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The holiday season is upon us and I hope that everyone had a Happy Thanksgiving. It is the time of year when certain things expand. If you believe the hype from Hallmark Christmas movies, our hearts expand with more kindness and joy at this time of year; our waistlines usually expand from all the holiday meals and sweet treats; and our Christmas list and associated budget seem to expand as it gets closer to Christmas (which reversely causes our wallets to shrink). Evidently, CMS thought it was a good time to expand on the requirements associated with hospital price transparency.  They also gave an early Christmas present however by delaying the new requirements until January 1, 2021. This means for now and until January 2021, hospitals are to continue to comply with the existing guidance which requires hospitals to make public their chargemaster charges (gross charges) online in a machine-readable format.

As a reminder, this requirement comes from the Health Care and Education Reconciliation Act of 2010 that “requires each hospital operating in the United States for each year to establish (and update) and make public a list of the hospital’s standard charges for items and services provided by the hospital, including for diagnosis related groups (DRGs)…”  The 2019 Outpatient Prospective Payment System (OPPS) proposed and final rules updated guidelines to require hospitals to make available a list of their current standard charges via the Internet in machine-readable format and to update this information at least annually, or more often as appropriate. CMS further clarified in these rules that this requirement applies to all hospitals operating within the United States and to all items and services provided by the hospital. CMS’s reasoning for the requirements is that they believe there is a direct connection between hospital charge transparency and more affordable, lower cost healthcare.

The expansion of the requirements was originally discussed in the 2020 OPPS Proposed Rule and made final in a separate Final Rule for Price Transparency Requirements for Hospitals to Make Standard Charges Public. The new requirements are based on feedback from the 2019 revised guidelines and from an Executive Order on “Improving Price and Quality Transparency in American Healthcare to Put Patients First” (June 24, 2019). I refer readers to the actual rule for all the reasons CMS believes these new requirements are necessary. Below is a summary of what the new requirements are, including many new definitions for clarification. At the same time as the release of this final rule, CMS also released a proposed rule entitled Transparency in Coverage that would place complementary transparency requirements on most individual and group market health insurance issuers and group health plans.

 

“Hospital” Definition

The requirements apply to hospitals which are defined in the new Final Rule (FR) as all institutions recognized, licensed and/or approved as a hospital by State or applicable local laws. This includes:

• All Medicare-enrolled hospitals plus hospitals that do not participate in Medicare,
• Hospitals in all States, the District of Columbia, and US territories as listed in the FR (Puerto Rico, Virgin Islands, Guam, etc.),
• Critical access hospitals (CAHs), inpatient psychiatric facilities (IPFs), sole community hospitals (SCHs), and inpatient rehabilitation facilities (IRFs),
• Each hospital location operating under a single license or approval that has a different set of standard charges, such as a hospital outpatient department located at an off-campus location.

It does not include entities such as ambulatory surgical centers (ASCs) or other non-hospital sites-of-care from which consumers may seek healthcare items or services, although CMS encourages such entities to make public their standard charges. It also does not apply to federally-owned or operated hospitals, such as Indian Health Service (IHS) facilities, Veterans (VA), and Department of Defense (DOD) hospitals because these hospitals generally do not provide services to the general public and their payment rates are not subject to negotiation.

 

“Items and Services” Definition

“Items and services” provided by the hospital are “all items and services, including individual items and services and service packages, that could be provided by a hospital to a patient in connection with an inpatient admission or an outpatient department visit for which the hospital has established a standard charge.” This includes:

• Supplies, procedures, room and board, facility use, and facility fees;
• Service packages which mean an aggregation of individual items and services into a single service with a single charge (such as DRG or APC charges);
• Services of employed physicians and non-physician practitioners; and
• Any other items or services for which a hospital has established a charge.

Disclaimer – Please do not shoot the messenger if some of the new requirements do not seem to make sense. CMS is convinced that hospitals routinely contract payer-specific rates for service packages. They also clarify that the word “charges” is equivalent to “payment rates” whether for an individual item/service or a service package.

 

“Standard Charges” Definition

This is the big definition that is significantly expanded from the current requirements. Under the new requirements the following are considered standard charges and must be included in both the Internet-posted machine-readable format and shoppable services postings (discussed in more detail below) when the new requirements become effective in 2021.

• Gross charges – charges as recorded in the chargemaster, absent any discounts.
• Payer-specific negotiated charges – charges the hospital has negotiated with a third party payer for an item or service.
• “Third party payer” is “an entity that, by statute, contract, or agreement, is legally responsible for payment of a claim for a healthcare item or service.”
• Hospitals should display all negotiated charges, including, for example, charges negotiated with Medicare Advantage plans, Medicaid MCOs, and other Medicaid managed care plans.
• Payer-specific negotiated charges would not include non-negotiated payment rates (such as those payment rates for FFS Medicare or Medicaid).
• CMS states that hospital payer-specific negotiated charges or rates can be found within the in-network contracts that hospitals have signed with third party payers. Per CMS, such contracts often include rates sheets that contain a list of hospital items and services (including service packages) and the corresponding negotiated rates. CMS recommends hospitals request an electronic copy of their contract and corresponding rate sheet from the third party payer if it is not already available in that format.
• Discounted Cash Price – the price the hospital would charge individuals who pay cash (or cash equivalent) for an individual item or service or service package.
• Groups that would benefit from knowing the discount cash price would be the uninsured and those who may have some healthcare coverage but who still bear the full cost of at least certain healthcare services.
• The “discounted cash price” would reflect the discounted rate published by the hospital, unrelated to any charity care or bill forgiveness that a hospital may choose or be required to apply to a particular individual’s bill.
• The discounted cash price may be generally analogous to the “walk-in” rate but would apply to all self-pay individuals, regardless of insurance status.
• For hospitals that have not determined a discounted cash price for self-pay consumers the hospital’s discounted cash price would simply be its gross charges as reflected in the chargemaster.
• De-identified Minimum Negotiated Charge – the lowest charge that a hospital has negotiated with all third party payers for an item or service.
• To determine the de-identified negotiated charges, hospitals consider the distribution of all negotiated charges across all third party payer plans and products for each hospital item or service and then selects the lowest and highest rates.
• The distribution would not include non-negotiated charges with third party payers
• The third party payer with which these rates are negotiated is not identified.
• De-identified Maximum Negotiated Charge - the highest charge that a hospital has negotiated with all third party payers for an item or service.
• Bullets for de-identified minimum negotiated charge listed above also apply to the de-identified maximum negotiated charge.

 

HOSPITALS MUST MAKE PUBLIC THEIR STANDARD CHARGES IN TWO WAYS:

• a comprehensive machine-readable file that makes public all standard charge information for all hospital items and services, and
• a consumer-friendly display of common “shoppable” services derived from the machine-readable file.

