Knowledge Base Category -
“No payment may be made under (Medicare) part A or part B for any expenses incurred for items or services — which, …, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, …”Social Security Act 1862(a)(1)(A)
If your work involves knowledge of Medicare requirements, you are likely very familiar with the above statement that is the basis for the concept of “medical necessity” for covered healthcare services. But do you actually consider the implications of this statement when billing Medicare for services?
It appears a large number of providers did not assess their services against this statement before billing Medicare for specimen validity testing as a recent Office of Inspector General (OIG) report found $66.3 million in overpayments for this type of testing. Specimen validity testing is used to analyze urine specimens prior to drug testing to determine whether the specimens have been adulterated or tampered with. Although necessary to assure the legitimacy of the drug testing, these tests themselves are not used to provide a diagnosis or treatment to a patient.
As the OIG report explains, the requirements for laboratory testing are that tests meet the requirement for medical necessity as described above and more specifically, to be covered under Medicare Part B, clinical laboratory tests must:
- Be ordered by a physician who is treating a beneficiary for a specific medical problem;
- Be related to the patient’s illness, injury, symptom or complaint; and
- The results must be used in the management of the patient’s problem.
The overpayments occurred because the same tests used for specimen validity testing may be medically necessary if used to diagnose certain conditions. “For example, tests for urinary pH and specific gravity may be performed to diagnose diseases of the kidney and urinary system. If these tests are used for diagnosis, treatment, or management, they may be Medicare-covered services. However, when used for the purpose of determining whether a specimen is adulterated, the test results are not being used to manage a beneficiary’s specific medical problem. In these cases, specimen validity testing is not a separately billable Medicare-covered service.”
Providers should have known this because, over the years, Medicare and their contractors have addressed this issue numerous times. Almost all the Medicare Administrative Contractors (MACs) have a Local Coverage Determination (LCD) for drug testing that includes direction that tests to validate urine specimens are not separately billable. The first such LCD instruction was in 2010 and in 2015 the Medicare National Correct Coding Initiative (NCCI) manual included the statement, “Providers performing validity testing on urine specimens utilized for drug testing should not separately bill the validity testing.” Beginning in 2016, new HCPCS codes for urine drug testing include specimen validity testing in their code descriptions and payments, regardless of whether specimen validity testing is performed or not. And in April 2016, NCCI edits were created to prevent payment for the type of lab tests performed for validity testing when billed on the same date of service as a urine drug test unless modified by the provider to indicate a “separate and distinct” service.
Although the number of overpayments dramatically decreased from 2014 to 2016, the OIG thinks further actions by CMS could reduce the risk of estimated overpayments of $12,146,760 over a 5-year period. The OIG recommends CMS “strengthen its system edits to prevent improper payments for specimen validity tests and instruct the Medicare contractors to educate providers on properly billing for specimen validity and urine drug tests.” Also, be warned that CMS may be recouping the overpayments identified in the OIG audit.
Now is a good time to investigate your billing practices for specimen validity testing with the understanding that if you have been separately billing these services, you owe the government some money back. Going forward, be sure to first apply the Social Security Act standard in determining whether to bill for services – i.e., to be paid under Medicare, a service must be reasonable and necessary for the diagnosis or treatment of illness or injury. After that, there are a lot more coverage rules that need to be considered, but it is a good place to start.
Debbie Rubio
Several years ago, there was a lot of excitement among laboratories and hospitals when CMS stated that a laboratory requisition did not have to be signed by the ordering practitioner. That excitement was short-lived however, when it became apparent that the lack of a signature requirement for lab requisitions did not mean a signed order for the laboratory testing was not required. Upon medical review by a Medicare contractor, the billing entity (such as the hospital) was required to submit a signed practitioner’s order, or other documentation, such as an office progress note, supporting the intent to order the specific laboratory tests. Many laboratories quickly realized it was easier and more efficient to continue to require the physician’s signature on the lab requisition.
Bearing this cautionary tale in mind, what does the proposed policy change to remove the requirement that written inpatient admission orders are a specific requirement for Medicare Part A payment actually mean for hospitals? I certainly do not think it means you no longer need an order for inpatient admission.
In fact, the 2019 Inpatient Prospective Payment System (IPPS) proposed rule states, “This proposal does not change the requirement that an individual is considered an inpatient if formally admitted as an inpatient under an order for inpatient admission.”
What it does mean is a shift in the focus of Medicare reviewers away from the admission order itself. The Proposed Rule affirms that Medicare reviewers will focus on the medical necessity of the inpatient services. The wording in the proposed rule also provides hints as to the types of “technical discrepancies” reviewers may overlook, such as:
- Missing practitioner admission signatures,
- Missing authentication signatures or co-signatures, or
- Signatures occurring after discharge.
