatment of opioid dependence
• Medicare also covers laboratory drug testing services when necessary

Providers need to watch for Medicare MLN Matters Special Edition articles in order to stay informed about the latest changes to CMS Programs. Read all about it!

When I was first introduced to the concept of Case Mix Index (CMI) in the late 90’s, documentation in the medical record was handwritten. And I can remember understanding that CMI depends on the physician’s pen.

Flash forward to 2016 and the electronic health record. It is now fair to say that it all begins with the click of a button. I am not sure if it is due to the fact that I wrote my college term papers on a Brother Typewriter or from auditing electronic records remotely, the “click of the button,” has not improved the telling of the patient’s story which is at the heart of what needs to happen.

In fact, it seems to me that it is harder than ever to find proof that your “patients are sicker.” Understanding CMI is a good way to answer the question of “how do I know my patients are sicker.” However, to understand CMI you need to first understand the basic fundamentals of the Inpatient Prospective Payment System (IPPS) and how a Coder in a hospital determines the Diagnosis-Related Group (DRG) assignment for every hospital inpatient stay.

Background:

In 1983, Congress mandated the Inpatient Prospective Payment System (IPPS) for all Medicare inpatients. IPPS uses Diagnosis-Related Groups (DRGs) to determine reimbursement for hospitals.  

Beginning October 1, 2007 the DRG system began transitioning to a new system called Medicare Severity MS-DRG. The transition to MS-DRGs allowed for an improved accounting of a hospital’s resource consumption for a patient and the patient’s severity of illness.  

Assigning a DRG:

Principal Diagnosis:

The Uniform Hospital Discharge Data Set (UHDDS) defines the Principal Diagnosis as “the condition established after study to be chiefly responsible for occasioning the admission of the patient to the hospital for care.”

Comorbidities and Complications (CCs and MCCs):

These are conditions that increase a patient’s resource consumption and may cause an increase in length of stay compared to a patient admitted for the same condition without a co-morbidity or complication.  When the DRG system transitioned to MS-DRGs the comorbidities and complications were divided into three levels. The three levels are DRGs without a CC or MCC, DRGs with a CC and DRGs with a MCC.

• Comorbidities (CC) are the conditions that patients “bring with them” when they are admitted to a hospital and continue to require some type of treatment or monitoring while in the inpatient setting.
• For example: A patient with a history of atrial fibrillation is continued on his home medications and placed on telemetry monitoring.
• A patient with a history of Diabetes is placed on pattern blood sugars with sliding scale insulin
• A patient has a history of hypercholesterolemia and is continued on their home Statin therapy.
• Complications (CC) are those conditions that occur during the inpatient hospitalization.
  For example:
• A patient undergoes hip surgery and experiences acute post-op blood loss anemia in the peri-operative period requiring serial Hemoglobin and Hematocrit checks and possibly blood transfusions. 
• Major Comorbidities and Complications (MCCs): DRGs with MCCs reflect the highest level of severity. For example:
• A patient with chronic systolic heart failure is admitted for a GI bleed, becomes volume overloaded and develops acute on chronic systolic heart failure during the admission.
• A patient with a history of chronic obstructive pulmonary disease undergoes surgery and develops post-op respiratory failure.
  

As many times as we have heard it said it remains true, if you don’t document it then it wasn’t done or in the case of DRG assignment it wasn’t present and treated during the hospitalization. A Coder’s ability to code to the most appropriate DRG is dependent upon the Physician documentation in the medical record.   Coding Guidelines do not allow coders to interpret lab findings, radiology findings, EKGs or pathology reports to assign diagnosis codes.

A successful DRG program in a hospital is dependent on the Physician providing a complete accounting of a patient’s Principal Diagnosis, comorbidities and complications, any procedures performed, the plan of care and the patient’s discharge status.  

Example:

A patient presents with chest pain and has a known history of GERD. A Myocardial Infarction (MI) was ruled out based on EKG and Cardiac Enzymes and the patient was discharged home with a new prescription for Prilosec. In this case chest pain is a symptom code and a more specific diagnosis would be chest pain related to GERD. However, if the only diagnosis written by the Physician in the record is chest pain then the coder can only assign the code for unspecified chest pain.

