Knowledge Base Category -
CMS issued a display copy of the FY 2024 IPPS Final Rule on Monday, August 1, 2023. This article contains a high-level look at the final operating payment rate changes, Rural Emergency Hospitals change, social determinants of health codes severity designation changes, when the New COVID-19 Treatment Add-On Payments are set to end, and updates to the Affordable Care Act Quality Programs.
Proposed Payment Rate Changes
The proposed increase in operating payment rates for general acute care hospitals paid under the IPPS that successfully participate in the Hospital Inpatient Quality Reporting (IQR) Program and meaningful electronic health record (EHR) use was 2.8%. This finalized increase is 3.1%.
The increase in operating and capital payment rates will generally increase hospital payments in FY 2024 by $2.2 billion.
Rural Emergency Hospitals (REHs) and Graduate Medical Education (GME)
REH’s became a new provider type effective January 1, 2023. You can read more about them in a related MLN Fact Sheet. CMS finalized their proposal to allow REH’s serve as training sites for Medicare GME payment purposes to “help support graduate medical training in rural areas.”
Severity Level Designation Change for Z Codes Describing Homelessness
The U.S. Department of Health and Human Services (HHS) defines Social Determinants of Health (SDOH) as "the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks." Effective February 18, 2018, the AHA Coding Clinic published advice allowing the reporting of SDOH codes Z55-Z65, based on information documented by all clinicians involved in the care of the patient.
For FY 2024, CMS finalized their proposal to change the severity level designation for diagnosis codes Z59.00 (Homelessness, unspecified), Z59.01 (Sheltered homelessness), and Z59.02 (Unsheltered homelessness) from NonCC to CC for FY 2024.
COVID-19 Treatment Add-On Payment (NCTAP) to End September 30, 2023
In response to the Public Health Emergency (PHE), CMS established NCTAP for eligible discharges during the PHE. In the FY 2022 final rule, CMS finalized the extension of NCTAP through the end of the FY in which the PHE ends. With the PHE ending on May 11, 2023, discharges involving eligible products would continue to be eligible for the NCTAP through September 30, 2023 (that is, through the end of FY 2023).”
Affordable Care Act Quality Programs
Hospital Readmission Reduction Program (HRRP)
CMS did not propose or finalize any changes to this value-based purchasing program that reduces payments to hospitals with excess readmissions.
Hospital-Acquired Condition (HAC) Reduction Program
This program creates an incentive for hospitals to reduce the incidence of hospital-acquired conditions by reducing payment by 1% for applicable hospitals ranking in the worst-performing quartile on select measures. For FY 2023, due to the ongoing COVID-19 PHE, no hospital was subject to the 1-percent payment reduction. You can read more about this program in a related FY 2023 CMS Fact Sheet.
For FY 2024, CMS finalized the proposal to establish a validation reconsideration process for hospitals who fail data validation beginning with the FY 2025 program year, affecting calendar year 2022 discharges. They also finalized modification of the validation targeting criteria to include hospitals granted extraordinary circumstances exceptions (ECEs) beginning with the FY 2027 program year, affecting calendar year 2024 discharges.
Hospital Value-Based Purchasing (VBP) Program
This is a budget-neutral program funded by reducing hospitals’ base operating DRG payments each fiscal year by 2% and redistributing the entire amount back to the hospitals as value-based incentive payments. Like the HAC Reduction Program, CMS finalized hospitals’ keeping the 2% payment due to the ongoing COVID-19 PHE. For FY 2024, CMS finalized several changes to this program for FY 2024, for example, CMS:
- Adopted the Severe Sepsis and Septic Shock: Management Bundle measure in the Safety Domain beginning with the FY 2026 program year.
- Adopted a modified version of the Medicare Spending Per Beneficiary (MSPB) Hospital measure beginning with the FY 2028 program year, and
- Adopted a modified version of the Hospital-level Risk-Standardized Rate (RSCR) Following Elective Primary Total Hip Arthroplasty (THA) and/or Total Knee Arthroplasty (TKA) measure beginning with the FY 2030 program year.