Reviewers may also be more willing to allow payment for inpatient admissions when there is not an admission order but “the intent, decision, and recommendation of the ordering physician or other qualified practitioner to admit the beneficiary as an inpatient can clearly be derived from the medical record.” This should still be a rare occurrence because hospitals are expected to comply with the Medicare Conditions of Participation which require an admission order.
The rule change for admission orders does not change the “two-midnight” policy. This change, if finalized, will allow hospital personnel to concentrate on ensuring documentation is present in the record to support the medical necessary expectation of a two-midnight stay instead of chasing physicians to obtain signatures before the patient is discharged.
Debbie Rubio
As I write this article, I realize the word “challenge” appears frequently in my articles. How could it not? Dealing with Medicare is a lot of things, but always a challenge. Especially since Medicare tends to change their guidance often and without warning. Sometimes guidance changes are couched as “clarifications” and sometimes providers wait and hope for additional guidance that seems to take forever to come. Such is the case with Medicare’s transmittal that manualizes the new laboratory date of service policy from the 2018 Outpatient Prospective Payment System (OPPS) Final Rule. The good news is that this transmittal includes a list of codes to which the new policy applies, which was not clear from the discussion in the final rule.
Prior to the new lab date of service policy, hospitals had to bill Medicare directly for all outpatient laboratory tests unless the test was ordered at least 14 days following the date of the patient’s discharge from an outpatient hospital procedure. This policy created unintentional operational consequences for hospitals and testing laboratories when molecular pathology tests and ADLTs, that are separately paid at the clinical lab fee schedule (CLFS) rate and not under the hospital OPPS rate, were performed on specimens collected during a hospital outpatient encounter. CMS recognized the concerns and in the 2018 OPPS Final Rule, changed the lab date of service policy as follows:
“In the case of a molecular pathology test or an Advanced Diagnostic Laboratory Test (ADLT) that meets the criteria of section 1834A(d)(5)(A) of the Act, the date of service must be the date the test was performed only if the following conditions are met:
- The test is performed following a hospital outpatient’s discharge from the hospital outpatient department;
- The specimen was collected from a hospital outpatient during an encounter (as both are defined 42 CFR 410.2);
- It was medically appropriate to have collected the sample from the hospital outpatient during the hospital outpatient encounter;
- The results of the test do not guide treatment provided during the hospital outpatient encounter; and
- The test was reasonable and medically necessary for the treatment of an illness.
This new exception to laboratory DOS policy will permit laboratories performing ADLTs and molecular pathology tests excluded from the Outpatient Prospective Payment System (OPPS) packaging policy to bill
Medicare directly for those tests, instead of requiring them to seek payment from the hospital outpatient department.” In fact, under the new policy the testing lab must bill for the applicable tests; the hospital can no longer bill Medicare directly for these tests.
In the final rule, CMS appeared to exclude some lab tests that now are included according to Transmittal 4000 – the final rule stated, “we are not including ADLTs under Criterion (B), GSP (genomic sequencing procedures) tests, PLA (proprietary laboratory analysis) tests, or protein-based MAAAs (multianalyte assays with algorithmic analyses) in the revised DOS policy at this time.” In CMS’s defense, I think they meant GSP, PLA, and MAAA laboratory tests that are conditionally packaged under OPPS. All ADLT and molecular pathology-type codes that are conditionally packaged laboratory tests codes under OPPS are not included in the new policy – only separately payable molecular path and ADLT test codes with an OPPS status indicator of “A” are included. As noted above, the transmittal includes a list of codes to which the policy applies –-
- CPTs 81105-81383, 81400-81408, 81410-81479, 81493, 81504, 81507, 81519–81528, 81540-81595, 0004M, 0006M–0009M, 0001U, 0004U, 0008U, 0010U, 0012U–0014U, 0016U–0019U, 0022U, and 0023U. (0004U was deleted effective January 1, 2018, but is included in Medicare’s listing.)
This new policy prevents hospitals from having to bill Medicare directly for these types of tests which encompassed accepting Medicare CLFS payment rates and paying a reference laboratory their charges to perform the tests. Under the new policy, Medicare pays the CLFS rate directly to the testing laboratory. Hospital labs will have to be aware of which tests fall under this policy (testing lab bills Medicare) and which do not (hospital lab bills Medicare directly). Also, hospitals must develop a process to provide the patients’ billing information to the testing lab in order for the testing lab to bill Medicare.
The transmittal is effective for dates of service on and after January 1, 2018, but the implementation date of the transmittal is not until July 2, 2018. I recommend hospitals proceed now with allowing the testing laboratory to bill for the applicable services. Should Medicare deny any payments prior to the implementation date, the transmittal allows for correction of the claim payment when brought to the Medicare contractor’s attention. Alternatively, testing labs may hold such claims until after the implementation date.
The challenge continues as we try to read between the lines, make our best guess, and remain prepared for CMS “clarifications” in order to code, bill and document correctly to meet Medicare guidelines. In my line of work, I guess this translates to job security.