This is why Coders and in more recent years Clinical Documentation Specialist send queries to Physicians. As far back as 2007, CMS has indicated that “we do not believe there is anything inappropriate, unethical or otherwise wrong with hospitals taking full advantage of coding opportunities to maximize Medicare payment that is supported by documentation in the medical record.” (Source: Federal Register / Vol. 72, No. 162 / Wednesday, August 22, 2007 / Rules and Regulations – page 47180)

Diagnosis-Related Group (DRG) is a diagnosis classification that groups patients that have a similar resource consumption and length-of-stay.

Relative Weight (RW) is a numeric weight assigned to each DRG that is indicative of the relative resource consumption associated with that DRG.

Case Mix Index (CMI) is defined by CMS as representing “the average diagnosis-related group (DRG) relative weight for the hospital. It is calculated by summing the DRG weights for all Medicare discharges and dividing by the number of discharges.”

GPA Example:

(A=4 grade points / B=3 grade points / C=2 grade points / D = 1 grade point / F = 0 grade points)

Formula for GPA: Total Grade Points ÷ Sum of Credit Hours = GPA

30 ÷ 10 = 3.0 GPA

Case Mix Index Example A:

Formula for Case Mix Index: Sum of Relative Weights ÷ Total Number of DRGs Coded = CMIExample A CMI: 3.7688 ÷ 4 = 0.9422 Case Mix IndexExample B: The Potential Impact Physician Queries can have on DRG Assignment

Example B CMI: 4.5823 ÷ 4 = 1.1456 Case Mix Index

“The higher the case mix index, the more complex the patient population and the higher the required level of resources utilized. Since severity is such an essential component of MS-DRG assignment and case mix index calculation, documentation and code assignment to the highest degree of accuracy and specificity is of utmost importance.” (Source: Optum 360 2016 DRG Expert)

Challenges for Hospitals:

Understanding what can make your hospitals CMI fluctuate?

• A decrease in CMI may be reflective of:
• Non-specific documentation by the Physician
• Increase in Medical Volume with a decrease in Surgical Volume as Surgical DRGs have a higher Relative Weight.
• Surgeons being on vacation
• Physicians being unresponsive to Coder and Clinical Documentation Specialist queries
• An increase in CMI may be reflective of:
• Tracheostomy procedures that have an extremely high Relative Weight
• Ventilator patients
• Open Heart Procedures
• Improved Physician Documentation
• Improved Physician response rate to queries resulting in an improved CC / MCC capture rate

Realizing the Importance of every Medical Professional’s role in the success of a hospital’s DRG program:

• The Physician’s Role: Is to provide complete and accurate documentation of a patient’s Principal Diagnosis, comorbidities and complications, any procedures performed, the plan of care and the patient’s discharge status in the medical record.
• The Clinical Documentation Specialist’s Role: Is to perform concurrent medical record reviews and ask queries whether verbal or written when indicated.  
• The Coder’s Role: May be concurrent medical record review or a retrospective review after discharge; also ask queries when indicated.

In 2013, the American Health Information Management Association (AHIMA) published the practice brief Guidelines for Achieving a Compliant Query Practice. The AHIMA brief states that “A query is a communication tool used to clarify documentation in the health record for accurate code assignment. The desired outcome from a query is an update of a health record to better reflect a practitioner’s intent and clinical thought processes, documented in a manner that supports accurate code assignment.”

ICD-10-CM/PCS and CMI

We are now six months post ICD-10-CM/PCS implementation. Has this transition impacted CMI? To answer this question I analyzed paid claims data from our sister company RealTime Medicare Data (RTMD). The following tables compare CMI data from October through December of 2014 compared to 2015.

Figure 1: Alabama CMI Compare Pre and Post ICD-10-CM/PCS Implementation

Figure 2: South Carolina CMI Compare Pre and Post ICD-10-CM/PCS Implementation

Figure 3: Texas CMI Compare Pre and Post ICD-10-CM/PCS Implementation

So far, it appears that the transition has not had a negative impact on CMI but it is still early and MMP, Inc. will continue to keep an eye on the trends and report key findings to our readers. In the meantime, remember that a successful DRG program is dependent on accurate documentation. Addressing issues that can impact CMI will enable you to capture the most accurate severity of illness, have a positive impact on reimbursement and support the medical necessity of inpatient admissions.