 

Comprehensive Machine-Readable File

• The machine-readable list of hospital items and services is required to include the following charges, as applicable, for each item and service: – the gross charge, the payer-specific negotiated charges, the discounted cash price, de-identified minimum negotiated charge, and de-identified maximum negotiated charge
• In addition to the above charges, the listing must include:
• A description of each item or service (including both individual items and services and service packages).
• Any code used by the hospital for purposes of accounting or billing for the item or service, including, but not limited to, the CPT code, HCPCS code, DRG, NDC, or other common payer identifier.
• Hospitals must post their standard charge information in a single digital file in a machine-readable format.
• A machine-readable format is a digital representation of data or information in a file that can be imported or read into a computer system for further processing.
• Examples of machine-readable formats include, but are not limited to, .XML, .JSON and .CSV formats.
• A PDF would not meet this definition because the data contained within the PDF file cannot be easily extracted without further processing or formatting.
• CMS requires that hospitals use a CMS-specified naming convention for the file (§ 180.50(d)(5)).
• The naming convention for the file must be:
  <ein>_<hospital-name>_standardcharges.[json|xml|csv]
• Hospitals have discretion to choose the Internet location they use to post their files as long as
• They are displayed on a publicly-available website,
• Are displayed prominently and
• Clearly identify the hospital location with which the standard charges information is associated
• The data must be easily accessible and without barriers, which means the data can be accessed free of charge, without having to establish a user account or password, and without having to submit personal identifiable information (PII)
• The data must be able to be digitally searched
• Files must be updated annually
• This means such updates must occur at least once in a 12-month period.
• Hospitals must clearly indicate the date of the last update to the standard charge data either within the file or otherwise clearly associated with the file.
• These requirements apply to each hospital location so that each location with separate charges makes a list public

 

Shoppable Services

A “shoppable service” is a service package that can be scheduled by a healthcare consumer in advance. Shoppable services are typically provided in non-urgent situations, which allows patients to price shop and schedule a service at a time that is convenient for them.

• Hospitals must make public the following prescribed standard charges for at least 300 shoppable services in a consumer-friendly manner.
• This includes 70 shoppable services specified by CMS that are provided by the hospital, plus as many additional shoppable services as would be necessary to reach a total of at least 300 shoppable services
• If a hospital does not provide some of the 70 CMS-specified services, then the hospital would identify enough shoppable services so that the total number of shoppable services is at least 300.
• Hospitals should select services based on the utilization or billing rate of the services in the past year. In other words, the shoppable services selected for display by the hospital should be commonly provided to the hospital’s patient population.
• If a hospital does not provide 300 shoppable services, the hospital must list as many shoppable services as they provide.
• The 70 CMS-specified shoppable services are found in Table 3of the FR and are divided into four broad categories: E&M Services, Laboratory and Pathology Services, Radiology Services, Medicine and Surgery Services.
• The hospital must display the following types of standard charges described above that apply to each shoppable service (and corresponding ancillary services, as applicable)– the payer-specific negotiated charges, the discounted cash price, de-identified minimum negotiated charge, and de-identified maximum negotiated charge.
• The shoppable services list must also include:
• A plain-language description of each shoppable service.
• An indicator when one or more of the CMS-specified shoppable services are not offered by the hospital.
• The location at which the shoppable service is provided, including whether the charges at that location apply to the inpatient setting, the outpatient department setting, or both.
• Any primary code used by the hospital for purposes of accounting or billing for the shoppable service, including, as applicable, the CPT code, the HCPCS code, the DRG, or other common service billing code.
• Hospitals may use, as applicable, an appropriate payer-specific billing code (for example, an APR-DRG code) in place of the MS-DRG code indicated for the five procedures in the list of 70 CMS-specified shoppable services that are identified by MS-DRG codes 216, 460, 470, 473, and 743.
• When the shoppable service is customarily accompanied by the provision of ancillary services, the hospital must present the shoppable service as a grouping of related services, meaning that the charge for the primary shoppable service (whether an individual item or service or service package) is displayed along with charges for ancillary services.
• An “ancillary service” is an item or service a hospital customarily provides as part of or in conjunction with a shoppable primary service.
• Ancillary items and services may include laboratory, radiology, drugs, delivery room (including maternity labor room), operating room (including post-anesthesia and postoperative recovery rooms), therapy services (physical, speech, occupational), hospital fees, room and board charges, and charges for employed professional services.
• They may also include additional services that are provided by the hospital, for example, local and/or global anesthesia, services of employed professionals, supplies, facility and/or ancillary facility fees, imaging services, lab services, and pre- and post-op follow up.
• A hospital must select an appropriate publicly available Internet location for purposes of making public the standard charge information for shoppable services in a consumer-friendly format.
• The information must be displayed in a prominent manner that identifies the hospital location with which the standard charge information is associated.
• The shoppable services information must be easily accessible, without barriers, including, but not limited to, ensuring the information is: (i) free of charge; (ii) accessible without having to register or establish a user account or password; (iii) accessible without having to submit PII; (iv) searchable by service description, billing code, and payer.
• Standard charge information must be updated at least once annually and the date must be indicated with the information.
• CMS did not finalize the requirement to provide a paper copy of information on consumer-friendly shoppable services.

 

Price Transparency Tool

CMS encourages, but does not require, that hospitals develop a price comparison tool to make standard charges available in a machine-readable format to third-party tool developers as well as the general public. They also determined that having a price transparency tool might meet the price transparency requirements for shoppable services.

“A hospital that maintains an Internet-based price estimator that meets certain criteria is deemed to have met our requirements at 45 CFR 180.60. The price estimator tool must:

• Allow healthcare consumers to, at the time they use the tool, obtain an estimate of the amount they will be obligated to pay the hospital for the shoppable service.
• Provide estimates for as many of the 70 CMS-specified shoppable services that are provided by the hospital, and as many additional hospital-selected shoppable services as is necessary for a combined total of at least 300 shoppable services.
• Is prominently displayed on the hospital’s website and be accessible without charge and without having to register or establish a user account or password.”

Like our hearts, waistlines, and these price transparency requirements, the length of my article has expanded beyond what I originally planned. I think that is enough information for this week’s article. Next week, I will address CMS’s plans for monitoring, penalties, and appeals.

This week I have started seeing Christmas decorations pop up in yards on my daily commute to work. While I am a firm believer in celebrating Thanksgiving before putting up Christmas decorations, I have been known to watch a Christmas movie before Black Friday. Ranked high among my favorite Christmas movies is A Christmas Carol, whether it is George C. Scott as Ebenezer Scrooge or the more modern take on the tale where Bill Murray stars in Scrooged.