Debbie Rubio
MEDICARE TRANSMITTALS
Adjustments to Qualified Medicare Beneficiary (QMB) Claims Processed Under CR 9911
Directs MACs to mass adjust QMB claims impacted by CR9911.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10494.pdf
April 2018 Integrated Outpatient Code Editor (I/OCE) Specifications Version 19.1 – REVISED
Revised to correct the status indicator for the drug code J0606 from SI=G to SI=K.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10514.pdf
April 2018 Update of the Hospital Outpatient Prospective Payment System (OPPS) - REVISED
Updated the number of drugs and biologicals with OPPS pass-through status effective April 1, 2018, from twelve to eleven and removed HCPCS code J0606, Injection, etelcalcetide, 0.1 mg, from Table 5, Attachment A in the CR since its status indicator remains "K" for the April update.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10515.pdf
Claims Processing Actions to Implement Certain Provisions of the Bipartisan Budget Act of 2018
Provides direction to MACs to reprocess claims related to several provisions of the Bipartisan Budget Act of 2018, specifically the Ambulance add-on payment provisions, the Work Geographic Practice Cost Index (GPCI) Floor, the 3% Home Health (HH) Rural Add-on Payment, and the repeal of outpatient therapy caps with requirement to submit the KX modifier for services in excess of the prior cap amounts.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10531.pdf
Institutional Billing for No Cost Items
Provides clarification of the billing instructions specific to drugs provided at no cost when claims processing edits prevent drug administration charges from being billed when the claim does not contain a covered/billable drug charge.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10521.pdf
New Waived Tests
New Clinical Laboratory Improvement Amendments of 1988 (CLIA) waived tests approved by the Food and Drug Administration (FDA).
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10586.pdf
Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD) – REVISED
Clarifies that the SET program must be provided in a physician’s office (Place of Service code 11).
NOTE: MMP contacted CMS and was informed another revision of this CR would be forthcoming.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10295.pdf
Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 24.2 Effective July 1, 2018
Change in Type of Service (TOS) for Current Procedural Terminology (CPT) Code 77067
Corrects the TOS indicator assigned to CPT code 77067 – Screening Mammography to “1” instead of “4” to allow screening mammography claims to be billed without referring physician information on the claim, consistent with Medicare’s coverage policy for screening mammograms.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10607.pdf
Notice of New Interest Rate for Medicare Overpayments and Underpayments - 3rd Qtr Notification for FY 2018
Medicare contractors shall implement an interest rate of 10.25 percent effective April 17, 2018 for Medicare overpayments and underpayments.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R303FM.pdf
Internet Only Manual Update to Pub 100-04, Chapter 16, Section 40.8 - Date of Service Policy
Updates the Date of Service (DOS) Policy for Clinical Laboratory and Pathology Specimens
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4000CP.pdf
Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes – July 2018 Update
Quarterly update of drug/biological HCPCS codes.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNmattersArticles/downloads/MM10624.pdf
MEDICARE SPECIAL EDITION ARTICLES
Prohibition Billing Dually Eligible Individuals Enrolled in the Qualified Medicare Beneficiary (QMB) Program - REVISED
Updates information about the Remittance Advice (RA) and Medicare Summary Notice (MSN) for all Medicare Fee-For-Service (FFS) QMB claims and includes new statistics on the number of beneficiaries enrolled in QMB.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE1128.pdf
Proper Coding for Specimen Validity Testing Billed in Combination with Drug Testing
Reminds laboratories and other providers performing validity testing on urine specimens utilized for drug testing not to separately bill the validity testing.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE18001.pdf
MEDICARE COVERAGE UPDATES
Decision Memo for Magnetic Resonance Imaging (MRI) (CAG-00399R4)
Evidence is sufficient to conclude that magnetic resonance imaging (MRI) for Medicare beneficiaries with an implanted pacemaker (PM), implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy pacemaker (CRT-P), or cardiac resynchronization therapy defibrillator (CRT-D) is reasonable and necessary. Will modify current NCD to eliminate the collection of additional information under the Coverage with Evidence Development paradigm.
https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=289&TimeFrame=7&DocType=All&bc=AgAAYAAAQAAA&
OTHER MEDICARE UPDATES
New Proposed RAC Review Topics – April 2018
April 2018 proposed topics include:
- Exact Duplicate Claims
- Implantable Automatic Defibrillators
- Group 3 Support Surfaces
- Percutaneous Implantation of Neurostimulator Electrode Array
March Patients Over Paperwork Newsletter
New OIG Compliance Resource Portal
OIG launches new compliance resource portal that provides links to handy resources for the public that can help ensure that you are in compliance with Federal health care laws.
https://oig.hhs.gov/compliance/compliance-resource-portal/
What do you have on your bedside table - an alarm clock, a lamp, perhaps a good book to lull you to sleep? A new addition to many bedside tables over the past few decades is a C-PAP (continuous positive airway pressure) machine for the treatment of sleep apnea. In recent years, the incidence of sleep apnea and C-PAP usage in the United States has increased significantly, likely due in part to the obesity epidemic, increased sleep testing, and the coming of age of the more health-conscious baby boomers. Sleep apnea is not to be taken lightly – the cost in health effects, productivity, and healthcare dollars is staggering. Some fascinating information on these topics from an internet search include:
American Academy of Sleep Medicine (AASM) 2014 Article
- Sleep apnea afflicts at least 25 million adults in the U.S., according to the National Healthy Sleep Awareness Project. It is now estimated that 26 percent of adults between the ages of 30 and 70 years have sleep apnea.
