Knowledge Base Category -
“The primary objective of the IPPS and the LTCH PPS is to create incentives for hospitals to operate efficiently and minimize unnecessary costs, while at the same time ensuring that payments are sufficient to adequately compensate hospitals for their legitimate costs in delivering necessary care to Medicare beneficiaries.”
- Source: Appendix A: Economic Analysis of FY 2022 IPPS Final Rule
CMS released the display copy of the Fiscal Year (FY) 2022 Inpatient Prospective Payment System (IPPS) Final Rule (CMS-1752-F) on Monday August 2, 2021. This article focuses on New Technology Add-On Payments (NTAP) for FY 2022.
New Technology Add-On Payment Pathways
There are now several pathways for a new services or technology to be approved for New Technology Add-On Payments (NTAPs) including:
- Traditional Pathway: To meet this pathway, the medical service or technology must be new, must be costly such that the DRG rate otherwise applicable to discharges involving the NTAP is inadequate, and must demonstrate a substantial clinical improvement over existing services or technologies.
- Certain Antimicrobial Products Alternative Pathway: In FY 2021 the alternative pathway for Qualified Infectious Disease Products (QIDPs) was expanded to include products approved under the Limited Population for Antibacterial and Antifungal Drugs (LPAD) pathway. In the Final Rule, CMS finalized policy to refer more broadly to “certain antimicrobial products” rather than specifying FDA programs for antimicrobials (i.e., QIDPs and LPADs). Products approved through this pathway will be considered new and not substantially similar to an existing technology and will not need to demonstrate that it meets the substantial clinical improvement criterion. However, the technology will need to meet the cost criterion.
- Certain Transformative New Devices Alternative Pathway: Beginning in FY 2021, “if a medical device is part of FDA’s Breakthrough Devices Program and received FDA marketing authorization, it will be considered new and not substantially similar to an existing technology for purposes of the new technology add-on payment under the IPPS.” However, the new device must meet the cost criterion and must receive marketing authorization for the indication covered by the Breakthrough Device Program designation.
For the alternative pathways, a technology is not required to have a specified FDA designation at the time the application for NTAP is made. Instead, “CMS will review the application based on the information provided under by the applicant under the alternative pathway specified by the applicant. However, to receive approval for the new technology add-on payment under that alternative pathway, the technology must have the applicable designation and meet all other requirements in the regulations in § 412.87(c) and (d), as applicable.”
Additional Payment for NTAP’s
Payment for an NTAP is based on the cost to hospitals for the new medical service or technology. As set forth in § 412.88(b)(2), unless the discharge qualifies for an outlier payment, the additional Medicare payment will be limited to the following:
- For “Traditional Pathway” and “Certain Transformative New Devices”, Medicare will make an add-on payment equal to the lesser of: (1) 65 percent of the costs of the new medical service or technology; or (2) 65 percent of the amount by which the costs of the case exceed the standard DRG payment.
- For Certain Antimicrobial NTAPs (QIDPs and LPADs), Medicare will make an add-on payment equal to the lesser of: (1) 75 percent of the costs of the new medical service or technology; or (2) 75 percent of the amount by which the costs of the case exceed the standard DRG payment.
Coding NTAPs
Section X is the New Technology section that was added to ICD-10-PCS effective October 1, 2015. CMS has indicated that Section X was created in response to public comments received regarding New Technology proposals presented at ICD-10 Coordination and Maintenance Committee Meetings, and general issues facing classification of new technology procedures. The public had opposed many requests to add new codes to the existing ICD-10-PCS sections for the use of specific drugs, devices, or supplies in an inpatient setting, even when the code related to an application for New Technology add-on payments.
NTAPs for FY 2022 by the Numbers
NTAPs are not budget neutral and generally this add-on payment is limited to the 2-to-3-year period after the date a technology becomes available. Due to the COVID-19 Public Health Emergency (PHE) impacting hospital volumes, CMS finalized using FY 2019 data for rate setting. They also finalized a one-year extension of NTAPs for technologies that would have otherwise been discontinued beginning October 1, 2021.
CMS estimates the payment amounts for new technology add-on payments in the Final Rule based on the applicant’s estimates. This amount and the estimated number of patients is highlighted in Appendix A of the Final Rule. Appendix A begins on page 2,174 of the display version of the Final Rule.
- A total of 42 services or technologies have been approved for NTAPs,
- The estimated total amount to be paid to hospitals is $1,424,341,317.63, and
- The estimated number of patients is 468,206.
- The estimated number one NTAP by volume and payment is Veklury® (remdesivir) with an estimated 174,996 cases and estimated total payment of $354,891,888.00. This drug is used in the treatment of COVID-19 patients.