Resources
August 1, 2023 CMS Fact Sheet: FY 2024 Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Care Hospital Prospective Payment System (LTCH PPS) Final Rule – CMS-1785-F and CMS-1788-F Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/fy-2024-hospital-inpatient-prospective-payment-system-ipps-and-long-term-care-hospital-prospective-0
CMS FY 2024 Final Rule Home Page: https://www.cms.gov/medicare/acute-inpatient-pps/fy-2024-ipps-final-rule-home-pageBeth Cobb
CMS published the CY 2024 OPPS/ASC Proposed Rule on July 13, 2023. By now, many news outlets have authored articles about this proposed rule. This article highlights topics that historically our clients have reached out to us to learn about.
Medicare Inpatient Only (IPO) Procedure List
Although CMS received several requests recommending services for removal from the IPO list, CMS did not find sufficient evidence that met the criteria and did not propose to remove any service from the IPO list for CY 2024.
CMS has proposed to add nine services with newly created codes by the AMA CPT Editorial Panel which will be in effect January 1, 2024 to the list and to reassign CPT code 0646T (Transcatheter tricuspid valve implantation (ttvi)/replacement with prosthetic valve, percutaneous approach, including right heart catheterization, temporary pacemaker insertion, and selective right ventricular or right atrial angiography, when performed) from status indicator “E1” to status indicator “C.” The proposed changes are available in Table 47 of the proposed rule.
OPPS Payment Methodology for 340B OPPS Payment Methodology for Purchased Drugs and Biologicals
On July 7, 2023, CMS published a proposed rule, referred to as “remedy proposed rule” to address reduced payment amounts to 340B hospitals for CYs 2018 through 2022 and to comply with the statutory requirement to maintain budget neutrality. The “remedy proposed rule” proposes changes to the calculation of the OPPS conversion factor beginning in CY 2025.
In the “remedy proposed rule,” CMS proposes to make one time lump-sum payments to each of the approximately 1,600 340B covered entity hospitals. Addendum AAA to the proposed rule lists the proposed lump-sum payment for each eligible hospital.
For CY 2024, CMS proposes to continue to pay the statutory default rate, which is generally ASP plus 6 percent.
340B Modifiers “JG” and “TB”
The Inflation Reduction Act of 2022 expanded the provider types that must report one of these modifiers no later than January 1, 2024 to now include critical access hospitals, Maryland All-Payer or Total Cost of Care Model Hospitals, and Non-excepted off-campus provider-based departments (PBD).
In the CY 2023 OPPS/ASC final rule, CMS maintained the requirements that 340B hospitals report one of two modifiers, “JG” – Drug or biological acquired with 340B drug pricing program discount, reported for informational purposes, or “TB” – Drug or biological acquired with 340B drug pricing program discount, reported for informational purposes for select entities.
In the CY 2024 OPPS/ASC proposed rule, CMS notes they “now believe utilizing a single modifier will allow for greater simplicity, especially because both modifiers are used for the same purpose: to identify separately payable drugs and biologicals acquired under the 340B program.”
CMS is proposing that all 340B covered entity hospitals would report the “TB” modifier effective January 1, 2025, even if the hospital previously reported the “JG” modifier. The “JG” modifier will remain effective through December 31, 2024. Beginning January 1, 2025, the “JG” modifier would be deleted.
CMS notes hospitals currently using the “JG” modifier could choose to continue to use it in CY 2024 or choose to transition to the “TB” modifier during that year.
Payment for Intensive Cardiac Rehabilitation Services (ICR) Provided by an Off-Campus Non-Excepted Provider Based Department (PBD) of a Hospital
CMS identified a disparity in payment for ICR services between services provided in a physician’s office and the same services provided by an off-campus, non-excepted PBD and notes that this “creates a significant barrier to beneficiary access to an already underutilized service.”
