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It is no secret that physical activity and exercise are good for you. For most healthy adults, the Department of Health and Human Services recommends at least 150 minutes of moderate aerobic activity or 75 minutes of vigorous aerobic activity a week, or a combination of the two. Medicare patients with certain conditions can participate in structured exercise programs as a benefit through Medicare. For example, there are cardiac and pulmonary rehabilitation programs for patients who meet certain cardiac and obstructive pulmonary criteria and in 2017 Medicare approved supervised exercise therapy for patients with symptomatic peripheral artery disease.

On February 1, 2019, CMS issued a new transmittal that clarified the payment rules and expanded the list of covered diagnosis codes for supervised exercise therapy (SET). Here are some things providers need to know about SET:

• On May 25, 2017, CMS issued a National Coverage Determination (NCD) to cover SET for Medicare beneficiaries with Intermittent Claudication (IC) for the treatment of symptomatic peripheral artery disease (PAD).
• Claudication is pain in the thigh, calf, or buttocks that occurs when walking. Intermittent claudication (IC) is the most common symptom experienced by people with PAD.
• SET involves the use of intermittent walking exercise, which alternates periods of walking to moderate-to-maximum claudication, with rest. SET has been recommended as the initial treatment for patients suffering from IC.
• SET consist of sessions lasting 30-60 minutes comprising a therapeutic exercise-training program for PAD in patients with claudication.
• It must be performed in an outpatient hospital setting or a physician’ s office.
• It must be delivered by qualified auxiliary personnel trained in exercise therapy for PAD and under the supervision of a physician or non-physician practitioner (PA, NP, or CNS).
• Medicare covers up to 36 sessions over a 12-week period with the option, at the discretion of the Medicare Administrative Contractor (MAC), to cover an additional 36 sessions (up to 72 sessions) over an extended period of time. Providers should append the KX modifier to sessions beyond the initial 36 to attest documentation is on file verifying that further treatment is medically necessary and meets the policy requirements.
• Patients must have a face-to-face visit with the physician responsible for PAD treatment to obtain the referral for SET. At this visit, the patient must receive information regarding cardiovascular disease and PAD risk factor reduction, which could include education, counseling, behavioral interventions, and outcome assessments. Be sure there is documentation of this visit in your SET records to support coverage.
• SET is non-covered for beneficiaries with absolute contraindications to exercise as determined by their primary attending physician.
• SET is reported with CPT code 93668 and an appropriate diagnosis code is required for coverage. Please see the ICD-10 diagnosis code table in the transmittal for covered diagnoses.

People should start their own exercise regimen while they are healthy and before health conditions qualify them for one of Medicare’s exercise programs. An ounce of prevention is worth a pound of cure.

While a majority of the country is in the grips of below freezing weather, here in the South our promised snow did not happen and temperatures by the first of next week are forecast to be in the 70’s. Some flowers, such as jonquils, are beginning to bloom and whether from the changing weather patterns or from early bloomers, I have a sinus headache. This time next year, many hospital laboratories will be in the middle of another large headache – that of reporting private payor data for clinical diagnostic laboratory tests (CDLTs) to Medicare.

The Protecting Access to Medicare Act of 2014 (PAMA) made significant changes to the way in which Medicare payments for laboratory tests paid under the Clinical Laboratory Fee Schedule (CLFS) are determined. Under the CLFS final rule “Medicare Clinical Diagnostic Laboratory Tests Payment System Final Rule” (CMS-1621-F), which was published in June 2016 and implemented the PAMA requirements, private payor rates became the basis for the revised CLFS rates beginning January 1, 2018. Medicare obtains the data for the private payor rates from applicable laboratories that are required to report their private payor payments and volumes to CMS. When this rule first came out the definition of applicable reporting labs had to do with the percentage of Medicare services for a particular NPI that were paid under the CLFS or the physician fee schedule. Since hospital Medicare revenues are mainly from inpatient and outpatient prospective payment systems (IPPS and OPPS), most hospital labs did not qualify as an applicable reporting laboratory with the exception of hospital laboratories that had their own NPI number.

In the 2019 Medicare Physician Fee Schedule (MPFS) Final Rule, CMS changed the definition of an applicable reporting laboratory to use the Medicare revenue from a hospital 14x type of bill for the data collection period beginning January 1, 2019. The official definition for applicable reporting laboratories is:

“Laboratories, including physician offices laboratories and hospital outreach laboratories that bill using a 14X TOB are required to report laboratory test HCPCS codes, associated private payor rates, and volume data if they:

• Have more than $12,500 in Medicare revenues from laboratory services on the Clinical Laboratory Fee Schedule (CLFS), and
• Receive more than 50 percent of their Medicare revenues from CLFS and physician fee schedule services during a data collection period”

As explained in the January 22, 2019 ‘Clinical Diagnostic Laboratories to Collect and Report Private Payor Rates Call’, hospitals will divide the CLFS and PFS revenues attributed to 14x Type of Bill by their total 14x

revenues. Since 14x revenues are “non-patient” services, they consist exclusively (or mostly) of lab services, meaning the percentage will likely always exceed 50%. This means if your hospital outreach lab’s 14x revenues equal or exceed $12,500 in the 6-month reporting period, then you are required to report the lab private payor data to Medicare.