NTAPs FY Trend: Number of Services or Technologies Approved for NTAP
- FY 2020: 18
- FY 2021: 24
- FY 2022: 40
NTAPs FY Trend: Estimated Number of Patients to Receive a New Technology during an Inpatient Stay
- FY 2020: 71,659
- FY 2021: 259,201
- FY 2022: 468,206
New COVID-19 Treatment Add-on Payments (NCTAPs)
As new therapies were approved in response to the COVID-19 PHE, New COVID-19 Treatments Add-on Payment (NCTAP) were created. CMS finalized the following related to NCTAPs in the FY 2022 IPPS Final Rule:
- The NCTAP for eligible COVID-19 products will extend through the end of the fiscal year in which the PHE ends, and
- A hospital will be eligible to receive the NCTAP and the traditional NTAP for qualifying patient stays, through the end of the fiscal year in which the PHE ends, with the NTAP reducing the amount of the NCTAP.
You can learn more about NCTAP’s on the related CMS COVID-19 NCTAP specific webpage (link).
Moving Forward
Identifying and coding new technologies is an opportunity not to be missed for those hospitals providing these services. That said, some questions come to mind for you to think about:
- Is your hospital providing any of these medical services or technology?
- Who needs to be aware of what the new technologies are? (i.e. Physicians, Pharmacy, Coding Professionals, Clinical Documentation Integrity Specialists, Case Managers)
- What process do you have in place to alert your Coding Staff of the need to code the new technologies?
Resources:
CMS August 2, 2021, Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fiscal-year-fy-2022-medicare-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-0
FY 2022 IPPS CMS webpage: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2022-ipps-final-rule-home-page
Beth Cobb
In general, my day-to-day focus as it relates to Medicare Fee-for-Service guidance, is the acute hospital inpatient and outpatient setting. Last week, CMS issued Christmas in July gifts, in the form of 4 final FY 2022 payment rules. While not my day-to-day focus, highlights, and links to information about the final rules are important enough to share with you, our readers, who may be impacted.
FY 2022 Skilled Nursing Facility (SNF) Prospective Payment System (CMS-1746-F)
Major provisions in this final rule are highlighted in a related CMS Fact Sheet (link) and includes:
- FY 2022 Updates to the SNF Payment Rates,
- Methodology for Recalibrating the Patient Driven Patient Model (PDPM) Parity Adjustment,
- Rebase and Revise the SNF Market Basket by using the 2018-based SNF market basket to update the PPS payment rates, instead of the 2014-based SNF market basket,
- Section 134 of the Consolidated Appropriations Act, 2021 – New Blood Clotting Factor Exclusion from SNF Consolidated Billing,
- Changes in the PDPM ICD-10 Code Mappings,
- SNF Quality Reporting Program (SNF QRP) update, and
- SNF Value-Based Purchasing (SNF VBP) Program.
FY 2022 Hospice Payment Rate Update Final Rule (CMS-1745-F)
Major provisions highlighted in a related CMS Fact Sheet (link) includes:
- FY 2022 Routine Annual Rate Setting Changes,
- Other Medicare Hospice Payment Policies,
- Changes to the Hospice Conditions of Participation (CoPs) in response to the COVID-19 Public Health Emergency (PHE),
- Hospice Quality Reporting Program, and
- Home Health Quality Reporting Program.
FY 2022 Inpatient Rehabilitation Facility (IRF) Prospective Payment System (PPS) Final Rule (CMS-1748-F)
Major provisions in this final rule in a related CMS Fact Sheet (link) includes:
- Updates to IRF Payment Rates,
- IRF Quality Reporting Program (IRF QRP) Updates, and
- Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Policy Issues.
FY 2022 Inpatient Psychiatric Facility (IPF) Prospective Payment System Final Rule (CMS-1750-F)
Major provisions highlighted in a related CMS Fact Sheet (link) includes:
- FY 2022 Updates to the IPF Payment Rates,
- Updates to the IPF Teaching Policy, and
- IPF Quality Reporting Program (IPF QRP) Updates.
Beth Cobb
For students,’ summer is quickly winding down and at least for my youngest nephew, he starts back to school on August 9th. More years ago, than I care to share, this time of year was crunch time to finish all my required summer reading before facing a quiz in the first week of English class. Inevitably, there were books that I just knew I would not enjoy, that ended up being my favorite read of the summer.
Now, instead of reading literary classics, my summer reading consists of the coming CY OPPS and Physician Fee Schedule Proposed Rules, the coming FY IPPS Final Rule, and the updated ICD-10-CM Official Guidelines for the new October 1st FY. Today, I offer a “Cliffs Notes®” version of changes in the ICD-10-CM Official Guidelines for FY 2022.
The ICD-10-CM Official Guidelines for FY 2022 were released on Monday, July 12 and can be found on the CDC ICD-10-CM webpage (link) as well as the 2022 ICD-10-CM CMS webpage (link).
Section B2. General Coding Guideline – Level of Detail in Coding
2021 Guidance: Diagnosis codes are to be used and reported at their highest number of characters available.
2022 Guidance: Adds to this sentence “and to the highest level of specificity documented in the medical record.
Section B12. General Coding Guideline – Laterality
The following paragraph has been added to this section. For CDI Professionals, note the guidance includes the possible need for a physician query.
