Knowledge Base Category -

In our modern texting, emailing, and messaging world, numerous acronyms have become common in order to allow us to communicate faster. One example is “LOL” which in texting lingo means “laugh out loud.” But to a Medicare patient or provider, LOL can mean “limitation on liability.” Limitation on Liability is one of the Financial Liability Protection provisions of the Social Security Act which protects beneficiaries, health care providers and suppliers under certain circumstances from unexpected liability for charges associated with claims that Medicare does not pay. Specifically, the LOL protections apply only when a provider believes that a Medicare covered item or service may be denied in a particular instance because it is not reasonable and necessary under §1862(a)(1) of the Act or because the item or service constitutes custodial care under §1862(a)(9) of the Act. If a provider believes a service will not be covered by Medicare because it is not medically necessary, they must give advance notice to the patient in order to shift the financial costs to the patient.

The Advance Beneficiary Notice of Noncoverage (ABN), Form CMS-R-131, is a form given to Fee-for-Service Medicare beneficiaries in situations where Medicare payment is expected to be denied. There are no substantive changes to the form for the latest approval but there is a new expiration date and the form has been revised to include language informing beneficiaries of their rights to CMS nondiscrimination practices and how to request the ABN in an alternative format if needed.  The effective date for use of this ABN form is 6/21/2017.

As a reminder, hospitals may issue an ABN for services that are not medically necessary, for therapy services that exceed the therapy cap amount and do not qualify for an exception, for experimental/investigational services, and since 2011 for preventive services when frequency limitations are exceeded. An ABN is mandatory in order to shift liability to the patient for these types of services. ABNs may also be used voluntarily for services that are not a Medicare benefit or are excluded from coverage. The ABN form is also used in certain situations by suppliers, physicians, hospices, home health agencies, CORFs, and SNFs (Part B only).

An ABN may be issued at the initiation of a service such as the beginning of a new patient encounter, start of a plan of care, or beginning of treatment - for example, diagnostic tests that are not medically necessary such as laboratory tests. A notice can also be given when services are reduced or terminated. Examples of this would be when a patient’s progression in rehabilitative therapy supports fewer visits per week but the patient wants to continue at the same frequency or when therapy services are no longer medically necessary but the patient wishes to continue.

Medicare has a number of resources with information about the Advance Beneficiary Notice.

• Medicare Claims Processing Manual, Chapter 30, Section 40.3
• MLN Booklet – Medicare Advance Beneficiary Notices
• ABN Form Instructions
• Medicare FFS ABN webpage with links to the ABN form (English and Spanish)

So be prepared to use the new ABN form in June; you wouldn’t want anyone to laugh at you for using the wrong form – LOL! 

TRANSMITTALS

Gender Dysphoria and Gender Reassignment Surgery

• MLN Matters® Number: MM9981
• Related Change Request (CR) #: CR 9981
• Related CR Release Date: March 3, 2017
• Effective Date: August 30, 2016
• Related CR Transmittal #: R194NCD
• Implementation Date: April 4, 2017
• https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM9981.pdf
• Affects physicians, providers and suppliers submitting claims to Medicare Administrative Contractors (MACs) for services to Medicare beneficiaries.

Summary: Coverage determinations for gender reassignment surgery will continue to be made by the local MACs on a case-by-case basis.

April 2017 Integrated Outpatient Code Editor (I/OCE) Specifications Version 18.1

• MLN Matters® Number: MM10002
• Related Change Request (CR) #: CR 10002
• Related CR Release Date: March 10, 2017
• Effective Date: April 1, 2017
• Related CR Transmittal #: R3735CP
• Implementation Date: April 3, 2017
• https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10002.pdf
• Affects providers who submit institutional claims to Medicare Administrative Contractors (MACs), including Home Health and Hospice (HH+H) MACs for services provided to Medicare beneficiaries.

Summary: Instructions and specifications for the Integrated Outpatient Code Editor (I/OCE) used for Outpatient Prospective Payment System (OPPS) and non-OPPS claims.

Clarification of Admission Order and Medical Review Requirements

• MLN Matters® Number: MM9979
• Related Change Request (CR) #: CR 9979
• Related CR Release Date: March 10, 2017
• Effective Date: January 1, 2016
• Related CR Transmittal #: R234BP
• Implementation Date: June 12, 2017
• https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM9979.pdf
• Affects physicians submitting claims to Medicare Administrative Contractors (MACs) for services to Medicare beneficiaries.