 

Using Medicare claims data from our sister company, RealTime Medicare Data (RTMD), I looked at the 14x revenue for a number of hospitals and I was surprised that most hospitals easily surpassed the $12,500 per 6-months threshold for reporting. The current data collection period began January 1, 2019 and goes through June 30, 2019. The reporting period for this collection period is January 1, 2020 through March 31, 2020. This gives hospitals time to evaluate their status and prepare for reporting.

I recommend hospitals first verify they are using the 14x type of bill correctly. The 14x type of bill is used to bill non-patient lab services, such as when a specimen is sent to the hospital lab for testing from a physician’s office. Patients that are referred to your laboratory for testing and actually physically come to the hospital lab for specimen collection are outpatients. Outpatient testing is billed to Medicare on a 13x type of bill. Although the data collection period has already begun, if you are not using the 14x bill type correctly, now is the time to correct it.

Hospitals then need to determine the amount of their 14x revenues for a six-month period. The current collection period of January-June 2019 will be the official period for determining 14x lab revenues for reporting purposes, but hospitals can estimate if they will meet the criteria based on prior data. If it appears your hospital laboratory will meet the definition of an applicable reporting lab, someone at your facility needs to learn the requirements for reporting so you are ready next year. Here are some resources to get you started with the process.

• Medicare's Laboratory PAMA webpage – a wealth of information and links to other resources on this page. If you are an applicable reporting lab, you will want to check out the CLFS Data Collection System User Guide.
• Medicare FAQs on the Final Rule (at the time this article was written, these FAQs were not yet updated with the new 2019 applicable lab definition)
• National Provider Call January 22 2019 – this website includes the presentation, audio recording, and transcript of this call. CMS will be having additional calls on this topic so be on the lookout for these.

The January 22, 2019 National Provider Call explained how to determine if you are a reporting laboratory under the new 14x definition. The CMS presenters were unsure exactly what data would be required to be reported to Medicare – was it only 14x data, or was the 14x data only for determining reporting status and all lab non-patient and outpatient data would have to be reported. They promised to clarify this in upcoming sub-regulatory guidance.

In general, reporting labs have to report the private payor rate for each test for which final payment has been made during the data collection period, the associated volume for each test, and the specific HCPCS code associated with the test. If an applicable laboratory has more than one payment rate for the same private payor for the same test, or more than one payment rate for different payors for the same test, the reporting entity will report each such payment rate and the volume for the test at each such rate.

There may be some insurances that pay a lump sum amount per claim, instead of individual line item payments, such as an insurance that pays under EAPGs for example. In this case, if the final private payor rate amount paid by HCPCS code and the associated volume paid at that final rate cannot be determined, the payment amount is not a private payor rate for purposes of applicable information and therefore is not reported to CMS.

Even from this cursory discussion of the required reporting for private payor lab rates, you can tell it will certainly be a huge headache. You cannot change that, but you can start now to know where you stand and what to expect as the reporting period approaches. 

Q:

The documentation in the record specified “intentional Wellbutrin overdose, but not done in a suicidal fashion”.  Should the intent be coded as “intentional self-harm?

A:

Assign the code for Poisoning, By Other Antidepressants, Accidental (Unintentional), Initial Encounter (T43.291A).  Per the guidelines specific for Chapter 19, when the intent of the overdose is not documented then we are to assign the code for accidental intent.  

References:

Coding Clinic, 2nd Quarter 2016, page 8

FY 2019 - ICD-10 Official Guidelines for Adverse Effects, Poisoning, Underdosing and Toxic Effects 

MEDICARE TRANSMITTALS – RECURRING UPDATES

 

January 2019 Update of the Hospital Outpatient Prospective Payment System (OPPS)

Describes changes to and billing instructions for various payment policies implemented in the January 2019 OPPS update.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11099.pdf

 

Clinical Laboratory Fee Schedule – Medicare Travel Allowance Fees for Collection of Specimens

Revises travel allowances payment amounts when billed on a per mileage basis using HCPCS code P9603 and when billed on a flat rate basis using HCPCS code P9604 for Calendar Year (CY) 2019.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11146.pdf

 

Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 25.1 Effective April 1, 2019

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11126.pdf

 

Calendar Year (CY) 2019 Annual Update for Clinical Laboratory Fee Schedule and Laboratory Services Subject to Reasonable Charge Payment

Provides instructions for the Calendar Year (CY) 2019 Clinical Laboratory Fee Schedule (CLFS), mapping for new codes for clinical laboratory tests, and updates for laboratory costs subject to the reasonable charge payment.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM11076.pdf

 

OTHER MEDICARE TRANSMITTALS

 

Medicare Claims Processing Manual Chapter 23 - Fee Schedule Administration and

Coding Requirements

Updates manual concerning National Correct Coding Initiative (NCCI) procedure-to-procedure (PTP) edits, medically unlikely edits (MUEs), and modifiers -59 and -91 usage.