“When laterality is not documented by the patient’s provider, code assignment for the affected side may be based on medical record documentation from other clinicians. If there is conflicting medical record documentation regarding the affected side, the patient’s attending provider should be queried for clarification. Codes for “unspecified” side should rarely be used, such as when the documentation in the record is insufficient to determine the affected side and it is not possible to obtain clarification.”
Section B14. General Coding Guideline – Documentation by Clinicians Other than the Patient’s Provider
As a reminder, in 2021 this section was updated to include the following statement regarding the assignment of social determinant codes: “Patient self-reported documentation may also be used to assign codes for social determinants of health, as long as the patient self-reported information is signed-off by and incorporated into the health record by either a clinician or provider.”
New for FY 2022, the guidelines:
-
• Defines “clinicians,”
• Adds “blood alcohol level” to the ever-growing list of code assignment exceptions,” and
• Along with BMI, coma scale, and NIHSS, adds blood alcohol level codes and codes for social determinants of health to the list of exception codes that should on be reported as a secondary diagnosis.
Section B18. General Coding Guideline – Use of Signs/Symptom/Unspecified Codes
A new paragraph has been added to this section reminding you that:
-
• Achieving complete and accurate documentation, code assignment, and reporting of diagnoses and procedures is a joint effort between the healthcare provider and the coder,
• Without consistent and complete documentation in the medical record, accurate coding can’t occur, and
• The entire record should be reviewed to determine the reason for the encounter and what conditions were being treated.
Section C. Chapter-Specific Coding Guideline – Chapter 1: Certain Infectious and Parasitic Diseases -Coronavirus infections – Section 1g – Coronavirus Infections
This section includes several updates related to coding COVID-19, for example:
-
• Updated information related to follow-up visits after COVID-19 infection has resolved, and
• New information related to Post COVID-19 Condition
Section C. Chapter-Specific Coding Guidelines – Chapter 5: Mental, Behavioral and Neurodevelopment disorders – Section b. 5 – Blood Alcohol Level
Blood Alcohol Level is a new section in Chapter 5 that provides the following guidance related to coding blood alcohol levels: “A code from category Y90, Evidence of alcohol involvement determined by blood alcohol level, may be assigned when this information is documented and the patient’s provider has documented a condition classifiable to category F10, Alcohol related disorders. The blood alcohol level does not need to be documented by the patient’s provider in order for it to be coded.”
Although there are other updates to be found in the FY 2022 Guidelines, as I promised a “Cliffs Notes®” review, I will stop here and encourage you to add this document to your own summer reading list.
Beth Cobb
Question
In last week’s article about the OPPS and ASC Proposed Rule you indicated that CMS has proposed to remove 258 procedures that were added to the ASC covered procedure list in CY 2021. What procedures are remaining on the ASC list?
Answer
In the CY 2021 Final Rule, the finalized additions to the ASC Covered Procedure List were separated into two tables:
- Table 59 listed procedures added under the standard review process, and
- Table 60 listed procedures added under the second alternative proposal considered for CY 2021.
The procedures proposed for removal from the ASC list for CY 2022 are from Table 60. The procedures listed in Table 59 were not proposed for removal from the ASC list and includes the following CPT/HCPCS codes:
- 0266T: Implantation or replacement of carotid sinus baroreflex activation device; total system (includes generator placement, unilateral or bilateral lead placement, intra-operative interrogation, programming, and repositioning, when performed),
- 0268T: Implantation or replacement of carotid sinus baroreflex activation device; pulse generator only (includes intra-operative interrogation, programming, and repositioning, when performed),
- 0404T: Transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency,
- 21365: Open treatment of complicated (e.g., comminuted or involving cranial nerve foramina) fracture(s) of malar area, including zygomatic arch and malar tripod; with internal fixation and multiple surgical approaches,
- 27130: Arthroplasty, acetabular and proximal femoral prosthetic replacement (total hip arthroplasty), with or without autograft or allograft,
- 27412: Autologous chondrocyte implantation, knee,
- 57282: Colpopexy, vaginal; extra-peritoneal approach (sacrospinous, iliococcygeus),
- 57283: Colpopexy, vaginal; intra-peritoneal approach (uteroscacral, levator myorrhaphy),
- 57425: Laparoscopy, surgical, colpopexy (suspension of vaginal apex),
- C9764: Revascularization, endovascular, open or percutaneous, and vessel(s); with intravascular lithotripsy, includes angioplasty within the same vessel(s), when performed, and
- C9766: Revascularization, endovascular, open or percutaneous, any vessel(s); with intravascular lithotripsy and atherectomy, includes angioplasty within the same vessel(s), when performed.