Summary: Clarifies the rulemaking language of the Centers for Medicare & Medicaid Services (CMS) as it relates to “Admission and Medical Review Criteria for Hospital Inpatient Services Under Medicare Part A; Requirements for Physician Orders.”

Billing for Advance Care Planning (ACP) Claims

• MLN Matters® Number: MM10000
• Related Change Request (CR) #: CR 10000
• Related CR Release Date: May 17, 2017
• Effective Date: January 1, 2016
• Related CR Transmittal #: R3739CP
• Implementation Date: June 19, 2017
• https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10000.pdf
• Affects providers who submit claims to Medicare Administrative Contractors (MACs) for Advance Care Planning (ACP) services provided as an optional element of the Annual Wellness Visit (AWV) to Medicare beneficiaries.

Summary: Provides billing instructions for ACP when furnished as an optional element of an AWV. CMS has made the CPT code 99497 (Advance care planning) separately payable for Medicare OPPS claims when the service meets the criteria for separate payment under OPPS.

April 2017 Update of the Hospital Outpatient Prospective Payment System (OPPS)

• MLN Matters® Number: MM 10005
• Related Change Request (CR) #: CR 10005
• Related CR Release Date: March 3, 2017
• Effective Date: April 1, 2017
• Related CR Transmittal #: R3728CP
• Implementation Date: April 3, 2017
• https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10005.pdf
• Affects providers and suppliers who submit claims to Medicare Administrative Contractors (MAC), including Home Health and Hospice (HH&H) MACs, for services provided to Medicare beneficiaries paid under the Outpatient Prospective Payment System (OPPS).

Summary: Describes changes to and billing instructions for various payment policies implemented in the April 2017 OPPS update.

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for July 2017

• MLN Matters Number: MM10036
• Related CR Release Date: March 17, 2017
• Related CR Transmittal Number: R3738CP
• Related Change Request (CR) Number: CR10036
• Effective Date: October 1, 2016
• Implementation Date: July 3, 2017
• https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10036.pdf
• Affects physicians, providers and suppliers submitting claims to Medicare Administrative Contractors (MACs) for services provided to Medicare beneficiaries.

Summary: Announces the changes that will be included in the July 2017 quarterly release of the edit module for clinical diagnostic laboratory services. This is a Recurring Update Notification that applies to Chapter 16, Section 120.2, of the ʺMedicare Claims Processing Manual.”

 

Clarification of Patient Discharge Status Codes and Hospital Transfer Policies

• SE0801 Rescinded March 15, 2017
• https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE0801.pdf

Summary: This article was rescinded on March 15, 2017. Information on the inpatient transfer policy is located in the "Medicare Claims Processing Manual" (100-04), Chapter 3. For questions concerning clarification on the proper usage of patient discharge status codes, providers should be utilizing the "UB-04 Manual" which is maintained by the National Uniform Billing Committee.  

 

OTHER MEDICARE ANNOUNCEMENTS

 

Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model; Delay of Effective Date

• Interim final rule with comment period; delay of effective date
• https://www.gpo.gov/fdsys/pkg/FR-2017-03-21/pdf/2017-05692.pdf

Summary: This interim final rule with comment period (IFC) further delays the effective date of the final rule entitled ‘‘Advancing Care Coordination Through Episode Payment Models (EPMs); Cardiac Rehabilitation Incentive Payment Model; and Changes to the Comprehensive Care for Joint Replacement Model’’ from March 21, 2017 until May 20, 2017. This IFC also delays the applicability date of the regulations at 42 CFR part 512 from July 1, 2017 to October 1, 2017 and effective date of the specific CJR regulations itemized in the DATES section from July 1, 2017 to October 1, 2017. We seek comment on the appropriateness of this delay, as well as a further applicability date delay until January 1, 2018.

Proposed Decision Memo for Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) (CAG-00449N)

• March 2, 2017
• https://www.cms.gov/medicare-coverage-database/details/nca-proposed-decision-memo.aspx?NCAId=287&TimeFrame=30&DocType=All&bc=AgAAYAAACAAAAA%3d%3d&

Summary: CMS) proposes that the evidence is sufficient to cover supervised exercise therapy (SET) for beneficiaries with intermittent claudication (IC) for the treatment of symptomatic peripheral artery disease (PAD). 

My grandson is in elementary school and the first thing he reports to his parents each afternoon is how he behaved in school. His teacher uses a color scale, on which the student moves up or down depending on good or bad behavior – green is good, blue is better, but red – oh no! The one excuse I am sure his parents would never accept for bad behavior is that he did not know the rules. From an early age, life has rules and it is our responsibility to know, understand, and follow those rules. Such is the case when submitting claims and accepting payment from Medicare for healthcare services.