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2018Downloads/R4188CP.pdf

 

Local Coverage Determinations (LCDs) – REVISED

Added language to show that MACs have the discretion to host multi-jurisdictional CACs.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10901.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/MM11080.pdf

 

Medicare Claims Processing Manual, Chapter 30 Revisions

Chapter revised to provide improved formatting and readability – current policy is not changing.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM10848.pdf

 

New Electronic System for Provider Reimbursement Review Board Appeals

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE19004.pdf

 

MEDICARE SPECIAL EDITION ARTICLES

 

Total Knee Arthroplasty (TKA) Removal from the Medicare Inpatient-Only (IPO) List and Application of the 2-Midnight Rule - Reissued

Addresses TKA procedures and application of the 2-Midnight Rule now that this procedure has been removed from Medicare’s inpatient-only (IPO) list.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/SE19002.pdf

 

MEDICARE EDUCATIONAL RESOURCES

 

Appropriate Use Criteria for Advanced Diagnostic Imaging MLN Fact Sheet

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/AUCDiagnosticImaging-909377.pdf

ICD-10-CM, ICD10-PCS, CPT, and HCPCS Code Sets MLN Fact Sheet

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ICD9-10CM-ICD10PCS-CPT-HCPCS-Code-Sets-Educational-Tool-ICN900943.pdf

Medicare Fast Facts

Medicare Fast Facts resources this month include:

• Proper Coding for Specimen Validity Testing Billed in Combination with Urine Drug Testing
• Proper Use of the KX Modifier for Part B Immunosuppressive Drug Claims

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Fast-Facts.html?DLSort=1&DLEntries=10&DLPage=1&DLSortDir=descending

 

OTHER MEDICARE UPDATES

 

Medicare Fee-for-Service Recovery Audit Program: Additional Documentation Limits for Medicare Institutional Providers (i.e. Facilities)

RAC ADR limits for facilities updated December 21, 2018

https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Recovery-Audit-Program/Downloads/ADR-Limits-Institutional-Provider-Facilities-May-2016-revised-12-21-18508ao.pdf

As you may be aware by now, on January 8, 2019 Medicare issued MLN Matters Article SE19002, “Total Knee Arthroplasty (TKA) Removal from the Medicare Inpatient-Only (IPO) List and Application of the 2-Midnight Rule,” and then after an instantaneous, critical response from the healthcare community immediately withdrew the article. On January 24, 2019, they reissued the article and again there was rapid negative critique of their scenarios. I, too, see the errors in some of their examples. In my opinion, they could write 100 examples and most would be subject to some criticism. I believe this is why they have been so hesitant to offer examples of the “case-by-case exception” for an inpatient admission when a greater-than-2-midnight stay is not expected. Hopefully CMS learns from this situation just how very hard it is to apply their rules. I maintain that even though their examples and wording are not perfect, there is something for hospitals to learn from this article.

Solid Documentation

The documentation in your medical records serves more than one function. Most importantly, medical documentation serves to communicate information about a patient’s condition and care between healthcare team members to ensure continuity of care, foster quality care, and improve efficiency of care. Medical documentation is also a legal document that serves as evidence of the care provided, especially in the case of a lawsuit. And it is the medical record that ultimately provides the justification and rationale to support payment for the medical items, tests, and services selected and provided to the patient.

Those of us that deal with Medicare are often reminded that documentation must support the medical necessity of services. It is not good when that reminder comes in the form of a claim denial following a complex medical review, such as reviews of the medical necessity of inpatient admissions. It is best to know what is expected up front so we can follow Medicare’s guidelines and make sure our documentation is thorough and solid enough to support Medicare’s requirements for payment.

Likewise, it is helpful when CMS shares the basis for their coverage and payment rationale, preferably in the form of guidance prior to an actual review. Hospitals have been waiting since the 2016 “case-by-case exception” for further guidance on what would justify the use of this exception. Also, hospitals have been confused by statements made in the final rule when total knee arthroplasty was removed from the inpatient-only list in 2018. TKAs are now paid by Medicare when performed as an outpatient or an inpatient, but when is inpatient admission for a TKA appropriate? Finally, CMS has issued a Special Edition MLN Matters Article SE19002 that addresses Total Knee Arthroplasty (TKA) Removal from the Medicare Inpatient-Only (IPO) List and Application of the 2-Midnight Rule. This article describes the circumstances when an inpatient admission for a TKA would be appropriate and even provides specific examples.