To eliminate this unintended outcome CMS is proposing the following:
“Pay for ICR services provided by an off-campus, non-excepted provider-based department of a hospital at 100 percent of the OPPS rate for CR services (which is also 100 percent of the PFS rate) rather than at 40 percent of the OPPS rate,” and
“Effective January 1, 2024, we propose to exclude ICR from the 40 percent Relativity Adjuster policy at the code level by modifying the claims processing of HCPCS codes G0422 (Intensive cardiac rehabilitation; with or without continuous ECG monitoring with exercise, per session) and G0423 (Intensive cardiac rehabilitation; with or without continuous ECG monitoring without exercise, per session) so that 100 percent of the OPPS rate for CR is paid irrespective of the presence of the “PN’’ modifier (signifying a service provided in a non-excepted off-campus provider-based department of a hospital) on the claim.”
Proposed Additions to the ASC Covered Procedures List (CPL) for CY 2024
CMS is proposing to update the ASC CPL by adding 26 dental surgical procedures. They note that they “expect to continue to gradually expand the ASC CPL, as medical practice and technology continue to evolve and advance in future years,” and encourage stakeholders to submit procedure recommendations to be added to the ASC CPL.
Appropriate Use Criteria (AUC) for Advanced Diagnostic Imaging
Although this falls under the purview of the CY 2024 Physician Fee Schedule Proposed Rule, I often receive questions from clients regarding when CMS plans to fully implement this program.
In the proposed rule, CMS notes that they “exhausted all reasonable options for fully operationalizing the AUC program,” and “propose to pause implementation of the AUC program for reevaluation and rescind the current AUC program regulations from §414.94.” They “expect this to be a hard pause to facilitate thorough program reevaluation and, as such…are not proposing a time frame within which implementation efforts may recommence.”
The comment period for the CY 2024 Hospital OPPS/ASC and Physician Fee Schedule Proposed Rules ends on September 11, 2023. I encourage you to take the time to review the proposed rules and submit comments.
Resources
Hospital Outpatient Prospective Payment-Notice of Proposed Rulemaking with Comment Period CY
Hospital Outpatient Prospective Payment Remedy for the 340B-Acquired Drug Payment Policy-Notice of Proposed Rulemaking with Comment Period: https://www.cms.gov/medicare/medicare-fee-service-payment/hospitaloutpatientpps/hospital-outpatient-regulations-and/cms-1793-p
MLN Fact Sheet: Medicare Part B Inflation Rebate Guidance: Use of the 340B Modifier (MLN4800856 March 2023): https://www.cms.gov/files/document/mln4800856-medicare-part-b-inflation-rebate-guidance-use-340b-modifier.pdf
CY 2024 Physician Fee Schedule Proposed Rule: https://www.cms.gov/medicare/medicare-fee-for-service-payment/physicianfeesched
Beth Cobb
Medicare Transmittals & MLN Articles
June 30, 2023: MLN MM13269: ICD-10 & Other Revisions to Laboratory National Coverage Determinations: October 2023 Update
CMS advises that you make sure your billing staff is aware of newly available codes, recent coding changes, and how to find NCD coding information. https://www.cms.gov/files/document/mm13269-icd-10-other-coding-revisions-laboratory-ncds-october-2023-update.pdf
July 5, 2023: MLN Matters MM13216: Ambulatory Surgical Center Payment System: July 2023 Update - Revised
Now in it’s fourth iteration, CMS has revised this MLN article to change the number of separately payable drugs in Section 5.a to 18 to agree with the change for HCPCS J9322 in Table 3 of Change Request (CR) 13216. Substantive changes are in dark red on page 3. https://www.cms.gov/files/document/mm13216-ambulatory-surgical-center-payment-system-july-2023-update.pdf
July 11, 2023: MLN SE19007: Activation of Validation Edits for Providers with Multiple Service Locations – Revised
Now in its fifth iteration, CMS has revised this special edition MLN article to add information on Round 5 testing and national implementation of edits. Substantive changes are in dark red on pages 1 and 4. Note that these are not new requirements, but CMS did announce a delay of activation of these edits on March 24, 2022 until further notice. On August 1, 2023, CMS will start deploying editing into full procedure and have told the MACs to develop implementation plans to permanently turn on the Reason Codes and set them up to RTP claims that don’t match exactly. https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnmattersarticles/downloads/se19007.pdf