- Obstructive sleep apnea increases the risk of high blood pressure, heart disease, Type 2 diabetes, stroke and depression.
- More than 37% of workers (are) sleep-deprived (contributing to) cognitive declines, heightened safety risks and increased economic costs.
- According to the National Safety Council (NSC), sleepy workers are estimated to cost employers $136 billion a year in health-related lost productivity.
- About 13% of work injuries are attributable to sleep deprivation.
- The National Transportation Safety Board (NTSB) estimates that fatigue has been a contributing factor in 20 percent of its (driving-related) investigations over the last two decades.
Wiley Online Library "The Laryngoscope" 2017 Article
- In 2014, 845,569 sleep studies were completed by 1.4% of Medicare beneficiaries for a total of $189 million.
- Since 2010, the number of studies performed has increased by 9.1%.
Sleep Review Journal 2017 Article
- The sleep testing services market is expected to be valued at $8,395.7 million by the end of 2021, reflecting a compound annual growth rate of 12.9% during the forecast period (2016–2021), according to a report by Persistence Market Research.
- The growth of the North America sleep services market is driven by favorable reimbursement policies and high awareness of sleep disease.
Another recent trend related to sleep apnea and sleep testing is the change in credentialing requirements by some Medicare Administrative Contractors (MACs) for hospital-based sleep centers. Prior to the recent changes almost all MACs required sleep testing centers to be certified by the American Academy of Sleep Medicine (AASM), The Joint Commission (formerly known as JCAHO), or Accreditation Commission for Health Care, Inc. (ACHC). Accreditation by either the Joint Commission Hospital or Ambulatory Care Accreditation programs was acceptable for hospital-based sleep centers. If the Joint Commission survey of the general hospital accreditation included the hospital-based sleep lab, an additional accreditation was not needed.
Things began to change in 2017 when 3 MACs, Wisconsin Physician Services (WPS), CGS, and Noridian changed their sleep lab certification requirements so that Joint Commission’s Hospital Accreditation was no longer sufficient to meet the credentialing requirements for a hospital sleep center. The new/revised Local Coverage Determinations (LCDs) require certification by the Joint Commission’s Ambulatory Care Accreditation Program or one of the other approved accreditors (AASM and ACHC). Although the WPS, CGS, and Noridian policies were effective in February, March and June of 2017 respectively, they all issued clarification statements allowing 90 days from the date of the statement to apply for accreditation and 1 year to obtain an accreditation award. This means the accreditation due date for WPS is May 12, 2018; for CGS, May 11, 2018; and June 22, 2018 for Noridian. Hospitals can elect to have all their ambulatory services accredited through the Joint Commission’s Ambulatory Care Accreditation Program or just specifically sleep services only. You can find more information in a Joint Commission Fact Sheet.
In March 2018, Palmetto GBA followed suit and sleep facilities in the Palmetto Jurisdictions J and M must have sleep-specific accreditation to be eligible for coverage. Palmetto is allowing a much shorter time frame for sleep centers to comply. Here is an excerpt from a future effective Palmetto Article that explains the new requirements and the timeline for compliance.
“As noted above in section 1, outpatient sleep centers affiliated with a hospital which is currently accredited by The Joint Commission (formerly JCAHO) through the hospital’s accreditation will now be required to obtain separate ambulatory care accreditation for the sleep center if ambulatory services accreditation for the sleep center is not currently in place. This accreditation must be obtained by October 1, 2018 in order to continue to render services to Medicare beneficiaries and submit claims to Palmetto GBA.”
This could be bad news for hospitals – if your sleep center is not accredited by The Joint Commission’s Ambulatory Care Accreditation Program or one of the other approved accreditors (AASM and ACHC), your claims for services rendered past the above noted MAC-imposed deadlines may be denied. Enough to make hospital administrators, finance, and sleep lab managers toss and turn and lose sleep.
Facility accreditation is not the only credentialing requirement for sleep centers. Sleep centers must be under the supervision or direction of a physician who meets certain certification requirements. And there are also requirements for the credentials and training of sleep technologists and technicians. Hospital offering sleep testing should carefully review the requirements of their Medicare contractors and other payers. Here is a list of the various coverage policies for sleep testing /polysomnography of the MACs.