An inpatient admission for a TKA is appropriate when 1) there is an expectation of medically necessary hospital services spanning 2 midnights or longer or 2) there is not an expectation of a 2 midnight stay but the physician/practitioner determines other complex medical factors support an inpatient admission.

Providers should read the SE Article carefully as it provides a lengthy discussion on the topic. Here is a summary of some of that discussion. Inpatient admission for a TKA is appropriate when:

• The admitting physician/practitioner has a reasonable expectation that the patient will require medically necessary hospital services spanning 2 midnights or longer and admits the patient to the hospital based on that expectation.
• If the patient remains an inpatient receiving medically necessary hospital services for greater than 2 midnights and the patient’s medical record documents the medical necessity of a hospital level of care, this meets the 2-Midnight Presumption. Under the 2-Midnight Presumption, which helps guide contractor selection of claims for medical review, hospital claims with lengths of stay greater than 2 midnights are presumed to be reasonable and necessary for Medicare Part A payment.
• Even if the patient is discharged prior to a second midnight, as long as documentation supports that at the time the inpatient order was written, there was a reasonable expectation of medically appropriate hospital care spanning 2-Midnights, this supports the 2-Midnight Benchmark. Under the 2-Midnight Benchmark, hospital claims are generally payable when the admitting practitioner reasonably expected the beneficiary to require medically necessary hospital care spanning 2 or more midnights and this expectation is supported by the medical record documentation. The 2-Midnight Benchmark helps guide contractor reviews of short stay hospital claims for Part A payment.
• The admitting physician/practitioner does not expect the patient to need hospital care beyond a second midnight, but determines the patient requires hospital inpatient care based on complex medical factors supported in the medical record and including but not limited to:
• Patient’s history, co-morbidities, and current medical needs
• Severity of signs and/or symptoms, and
• Risk of Adverse Events

The article also emphasizes that TKAs do not always have to be performed as an outpatient and that CMS does not target TKA Short Stay inpatient claims for review.

It is also interesting to note that in the 2018 OPPS Final Rule, CMS made the following statements:

“However, we do not expect a significant volume of TKA cases currently being performed in the hospital inpatient setting to shift to the hospital outpatient setting as a result of removing this procedure from the IPO list. At this time, we expect that a significant number of Medicare beneficiaries will continue to receive treatment as an inpatient for TKA procedures.”

In a seemingly contradictory statement, SE19002 notes, “CMS has not made any pre-determinations on the number of patients receiving TKA procedures that should be treated as an inpatient or outpatient.”

Sometimes even CMS’s documentation is not solid enough to stand up to an audit.

The mission of the Office of the Inspector General (OIG) is “to protect the integrity of Department of Health & Human Services (HHS) programs as well as the health and welfare of program beneficiaries” with most of their resources focused on oversight of Medicare and Medicaid. I believe this is a noble mission as these programs provide benefits to our elderly and others in need of healthcare. On a personal note, I am getting closer to the day when I will be a Medicare beneficiary and I am even more thankful that agencies such as the OIG have worked hard over the years to protect the Medicare Trust Fund so benefits remain.

Hospitals often feel the sting of OIG investigations, especially when findings indicate a need to refund payments. The benefit of even these investigations, other than protecting the integrity of the programs, is that the reports provide guidance to all hospitals furnishing the same or similar services. The OIG also examines practices of the Medicare and Medicaid agencies themselves and the contractors who administer the programs. The OIG added several new issues to their Work Plan website in January 2019, some of which focus on outcomes from program changes, recommended actions from prior audit findings, and expansion of a prior review in a new direction.

Laboratory Tests Payment Rates

In 2018, CMS began paying for clinical laboratory services under a new system mandated by the Protecting Access to Medicare Act (PAMA) of 2014. Lab payment rates under the new system are set based on the current charges in the private health-care market (as reported to CMS by applicable reporting laboratories). PAMA also requires an annual publicly reported analysis of the top 25 laboratory tests by expenditures by the OIG. In 2019, the OIG will release an analysis of the first year of payments made under the new system for setting payment rates.

Post-Acute-Care Transfer Policy (PACT Policy)

Prior OIG audits identified issues where incorrect discharge dispositions reported on hospital inpatient claims resulted in Medicare overpayments. Under the PACT policy, select Medicare MS-DRG payments for hospital inpatient stays discharged to certain post-acute care settings are paid a prorated rate instead of the full MS-DRG payment amount that would be paid if the patient was discharged to home. Medicare has common working file (CWF) edits that should be able to identify when discharges to these post-acute care settings occur and are reported incorrectly. Then Medicare can notify the hospital to correct the discharge status on the claim so they will receive an accurate payment. The prior audits revealed that Medicare’s edits were not working properly. This follow-up audit will determine whether CMS corrected the CWF edits and ensured they are working properly.