Palmetto GBA recently posted information on the final resolution to Medicare Plan Overpayments on their website. The plan for resolving payments includes three letters. The first letter can be likened to the Ghost of Christmas past. The second letter serves as the Ghost of Christmas present as hospitals find out which Medicare Advantage (MA) plans have agreed to waive its claims filing deadline. Last but not least is the third letter or the Ghost of Christmas Future as it is set to be issued next year in early January and it will be up to each provider to decide their future road to a final resolution.

Background: Potential Overpayments

By the end of February 2018 the Jurisdiction J (JJ) Medicare Administrative Contractor (MAC) contract had transitioned from Cahaba GBA to Palmetto GBA. In May of 2018, Palmetto GBA identified potential overpayments related to Part A claims for Medicare Fee-for-Service (FFS) claims paid for beneficiaries covered under a Medicare Advantage (MA) plan on the date of service.

The potential overpayments had been under Cahaba GBA’s watch and occurred due to the fact that Cahaba did not have the required edits in place to reject claims if a beneficiary was identified as being enrolled in an MA plan at the time of service rather than Medicare FFS.  

Affected hospitals were sent a letter in June 2018 providing them a claims listing of potential overpayments. At that time Palmetto noted “if overpayments exist and result in financial hardship,” several options for returning overpayments including an extended repayment plan would be provided to hospitals.

November 2019: Final Plan for Resolving Erroneous Payments

Last week Palmetto GBA posted information on their website letting providers know that in late November they will begin sending out the first of three letters. The first letter will be purely informational. If a hospital receives the second and or third letter provider follow-up will be required.

• First Letter, Late November: When CMS made companies that sponsor MA plans aware of the overpayments “several dozen MAOs, which collectively sponsor 195 MA plans, on a purely voluntary basis agreed to make repayments to the Medicare FFS program.” Voluntary repayments totaled $26 million, resolved 133,000 erroneous claims, and benefited nearly 2,000 providers. This letter is “purely informational…and providers will not have to take any follow-up actions on the claims referenced in the first letter.”

• Second Letter, Early December: In this phase, CMS will require repayment of about $2.7 million in FFS payments. The letters will identify MA plans that have agreed to waive their claim filing deadlines and give consideration to claims involving these enrollees. This means hospitals have to repay the “overpayments” to Medicare FFS, but they can also submit new claims to these MA plans for the services erroneously billed to Medicare FFS.

• Third Letter: Settlement Offers to be issued early January 2020: CMS will make offers to resolve any remaining overpayments. “Settlement offers will identify the total potential MA overpayment, and will provide for 40 percent of the total to be repaid to Medicare and 60 percent of the total to be retained by providers.” This offer must be accepted within 60 days, otherwise a demand letter will be sent for the total potential MA overpayment amount.

Next Steps

Palmetto has advised reading the following three documents posted on their website and sharing this information with your staff:

• Medicare Advantage (MA) Plan Overpayments - Frequently Asked Questions (FAQ) 
• Medicare Advantage (MA) Plan Overpayments - Update 
• Medicare Advantage (MA) Plan Overpayments: Update 

In addition to reading these documents, Palmetto GBA has included the following sentence in all caps and bolded in third documented listed above:

PALMETTO GBA ADVISES ALL PROVIDERS TO LOOK FOR ENVELOPES FROM MEDICARE WITH “ATTN: CHIEF EXECUTIVE OFFICER” STAMPED IN RED UNDERNEATH THE PROVIDER’S BUSINESS ADDRESS.”

Q:

I have noticed that the Medicare (CMS) Detailed Notice of Discharge (DND) form we are using at our hospital has an expiration date of 10/31/19. Is it still ok to be using this form?

A:

For now, yes. As a reminder, the DND is used when a Medicare patient requests expedited review by the Quality Improvement Organization (QIO) of a discharge decision. The form provides the specific reasons the hospital, Medicare (or Medicare Advantage plan), and the patient’s doctor think the patient is ready for discharge. The form allows a review of the case by the QIO.

According to an update on Medicare’s Beneficiary Notices Initiative (BNI) website concerning the DND form with an expiration date of 10/31/19 – “This notice is now going through the Paperwork Reduction Act clearance process. The currently available hospital notice is covered under an extension and hospitals should continue using the current notice until CMS publishes the updated notice. Hospitals following this direction are fully compliant with our requirements.”

Over the past few weeks, articles in our Wednesday@One newsletter have addressed some of the new and revised policies from the 2020 Medicare Outpatient Prospective Payment System (OPPS) Final Rule. One such article last week discussed the continuation of two policies that the courts have already found to be outside of CMS’s authority – 1) the second year and further decrease in payment rates for outpatient clinic visits in excepted off-campus provider-based departments to the same rate (40% of OPPS rates) as paid for services in nonexcepted off-campus PBDs and 2) payment of separately payable drugs purchased through the 340B program at average sales price (ASP) minus 22.5%. This article will examine the changes in the level of supervision required for hospital outpatient therapeutic services and the new requirement for prior authorization for select cosmetic procedures. The change in supervision requirements is a relief for hospitals, especially critical access and small rural hospitals. Unfortunately, the prior authorizations are an added burden on hospitals, regardless of how CMS tries to couch it.

Level of Supervision of Outpatient Therapeutic Services in Hospitals and Critical Access Hospitals (CAHs)

Around 2010 and in subsequent years, CMS “clarified” in the OPPS final rules, that they expected direct supervision of therapeutic services in a hospital outpatient setting.  Direct supervision in a hospital was defined to mean that a physician was immediately available to direct or take over performance of the procedure. Due to the difficulties in meeting this requirement, CMS or Congress have continually had a nonenforcement rule for CAHs and small rural hospitals for this policy, the latest of which is expiring December 31, 2019. You can read more about the direct supervision requirements and where we currently stand in a prior Wednesday@One article.

In the 2020 OPPS Final Rule, CMS finalized their proposed policy to change the “generally applicable minimum required level of supervision for hospital outpatient therapeutic services from direct supervision to general supervision for services furnished by all hospitals and CAHs.” General supervision means that the procedure is furnished under the physician’s overall direction and control, but that the physician’s presence is not required during the performance of the procedure. CMS took this action to reduce the burden for outpatient hospital providers, to allow more flexibility to provide medical care, and to eliminate what has in effect been a two-tiered system of supervision levels between CAHs/small rural hospitals and all other hospitals. CMS feels comfortable changing the required level of supervision for hospital outpatient therapeutic services because:

• CMS is not aware of any supervision-related complaints from patients or of any data or information from providers indicating the quality of care for services furnished under general supervision was affected,
• There are Medicare Conditions of Participation (CoPs) and State and federal laws that require physician direction and supervision of hospital services to ensure the safety, health, and quality standards of outpatient therapeutic services,
• Hospitals and physicians can decide to furnish direct supervision for services when they believe a higher level of supervision is necessary to ensure the quality and safety of the procedure and to protect the patient from complications that might occur,
• CMS retains the ability to change the supervision level of an individual hospital outpatient therapeutic service or the default minimum level to a more intensive level of supervision, and
• CMS plans to monitor care furnished to Medicare beneficiaries to determine if there is any decline in the quality of therapeutic outpatient services provided as a result of this policy.