Debbie Rubio
When we think of copycat products, we often picture the nefarious character flipping open his overcoat to reveal a row of “Rolex” watches available at bargain basement prices - in other words, counterfeit products of a lesser quality and illegally bearing a trademark name. But in the world of biological drugs, legitimate but costly copycat products offer physicians and patients other options for treatment. With appropriate payment policies, the United States biosimilar product marketplace can continue to grow resulting in cost savings and those additional treatment options. In the 2018 Medicare Physician Fee Schedule Final Rule (MPFS), CMS changed the payment policy for biosimilars to separately code and determine payment for each biological biosimilar product under Medicare Part B.
The original policy addressing biosimilars was from the 2016 MPFS rule. At that time CMS decided to base the payment amount for a biosimilar biological product on the average sales price (ASP) of all biosimilars for one reference product and to assign one payment code (HCPCS code) to all biosimilars for the same reference product. “In general, this means that products that rely on a common reference product’s biologics license application (that is, FDA’s previous finding of safety, purity, and potency for the common reference product) are grouped into the same payment calculation for determining a single ASP payment limit and that a single HCPCS code is used for such biosimilar products. The regulation went into effect on January 1, 2016.” Biosimilars sharing the same HCPCS code, but produced by different manufacturers, were distinguished by HCPCS modifiers.
There were varying opinions about Medicare’s payment policy for biosimilars from the beginning – some stakeholders supporting the use of one HCPCS code and others opposing it. In the 2018 MPFS FR, CMS notes, “The biosimilar product marketplace has continued to grow, and four biosimilar biological products that are paid under Part B have been licensed, including one product approved in 2017 that is sharing a HCPCS code with another previously licensed biosimilar biological product. Based on the number of biosimilar biological products that are reported to be nearing approval and the approvals made over the past 2 years, CMS anticipates that several more biosimilar biological products will be licensed for use in the United States during the next year and that during the following years, the marketplace will continue to grow steadily, provided that the approved products are marketed without delay. …CMS is aware of concerns that current Medicare policy may discourage development of new biosimilars and other innovation in this area potentially resulting in higher costs over time due to a lack of competition in the market place.”
As usual for CMS rules, the topic was discussed in great detail in the 2018 MPFS Final Rule (starting on page 53182). Some of the more interesting points of the discussion include,
Facts about Biosimilars:
- Biosimilars are similar, but not identical, to their reference products, and due to these subtle differences, they may have different therapeutic and adverse effects on patients, requiring clinical distinctions between the products.
- None of the currently available biosimilars are approved as interchangeable. The current biosimilar approval process does not compare biosimilar biological products to each other, rather, only similarity to a reference product is established and the licensing of a biological product under the biosimilar pathway does not mean that the products are interchangeable.
- Biosimilar biological products may be approved for fewer indications than the reference product and the approved indications within a group of biosimilar biological products with the same reference product may vary.
- These products are likely to be expensive and may have different acquisition costs. The development costs for these products and their manufacturing facilities are estimated to be in the hundreds of millions of dollars.
Stakeholders’ Comments
- Grouping (biosimilars) for payment could lead to prescribing choices based on cost rather than clinical considerations.
- The current policy may impair access to biosimilars, could potentially limit the introduction of biosimilars to the US market, and would fail to maximize competition and savings.
- Grouping products for payment that do not have all the same indications could cause clinicians and patients to think the products are interchangeable or could lead to off-label use.
- Blended payment could be a significant financial risk to the provider because the products that would be the best choice for a patient may not be paid above acquisition cost.
- ‘‘Race to the bottom’’ pricing competition would result from shared codes and lead to prices that could not sustain educational efforts and other activities associated with marketing new and complex biological products, ultimately resulting in manufacturers leaving the United States marketplace.
- Determining a payment for each biosimilar product by using individual HCPCS codes would drive and reward innovators, producing the potential cost savings of at least 10–15 percent compared to the reference biologic ASP necessary for biosimilar products to compete with the reference biological.
Because of the above facts and concerns, CMS has “become increasingly concerned about the relationship between cost, prices and competition; specifically, many commenters’ continued unease regarding the effects of our payment policy on patient and provider choices, as well as the biosimilar marketplace. We have also considered how the payment policy could affect market entry of new biosimilar manufacturers. If payment amounts limit manufacturers’ willingness to invest in the development of new biosimilars, it could in the long term, decrease the number of biosimilar biological products that are available to prescribe and thus impair price competition. Given that the United States’ biosimilar biological product marketplace is still relatively new, we believe that it is important to maintain a payment policy innovation as well as reasonable pricing for consumers. We agree that it is important to consider and effect policy changes early, as this portion of the drug marketplace develops, in order to support a robust marketplace that provides choices for providers and patients while maximizing savings.”