“I don’t know why my brain has kept all the words to the Gilligan’s Island theme song and has deleted everything about triangles.”- Jeff Foxworthy

This month CMS appears to have stuck with their “theme” from past transmittals as a lot of the newly released transmittals are periodic updates of different CMS edits and systems. In contrast, this month, we are broadening our “theme” of bringing you monthly transmittal updates by making this an “all inclusive” Medicare Updates article (i.e., Transmittals, Conditions of Participation, Code of Federal Regulations).

Transmittals

April 2016 Integrated Outpatient Code Editor (I/OCE) Specifications Version 17.1

• Transmittal 3477, Change Request 9553, MLN Matters MM9553
• Issued March 22, 2016; Effective: April 1, 2016; Implementation date April 4, 2016
• Affects providers who submit claims to Medicare Administrative Contractors (MACs), including Home Health and Hospices (HH+H) MACs, for services provided to Medicare beneficiaries
• Updates Chapter 4, section 40.1; Medicare Claims Processing Manual

Summary of Changes: This notification providers the Integrated OCE instructions and specifications for the Integrated OCE that will be effective April 1, 2016.

Quarterly Update to the Correct Coding Initiative (CCI) Edits, Version 22.2, Effective July 1, 2016

• Transmittal 3482, Change Request 9516, MLN Matters MM9516
• Issued March 18, 2016; Effective: July 1, 2016; Implementation date July 5, 2016
• Affects providers submitting claims to MACs for services provided to Medicare beneficiaries
• Updates Chapter 23, section 20.9; Medicare Claims Processing Manual

Summary of Changes: This is the normal update to the CCI procedure to procedure edits.

April 2016 Update of the Ambulatory Surgical Center (ASC) Payment System

• Transmittal 3478, Change Request 9557, MLN Matters MM9577
• Issued March 11, 2016; Effective: April 1, 2016; Implementation date April 4, 2016
• Affects Ambulatory Surgical Centers (ASCs) who submit claims to MACs
• Updates Chapter 14, section 10; Medicare Claims Processing Manual

Summary of Changes: This Recurring Update Notification describes changes to billing instructions for various payment policies implemented in the April 2016 ASC payment system update. As appropriate, this notification also includes updates to the Healthcare Common Procedure Coding System (HCPCS).

Telehealth Services

• Transmittal 221, Change Request 9428, MLN Matters MM9428
• Issued March 11, 2016; Effective: January 1, 2015; Implementation date April 11, 2016
• Affects providers submitting claims to MACs for telehealth services provided to Medicare beneficiaries
• Updates telehealth language has been removed from the Medicare Benefit Policy Manual, Chapter 15, Section 270 and a reference added in text to see the Medicare Claims Processing Manual, Chapter 12, section 190 for further information regarding telehealth services (see related Transmittal 3476)

Summary of Changes: The purpose of this change request is to display the list of telehealth services that were once available through the manual updates to now be displayed via a web-link going forward. CMS is also adding CRNAs to the list of Medicare practitioners who may bill for covered telehealth services.

July Quarterly Update to 2016 Annual Update of HCPCS Codes Used for Skilled Nursing Facility (SNF) Consolidated Billing (CB) Enforcement

• Transmittal 3473, Change Request 9561, MLN Matters MM9561
• Issued March 4, 2016; Effective: January 1, 2016; Implementation date July 5, 2016
• Affects providers submitting claims to MACs for services provided to Medicare beneficiaries during a SNF stay.
• Changes to CPT/HCPCS codes and Medicare Physician Fee Schedule designations will be used to revise Common Working File (CWF) edits to allow MACs to make appropriate payments in accordance with policy for SNF consolidated billing in Chapter 6, section 20.6; Medicare Claims Processing Manual

Summary: This notification provides updates to the lists of Healthcare Common Procedure Coding System (HCPCS) codes that are subject to the consolidated billing provision of the SNF Prospective Payment System (PPS).

April 2016 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• Transmittal 3471, Change Request 9549, MLN Matters MM9549
• Issued February 26, 2016; Effective: April 1, 2016; Implementation date April 4, 2016
• Affects providers who submit claims to MACs for services provided to Medicare beneficiaries paid under the OPPS.
• Updates Chapter 4, section 50.8; Medicare Claims Processing Manual

Summary: This Recurring Update Notification describes changes to and billing instructions for various payment policies implemented in the April 2016 OPPS update.