This policy becomes effective January 1, 2020 and will remain in place for future years unless modified by later notice and comment rulemaking.

Prior Authorization for Select Hospital Outpatient Services

As part of their responsibility to protect the Medicare Trust Funds, CMS routinely monitors the utilization of services. They have identified several surgical procedures with higher than expected volume increases that could be potentially noncovered by Medicare due to their cosmetic nature. In order to manage the growth of Medicare spending and control unnecessary increases in the volume of hospital outpatient department (OPD) services, CMS is implementing a policy for the prior authorization of certain procedures to “reduce the instances in which Medicare pays for these services when they are merely cosmetic and not medically necessary.”

• The affected procedures are blepharoplasty, botulinum toxin injections, panniculectomy, rhinoplasty and vein ablation. A listing of the affected CPT codes can be found in the final rule. (See page 316 of the 2020 OPPS Final Rule pdf.)
• The requirement would begin for dates of service on or after July 1, 2020.
• Prior authorization is a process through which a request for provisional affirmation of coverage is submitted to Medicare or its contractors for review before the service is provided to the patient and before the claim is submitted.
• The PA request should include all documentation necessary to show that the service meets applicable Medicare coverage, coding and payment rules.
• Claims submitted for services that require a PA that have not received a provisional affirmation of coverage from Medicare would be denied unless the provider is exempt.
• Claims associated with the denied service, such as anesthesiology services, physician services, and/or facility services will also be denied.
• Upon submission of a PA request, CMS or its contractors would issue a decision (affirmative or non-affirmative) within 10 business days.
• Providers can request an expedited review if a delay could seriously jeopardize the patient’s life, health or ability to regain maximum function and a decision will be rendered within 2 business days. Documentation supporting the risk of serious jeopardy must be submitted with the request for an expedited PA.
• Exemption Process - CMS may elect to exempt providers from the PA process who achieve a PA affirmation threshold of at least 90% during a semiannual assessment. This exemption could be removed if the provider subsequently has a rate of non-payable claims greater than 10%.
• A non-affirmation PA decision is not appealable, but the provider will receive a detailed explanation as to why the request was non-affirmed and can resubmit an unlimited number of requests. Appeal rights exist once a claim is denied.
• There will be more sub-regulatory guidance before the requirement becomes effective, but the final rule indicates either the hospital or the physician may submit the PA request, though the hospital is ultimately responsible for ensuring this condition of payment is met.
• A unique tracking number (UTN) corresponding to the PA decision must be included on the OPD claim.

CMS argues this is not an additional burden on hospitals since no new documentation is required beyond what should already be present in the record and the hospital is just having to submit the records before the procedure instead of afterwards as they would have to do in the case of a Medicare medical review. Everyone knows it will be an additional burden, but the good news is that hospitals are used to PA requirements from most other payers, it causes the hospital to get the required documentation together before providing the service, and it likely will prevent some inappropriate payments for cosmetic procedures that do not meet Medicare’s medical necessity requirements.

So, a little relief for some, a little burden for others – is that a wash?

Last week’s Wednesday@One included a lengthy article about the requirements for hospitals to make public their standard charges, including payer-negotiated charges as described in the Final Rule for Price Transparency Requirements for Hospitals to Make Standard Charges Public. The only piece of good news from that Rule was the delay in implementation of the new requirements until January 1, 2021. Until then, hospitals still have to comply with the existing guidance which requires hospitals to make public their chargemaster charges (gross charges) online in a machine-readable format.

If you read last week’s article, you know that complying with the new price transparency rule will be quite a challenge – that is, if the legality of the new requirements holds up. There are already lawsuits challenging the new requirements, especially concerning the release of payer-negotiated rates. Being ever optimistic, CMS included in the final rule how they plan to oversight compliance and what will happen should a provider be found in noncompliance.

Monitoring

For monitoring compliance with the new price transparency requirements, CMS plans to rely predominately on complaints from individuals or entities regarding a hospital’s potential noncompliance.

Monitoring methods may include, but are not limited to, the following, as appropriate:

• CMS’ evaluation of complaints made by individuals or entities to CMS.
• CMS review of individuals’ or entities’ analysis of noncompliance.
• CMS audit of hospitals’ websites.

CMS will be reviewing and auditing to determine if a hospital’s noncompliance constitutes a material violation of one or more requirements. This may include, but is not limited to, failure to make public its standard charges as required or failure to make public its standard charges in the form and manner required.

Actions to Address Noncompliance

CMS may take the following actions if they determine the hospital is noncompliant with the price transparency requirements:

• Provide a written warning notice to the hospital of the specific violation(s) - (notice of violation).
• Request a Corrective Action Plan (CAP) from the hospital if its noncompliance constitutes a material violation of one or more requirements.
• The CAP must be in the form and manner, and submitted by the deadline, specified in the notice of violation issued by CMS to the hospital.
• The CAP must specify the corrective actions or processes the hospital will take to address the deficiencies identified and the timeframe for completion.
• A CAP is subject to CMS review and approval.
• Hospitals must comply with the requirements of the CAP.
• CMS may monitor and evaluate the hospital’s compliance with the CAP.

Penalties

CMS may impose a civil monetary penalty (CMP) on the hospital and publicize the penalty on a CMS website if:

• A hospital fails to submit a CAP in the form, manner, or by the deadline, specified in a notice of violation or
• The hospital fails to correct violation(s) within the specified timeframes of the CAP.

The maximum daily dollar amount for a CMP to which a hospital may be subject is $300, even if the hospital is in violation of multiple discrete requirements of 45 CFR, part 180.

CMS will provide a written notice of imposition of a CMP to the hospital via a certified/traceable delivery. The notice will contain the following elements:

• The basis for the hospital’s noncompliance – that is, the requirement(s) the hospital violated, and the hospital’s failure to submit and/or comply with a requested CAP.
• The effective date of the violation as determined by CMS.
• The amount of the penalty as of the date of the notice.
• Payment instructions. The payment must be made in full within 60 calendar days after the date of the notice of imposition of a CMP from CMS or within 60 calendar days after the date of a final and binding appeal decision to uphold, in whole or in part, the CMP.
• Intent to post the notice of imposition of a CMP on a CMS website.
• Statements that:
• penalties may continue to be imposed for continuing violations,
• the hospital has a right to a hearing, and
• if the hospital fails to request a hearing within 30 calendar days, the penalty and subsequent penalties will be imposed without right of appeal.