It is important to note that it is not always a coding error that results in an incorrect discharge status code. Often the assigned discharge code matches the documentation in the medical record, but circumstances change at or shortly after discharge that result in the patient going somewhere other than home. This is why it is important to have processes in place to follow up on discharged Medicare patients. For more information on the PACT policy and suggestions on how best to handle this, please see this September 2018 Wednesday@One PACT Article.

Outlier Payments and Device Credit Policy

For years and throughout many different audits, the OIG has found problems with hospitals not reporting appropriately under the device credit policy. The device credit policy requires hospitals to report information on the claim notifying Medicare when they have received certain devices at no or significantly reduced cost. Medicare then reduces the outpatient or inpatient payment amount by the device credit amount reported. This newly announced Work Plan item is a twist on an old issue. For no-cost devices, Medicare instructs providers to report the device line item with a minimal charge (such as $0 or $1), but there is no guidance from Medicare on the charges reported for partial-credit devices. The new OIG audit will look for overstated Medicare charges on outpatient claims with a reported medical device credit that have an outlier payment. Specifically, they would look for elevated charge amounts, such as too large an amount on the partially credited device or device procedure that results in an inappropriate outlier payment. The OIG “will determine whether Medicare payments for replaced medical devices and their respective outlier payments were made in accordance with Medicare requirements.”

For this last issue on the device credit policy, hospitals may want to assess what charges they report for partially credited devices and make sure the charge amounts are appropriate and would not lead to inappropriate outlier payments. Also, this may be a good time to review your entire procedure for complying with the device credit policy, which is a difficult endeavor.  The other two new audit issues are more reviews of CMS actions than hospital actions, but again a good time to review your internal policies for determining and reporting discharge status.

There is nothing hospitals can do about the new laboratory prices. It is a good time to remind hospitals that for 2019, CMS changed the definition of an applicable reporting laboratory required to report lab private-payor data to Medicare. This was done to include more hospital laboratories in the reporting. Under the new definition, hospital outreach laboratories that have over $12,500 of Medicare lab revenues in a six-month period under the 14x type of bill (non-patients) are required to report. You can find more information about PAMA and applicable reporting labs at Medicare Lab PAMA webpage.

Medicare publishes updates to most of their payment systems on a quarterly basis. In this newsletter, we review the updates related to hospitals, such as the quarterly updates to the Outpatient Prospective Payment System (OPPS). The January OPPS Update always has a long and wordy transmittal since it is the update that incorporates the changes from the annual OPPS Final Rule and CPT/HCPCS coding changes for the calendar year. Many of the issues from the final rule have already been written about and discussed again, again, and again – the January update is just one more repetition of the changes. The good part of all these repeats is that it gives numerous opportunities for providers to see the news, and less chance that they would miss an important update.

So, here again is a summary of the high points of the January 2019 OPPS Update. Since there are so many code updates, please refer to this link to the January 2019 OPPS Update MLN Matters article to see the new and revised codes.

• CMS is establishing one new device pass-through category for January 2019 for Generator, neurostimulator (implantable), non-rechargeable, with transvenous sensing and stimulation leads (HCPCS code C1823). This device will be paid a pass-through payment based on cost-to-charge ratio. The applicable APC 5464 billed with CPT 0424T (Insertion or replacement of neurostimulator system for treatment of central sleep apnea; complete system (transvenous placement of right or left stimulation lead, sensing lead, implantable pulse generator) will have a device off-set amount applied to the payment rate.
• CMS changed the definition of device-intensive procedures this year, lowering the device offset percentage threshold from greater than 40 percent to greater than 30 percent and allowing procedures that involve single-use devices, regardless of whether or not they remain in the body after the conclusion of the procedure, to qualify as device-intensive procedures. See the prior Wednesday@One article for more information on this change.
• CMS created new HCPCS code C1890 for ASC use only, to report with device-intensive procedures when an implantable or inserted medical device is not used.
• There are three new comprehensive APCs (C-APCs) for 2019 - C-APC 5163 (Level 3 Ear, Nose, and Throat (ENT) Procedures), C-APC 5183 (Level 3 Vascular Procedures), and C-APC 5184 (Level 4 Vascular Procedures). C-APC claims are paid one comprehensive payment for the primary procedure with packaging of payment for adjunctive services into the primary procedure payment.
• CMS removed four procedures from the inpatient-only list for 2019 and added one procedure to it. Wednesday@One Article for 2019 IPO List discusses the changes in greater detail.
• New modifier “ER” is to be reported by hospitals (except CAHs) on all line items for services provided in a provider-based off-campus emergency department beginning January 1, 2018. See the MLN Matters article for the criteria for “dedicated emergency department.”
• CMS is reducing the payment rate for clinic visits (G0463) provided in excepted off-campus provider-based departments. Excepted off-campus PBDs are those PBDs that were furnishing and billing for services as of November 2, 2015, report services with a PO modifier, and are still paid OPPS payment rates. Under the new reduction, clinic visits in excepted off-campus PBDs will be paid 70% of the OPPS rate for 2019 and 40% for 2020 and beyond.
• There is a new Revenue-Code-to-Cost‑Center crosswalk for Partial Hospitalization Programs (PHPs) and several deleted and new PHP CPT codes.
• There are a lot of new and changed HCPCS codes for drugs, biologicals, and radiopharmaceuticals. See the MLN Matters article for tables of these codes. Notice particularly new codes that have a different dose description than the old code, such as Rituximab (old code J9310, 100 mg and new code J9312, 10 mg).
• Separately payable drugs will be paid at ASP+6%, except for drugs purchased through the 340B program, which are paid at ASP-22.5%. The reduced payment rate for drugs purchased through the 340B program now applies to such drugs billed by nonexcepted off-campus PBDs of a hospital paid under the PFS. This means nonexcepted off-campus PBDs must report the JG modifier on line items for separately payable (Status Indicator = K) drugs purchased through the 340B program.
• The payment for skin substitute products that do not qualify for pass-through status will continue to be packaged into the payment for the associated skin substitute application procedure. The procedure code is selected based on the designation of the skin substitute as high or low cost. The MLN Matters article includes a table with the 2018 and 2019 high/low skin substitute designations.