Effective January 1, 2018, newly approved biosimilar biological products with a common reference product will no longer be grouped into the same HCPCS code. Each biosimilar will be assigned a unique HCPCS code and payment will be based on the ASP for that individual biosimilar. Biosimilar HCPCS codes in use prior to January 1, 2018 are being changed and replaced to be in compliance with the new payment policy. This is described on the Medicare Biosimilar webpage and addressed in the April 2018 OPPS Update MLN Matters Article. Effective April 1, 2018, the descriptor for HCPCS code Q5101 (filgrastim biosimilar) is being changed to “Injection, zarxio.” HCPCS code Q5102 (infliximab biosimilar) is being replaced effective April 1, 2018 with HCPCS codes Q5103 (Injection, inflectra) and Q5104 (Injection, renflexis). The new biosimilar payment policy also makes the use of modifiers that describe the manufacturer of a biosimilar product unnecessary. Therefore, modifiers ZA, ZB, and ZC will be discontinued for dates of service on or after April 1, 2018. However, please note that HCPCS code Q5102 and the requirement to use applicable biosimilar modifiers remain in effect for dates of service prior to April 1, 2018.
Debbie Rubio
MEDICARE TRANSMITTALS
ICD-10 and Other Coding Revisions to National Coverage Determinations (NCDs) – (Revised 3/1/18)
A maintenance update of the ICD-10 conversions and other coding updates specific to National Coverage Determinations (NCDs).
Appropriate Use Criteria for Advanced Diagnostic Imaging – Voluntary Participation and Reporting Period - Claims Processing Requirements – HCPCS Modifier QQ
New HCPCS modifier (QQ) that may be reported with CPT code for an advanced diagnostic imaging service when the ordering physician consults appropriate use criteria.
April 2018 Integrated Outpatient Code Editor (I/OCE) Specifications Version 19.1
The modifications of the I/OCE for the April 2018 V19.1 update.
April 2018 Update of the Hospital Outpatient Prospective Payment System (OPPS)
Changes to the OPPS to be implemented in the April 2018 update.
Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - April 2018 Update
The HCPCS code set is updated on a quarterly basis. Change Request (CR) 10454 informs MACs of the April 2018 updates of specific biosimilar biological product HCPCS code, modifiers used with these biosimilar biologic products and an autologous cellular immunotherapy treatment.
Clarification of Instructions Regarding the Intensive Level of Rehabilitation Therapy Services Requirements
Instructions for conducting medical review of Inpatient Rehabilitation Facility (IRF) claims when reviewing the requirements for the intensive level of rehabilitation therapy services.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R771PI.pdf
Correction to Pub. 100-04, Chapter 5
Updates the list of Types of Bill subject to application of the therapy caps and related policies to Critical Access Hospital (CAH) claims in accordance with CR 8426.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R3995CP.pdf
Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment – (Revised 3/15/18)
Changes in the April 2018 quarterly update to the Clinical Laboratory Fee Schedule (CLFS).
Internet Only Manual Update to Pub 100-04, Chapter 16, Section 40.8 -Date of Service Policy
Manualizes the additional exception to the current laboratory DOS regulations from the CY 2018 OPPS/ASC final rule published December 14, 2017, so that the DOS for Advanced Diagnostic Laboratory Tests and molecular pathology tests excluded from OPPS packaging policy is the date the test was performed if certain conditions are met. This new exception to the laboratory DOS policy is effective beginning on January 1, 2018.
https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4000CP.pdf
MEDICARE SPECIAL EDITION ARTICLES
Billing Requirements for OPPS Providers with Multiple Service Locations
Enforcement editing requirements for hospitals operating off-campus, outpatient, provider-based departments of a hospital’s facilities (facility address and appropriate modifiers).
MEDICARE COVERAGE UPDATES
MEDICARE PRESS RELEASES
CMS finalizes coverage of Next Generation Sequencing tests, ensuring enhanced access for cancer patients
CMS finalized a National Coverage Determination that covers diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer (i.e., recurrent, metastatic, relapsed, refractory, or stages III or IV cancer).
Trump Administration Announces MyHealthEData Initiative to Put Patients at the Center of the US Healthcare System
The MyHealthEData initiative will work to make clear that patients deserve to not only electronically receive a copy of their entire health record, but also be able to share their data with whomever they want, making the patient the center of the healthcare system.
MEDICARE EDUCATIONAL RESOURCES
OTHER MEDICARE UPDATES
Enforcement Instruction on Supervision Requirements for Outpatient Therapeutic Services in Critical Access Hospitals and Small Rural Hospitals
February Patients Over Paperwork Newsletter
Update on CMS’s initiative to evaluate and streamline regulations with a goal to reduce unnecessary burden, to increase efficiencies, and to improve the beneficiary experience.
Website for Providers about New Medicare Cards
New Medicare cards start going out in April and providers must be able to accept them. This website has information and other resources on the new cards.
https://www.cms.gov/Medicare/New-Medicare-Card/Providers/Providers.html
January 1, 2020 – that is the date currently planned for full implementation of the required consultation of Appropriate Use Criteria (AUC) for ordering advanced diagnostic imaging services and the required claim reporting of such. Though that seems a long time away, Medicare is making first steps towards this implementation. And once here, the process will require coordination of several providers, so planning ahead is a good idea for all involved. 2020 will be here before you know it.