CMS can issue additional notices either subsequently for continuing justification or as a “clarifying modification” to conform to adjudicated finding when an appealed “CMP is upheld, in part, by a final and binding decision.”

CMS will post notices of all CMPs, initial and subsequent, on a CMS website. This website will also include posting that the CMP is under review, while they review the hospital’s request for a hearing (appeal). This posting will be maintained or removed based on the outcome of the appeal.

Appeals

“A hospital upon which CMS has imposed a penalty under 45 CFR part 180 may appeal that penalty in accordance with 45 CFR part 150, subpart D, with the exceptions (for the propose of applying the provisions of part 150 to CMPs under part 180) as described in this section of this final rule.”

Generally, under this approach, a hospital upon which CMS has imposed a penalty may request a hearing before an Administrative Law Judge (ALJ) of that penalty. The Administrator of CMS, at his or her discretion, may review in whole or in part the ALJ’s decision. A hospital against which a final order imposing a CMP is entered may obtain judicial review.

If the hospital does not request a hearing within 30 calendar days, CMS may impose the original CMP and additional penalties due to continuing violations without further right of appeal for the hospital. The only exception to this is if the hospital can show good cause as to why they did not request a hearing within the time limits (30 days).

Monitoring through complaints, a limit of $300 per day fine, and an ALJ appeal process may not seem to reflect the highest priority for the price transparency initiative. Some commentaries say this rule and the proposed rule relating to price transparency for health insurers and health plans, especially the parts being challenged in court, may be politically motivated since it is an election year. Monitoring complaints sounds simple but, I think it could be effective for CMS and scary for hospitals. If you fail to follow the rules, one disgruntled patient or employee who hears about these requirements could go looking for your charges and report your noncompliance to CMS. And I would not be surprised to have some watchdog group or the press scrutinizing hospital websites also.

There has been a lot of talk lately about surprise medical bills.  These are usually that seemingly never-ending stream of bills people get after having a procedure or surgery from “other” physicians such as anesthesiologists, radiologists, pathologists, etc. But what if you were a Medicare Advantage (MA) insurer and that surprise bill was for $375,000 or more for an innovative therapy newly approved by Medicare? Luckily for the MA plans, Medicare fee-for-service (FFS) will be paying for CAR T-cell therapy for MA beneficiaries for two years – 2019 and 2020. CMS has instructed the MA plans to account for CAR T-cell therapy for cancer items and services in their contract year 2021 bids.

Chimeric Antigen Receptor (CAR) T-cell therapy is an immunotherapy where a patient’s lymphocyte T-cells are genetically altered to improve their ability to fight cancer. In a new National Coverage Determination, CMS approved coverage for CAR T-cell therapy:

Effective for services performed on or after August 7, 2019, the Centers for Medicare & Medicaid Services (CMS) covers autologous treatment for cancer with T-cells expressing at least one Chimeric Antigen Receptor (CAR) when administered at healthcare facilities enrolled in the Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategies (REMS) and used for a medically accepted indication as defined at Social Security Act Section 1861(t)(2) ‐i.e., is used for either an FDA-approved indication (according to the FDA-approved label for that product), or for other uses when the product has been FDA-approved and the use is supported in one or more CMS-approved compendia.

 

On October 24, 2019, CMS released MLN Matters Article SE19024 concerning billing instructions for beneficiaries enrolled in MA plans for CAR T-cell therapy. As a result of the significant cost of this therapy, effective August 7, 2019, original fee-for-service Medicare will pay for CAR T-cell therapy for cancer obtained by beneficiaries enrolled in Medicare Advantage (MA) plans when the coverage criteria outlined in the decision memorandum is met. This applies for Calendar Years (CYs) 2019 and 2020 only.

The MLN article goes on to provide billing instructions for MA beneficiaries. The main issue with billing for CAR T-cell therapy is that providers can choose different methods of reporting charges for the various steps required to collect and prepare CAR T-cells. These costs can be included in the charge for the biological or they may be reported separately for tracking purposes. Medicare payment for the preparation services is included in the payment for the biological. HCPCS and revenue codes reported separately for the preparation services are not paid separately and will be rejected by Medicare. As stated above, this option is only for tracking purposes.

Do not report the same charge(s) twice. Providers should choose one option described below. You must not include charges for pre-infusion steps in both the drug revenue code (0891) and separately listed for the pre-infusion revenue codes (0871, 0872, and 0873).

When all services are provided on an outpatient basis:

• Report CPT code 0540T with Revenue Code 0874 for the administration of CAR T-cells
• Report HCPCS Q-code Q2041 or Q2042 for the drug/biological with Revenue Code 0891
• Option 1 for charges to collect and prepare CAR T-cells - report
• HCPCS 0537T with revenue code 0871
• HCPCS 0538T with revenue code 0872
• HCPCS 0539T with revenue code 0873
• Option 2 for charges to collect and prepare CAR T-cells - include the charges for these various steps in the charge submitted for the biological

When CAR-T dosing and preparation services are done in an outpatient setting, but the T-cells are administered in the hospital inpatient setting:

• Report the administration of the T-cells on the inpatient claim with revenue code 0874
• Report the drug/biological on the inpatient claim with revenue code 0891
• Option 1 for charges to collect and prepare CAR T-cells - report on inpatient claim under revenue codes 0871, 0872, and 0873 OR
• Option 2 for charges to collect and prepare CAR T-cells - include the charges for these various steps in the charge reported for the biological using revenue code 0891

If CAR-T dosing and preparation Services are performed in the hospital outpatient setting, but the viable T-cells are never administered back to the patient, report CPT codes 0537T, 0538T, and 0539T (as appropriate) and the charges associated with each code under the appropriate revenue code on the outpatient claim. Medicare will not pay for these services when the T-cells are not administered. They will reject these codes but reporting allows tracking of the services and inclusion of the associated costs in your charges.

For more details on billing CAR-T, refer to the MLN Matters Article referenced above or MLN Matters Article SE19009.

The Calendar Year (CY) 2020 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Final Rule was released Friday November 1st. This week MMP highlights finalized changes to the Inpatient Only (IPO) List, a related change to medical review guidance for review contractors, and additions to the ASC Covered Procedures List (CPL). 

Total Hip Arthroplasty (THA) Removed from the IPO List

For several years now, CMS has discussed the removal of total hip arthroplasty (THA) as well as partial hip arthroplasty (PHA) from the IPO List. In response to the CY 2018 Proposed Rule, several surgeons and other stakeholders believe that, “given thorough preoperative screening by medical teams with significant experience and expertise involving hip replacement procedures, the THA procedure could be provided on an outpatient basis for some Medicare beneficiaries.”