These are some of the highlights from the January 2019 OPPS updates. Please refer to MLN Matters Article MM11099 for all the updates and additional details.

Q:

Has CMS provided any updated information concerning the Discharge Planning Conditions of Participation proposed rule?

A:

The short answer is yes. But before discussing the updates I believe it’s important to provide the background.

Discharge Planning Conditions of Participation (CoP) Background

• The current hospital discharge planning requirements in the Code of Federal Regulations (CFR) §482.43, “Discharge planning,” were originally published on December 13, 1994 (59 FR 64141), and were last updated on August 11, 2004 (69 FR 49268). Under the current discharge planning requirements, hospitals must have in effect a discharge planning process that applies to all inpatients. The hospital must also have policies and procedures specified in writing.

• May 17, 2013: CMS released updates to Appendix A of the State Operations Manual providing revised interpretive guidelines for the Discharge Planning CoPs. Notably, this revision included “blue boxes” that CMS indicated displayed “successful practices currently found throughout the industry in the area of care transitions.”

• Post–Acute Care Transformations Act of 2014 (IMPACT Act): This Act required the standardization of Post-Acute Care (PAC) assessment data that can be evaluated and compared across PAC provider settings, and used by hospitals, CAHs, and PAC providers, to facilitate coordinated care and improved Medicare beneficiary outcomes.

• November 3, 2015: CMS published a Proposed Rule titled Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals, and Home Health Agencies. CMS noted the proposed rule would also implement discharge planning requirements in the IMPACT Act and they accepted comments through 5 p.m. on January 4, 2016.

Now, back to the original question, on November 2, 2018 CMS published an Extension of Timeline for Publication of Final Rule in the Federal Register. CMS cited “the complexity of the rule and scope of public comments” as warranting the extension.

CMS goes on to note that 299 public comments were submitted in response to the proposed rule. Based on comments CMS “determined that there are significant policy issues that need to be resolved in order to address all of the issues raised by public comments to the proposed rule and to ensure appropriate coordination with other government agencies.” 

CMS ended by indicating their commitment “to publishing a final rule that provides clear health and safety standards for hospitals, HHAs, and CAHs. At this time, we believe we can best achieve this balance by issuing this notification of continuation.”

The timeline has now been extended to November 3, 2019 for publication of a final rule.

In all the years I have been writing articles for this newsletter, I am sure that I have at least once referenced the saying, “the devil is in the details” because this saying so perfectly fits in the Medicare world. It is often all about the details. A perfect example of this is from the recent OIG report on payments for hyperbaric oxygen (HBO) therapy that did not comply with Medicare requirements. Specifically, the OIG looked at HBO therapy services paid by the Medicare Administrative Contractor (MAC), First Coast, during calendar years 2012 through 2015. The OIG selected First Coast, the MAC for Jurisdiction N, because it paid the second largest amount for HBO therapy in 2013 and 2014; the highest MAC payor, WPS, had already been audited by the OIG (OIG Review of WPS HBO Payments). The OIG found that First Coast made payments for HBO that did not comply with Medicare requirements for 110 of 115 claims – a denial rate of 92%. Based on these findings, the OIG estimates First Coast has “overpaid providers in Jurisdiction N $39.7 million during the audit period for HBO therapy that did not comply with Medicare requirements.”