This new program was established by the Protecting Access to Medicare Act (PAMA) of 2014, to ensure advanced diagnostic imaging services are being ordered appropriately. The program will require ordering physicians/practitioners to consult appropriate use criteria (AUC) through a qualified electronic portal (known as a Clinical Decision Support Mechanism (CDSM)) prior to ordering advanced imaging services. The CDSM lets the ordering professional know whether the order adheres, or does not adhere, to AUC, or if there is no AUC applicable. The final part of the requirement is that the furnishing professional (e.g. the radiologist) and the performing facility must report consultation information on their respective claims. Per CMS, “Ultimately, this program will result in identified outlier ordering professionals being subject to prior authorization.”
The program applies to advanced imaging services –
- Specifically, computerized tomography (CT), positron emission tomography (PET), nuclear medicine (NM), and magnetic resonance imaging (MRI);
- Furnished in physician offices, hospital outpatient departments (including emergency departments), ambulatory surgical centers, and any other outpatient setting determined appropriate in the future; and
- Paid under the physician fee schedule (PFS), the hospital outpatient prospective payment system(OPPS), or the ambulatory surgical center payment system.
There are exceptions to the requirements for ordering professionals with significant hardships, patients with emergency medical conditions, and inpatients paid under Part A.
MLN Matters MM10481 announces a new modifier for voluntary reporting. “Effective July 1, 2018, HCPCS modifier QQ (Ordering Professional Consulted A Qualified Clinical Decision Support Mechanism For This Service And The Related Data Was Provided To The Furnishing Professional) is available for this reporting. The modifier may be:
- Used when the furnishing professional is aware of the result of the ordering professional’s consultation with a CDSM for that patient,
- Reported on the same claim line as the CPT code for an advanced diagnostic imaging service furnished in an applicable setting and paid for under an applicable payment system, and,
- Reported on both the facility and professional claim.”
CMS has not yet provided detailed claim-reporting instructions for the future beyond the voluntary reporting of the QQ modifier. CMS indicates the ordering practitioner’s National Provider Identifier (NPI) and the specific CDSM consulted will have to be reported once the program is fully implemented. CMS will publish claim instructions prior to any additional reporting requirements. The MLN article includes a list of applicable CPT codes, though for now the modifier may be used on codes outside the specified ranges. The new modifier is voluntary and Medicare will continue to pay for advanced imaging services with or without the modifier.
CMS has a website about the Appropriate Use Criteria program with more information. The website includes a definition of AUC as “criteria that are evidence-based (to the extent feasible) and assist professionals who order and furnish applicable imaging services to make the most appropriate treatment decisions for a specific clinical condition.” The website also includes a list of qualified CDSMs and priority clinical areas.
Appropriate consultation and claim reporting will require coordination between the ordering professional, the furnishing physician (radiologist) and the facility providing the service. For example, how will the ordering physician convey to the performing facility and furnishing physician that he/she has consulted a CDSM, which CDSM was consulted, and what the results were? How will the facility and furnishing physician get modifiers and other required information on the claim? A lot to consider and plan – 2020 will be here before you know it.
Debbie Rubio
MEDICARE TRANSMITTALS
Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - April 2018 Update
The April 2018 updates of specific biosimilar biological product HCPCS code, modifiers used with these biosimilar biologic products and an autologous cellular immunotherapy treatment.
E/M Service Documentation Provided By Students (Manual Update)
Allows the teaching physician to verify in the medical record any student documentation of components of E/M services, rather than re-documenting the work.
Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 24.1, Effective April 1, 2018
Medicare Fee-for-Service Recovery Audit Program Additional Documentation Limits for Medicare Institutional Providers (i.e. Facilities)
New ADR limits for the Recovery Audit Program.
Diagnosis Code Update for Add-on Payments for Blood Clotting Factor Administered to Hemophilia Inpatients
Updates to diagnosis codes required in order to allow add-on payments under the Inpatient Prospective Payment System (IPPS) for blood clotting factor administered to hemophilia inpatients.
Quarterly Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment
Changes in the April 2018 quarterly update to the Clinical Laboratory Fee Schedule (CLFS).
Replacement of Mammography HCPCS Codes, Waiver of Coinsurance and Deductible for Preventive and Other Services, and Addition of Anesthesia and Prolonged Preventive Services – REVISED
Healthcare Common Procedure Coding System (HCPCS) Codes Subject to and Excluded from Clinical Laboratory Improvement Amendments (CLIA) Edits – REVISED
Revised to add HCPCS code G0475 as a code that is subject to CLIA edits effective, April 13, 2015.