Coverage Updates
July 17, 2023: Beta Amyloid Positron Emission Tomography in Dementia and Neurodegenerative Disease Proposed Decision Memo
CMS is proposing to remove National Coverage Determination (NCD) 220.6.20, ending coverage with evidence development (CED) from positron emission tomography (PET) beta amyloid imaging and permitting Medicare coverage determinations for PET beta amyloid imaging be made by the Medicare Administrative Contractors (MACs). https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=308
July 20, 2023: HCPCS Modifier JZ Reminder
Palmetto GBA JJ Part B published a reminder that “the JZ HCPCS modifier is reports on a claim to attest that no amount of drug was discarded and eligible for payment. The modifier should only be used for claims that bill for single-dose container drugs. Effective July 1, 2023 providers are required to use the JZ modifier on applicable claims. https://www.palmettogba.com/palmetto/jjb.nsf/DID/1HF9LYKONE#ls
Compliance Education Updates
June 2023: Medicare’s Home Health Benefit Brochure Revised
CMS has revised their Medicare home health brochure. This brochure includes information about a beneficiary knowing their rights, where to get more information, what is covered, who can get covered home health care, what to pay, and how to protect yourself and Medicare from fraud. https://tinyurl.com/yc2ej3sv
June 2023: MLN Fact Sheet Telehealth Services Revised
CMS has recently updated this Fact Sheet and notes that they have made significant updates to explain recent policy changes. https://www.cms.gov/files/document/mln901705-telehealth-services.pdf
Beth Cobb
June 29, 2023 HHS Press Release: CDC Recommends Older and Immunocompromised Adults to Receive the RSV Vaccine
HHS Secretary Xavier Becerra issued the following statement in response to the CDC recommendation of the Respiratory Syncytial Virus (RSV) vaccine for seniors over 60: “For the first time in U.S. history, people 60 years and older can now receive a vaccine for protection against RSV virus…As we prepare for the fall vaccine campaign, we will follow the data and science to protect our nation’s most vulnerable adults, those living in nursing or long-term care facilities, and the immunocompromised.” https://tinyurl.com/yw9buepd
June 29, 2023: MLN Connects: New TCET Pathway
CMS published the following information in the June 29, 2023 edition of MLN Connects:
CMS is committed to fostering innovation while ensuring that people with Medicare have faster and more consistent access to emerging technologies that will improve health outcomes. As part of this commitment, CMS announced a proposed Transitional Coverage for Emerging Technologies pathway. This announcement includes a proposed procedural notice and several proposed guidance documents that propose a substantial transformation to our approach to coverage reviews and evidence development. Comment on the Federal Register notice by August 28. More Information:
Related CMS Blog: https://www.cms.gov/blog/transforming-medicare-coverage-new-medicare-coverage-pathway-emerging-technologies-and-revamped, and
CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/notice-comment-transitional-coverage-emerging-technologies-cms-3421-nc
June 29, 2023: MLN Connects: New Details of Plan to Cover New Alzheimer’s Drugs
CMS released new details about how people can get drugs that may slow the progression of Alzheimer’s disease covered by Medicare. Medicare will cover drugs with traditional FDA approval when a physician and clinical team participates in the collection of evidence about how these drugs work in the real world, also known as a registry. Clinicians will be able to submit this information through a nationwide, CMS-facilitated portal. Related CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/cms-announces-new-details-plan-cover-new-alzheimers-drugs
July 7, 2023: OPPS: Remedy for the 340B-Acquired Drug Payment Policy for Calendar Years 2018-2022 Proposed Rule (CMS 1793-P)
In response to the Supreme Court’s decision in American Hospital Association v. Becerra (142 S. Ct. 1896 (2022), and the district court’s remand, CMS published a proposed rule to remedy the payment rates the Court held were invalid and noted that aspects of this proposed rule policy will affect nearly all hospitals paid under the OPPS. The proposed rule contains the calculations of the amounts owed to each of the approximately 1,600 affected 340B covered entity hospitals. The 60-day comment period will end on September 5, 2023.