CMS finalized their proposal to remove CPT code 27130 (Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty) with or without autograft or allograft) from the IPO List. This procedure will be assigned to C-APC 5115 (Level 5 Musculoskeletal Procedures) with a status indicator of “J1.” Note, CMS is also removing anesthesia code 01214 (anesthesia for open procedure involving hip joint; total hip arthroplasty) as a conforming change.

Similar to when the Total Knee Arthroplasty (TKA) procedure was removed from the IPO list, CMS has no plans to establish patient selection criteria for THA or any procedure. They do reiterate findings that may “likely (but not necessarily)” make a good candidate and who may not be a strong candidate for outpatient THA.

 “Likely” Candidate for Outpatient THA

• A patient with a relatively low anesthesia risk, and
• No significant comorbidities, and
• Has family members at home to assist with post-operative care.

Unlikely Candidate for Outpatient THA

• “A patient requiring a revision of a prior hip replacement, and/or
• Has other complicating clinical conditions including multiple co-morbidities such as obesity, diabetes, heart disease.”

All Procedure Codes being removed from IPO List for CY 2020 page 675

In addition to THA, CMS received several comments regarding procedures believed to meet the criterion for removal from the IPO list. The following table reflects the changes to the IPO list for CY 2020.

‍Short Inpatient Hospital Stays

The Two-Midnight Rule, as finalized in the FY 2014 IPPS Final Rule, clarified when an inpatient admission is considered reasonable and necessary for purposes of Medicare Part A payment. This policy established a benchmark for when a patient is considered appropriate for inpatient hospital admission and payment.

CMS also clarified that “when a beneficiary enters a hospital for a surgical procedure not designated as an inpatient-only (IPO) procedure as described in 42 CFR 419.22(n), a diagnostic test, or any other treatment, and the physician expects to keep the beneficiary in the hospital for only a limited period of time that does not cross 2 midnights, the services would be generally inappropriate under Medicare Part A.”

In the CY 2016 OPPS/ASC Final Rule CMS “finalized a proposal to allow for case-by case exceptions to the 2-midnight benchmark, whereby Medicare Part A payment may be made for inpatient admissions where the admitting physician does not expect the patient to require hospital care spanning 2 midnights, if the documentation in the medical record supports the physician’s determination that the patient nonetheless requires inpatient hospital care.” The following criteria are relevant to making this determination:

• Complex medical factors such as history and comorbidities;
• The severity of signs and symptoms;
• Current medical needs; and
• The risk of an adverse event.

Medical Review of Certain Inpatient Hospital Admissions under Medicare Part A for CY 2020 and Subsequent Years

When a procedure is removed from the IPO list, documentation in the record must support the need for the inpatient admission. These surgical claims are also subject to initial medical reviews of claims for short-stay inpatient admissions conducted by the Beneficiary and Family-Centered Care Quality Improvement Organization (BFCC-QIO).

BFCC-QIO’s may “refer a provider to the Recovery Audit Contractors (RACs) for further medical review due to exhibiting persistent noncompliance with Medicare payment policies, including, but not limited to:

• Having high denial rates;
• Consistently failing to adhere to the 2-midnight rule; or
• Failing to improve their performance after QIO educational intervention.”

For CY 2020 and subsequent years, CMS proposed a 1-year exemption from site-of-service claim denials, BFCC-QIO referrals to RACs, and RAC reviews for “patient status” (that is, site-of-service) for procedures that are removed from the IPO list under the OPPS beginning on January 1, 2020.

In response to public comments CMS finalized a two-year exemption rather than the proposed one year. CMS notes in a related Fact Sheet, “this two-year exemption period will allow providers time to update their billing systems and gain experience with respect to newly removed procedures eligible to be paid under either the Inpatient Prospective Payment System (IPPS) or OPPS, while avoiding potential adverse site of service determinations.”

As a provider, it is important to be mindful that this exemption is specific to site-of-service claim denials. This exemption does not include medical necessity based on a National or Local Coverage Determination meaning irrespective of site-of-service, a short stay claim can still be denied for lack of documentation supporting medical necessity of the procedure.

Total Hip Arthroplasty Moving Forward

“The removal of any procedure from the IPO list, including THA, does not require the procedure to be performed only on an outpatient basis. That is, when a procedure is removed from the IPO, it simply means that Medicare will pay for it in either the hospital inpatient or outpatient setting; it does not mean that the procedure must be performed on an outpatient basis.”

Following are a few things to think about as you plan for this change effective January 1, 2020:

• Make sure your Medical Staff is aware of the changes made to the IPO List.
• Potentially, develop protocols for patient site-of-service selection (IP vs. OP)?
• Educate Clinical Documentation Specialists who can assist with capturing the complexity of these patients through record review and potential physician queries.

Additions to the List of Ambulatory Surgical Center (ASC) Covered Surgical Procedures

In the CY 2019 OPPS Final Rule, CMS finalized the revision to the definition of a surgical procedure under the ASC payment system to include “procedures that are described by Level II HCPCS codes or by Category I CPT codes or by Category III CPT codes that directly crosswalk or are clinically similar to procedures in the CPT surgical range that we have determined are not expected to pose a significant risk to beneficiary safety when performed in an ASC, for which standard medical practice dictates that the beneficiary would not typically be expected to require an overnight stay following the procedure, and are separately paid under the OPPS.”

For FY 2020, CMS conducted a review of HCPCS codes currently paid under the OPPS but are not included on the ASC CPL. Based on this review, the following table highlights the procedures to be added to the ASC Covered Procedure List (CPL) for CY 2020.

Specific to the proposal to add Total Knee Arthroplasty (TKA) to the ASC CPL, CMS noted in the Proposed Rule that “we agree with commenters that there is a small subset of Medicare beneficiaries who may be suitable candidates to receive TKA procedures in an ASC setting based on their clinical characteristics. For example, based on Medicare Advantage encounter data, we estimate over 800 TKA procedure were performed in an ASC on Medicare Advantage enrollees in 2016. We believe that beneficiaries not enrolled in an MA plan should also have the option of choosing to receive the TKA procedure in an ASC setting based on their physicians’ determinations.”

Further, CMS noted “TKA procedures are still predominantly performed in the inpatient hospital setting in CY 2018 (82 percent of the time) based on professional claims data, and we are cognizant of the fact that the majority of beneficiaries may not be suitable candidates to receive TKA in an ASC setting. We believe that appropriate limits are necessary to ensure that Medicare Part B payment will only be made for TKA procedures performed in an ASC setting when the setting is clinically appropriate. Therefore, we are soliciting public comment on the appropriate approach to provide safeguards for Medicare beneficiaries who should not receive the TKA procedure in an ASC setting.”