The OIG Report of First Coast HBO Overpayments gives three examples of ways providers did not comply with Medicare requirements. These examples mirror issues I often see when reviewing HBO records. Also interesting is the fact that the errors are associated with the most common Medicare coverage conditions for HBO therapy. Medicare’s requirements for HBO therapy can be found in the National Coverage Determination (NCD) 20.29 for Hyperbaric Oxygen Therapy. Below is a summary of what the OIG found, along with additional information from other Medicare resources.

HBO Covered Condition – Chronic Refractory Osteomyelitis, unresponsive to conventional medical and surgical management:

The OIG example about osteomyelitis was for ‘Medicare Payment for HBO Therapy Without Failing Conventional Treatment,’ and it specifically noted “HBO therapy treatment began before the conventional

treatment had been completed.”

The First Coast HBO LCD (Local Coverage Determination) states concerning osteomyelitis, “(it) must be chronic and refractory to usual standard of care management (i.e., prolonged antibiotics therapy preferably directed by appropriate culture and sensitivity information, drainage of the abscesses, immobilization of the affected extremity, and surgical debridement with removal of infected bone). HBO for osteomyelitis that is not documented to be chronic and refractory to conventional treatment, and HBO not provided in an adjunctive fashion, is not covered.”

The medical record must also contain documentation that supports the diagnosis of chronic refractory osteomyelitis. For example, Palmetto GBA in findings and education from their reviews of HBO, requires the diagnosis be supported by imaging studies or bone description and positive cultures. When reviewing such records, I notice it is often difficult to determine how long the patient has had osteomyelitis, how the diagnosis of OM was confirmed, and exactly what treatments have been tried.

HBO Covered Condition – Preparation and preservation of compromised skin grafts (not for primary management of wounds):

In the OIG report, “there was no evidence that the beneficiary ever received a flap procedure. She had surgery that resulted in a wound that became infected and did not heal, but there was no evidence that she ever received a flap.” The OIG listed this as ‘HBO therapy That Was Not Medically Necessary.’

Additional guidance concerning HBO for skin grafts/flaps can again be found in the First Coast LCD and from Palmetto GBA education. From the FC LCD, “Preparation and preservation of compromised skin grafts utilizes HBO therapy for graft salvage in cases where hypoxia or decreased perfusion has compromised viability.” The LCD reiterates that per the NCD, coverage under this indication is “not for primary management of wounds.” The LCD also points out HBO for this indication requires the presence of a compromised skin graft, and does not include HBO treatment that is empiric treatment or prophylactic maintenance of grafts or solely for preparation of a wound bed for receiving a graft.

In a Palmetto Ask the Contractor teleconference from May 2018, Dr. Leland Garrett, Medical Director, responded to questions concerning HBO coverage and documentation requirements. Per Dr. Garrett, for Medicare coverage, skin grafts and flaps treated with HBO should not be a chronic wound that had a flap performed several months ago and has reopened as a new (non) healing wound. It is for more acute situations where the flap or graft area has dehisced or is lost partially or fully. Preservation would be to use HBO to prevent (or repair) the dehisced side, and preparation would be the use of HBO to a site where the previous graft or flap was completely lost and is being oxygenated with HBO as an attempt to promote granulation tissue for the site for a new graft or flap …”.  The physician’s documentation should include information about the original graft or flap procedure including the date of the procedure, or preferably, a copy of the operative note. The documentation should also describe what has happened to the graft/flap site since the procedure that would cause the patient to need HBO.

HBO Covered Condition – Diabetic Wounds of the Lower Extremities in patients who meet the following three criteria:

1. “Patient has type I or type II diabetes and has a lower extremity wound that is due to diabetes;
2. Patient has a wound classified as Wagner grade III or higher; and
3. Patient has failed an adequate course of standard wound therapy.

The use of HBO therapy is covered as adjunctive therapy only after there are no measurable signs of healing for at least 30 –days of treatment with standard wound therapy and must be used in addition to standard wound care. Standard wound care in patients with diabetic wounds includes: assessment of a patient’s vascular status and correction of any vascular problems in the affected limb if possible, optimization of nutritional status, optimization of glucose control, debridement by any means to remove devitalized tissue, maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings, appropriate off-loading, and necessary treatment to resolve any infection that might be present. Failure to respond to standard wound care occurs when there are no measurable signs of healing for at least 30 consecutive days. Wounds must be evaluated at least every 30 days during administration of HBO therapy. Continued treatment with HBO therapy is not covered if measurable signs of healing have not been demonstrated within any 30-day period of treatment.” (NCD 20.29)

These plentiful NCD requirements seem to be a challenge to providers. The OIG’s 3rd and final example is ‘HBO Therapy With Insufficient Documentation.’ In this case, the medical records did not contain sufficient documentation to support that there were at least 30 days of standard wound care therapy provided prior to HBO therapy. Since the NCD provides so many details for diabetic wounds, there is not a lot to add from the First Coast LCD or Palmetto findings. I recommend making a check list for diabetic wounds from the NCD requirements looking at each requirement from two perspectives – 1) does the patient meet the criterium and 2) is there documentation to support it. For example, your checklist would be:

• Is the patient diabetic? Is there documentation of such in the medical record?
• Does the patient have a lower extremity wound due to diabetes? Is the record clear that the wound is a diabetic wound?
• Is the wound a Wagner Grade III or higher and is that clearly documented in the record? Check for consistency in the documentation of the Wagner grade in physician’s progress notes and nursing assessments.
• Has the patient been receiving conservative wound care for treatment of the wound for at least 30 days? Does the medical record describe the different types of assessments and interventions that have been done to promote wound healing?
• Has there been no measurable signs of healing for at least 30 consecutive days? For example, the wound may fail to decrease in size as one indication of lack of healing, or there may be other wound characteristics signifying lack of healing. The First Coast LCD contains this statement – “Documentation of all aspects of optimization defined by the NCD (clarified by this LCD) and the absence of improvement in the wound characteristics constitutes stalled wound healing and suggests that it may benefit from adjunctive HBOT.”

The conditions addressed above are frequent reasons for a need for HBO therapy and providers need to ensure the coverage criteria and documentation requirements are met to receive appropriate reimbursement. Also remember to include other required elements in your HBO therapy – make sure you have:

• A physician’s (or practitioner’s) order for the HBO therapy,
• The physician/NPP’s explanation of the reason for HBO therapy (diagnosis or condition warranting the HBO treatment),
• The expected benefits of HBO treatment – these are the HBO treatment goals, and
• An evaluation of the patient’s progress from HBO therapy at least every 30 days.

This sounds like a lot of documentation but it is really just the basics of what is wrong with the patient, what is being done to help the patient, what is the expected outcome, and what is the actual outcome. The difficulty is, the devil is in the details.

Q:

What is the latest on the laboratory date of service policy?

A:

The latest news concerning the laboratory date of service policy is another extension from CMS of the enforcement discretion of the laboratory date of service exception policy until July 1, 2019. To understand this better, let’s briefly examine the lab date of service policy.

The laboratory date of service policy affects who bills Medicare directly for hospital laboratory testing – the hospital laboratory or the testing (performing) laboratory. Hospitals are required to bill Medicare directly for laboratory tests performed by an outside testing lab under arrangements on hospital inpatients and outpatients based on the following date of service rules. When the hospital bills Medicare directly, the hospital must pay the testing laboratory for performing the test(s).

1. Generally, the date of service (DOS) for clinical diagnostic laboratory tests is the date of specimen collection.
2. When a physician orders a laboratory test at least 14 days following the patient’s discharge from the hospital, the lab DOS “14-day rule” applies. This means the DOS is the date the test is performed, instead of the date of specimen collection. 
3. The lab DOS exception policy referenced above was published in the 2018 OPPS Final Rule with an effective date of January 1, 2018. The new lab DOS policy established another exception for Advanced Diagnostic Laboratory Tests (ADLTs) and molecular pathology tests excluded from OPPS packaging policy so that the DOS is the date the test was performed, if the following conditions are met.

1. The test is performed following a hospital outpatient’s discharge from the hospital outpatient department; 
2. The specimen was collected from a hospital outpatient during an encounter; 
3. It was medically appropriate to have collected the sample from the hospital outpatient during the hospital outpatient encounter; 
4. The results of the test do not guide treatment provided during the hospital outpatient encounter; and
5. The test was reasonable and medically necessary for the treatment of an illness.

If all of the requirements are met, the DOS of the test must be the date the test was performed, which effectively separates the laboratory test from the hospital outpatient encounter. As a result, the laboratory performing the test must bill Medicare directly for the test, instead of seeking payment from the hospital outpatient department. The hospital laboratory must not bill Medicare directly for the test unless they actually perform the test.

 

Since this is a major change for hospital laboratories in how they handle billing of certain lab tests, CMS has twice delayed the enforcement of this policy to allow hospitals time to change their processes to comply with the new policy. As stated above, the latest extension of enforcement discretion was published on December 26, 2018 and announces another 6-month extension to July 1, 2019.

Hospital laboratories that are able to comply with the new laboratory DOS exception policy should do so now, and all hospital labs should comply as soon as possible. A hospital laboratory that is not able to comply with the exception policy at this time may continue to bill Medicare for the applicable tests during the extension of the enforcement discretion period. In this case, the testing laboratory would seek payment for the test from the hospital.

You can find more information about the Laboratory Date of Service Policy on CMS’s Laboratory Date of Service Policy webpage. This webpage includes the enforcement discretion announcement and associated Q&As in the Enforcement Discretion documents in the Download section at the bottom of the page.