Coding Revisions to National Coverage Determinations

• Transmittal 1630, Change Request 9540
• Issued February 26, 2016; Effective: July 1, 2016; Implementation date July 5, 2016

Summary of Changes: This is the 6th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, CR9087, and CR9252. Some are the result of revisions required to other NCD-related CRs released separately.

Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases as needed. No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process.

Conditions of Participation (CoPs)    

Advance Copy – Interpretive Guidelines for the Organ Transplant CoPs at 42 Code of Federal Regulations (CFR) §§ 482.68 through 482.104

• Memo # 16-10-Transplant
• Posting Date March 11, 2016

Summary: CMS has updated the Organ Transplant Interpretive Guidelines to incorporate previously-published changes, clarify certain areas, and address feedback received based on previously-released drafts. New Appendix X Interpretive Guidelines supersede all previous versions and will be published in a new Appendix X of the State Operations Manual (SOM).

The month of March is National Nutrition Month and March 9, 2016 was Registered Dietitian Nutritionist Day.   According to the Academy of Nutrition and Dietetics website - “As the nation’s food and nutrition experts, registered dietitian nutritionists are committed to improving the health of their patients and community.” We at MMP, Inc. would like to acknowledge dietitians, nutritionists, and all those who work in the field of nutrition and thank them for their commitment to helping hospital patients. We also want to take this opportunity to look at some guidelines and information related to hospital dietitian services allowed and covered by Medicare.

Ordering Therapeutic Diets

Several years ago, a deficiency report released by CMS identified 147 deficiencies for hospitals related to dietary standards. In response to these deficiencies and to minimize regulatory requirements for hospitals, CMS revised the Hospital Conditions of Participation at section 482.28(b)(2) effective July 11, 2014 as follows:

§482.28(b)(2) -All patient diets, including therapeutic diets, must be ordered by a practitioner responsible for the care of the patient, or by a qualified dietitian or qualified nutrition professional as authorized by the medical staff and in accordance with State law governing dietitians and nutrition professionals.

The final rule can be read at Federal Register Final Rule May 12, 2014

The revision allows registered dietitians to order patient diets independently, which they are trained to do, without requiring the supervision or approval of a physician or other practitioner, if allowed by State law and hospital privileging.

CMS made the following comments related to this change:

“[T]he addition of ordering privileges enhances the ability that RDNs already have to provide timely, cost-effective, and evidence-based nutrition services as the recognized nutrition experts on a hospital interdisciplinary team.”

“We believe that the greater flexibility for hospitals and medical staffs to enlist the services of non-physician practitioners to carry out the patient care duties for which they are trained and licensed will allow them to meet the needs of their patients most efficiently and effectively.”

The problem many hospitals may face with the revised rule relates to State law. Another

link from the Academy of Nutrition and Dietetics website shows the status of State laws for allowing therapeutic diet orders by dietitians, including a color-coded map. Therefore hospitals and dietitians must be familiar with the laws for their particular State before seeking hospital privileging for RDNs to order patient diets. For example, Alabama State law states in section 420-5-7-.14 (3)(a): "Therapeutic diets shall be prescribed by the practitioner or practitioners responsible for the care of the patients." The Academy of Nutrition and Dietetics will be working with affiliate leaders to remove existing impediments through statutory or regulatory changes.

Medical Nutrition Therapy (MNT) Services

Medicare covers medical nutrition therapy (MNT) upon physician referral for beneficiaries with diabetes or renal disease when furnished by a registered dietitian or nutrition professional meeting certain requirements. Basic coverage includes initial assessment visit, follow-up visits for interventions, and reassessments within the year for a total of 3 hours for the first calendar year of a diagnosis of diabetes or renal disease and 2 hours for subsequent years for a renal disease diagnosis.

Important points about MNT services include:

• The treating physician must make a referral and indicate a diagnosis of diabetes or renal disease.
• Renal disease means chronic renal insufficiency (not severe enough to require dialysis or a transplant; GFR of 13-50) or successful renal transplant within the last 36 months.
• Diabetes Self Management Training (DSMT) and MNT can be provided within the same time period, but not on the same day.
• The number of hours covered in an episode of care may not be exceeded unless a second referral is received from the treating physician.
• Additional covered hours of MNT services may be covered beyond the number of hours typically covered under an episode of care when the treating physician determines there is a change of diagnosis or medical condition within such episode of care that makes a change in diet necessary.
• Hours may not be carried over into the following calendar year.
• MNT can be provided individually (one-to-one) or in a group setting.