Resources:
- CY 2021 OPPS Final Rule and ASC Payment System Final Rule [CMS-1736-FC]: https://www.cms.gov/medicaremedicare-fee-service-paymenthospitaloutpatientppshospital-outpatient-regulations-and-notices/cms-1736-fc
- CY 2022 OPPS and ASC Payment System Proposed Rule {CMS-1753-O]
Note, see table 45 for procedures proposed for removal from the ASC Covered Procedures List. (link) - Related MMP Article: CY 2022 OPps and ASC Proposed Rule – Inpatient Only List and ASC Covered Procedure List (link)
Beth Cobb
The Calendar Year (CY) 2022 Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System Proposed Rule (link) was released on July 19, 2021.
CMS estimates “that total payments to OPPS providers (including beneficiary cost-sharing and estimated changes in enrollment, utilization, and case-mix) for calendar year (CY) 2022 would be approximately $82.704 billion, an increase of approximately $10.757 billion compared to estimated CY 2021 OPPS payments.”
CMS, in general, plans to use 2019 claims data for rate setting due to the COVID-19 PHE. Examples of specific decreases or increases in claims in CY 2020 cited by CMS includes:
- An approximate 20 percent decrease in the overall volume of outpatient hospital claims,
- An approximate 30 percent decrease in volume in the APCs for hospital emergency department and clinic visits,
- For HCPCS code Q3013 (Telehealth originating site facility fee) in the hospital outpatient claims, the approximate 35,000 services billed in CY 2019 increased to 1.8 million services in the CY 2020.
Inpatient Only Procedure List
Historically, CMS used the following five criteria to assess for removal of a procedure from the Inpatient Only (IPO) list.
- Most outpatient departments are equipped to provide the services to the Medicare population.
- The simplest procedure described by the code may be furnished in most outpatient departments.
- The procedure is related to codes that we have already removed from the IPO list.
- A determination is made that the procedure is being furnished in numerous hospitals on an outpatient basis.
- A determination is made that the procedure can be appropriately and safely furnished in an ASC and is on the list of approved ASC services or has been proposed by us for addition to the ASC list
In a complete one-eighty, CMS has proposed to halt the elimination of the IPO list and, “after clinical review of the services removed from the IPO list in CY 2021,” add the 298 services removed in CY 2021 back to the IPO list beginning in CY 2022. CMS has also proposed to codify the five longstanding criteria for potential removal from the IPO list.
CMS noted that “many commenters, including hospital associations and hospital systems, professional associations, and medical specialty societies, vociferously opposed eliminating the IPO list. These commenters primarily cited patient safety concerns, stating that the IPO list serves as an important programmatic safeguard and maintains a common standard of medical judgment in the Medicare program.”
CMS requests public comments on several questions related to the IPO list. For example, “what information or support would be helpful for providers and physicians in their considerations of site-of-service selections?
Proposed Medical Review of Certain Inpatient Hospital Admissions under Medicare Part A for CY 2022 and Subsequent Years
Once a surgical procedure has been removed from the IPO List, documentation in the record must support the need for the inpatient admission. CMS reminds providers that “removal of a service from the IPO list has never meant that a beneficiary cannot receive the service as a hospital inpatient – as always, the physician should use his or her complex medical judgment to determine the appropriate setting on a case-by-case basis.”
For CY 2020, CMS finalized a two-year exemption from site-of-service claim denials, Beneficiary and Family Centered Care Quality Improvement Organization (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.
For CY 2021, CMS finalized “that procedures removed from the IPO list after January 1, 2021, were indefinitely exempted from site-of-service claims denials under Medicare Part A, eligibility for BFCC-QIO referrals to RACs for noncompliance with the 2-Midngiht rule, and RAC reviews for “patient status” (that is, site-of-service).” This exemption was to remain in place until Medicare claims data indicated a procedure was being performed more than 50 percent of the time in the outpatient setting.
On Monday, July 19th, WPS posted the following notice about spinal neurostimulators prior authorization requests:
For CY 2022, CMS has proposed to “rescind the indefinite exemption and instead apply a 2-year exemption from two midnight medical review activities for services removed from the IPO list on or after January 1, 2021.”
As a provider, keep in mind this exemption is specific to site-of-service claim denials and does not include exemption from medical necessity reviews of services provided based on a National or Local Coverage Determinations (NCDs and LCDs) when applicable.
Proposed Changes to the Ambulatory Surgical Center (ASC) Covered Procedure List (CPL)
CMS is also doing an about face for the ASC CPL. Of the 267 procedures added to the list in CY 2021, CMS has proposed to remove 258 procedures as they do not believe they meet the proposed revisions to the CY 2022 ASC CPL criteria.
CMS notes, “Based on our internal review of preliminary claims submitted to Medicare, we do not believe that ASCs have been furnishing the majority of the 267 procedures finalized in 2021. Because of this, we believe it is unlikely that ASCs have made practice changes in reliance on the policy we adopted in CY 2021. Therefore, we do not anticipate that ASCs would be significantly affected by the removal of these 258 procedures from the ASC CPL.”