Inpatient, outpatient or ASC, documentation is crucial to accurately reflect the complexity of the patient and support the medical necessity for services provided.

Q:

Is it appropriate to bill evaluation and management (E/M) codes or a clinic visit code on the same day as other wound care services such as debridement?

A:

It depends. Providers need to be cautious however, because as explained in a recent article from First Coast, the Medicare Administrative Contractor (MAC) for Jurisdiction N, data reflects improper billing of wound care and E/M codes on the same date of service. Providers may report an E/M service with modifier “25” when a significant, separately identifiable E/M service by the same physician on the day of a procedure is performed. If that separate E/M service involves the use of facility resources, a separate clinic visit code may be reported by the facility also.

A separate and distinct E/M service could involve the management of the patient’s underlying medical conditions in addition to the management of wound care. Reporting the E/M code with modifier “25” attests that the patient’s condition required a significant, separately identifiable E/M service above and beyond the usual preoperative and postoperative care associated with the procedure or service that was performed. If the sole purpose of the visit is wound care management, only the wound care codes should be reported. This includes measurements and assessment of the wound(s) as well as debridement, dressings, or other wound treatments performed.

The First Coast article includes excerpts from their Wound Care LCD. The key to supporting a separate E/M code with wound care services is documentation. The documentation should clearly indicate the other conditions that were addressed and managed during the wound care visit.

MEDICARE TRANSMITTALS – RECURRING UPDATES

 

Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2020

Announces changes to be included in the January 2020 quarterly release of the edit module for clinical diagnostic laboratory services.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM11485.pdf

January 2020 Quarterly Average Sales Price (ASP) Medicare Part B Drug Pricing Files and Revisions to Prior Quarterly Pricing Files

Informs MACs about new and revised Average Sales Price (ASP) and ASP Not Otherwise Classified (NOC) drug pricing files for Medicare Part B drugs.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM11495.pdf

Updating Calendar Year (CY) 2020 Medicare Diabetes Prevention Program (MDPP) Payment Rates

CMS intends to calculate the payment rates for each calendar year, based on the Consumer Price Index for All Urban Consumers (CPI-U); and instruct the MACs and the Railroad Specialty MAC to update the MDPP payment rates each year.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM11455.pdf

Notice of New Interest Rate for Medicare Overpayments and Underpayments - 1st Qtr Notification for FY 2020

The interest rate for the first quarter of FY 2020 is 10.125%. 

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/2019Downloads/R327FM.pdf

 

OTHER MEDICARE TRANSMITTALS

 

Provider Enrollment Rebuttal Process

Puts into operation the provision which permits providers/suppliers whose Medicare billing privileges are deactivated to file a rebuttal.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM10978.pdf

Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) Updates for Fiscal Year (FY) 2020

Identifies changes as part of the annual IPF PPS update established in the IPF PPS FY 2020 Final Rule. These changes are applicable to discharges occurring from October 1, 2019, through September 30, 2020 (FY 2020).

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11420.pdf

Fiscal Year (FY) 2020 Inpatient Prospective Payment System (IPPS) and Long Term Care Hospital (LTCH) PPS Changes

The Fiscal Year (FY) 2020 update to the Inpatient Prospective Payment System (IPPS) and LTCH Prospective Payment System (PPS).

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM11361.pdf

Add Dates of Service (DOS) for Pneumococcal Pneumonia Vaccination (PPV) Health Care Procedure Code System (HCPCS) Codes (90670, 90732), and Remove Next Eligible Dates for PPV HCPCS

Instructs Medicare's Common Working File (CWF) to send the Date of Service (DOS) for both PPV HCPCS codes (90670 and 90732) to the Medicare Beneficiary Database (MBD).This will allow other systems to know whether the DOS was for the initial vaccine or the second vaccine. Once the CR is implemented, providers will receive more detail in reply to eligibility transactions on whether their beneficiaries have received one or both PPV vaccines.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM11335.pdf

 

REVISED MEDICARE TRANSMITTALS

 

International Classification of Diseases, 10th Revision (ICD-10) and Other Coding Revisions to National Coverage Determination (NCDs) – January 2020 Update – REVISED

Revised on October 1, 2019, to clarify that the effective date is January 1, 2020, unless noted otherwise.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11392.pdf

October 2019 Update of the Hospital Outpatient Prospective Payment System (OPPS) – REVISED

Revised to correct Table 7 to reinstate C9043 rather than delete it effective October 1, 2019. Also adds a new HCPCS code J0642, which is effective October 1, 2019, and revises the descriptor for J0641.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM11451.pdf

 

MEDICARE SPECIAL EDITION ARTICLES

 

Billing Instructions for Beneficiaries Enrolled in Medicare Advantage (MA) Plans for Services Covered by Decision Memo CAG-00451N

CMS is providing this information for hospitals providing CAR T-cell therapy to beneficiaries enrolled in Medicare Advantage (MA) plans.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/SE19024.pdf

 

MEDICARE EDUCATIONAL RESOURCES

 

Medicare Fast Facts

Medicare Fast Facts resources this month include:

• Cardiac Device Credits: Medicare Billing
• Proper Use of the KX Modifier for Part B Immunosuppressive Drug Claims
• Payment for Outpatient Services Provided to Beneficiaries Who Are Inpatients of Other Facilities

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

 

Final Rule: Revisions to Requirements for Discharge Planning for Hospitals, Critical Access Hospitals (CAH), and Home Health Agencies (HHA), and Hospital and CAH Changes to Promote Innovation, Flexibility, and Improvement in Patient Care

The rule finalizes requirements for hospitals, CAHs, and HHAs to implement discharge planning processes that will provide more information (such as a PAC provider or supplier’s performance in quality measures and resource measures) to patients and their families to help them make more informed decisions about PACs in order to better address their goals for care and treatment preferences.

https://www.cms.gov/newsroom/fact-sheets/cms-discharge-planning-rule-supports-interoperability-and-patient-preferences

Final Rule: Omnibus Burden Reduction (Conditions of Participation) 

Finalizes provisions of three separate proposed rules: the Omnibus Burden Reduction proposed rule (dated September 20, 2018); Hospital and Critical Access Hospital Changes to Promote Innovation, Flexibility, and Improvement in Patient Care proposed rule (dated June 6, 2016); and the Fire Safety Requirements for Certain Dialysis Facilities proposed rule (dated November 4, 2016).

https://www.cms.gov/newsroom/fact-sheets/omnibus-burden-reduction-conditions-participation-final-rule-cms-3346-f