Dietitians and nutritionists must meet the profession standards as described in Section 300.3 of the Medicare Claims Processing Manual, Chapter 4 and be enrolled as a provider in the Medicare program.

The following codes can be paid if submitted by a registered dietitian or nutrition professional who meets the specified requirements; or a hospital that has received reassigned benefits from a registered dietitian or nutritionist. Payment is only made for MNT services actually attended by the beneficiary and documented by the provider. MNT is not covered for inpatients of a hospital or skilled nursing facility.

• 97802 – MNT; initial assessment and intervention, individual, face-to-face with the patient, each 15 minutes (only for the initial visit)
• 97803 - Re-assessment and intervention, individual, face-to-face with the patient, each 15 minutes
• 97804 - Group (2 or more individual(s)), each 30 minutes
• G0270 - Medical Nutrition Therapy; reassessment and subsequent intervention(s) following second referral in same year for change in diagnosis, medical condition or treatment regimen (including additional hours needed for renal disease), individual, face to face with the patient, each 15 minutes
• G0271 - Medical Nutrition Therapy; reassessment and subsequent intervention(s) following second referral in same year for change in diagnosis, medical condition, or treatment regimen (including additional hours needed for renal disease) group (2 or more individuals), each 30 minutes

So here’s to eating right for everyone, but especially hospital patients, diabetic patients, and patients with renal disease. The knowledgeable advice and direction of a dietitian/nutritionist can make a critical difference.

“The secret of getting ahead is getting started. The secret of getting started is breaking your complex overwhelming tasks into small manageable tasks, and then starting on the first one.”- Mark Twain

On January 26th, 2015 Health and Human Services Secretary Sylvia M. Burwell “announced measurable goals and a timeline to move the Medicare program, and the health care system at large, toward paying providers based on the quality, rather than the quantity of care they give patients.” This was the first time that CMS had set the following explicit goals for Alternative Payment Models (APMs) and Value Based Payment goals.

Alternative Payment Models Goal

By the end of 2016 have 30 percent of Medicare payments in alternative payment models.

By the end of 2018 have 50 percent of Medicare payments in alternative payment models.

Value Based Payments Goal

By 2016 have 85 percent of Medicare fee-for-service payments tied to quality of value.

By 2018 have 90 percent of Medicare fee-for-service payments tied to quality of value.

On March 3, 2016 CMS announced in a Fact Sheet that it estimates that the first target of 30 percent of Medicare payments being tied to APMs has been met 11 months ahead of schedule. CMS indicates that “when it comes to improving the way providers are paid, we aim to reward value and care coordination – rather than volume and care duplication.”

Alternative Payment Models by the Numbers

• $411 million is the amount that Medicare Accountable Care Organizations (ACOs) saved the program in 2014 alone through markedly improved quality and patient experience over previous years.
• $3,000 saved per Medicare beneficiary on average is what was saved in just one year through the Independence at Home Demonstration.
• 17% is the reduction from 2010 to 2014 in the number of hospital acquired conditions (HACs). This represents over 87,000 lives saved and $20 billion in cost savings.
• 565,000 is the estimated number of readmissions prevented across all conditions between April 2010 and May 2015.
• Medicare spent $315.9 billion less on personal healthcare expenses between 2009 and 2013 than what would have been spent if the 2000-2008 average growth rate had continued through 2013.

Health Care Payment Learning and Action Network

CMS created the Health Care Payment Learning and Action Network (LAN) March of 2015 “to help align the important work being done across the private, public, and non-profit sectors.”

CMS notes that this network has accelerated the transition to APMs by “fostering collaboration between Department of Health and Human Services (HHS), private payers, large employers, providers, consumers, and state and federal partners.”

Ready or not, the shift in payment is happening. To learn more about LAN you can visit the LAN web page at the CMS Innovation Center as well as the LAN website where you can join the network, view their Work Products, participate in webinars and sign up for the LAN e-newsletter.