In November 2016, CMS released a transmittal that updates the section on Provider Liability in Chapter 3 of the Medicare Financial Management Manual. Specifically, the update adds new reasons for why a provider, physician, or supplier should have known certain services were noncovered. Section 90 of this chapter begins by stating “A provider is liable for overpayments it received unless it is found to be without fault.” To be without fault, the provider must have:

• Exercised reasonable care in billing for, and accepting Medicare payment,
• Made full disclosure of all material facts,
• Had a reasonable basis for assuming payment was correct based on Medicare instructions, regulations, and other facts, and/or
• Promptly communicated with the Medicare contractor if there was a reason to question the payment.

A provider may know or should have known a payment is incorrect if there is a Medicare policy or rule that specifically prohibits the payment. Prior to this updated transmittal, the reasons listed in the manual when a provider should have known about a policy or rule were 1) the policy or rule is in the provider manual or in Federal regulations, 2) the Medicare contractor provided general notice to the medical community concerning the policy or rule, or 3) the Medicare contractor gave written notice of the policy or rule to the particular provider. Transmittal 275 (MLN Matters Article MM9708) expands the term provider to be “provider, physician, or supplier” and adds the following reasons they should be aware of a particular Medicare policy or rule.

The provider, physician, or supplier:

1. Was previously investigated or audited as a result of not following the policy or rule;
2. Previously agreed to a Corporate Integrity Agreement as a result of not following the policy or rule;
3. Was previously informed that its claims had been reviewed/denied as a result of the claims not meeting certain Medicare requirements which are related to the policy or rule; or
4. Previously received documented training/outreach from CMS or one of its contractors related to the same policy or rule.

As a provider, what is your responsibility related to overpayments and ensuring reasonable care in billing and accepting Medicare payment?

Know the Rules

If the rules were static, this would still be a huge challenge. There are laws, regulations (e.g. Code of Federal Regulations), and sub-regulatory guidance (e.g. Medicare policy manuals). Medicare has an expansive website with information in every corner, including an educational section (Medicare Learning Network – MLN). I recommend providers subscribe to the CMS and OIG (Office of Inspector General) list serves at a minimum. Also providers should have a thorough knowledge of the Medicare Benefit Policy, Claims Processing, and National Coverage Determination (NCD) manuals. Then there is the website of your Medicare Administrative Contractor (MAC) and their Local Coverage Determinations (LCDs) and coverage articles. It is an overwhelming amount of information to digest so I also recommend subscribing to newsletters from some reputable healthcare consultants/educators who can target key issues and provide relevant information in an easy to read, understandable format. Hopefully you find this Wednesday@One newsletter serves this function well.

Keep Up with Rule Changes

Unfortunately, the rules are not static – they are ever changing at a rapid pace. The list serves, websites, and newsletters mentioned above should address the changes also. More specifically, watch the Medicare transmittals, most of which are converted into the easier to read and understand format of MLN Matters articles. The transmittals provide updates of Medicare sub-regulatory guidance. All the MACs have a news section on their websites for updates and specific webpages related to coverage policies and medical review. There are major rule changes on an annual basis for the Inpatient Prospective Payment System (IPPS), Outpatient Prospective Payment System (OPPS), Physician Fee Schedule, etc. Medicare provides fact sheets related to these rules and numerous independent newsletters also offer summaries and in-depth analyses of the key issues.

Understand the Rules

Interpreting the rules correctly is no small task. Once again all of the references mentioned above are helpful but a focus on Medicare review activities to understand Medicare expectations is extremely helpful here. The medical review webpage areas of the MAC websites, OIG reports, the Medicare Quarterly Compliance Newsletter, etc. often provide more granular details on what is expected to comply with certain rules. These issues are also the more “at risk” issues and a good place to focus your internal efforts as well.

Know Your Facility History of Billing Compliance

Notice that the third existing reason why providers “should have known” and all four of the new reasons relate to the provider’s own history of compliance. Facilities need to know if they have been notified, investigated, audited, had claims denied, or educated due to noncompliance with a particular policy or rule. This also includes having been put under a Corporate Integrity Agreement (CIA). If so, your facility has no excuse for not knowing these rules.

Have Appropriate Processes

Knowing the rules is of no benefit unless you correctly apply the rules to your facility’s practices. I will not say much about this, because after all, this is what providers do, so you know how to address it. Internal policies and procedures to ensure appropriate processes are necessary as is employee education and training.