A complete list of the 258 procedures can be found in table 45 of the proposed rule.
Proposed Revisions to the CY 2022 ASC CPL Criteria
In CY 2021, CMS revised their policy for adding surgical procedures to the ASC CPL. For CY 2022, they have proposed to revise the requirements for covered surgical procedures to reinstate the specifications established prior to CY 2021. One key proposal would once again define covered surgical procedures as surgical procedures specified by the Secretary and published in the Federal Register and/or via the Internet on the CMS website that are separately paid under the OPPS, that would not be expected to pose a significant safety risk to a Medicare beneficiary when performed in an ASC, and for which standard medical practice dictates that the beneficiary would not typically be expected to require active medical monitoring and care at midnight following the procedure.
Inpatient, outpatient or ASC, documentation is crucial to accurately reflect the complexity of the patient, support the medical necessity for services provided and support the setting in which the services are performed.
While this article highlights a couple of topics in the proposed rule, I encourage you to review the entire document for other key proposals such as the proposed increase in civil monetary penalties (CMP) for hospital noncompliance with the Price Transparency requirements. You can also read more about what is being proposed in a related CMS Fact Sheet (link).
Beth Cobb
Welcome to the second monthly edition of MMP’s P.A.R. Pro Tips. For those new to the Wednesday@One, MMP has collaborated with RealTime Medicare Data (RTMD), to develop a proprietary Protection Assessment Report (P.A.R.). This report is a combination of current Medicare Fee-for-Service review targets with hospital specific Medicare Fee-For-Service paid claims data. As a bonus to our Wednesday@One readers, we have begun to provide useful “Did You Know” information that we come across in our ongoing review of key websites (i.e., Medicare Administrative Contractors (MACs), OIG, Recovery Auditors, etc.)
Did You Know?
The Prior Authorization for Certain Hospital OPD Services was implemented effective July 1, 2020. On July 1, 2021, two additional services were added to the list of services requiring prior authorization (Spinal Neurostimlators and Cervical Fusion with Disc Removal). The full list of HCPCS codes requiring prior authorization is available on the CMS webpage dedicated to this process (link).
Pro Tip: MAC Education
MACs nationwide have been providing education to providers regarding this program and more specifically the two new services that have been added to the list of services requiring prior authorization. Following is a sampling of information available for hospital outpatient departments:
CGS (Jurisdiction 15)
CGS’ OPD Prior Authorization webpage (link) walks providers through the process of submitting a prior authorization request, outlines medical record documentation requirements to meet coverage criteria, provides a detailed exemption process timeline, and information about claims submission and appeals. There are also several “NOTES” included throughout this webpage, for example:
First Coast Service Options, Inc. (Jurisdiction N)
In late June, First Coast modified their article Vein ablation and related services (link). This article includes:
- Clinical definitions of veins, varicose veins, endovenous ablation, and chronic venous insufficiency,
- Applicable HCPCS codes,
- Documentation requirements,
- Best practice/documentation feedback/tips and help,
- Billing and coding alerts, and
- References, including links to applicable Local Coverage Determination (LCD) and related Local Coverage Article (LCA).
First Coast also released an updated Prior Authorization (PA) program Q&A document (link) on July 15th.
National Government Services (NGS Jurisdiction K)
On July 7, 2021, NGS posted an Outpatient Department Prior Authorization for Implanted Neurostimulators Alert (link). The alert begins by reminding providers that HCPCS 63650 is the only code that needs to be prior authorized for trial and permanent placement. The alert goes on to provide documentation requirements and links to related content.
Noridian (Jurisdiction E)
Noridian has created a Prior Authorization Lookup Tool to help providers determine which HCPSC codes require a prior authorization (link). They are also providing Prior Authorization for Certain Hospital Outpatient Department (OPD) Services webinars (link). One is scheduled for today July 21, 2021, and another one is scheduled for August 12, 2021.
Novitas Solutions Jurisdiction (Jurisdiction H)
On the Novitas webpage that is dedicated to this program (link), you will find the following:
- Program background information,
- Quick links to key documents,
- General information,
- Upcoming Education events,
- Links to all applicable LCDs and LCAs,
- Information about expedited requests, and
- Contact Information.
Palmetto GBA (Jurisdiction J)
Palmetto has made available a Cervical Disc Spinal Fusion and Spinal Cord Stimulator On-Demand Webcast (link). On July 15th, Palmetto also posted an article detailing the Prior Authorization Exemption Process (link).
WPS (Jurisdiction 5)
On Monday, July 19th, WPS posted the following notice about spinal neurostimulators prior authorization requests:
“Providers who perform and bill CPT code 63650 (percutaneous implantation of neurostimulator electrode array, epidural) must remember to request prior authorization (PA) for both the trial and permanent placement.
Providers should submit a PA for the trial placement only if the plan is to perform the procedure in a hospital outpatient department (HOPD). Providers should submit one prior authorization request (PAR) when both the trial and the permanent placement will be in the same HOPD. WPS will only assign one Unique Tracking Number (UTN) that the provider should use to bill for both claims.