Modernizing and Clarifying the Physician Self-Referral Regulations Proposed Rule

A proposed rule to modernize and clarify the regulations that interpret the Medicare physician self-referral law (often called the “Stark Law”), which has not been significantly updated since it was enacted in 1989.

https://www.cms.gov/newsroom/fact-sheets/modernizing-and-clarifying-physician-self-referral-regulations-proposed-rule

Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2020

The annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review. The 2020 AIC threshold is $170 for ALJ hearings and $1,670 for judicial review. 

https://www.govinfo.gov/content/pkg/FR-2019-10-07/pdf/2019-21751.pdf

Medicare Quarterly Provider Compliance Newsletter October 2019

This quarter’s newsletter addresses Ambulance Services Subject to SNF Consolidated Billing Requirements and Outpatient Physical Therapy Services.

https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/MedQtrlyComp-Newsletter-MLN7346924.pdf

 

MAC UPDATES

 

Palmetto GBA 2020 Medical Review TPE Teleconference Schedule

https://www.palmettogba.com/palmetto/providers.nsf/ls/JJ%20Part%20A"BGQT2X1030?opendocument

It is a fact of life that many of the things we do are under the oversight of others. As children, our parents watch over what we do, then teachers, and when we enter the work force, we have bosses and supervisors. Even corporations, businesses, hospitals, etc. have departments whose function is to watch over the activities in whole or part of other departments (think Compliance for example). Our governments are replete with checks and balances, and divisions whose function is oversight. The Office of Inspector General, for instance, is a sub-department of the Department of Health and Human Services (HHS), whose mission is to protect the integrity of HHS programs as well as the health and welfare of program beneficiaries.

According to the OIG website, “A majority of OIG's resources goes toward the oversight of Medicare and Medicaid (and that) oversight extends to programs under other HHS institutions, including the Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration.” To fulfill their mission, the OIG develops a Work Plan that describes the “various projects including OIG audits and evaluations that are underway or planned to be addressed during the fiscal year and beyond by OIG's Office of Audit Services and Office of Evaluation and Inspections.” The OIG used to only publish the Work Plan once a year; in 2015 they added a mid-year update. Since October 2017 the Work Plan is updated monthly to align with their work planning process.

If you are signed up for the OIG listserv, you will receive updates concerning completed reports, investigations, enforcement actions, and notification of when new Work Plan items are added. Not all of the Work Plan items apply to hospitals, but I recommend reviewing the additions monthly to see if there are issues that apply to your line of business. Just last week, this newsletter addressed the new OIG Work Plan item related to the Medicare 3-Day Window Payment Policy. For October, the OIG added two new issues that could have implications for hospitals.

The first is Medicare Part B Payments for Speech-Language Pathology (SLP). The OIG plans “to determine whether the claims using the KX modifier adhere to Federal requirements (and) … evaluate payment trends to identify Medicare payments for outpatient speech therapy services billed using the KX modifier that are potentially unallowable.” The KX modifier is appended on the claim to therapy services when Medicare payments for these services exceed an annual spending threshold – this was formerly the “therapy cap” and was $2,010 for 2018 and $2,040 for 2019 for physical therapy and SLP services combined (occupational therapy has a separate but equal threshold). Use of the KX modifier with therapy services attests that the services beyond the threshold amount are medically necessary. These means the patient needs the SLP services, is benefiting from them, and the services require the skills of a therapist. The OIG will be looking at the documentation in the medical record to support this. This is the same documentation that should be in every SLP therapy record, but it will be under greater scrutiny when the services billed exceed the threshold amount described above.

SLP therapists (and PT/OT therapists as well) need to make sure their evaluation, plan of care, progress notes, daily treatment notes, and discharge summaries clearly describe the patient’s condition including their functional limitations; identify the treatments needed that can only be provided by a therapist; include specific, measurable goals; and explain the patient’s progress and outcomes related to the goals. The record must justify on-going treatment when needed, but it is also the therapist responsibility to discontinue treatment when the patient is no longer benefiting from therapy or when the treatment can be handled by the patient, alone or with the assistance of a caregiver or other non-skilled person.

Hospitals and therapists should not use the KX modifier for therapy that is not medically necessary. On the flip side, hospitals and therapists need to have systems in place to make sure they are appropriately applying the KX modifier to SLP and other therapy services when the threshold is exceeded and the services are medically necessary. I see numerous automatic Medicare denials for therapy services “exceeding benefit maximum for this period,” where the provider has failed to append the KX modifier.  This will likely require coordination between the therapists and the registration department responsible for checking Medicare benefit and eligibility information.

The second issue is Review of Medicare Part B Urine Drug Testing (UDT) Services and you will never believe it, but the problem is again medical necessity. The use of UDT is widespread these days due to the national opioid crisis. According to the OIG description of this item, “UDT results influence treatment and level-of-care decisions for individuals with SUDs (substance use disorders).” The major issue seems to be whether screening UDTs are sufficient or whether definitive drug tests are needed. Screening drug tests, also known as presumptive tests, cover a range of drugs and identify whether a particular substance is present or not. These tests are billed with one CPT code, once per day, irrespective of the number of Drug Class procedures or results on any date of service. Definitive drug tests identify specific drugs and associated metabolites, and generally include a quantitative concentration of the drug. Definitive drug testing requires more sophisticated instrumentation to perform the testing and is billed per drug tested at a much higher reimbursement rate than drug screening. Sometimes, definitive drug testing is legitimately needed for SUD treatment, but often screening tests are sufficient. The OIG article notes that “the 2018 Medicare fee-for-service improper payment data showed that … the overpayment rate for definitive drug testing for 22 or more drug classes was 71.7 percent.” As with all medical necessity issues, the physician’s record must clearly support the need for definitive drug testing, including the specific need for each drug definitively tested.

                                                                                                                                                                                   

What do hospitals need to do related to the new OIG Work Plan issues above?

This is a great time for an internal review of these two topics. Does your hospital have processes in place to accurately know where the patient is on their therapy spending for the year? Are you appropriately appending the KX modifier when needed? Do your therapy records have the documentation to support the medical necessity of the services?

Do you bill for definitive drug testing? If so, are more than a few drugs tested at once? Does the medical record support the medical necessity of definitively testing for multiple drugs at once? Remember this documentation may be in the physician’s office note, not in the hospital record. In this case, do you have a way to access the physician’s record and does it support medical necessity? This requires coordination and communication between the hospital lab and the ordering physician. Both must have a good understanding of what constitutes medical necessity for this type of testing and the hospital may have to lead in this effort by educating the physicians on the medical necessity requirements and making them aware of the consequences of improper billing for the billing hospital laboratory.

Before the OIG oversights your hospital, you may want to “oversight” yourself so you will be prepared.