Internal Communication

The importance of communication between departments cannot be overemphasized. For example, who within the facility knows the compliance history referenced above and who within the facility is responsible for keeping up with rule changes and disseminating that information to the affected departments? A team approach is required for education and establishing processes. Be sure to include all key stakeholders.

Checks and Rechecks

Oversight of processes and compliance with the rules is also necessary. Such oversight can be in the form of internal monitoring, internal audits, or audits with contracted external consultants or auditors. This process should start by identifying risk areas and developing an overall compliance audit plan. I recommend considering the issues Medicare agencies and entities are reviewing (such as the OIG Annual Work Plan, MAC medical review topics, etc.)

The tasks of knowing, understanding and implementing processes to keep up with all of the Medicare policies and rules may seem overwhelming, but it is the cost of doing business with Medicare. Like in elementary school, you have to know the rules and you have to comply or you do not get a star for the day.

“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 patient 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

Annually, CMS releases an updated Inpatient Only (IPO) List in the Calendar Year (CY) Outpatient Prospective Payment System (OPPS) Final Rule. CMS is removing seven CPT codes from this list for CY 2017. This article reminds the reader of two important principles of the IPO list, outlines the criteria for potential removal from the list, lists the codes being removed and their new status indicator assignment, and ends with public comments regarding the removal of Total Knee Arthroplasty (TKA) CPT code 22447 from the IPO list. 

Important Principles of the IPO List

CMS notes in the 2017 OPPS Final Rule that it is not uncommon to receive questions about the IPO list leading them to believe there may be a misunderstanding by some regarding certain aspects of the IPO list. Specifically, the following two aspects:

• “First, just because a procedure is not on the IPO list does not mean that the procedure cannot be performed on an inpatient basis. IPO list procedures must be performed on an inpatient basis (regardless of the expected length of the hospital stay) in order to qualify for Medicare payment, but procedures that are not on the IPO list can be and very often are performed on individuals who are inpatients (as well as individuals who are hospital outpatients and ASC patients).
• Second, the IPO list status of a procedure has no effect on the MPFS professional payment for the procedure. Whether or not a procedure is on the IPO list is not in any way a factor in the MPFS payment methodology.”

Established Criteria for Procedure Removal from Inpatient Only (IPO) List

The criteria for consideration of removal of a CPT code from the IPO list includes the following:

• Most outpatient departments are equipped to provide the services to the Medicare population.
• The simplest procedure described by the code may be performed in most outpatient departments.
• The procedure is related to codes that we have already removed from the IPO list.
• A determination is made that the procedure is being performed in numerous hospitals on an outpatient basis.
• A determination is made that the procedure can be appropriately and safely performed in an ASC, and is on the list of approved ASC procedures or has been proposed by us for addition to the ASC list.

CY 2017 Procedures Removed from the IPO List

‍Codes Removed from IPO List assigned Status Indicators

The spine procedure codes removed from the IPO list are add-on codes to procedures currently performed in the Hospital Outpatient Department and describe variations of (including additional instrumentation used with) the base code procedure. As add-on codes, these codes will be assigned to status indicator “N.”

“The Laryngoplasty codes are related to and clinically similar to CPT code 21495 (Open treatment of hyoid fracture), which is currently not on the IPO list. The two laryngoplasty procedure codes will be assigned to APC 5165 (Level 5 ENT Procedures) with status indicator “J1.”

Response to Solicitation of Public Comments on the Possible Removal of Total Knee Arthroplasty (TKA) Procedure from the IPO List

In the 2017 OPPS Proposed Rule CMS solicited comment from the public on a list of questions relating to the removal of TKA from the IPO list in the future. They also acknowledged the fact that “TKA candidates, although they all have osteoarthritis severe enough to warrant knee replacement, are a varied group in which the anticipated length of hospitalization is dictated more by comorbidities and diseases of other organ systems. Some patients may be appropriate for outpatient surgery while others may be appropriate for inpatient surgery.” But before we review comments received and CMS’s response, let’s look at knee CPTs by the numbers.