If the trial and permanent placement are to occur at two separate HOPDs, then the provider will need two separate UTNs as each HOPD has their own Provider Transaction Access Number (PTAN) and National Provider Identifier (NPI).”
What Can You Do?
For those involved in the Prior Authorization process at your hospital, be sure and check out available resources on your MAC specific webpage. CMS’s Review Contractor Directory – Interactive Map (link) among other Medicare Contractors, provides links to your state specific MAC.
Beth Cobb
Over the years, hyperbaric oxygen (HBO) therapy has been and continues to be a review focus by Medicare Review Contractors. Most recently, Palmetto GBA published their findings from a Post-Payment review of claims in their Medicare Administrative Contractor (MAC) Jurisdiction M. But first, let’s take a look back at who else has been reviewing HBO therapy services.
Strategic Health Solutions, LLC: April 2012 to March 31, 2013 Claims Review
In 2014, Strategic Health Solutions, LLC, the first Supplemental Medical Review Contractor (SMRC), completed a review of 2,000 HBO claims with dates of service April 1, 2012 to March 31, 2013. Of the 2,000 claims, 594 were denied for no response and 570 were denied after review resulting in an error rate of 58%. Documentation cited as not being in the record included:
- Specific timelines and goals for therapy. For example, the documentation simply stated “continue HBO” or “until healed”
- Radiology and pathology reports confirming diagnoses such as osteomyelitis or gas gangrene
- Monitoring for improvement or lack of improvement
In addition, when documentation was provided, descriptions of diabetic wounds did not meet Wagner Criteria for Grade three (III) or four (IV) wounds and therapy was provided beyond the 30 days allowed under Medicare coverage guidelines.
OIG: February 2018 Report: Wisconsin Physicians Service Paid Providers for HBO Services that Did Not Comply with Medicare Requirements
For this audit (link), the OIG focused on WPS who is the current Medicare Administrative Contractor for Jurisdictions 5 and 8. Based on their results, the OIG estimated that WPS overpaid providers in Jurisdiction 5 $42.6 million dollars during the audit period of claims paid in 2013 and 2014.
OIG: December 2018 Report: First Coast Options, Inc., Paid Providers for HBO Services that Did Not Comply with Medicare Requirements
Similar to the WPS Audit, the OIG focused on 2013 and 2014 claims and estimated that First Coast overpaid providers in Jurisdiction N $39.7 million (link).
Noridian SMRC: October 2020 Outpatient HBO Notification of Medical Review
In October 2020, the current SMRC announced a post-payment review of HBO therapy with dates of service from January 1, 2018 through December 31, 2018 (link). Noridian indicates in the notification that, “over the years, HBO therapy services formed the basis of several Office of Inspector (OIG) reports. Findings from these OIG reports note that Medicare beneficiaries received treatments for non-covered conditions, medical documentation did not adequately support treatments, and that Medicare beneficiaries received more treatments than were considered medically necessary.”
Palmetto GBA: January to March 2021 Claims Review
As mentioned at the beginning of this article, Palmetto GBA has completed a post-payment service specific probe review of HBO therapy for North Carolina, South Carolina, Virginia and West Virginia (link)). Cumulatively, 285 claims were reviewed and 144 were completely or partially denied resulting in an overall claim denial rate of 50.53 percent. Examples of top denial reasons includes:
- No documentation of medical necessity,
- The recommended protocol was not ordered and/or followed,
- Billing Error,
- Units billed more than ordered, and
- Services not documented,
Based on the “medium to high impact severity errors,” Palmetto plans to continue this targeted medical review.
Moving Forward:
If your facility provides HBO therapy, make sure you are aware of Medicare’s requirements for HBO therapy, which can be found in the National Coverage Determination (NCD) 20.29 for Hyperbaric Oxygen Therapy (link)). Note, this NCD includes a list of covered indications and a longer list of non-covered indications.
Also, I recommend reading Palmetto’s review article as it includes ways to avoid denials. Palmetto GBA has two education resources related to HBO for Providers:
Add Hospital Provider Compliance Audits to the List of OIG Activities You Need to Know
My oldest nephew is in the midst of his second semester of college life. Academically speaking, he excelled during the first semester. Unfortunately, that is not the case with his Freshman English class this spring. Evidently, the class involves writing several papers and his Professor has been less than impressed with my nephew’s writing efforts. My nephew has met with his Professor to try and understand what he can do to improve his writing skills. Unfortunately, even though his Professor has taken the time to talk with him, my nephew doesn’t seem to be able to pinpoint exactly what he needs to do from this discussion.
The OIG has been conducting Medicare Hospital Provider Compliance Audits as far back as March of 2011. To date, they have completed 190 audits. You can find a table of all these audits on the OIG’s Hospital Compliance Reviews webpage. Unlike my nephew’s English Professor, the OIG is very clear about what their audits focus on. Specifically, they focus on what they describe as “risk areas that we identified as a result of prior OIG audits at other hospitals.”