Modifications to the Implementation of the Paperwork (PWK) Segment of the Electronic Submission of Medical Documentation (esMD) System
Enables MACs to receive unsolicited documentation (also known as paperwork (PWK)) via the Electronic Submission of Medical Documentation (esMD) system.
Update to the Medicare Physician Fee Schedule Database (MPFSDB) - April 2018 Update
Remittance Advice Remark Code (RARC), Claims Adjustment Reason Code (CARC), Medicare Remit Easy Print (MREP) and PC Print Update
Updates the Remittance Advice Remark Codes (RARC) and Claims Adjustment Reason Code (CARC) lists and instructs Medicare Shared System Maintainers (SSMs) to update Medicare Remit Easy Print (MREP) and PC Print.
ICD-10 and Other Coding Revisions to National Coverage Determinations (NCDs)
A maintenance update of the International Classification of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.
MEDICARE COVERAGE UPDATES
Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery Disease (PAD)
Effective May 25, 2017, new NCD to cover Supervised Exercise Therapy (SET) for beneficiaries with Intermittent Claudication (IC) for the treatment of symptomatic Peripheral Artery Disease (PAD).
Decision Memo for Implantable Cardioverter Defibrillators (CAG-00157R4)
Changes to the ICD NCD from the 2005 reconsideration.
OTHER MEDICARE UPDATES
Medicare Fee-for-Service Recovery Audit Program Additional Documentation Limits for Medicare Institutional Providers (i.e. Facilities)
Correction: Hospital Outpatient Prospective Payment (OPPS) and Ambulatory Surgical Center (ASC) Payment Systems and Quality Reporting Programs
https://www.gpo.gov/fdsys/pkg/FR-2018-01-31/pdf/C1-2017-27949.pdf
Targeted Probe and Educate (TPE) Website Update
New resources available on the TPE website.
MEDICARE EDUCATIONAL RESOURCES
Transition to New Medicare Numbers and Cards FACTSHEET
It is that time of year when the winter season tries its best to hang on while spring makes faltering attempts to assert itself. The intermittent but increasing days of warmer weather are accompanied by spring rains, spring fever, spring breaks, and oh don’t forget taxes. If you have family or friends in the accounting business, you experience first hand that it is also the “busy season” for tax accountants. Income taxes are one of the prime examples of the government taking away. In the recent Bipartisan Budget Act (BBA) of 2018, an example of our government giving and taking relates to rehabilitative therapy services and the infamous therapy cap.
Since the Balanced Budget Act of 1997, there has been an annual limitation on the amount Medicare will pay for rehabilitative therapy services for a beneficiary. This is known as the therapy caps. There has been one therapy cap for outpatient occupational therapy (OT) services and another separate therapy cap for physical therapy (PT) and speech-language pathology (SLP) services combined. Finally, however, the therapy cap is gone. The BBA signed into law on February 9, 2018 repealed the therapy cap effective for claims on and after January 1, 2018.
There are a few catches to the repeal. Providers must continue to report the KX modifier for therapy services that exceed the dollar amount previously known as the therapy cap. That amount remains $2,010 for 2018 – one $2,010 limit for physical therapy and speech-language services combined and another $2,010 limit for occupational therapy. The KX modifier is attestation the services above this dollar amount are reasonable and necessary and that there is documentation of medical necessity for the services in the patient’s medical record. Since there is not technically a therapy cap, it is not yet known if therapy services exceeding the dollar amount reported without a KX modifier will be denied. Such details should be forthcoming from CMS in sub-regulatory guidance. All types of therapy providers, including those in a hospital outpatient setting, are affected by the new rules.
There will also continue to be targeted medical reviews of therapy services that exceed a threshold amount. The BBA lowered that threshold amount for 2018 through 2028 from $3,700 to $3,000 – again, one threshold for PT/Speech combined and a separate threshold for OT. Not all therapy services exceeding the new, lower threshold will be reviewed. Targeted reviews for therapy exceeding the threshold will be selected based on such factors as therapy providers with a high claims denial rate for therapy services or with aberrant billing practices compared to their peers. The Supplemental Medical Review Contractor (SMRC) currently performs these types of reviews for CMS.
The bad news (i.e. the taking away) for therapy providers from the Bipartisan Budget Act relates to payment rates for services provided by therapy assistants. The BBA mandates that for PT and OT services furnished on and after January 1, 2022, the payment rate will be 85% of the usual payment when the services are provided in whole or in part by a therapy assistant. A modifier will be created to be reported when therapy services are provided by a therapy assistant to trigger the reduced payment rate.
This requirement for reduced payment for therapy assistant services offsets the excitement of the therapy cap repeal. At least there are a few years prior to any reduction in payment for assistant services. A lot can happen between now and then – maybe even another incident of the “government giveth.” We can always hope.
Debbie Rubio
Yes! Help me improve my Medicare FFS business.
Please, no soliciting.
We are an environmentally conscious company, dedicated to living “green” both at work and as individuals.