Knee CPTs by the Numbers

• 2000: CPT 27447 (Arthroplasty, knee, condyle and plateau; medial and lateral compartments with or without patella resurfacing (total knee arthroplasty)) was placed on the original IPO list in the 2000 OPPS Final Rule (65 FR 18781)
• 4.6 days: The geometric mean average length of stay (GMLOS) in 2000 for the DRG to which uncomplicated TKA procedures were assigned.
• 2.8 days: The GMLOS for the MS-DRG in 2016
• 2002: A similar procedure described by CPT code 27446 (Arthroplasty, knee, condyle and plateau; medial OR lateral compartment) (unicompartmental knee replacement) was removed from the IPO list.
• 2008: CPT code 27446 was added to the ASC covered surgical procedures.
• 2013: CMS Proposed to remove the procedure described by CPT code 27447 from the IPO List in the CY 2013 OPPS/ASC proposed rule. After consideration of public comments, this proposal was not finalized.

The Public Weighs in on Removing CPT 27447 from the IPO List

The following are comments were published in the 2017 OPPS Final Rule.

• “The overwhelming majority of the commenters…supported removing TKA from the IPO list.”
• Those supporting the removal of TKA included “ASCs, therapeutic professional associations, hospital associations, as well as many surgeons.”
• Most supporters “noted that an appropriate patient selection protocol should be used to determine the patients who are best suited for outpatient joint replacement.”
• A few commenters opposing the removal of a TKA procedure represented professional organizations, health systems, and hospital associations. “The comments believed that the increased likelihood that Medicare patients have comorbidities that require the need for intensive rehabilitation after a TKA procedure preclude this procedure from being performed in the outpatient setting. They also state that most outpatient departments are not currently equipped to provide TKA procedures to Medicare beneficiaries, which require exceptional patient selection, exceptional surgical technique, and a carefully constructed postoperative care plan
• Commenters expressed concern about the implications that the removal of this procedure would have for pricing methodologies, target pricing, and reconciliation process in the Comprehensive Care for Joint Replacement and Bundled Payments for Care Improvement Models currently in place through the CMS Innovation Center.

CMS responded to comments in typical CMS fashion by indicating that they “thank the stakeholder public for the many detailed comments on this topic. We will consider all of these comments in future policy making.”

So for now, 27447 remains on the IPO List. The Final Rule and IPO list in Addenda E can be accessed on the CMS Hospital 2017 OPPS web page. Additional guidance about Inpatient-only Services in general can be found in the Medicare Claims Processing Manual, Chapter 4 – Part B Hospital, Section 180.7.

The October 2016 release of the Medicare Quarterly Provider Compliance Newsletter included two issues specific to hospitals. This article focuses on the Recovery Auditors automated review performed to identify discharge status codes that had been improperly submitted under the IPPS Post-Acute Care Transfer (PACT) Policy.

Recovery Auditor Finding

“Analysis of discharge status codes and secondary claim data identified improper payments. Where a hospital used discharge status code 01, but should have shown a transfer to another care setting with a different discharge status code, the hospital may be overpaid for the inpatient services. It is crucial that hospitals place the correct discharge status code on claims to avoid subsequent overpayment identification and recovery.”

Transfer Policy Background

MLN® Acute Care Hospital Inpatient Prospective Payment System Fact Sheet (ICN 006815) indicates that under the Transfer Policy DRG payments are reduced when:

• The patient’s LOS is at least 1 day less than the geometric mean LOS for the DRG;
• The patient is transferred to another hospital covered by the Acute Care Hospital IPPS or, for certain MS-DRGs, discharged to a post-acute setting (PACT Policy);
• The patient is transferred to a hospital that does not have an agreement to participate in the Medicare Program (effective October 1, 2010); and
• The patient is transferred to a CAH (effective October 1, 2010)

PACT Policy and Discharge Status Codes

Cases with a length of stay less than the Geometric Mean Length of Stay (GMLOS) for a PACT DRG will not reimburse the full Diagnosis Related Group (DRG) payment if the patient was transferred to a post-acute care (PAC) setting. This policy involves the following patient discharge status codes:

When a patient is discharged with the status code of 01, Medicare’s overpayment edit will look for:

• “The presence of a transfer claim to a Skilled Nursing Facility, Cancer Hospital, Psychiatric Hospital, Children’s Hospital, Inpatient Rehab Facility, or Long Term Care Facility that commences or continues within one day of the acute care discharge, or
• A transfer claim to Home Health Care that commences or continues within three days of the acute care discharge.”

How to Avoid this Problem

Medicare advises that “hospitals should take steps to assure claims coders understand that the patient discharge status code is a crucial data element in determining payment for inpatient stays.” They go on to provide links to resources providing more information on how to avoid these errors.

MMP, Inc. advises that key stakeholders in your facility read and share the October 2016 issue of the Medicare Quarterly Compliance Newsletter.

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