Two years into their Hospital Provider Compliance Audits, the OIG began to extrapolate audit findings with adverse financial consequences for Providers. In May of 2013, Nashville Tennessee based Saint Thomas Hospital, was the first hospital subject to extrapolation. In the Saint Thomas audit, the OIG identified overpayments of $293,359 and extrapolated this amount over the claims during the audit period. Through extrapolation, the OIG recommended that the Hospital refund to the contractor $1,092,248. In general, every hospital that has been subject to extrapolation during an OIG Hospital Provider Compliance Audit has disagreed with the OIG’s method for extrapolation.
OIG Hospital Provider Compliance Audit: Sunrise Hospital & Medical Center The OIG’s most recent audit was released on April 1, 2021 and details their audit of Sunrise Hospital & Medical Center located in Las Vegas, Nevada. Medicare paid the Hospital approximately $245 million for 15 million inpatient and 25,308 outpatient claims from January 1, 2017, through December 31, 2018 (the audit period).
The OIG’s audit covered about $41 million in Medicare payments to the hospital for 2,117 claims potentially at risk for billing errors. Ultimately, the audit included a stratified random sample of 100 claims (85 inpatient and 15 outpatient) with payments totaling $2.4 million. The at risk areas specific to this audit included:
- Inpatient rehabilitation facility claims,
- Inpatient comprehensive error rate testing (CERT) DRG codes,
- Inpatient high-severity level DRG codes,
- Inpatient mechanical ventilation,
- Inpatient claims paid in excess of $25,000,
- Inpatient same day discharge and readmit,
- Outpatient bypass modifiers,
- Outpatient claims paid in excess of $25,000,
- Outpatient claims paid in excess of charges, and
- Outpatient skilled nursing facility (SNF) consolidated billing.
The OIG found that the hospital complied with Medicare billing requirements for 46 of the 100 inpatient and outpatient claims reviewed. For the remaining 54 claims, the OIG found that the hospital did not fully comply with Medicare billing requirements. Specific claims and monetary impact included:
- 50 Inpatient claims had billing errors resulting in net overpayments of $1,002,049,
- 36 of these claims were Inpatient Rehabilitation Facility admissions where the OIG believed the Hospital had incorrectly billed for stays not meeting Medicare criteria for acute inpatient rehabilitation.
- 4 Outpatient claims had billing errors resulting in net underpayments of $2,099.
- The OIG estimated that the Hospital received overpayments of at least $23,615,809 for the audit period.
Ultimately, the OIG extrapolated the audit findings and recommended that the Hospital refund to the Medicare contractor $23.6 million in net estimated overpayments. The Hospital disagreed with most of the OIG’s findings. However, at the end of the day, the OIG indicated that “after review and consideration of the Hospital’s comments, we maintain that our findings and recommendations are correct.”
Moving Forward
In spite of the COVID-19 pandemic, the OIG managed to publish the results from nine Hospital Provider Compliance Audits in 2020. Given that the OIG has been conducting this type of audit since 2011 and their propensity to extrapolate audit findings, understanding provider compliance “at risk” issues has become as important as knowing what items are on the OIG’s Work Plan.
Beth Cobb
As a child of the 70’s in the south, the television line up at my house on Saturday night, when we were not at some type of ball game, was Looney Tunes, Hee Haw, Love Boat and Fantasy Island. That said, let us focus on Hee Haw’s Gossip Girls and their song that hopefully won’t get stuck on a loop in your head:
“Now, we’re not ones to go ‘round spreadin’ rumors, Why, really we’re just not the gossipy kind, No, you’ll never hear of us repeating gossip, So you’d better be sure and listen close the first time!”
Recently, I have read that Livanta, one of the current Beneficiary and Family Centered Care – Quality Improvement Organizations (BFCC-QIS), was going to be the new Medicare contractor responsible for Short Stay Reviews (SSRs) and higher-weighed-DRG (HWDRG) reviews nationwide. As background information, in May 2019, BFCC-QIO short stay reviews were put on hold as CMS planned to procure a new BFCC-QIO contractor who would perform SSRs and HWDRG reviews on a national basis. CMS anticipated awarding this contract by the 3rd quarter of calendar year 2019. As of last week, I had been unable to find an award notice from CMS and unlike the Gossip Girls, I have been waiting to find confirmation from CMS or Livanta before sharing information in our newsletter.
This past Friday April 9th, I found that Livanta has provided confirmation on their website, with the following bolded notice:
Attention Providers: Livanta was awarded the contract for performing claim reviews for Short Stay and Higher-Weight Diagnosis Related Group (HWDRG) claims in all U.S. states and territories.
Under the announcement there is a link to a new Livanta National Medicare Claim Review Contractor Webpage. Important information available to Providers on this webpage includes:
- Frequently asked questions such as information about HWDRG and Short Stay Reviews (SSRs).
- Information about a Memorandum of Agreement (MOA) that acute care inpatient hospitals, inpatient psychiatric hospitals, and long-term acute care (LTAC) hospitals are required to submit to Livanta. Note, the MOA template is available as a download on this page.
- Information about medical record reimbursement and the process for submitting medical records to Livanta.
As to the timing of when these reviews will begin, Livanta offers the following information:
“In the coming weeks, Livanta will begin conducting this work in all states, territories, and Washington, D.C. As part of the review activities, Livanta’s reviewers will evaluate whether the services performed were medically necessary and paid appropriately.”
Beth Cobb
Reading CMS’s recently released Change Request (CR) 12104 titled Claims Processing Instructions for National Coverage Determination (NCD) 20.4 Implantable Cardiac Defibrillators (ICDs) made me feel like I had entered the land of Fantasia from The Never Ending Story or as if I was waking up to Sonny and Cher singing I Got You Babe for the umpteenth time in the Bill Murray classic Ground Hog’s Day. Either way, it has been a long road from the release of a Proposed Decision Memo to the transmittal providing claims processing instructions.
The Never Ending Story, Gets It’s Ending
· May 30, 2017: CMS announced the opening of a National Coverage Analysis (NCA)for Implantable Cardioverter Defibrillators.
· November 20, 2017: CMS issued a Proposed Decision Memo.
· February 15, 2018: CMS issued a Final Decision Memo.
· November 21, 2018: Transmittal 209 (CR 10865) was issued reflecting the reconsideration of an updated version of NCD 20.4. CMS noted that a subsequent CR would be released at a later date containing a Claims Processing Manual update with accompanying instructions. Until that time, CMS instructed that Medicare Administrative Contractors (MACs) shall be responsible for implementing NCD 20.4.
· February 15, 2019: Transmittal 211 was rescinded and replaced with Transmittal 213 to change the implementation date from February 26, 2019 to March 26, 2019.
· March 26, 2019: CMS’ final implementation date for NCD20.4.
· March 26, 2019: Eleven of the twelve MACs published a Local Coverage Article titled Billing and Coding: Implantable Automatic Defibrillators including:
o First Coast Service Options, Inc. (Jurisdiction N) – Article A56341,
o National Government Services, Inc. (Jurisdictions 6 and K) – Article A56326,
o Noridian Healthcare Solutions, LLC (Jurisdiction E) – Article A56340,
o Noridian Healthcare Solutions, LLC (Jurisdiction F) - Article A56342,
o Novitas Solutions, Inc. (Jurisdictions H and L) – Article A56355,
o Palmetto GBA (Jurisdictions J and M) – Article A56343, and
o Wisconsin Physician Service Insurance Corporation (Jurisdictions 5 and 8) – ArticleA56391.
· March 2, 2020: CMS published MLN SE20006 updating providers on Medicare coverage rules and policies for NCD 20.4. Specifically, this article addresses concerns related to requiring the use of heart failure diagnosis codes. They end this article by stating that “it is incumbent upon the provider to select the proper code(s). We believe the listed covered codes encompass the various clinical scenarios that occur for patients who meet the NCD coverage requirements and are provided, not to write additional parameters into the NCD, but to ensure there is an appropriate code for the covered indications.”
· March 23, 2021: CMS released CR 12104 and a related MLN MM12104 on March 24, 2021 detailing the claims processing instructions for NCD 20.4.
In Ground Hog’s Day, Bill Murry keeps reliving the same day over and over until he finally turns it around into the perfect day. Almost four years from the opening of the coverage analysis, CMS has provided the final piece to implantable cardiac defibrillators.
Moving Forward to Your Happy Ending
· First, now is a good time to review NCD 20.4 to understand the indications for when an ICD implantation is considered medically necessary by CMS.
· Transmittal 12104 details the codes you “shall” use on your claims when billing for services provided. To assist in understanding the codes, I recommend that you read your MAC’s related coding and billing article as it outlines codes specific to each CMS indication for coverage in the NCD.
· For patients clinically meeting the indications for a pacemaker and an ICD, all twelve MACs have published billing and coding: single chamber and dual chamber permanent cardiac pacemaker articles related to the single and dual chamber pacemaker NCD 20.8.3.
· This is also a good time to review a sample of claims at your hospital for documentation supporting medical necessity as well as appropriate coding.
· Be aware that all Recovery Auditors have been approved to perform audits for medical necessity and documentation requirements for implantable automatic defibrillators in the outpatient (Issue RAC Issue 0093) and inpatient (RAC Issue 0195) setting.
· Last, know that the implementation date for Transmittal 12104 is July 6, 2021. However, take note that CMS indicates that MACs will not search their files for claims for ICD services between February 15, 2018, and the implementation date of this transmittal. “However, MACs should adjust those claims that are brought to their attention.”
Beth Cobb
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