Proposed Rule: https://www.cms.gov/medicare/medicare-fee-service-payment/hospitaloutpatientpps/hospital-outpatient-regulations-and/cms-1793-p
Related CMS Fact Sheet: https://www.cms.gov/newsroom/fact-sheets/hospital-outpatient-prospective-payment-system-remedy-340b-acquired-drug-payment-policy-calendar
July 12, 2023: Medicare Dental Services
CMS has created a Medical Dental Coverage webpage for health care providers. You will find links to information about what Medicare does and does not cover, what are inextricably linked dental services, if Medicare pays for multiple dental visits, who can provide and bill for dental services, how to submit a claim and additional resources. https://www.cms.gov/Medicare/Coverage/MedicareDentalCoverage
Beneficiary Notice of Noncoverage, Form CMS-R-131 Renewed
Reminder, the ABN, Form CMS-R-131, and form instructions have been approved by the Office of Management and Budget (OMB) for renewal. The renewed form has an expiration date of January 31, 2026, and became mandatory on June 30, 2023. Any ABN signed on or after June 30, 2023, with a prior expiration date will not be considered valid. https://www.cms.gov/medicare/medicare-general-information/bni/abn
July 20, 2023: The Joint Commission Eliminates Additional 200 Standards Across All Accreditation Programs
The Joint Commission announced in a press release that they are eliminating and consolidating more than 200 standards, effective August 27, 2023. “The second phase of this project includes a focus on The Joint Commission’s other accreditation programs in addition to the Hospital Accreditation Program (i.e., Ambulatory Health Care, Behavioral Health Care, and Laboratory). https://www.jointcommission.org/resources/news-and-multimedia/news/2023/07/the-joint-commission-eliminates-additional-200-standards-across-all-accreditation-programs/Beth Cobb
There are five covered indications in section B of National Coverage Determination (NCD) 20.7 Percutaneous Transluminal Angioplasty (PTA) for when PTA is covered.
In June 2022, the Multispecialty Carotid Alliance (MSCA) submitted a letter to CMS for reconsideration of covered indication B4 (concurrent with carotid stent placement in patients at high risk for carotid endarterectomy (CEA).
Last week, on July 11, 2023, CMS published Proposed Decision Memo CAG-00085R8: Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting. CMS notes, the scope of this reconsideration is limited to PTA concurrent with CAS including transcarotid artery revascularization (TCAR) procedures.
CMS summarizes that their proposals, which affect NCD 20.7 sections B4 and D, will revise Medicare coverage for PTA of the carotid arteries concurrent with stenting by:
- Expanding coverage to individuals previously only eligible for coverage in clinical trials.
- Expanding coverage to standard surgical risk individuals by removing the limitation of coverage to only high surgical risk individuals.
- Removing facility standards and approval requirements.
- Adding formal shared decision-making with the individual prior to furnishing CAS; and
- Allowing MAC discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.
CAS By the Numbers
CY 2022 PTA of Carotid Artery Concurrent with Stenting Top 5 States by Volume & Overall Nationwide |
||
Provider State |
Claims Volume |
Total Claims Payment |
FL |
1,250 |
$19,318,373.57 |
TX |
1,158 |
$20,279,078.22 |
CA |
1,007 |
$24,699,603.30 |
PA |
541 |
$10,394,841.24 |
NY |
523 |
$13,379,059.31 |
Nationwide |
13,471 |
$246,555,039.68 |
Data Source: RealTime Medicare Data (RTMD) Medicare Fee-for-Service paid claims data for DOS CY 2022 |
Moving Forward
CMS is seeking comments on whether the shared decision-making interaction should require the use of a validated shared decision-making tool and/or if there are other options to achieve the goal of truly informed decision-making. The comment period is from July 11, 2023 through August 10, 2023.
Resources
NCD 20.7: https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=201
Proposed Decision Memo CAG-0085R8: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&ncaid=311&fromTracking=Y&
Beth Cobb
Did You Know?
June is cataract awareness month and according to the National Eye Institute (https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/cataracts), most cataracts are age-related, there are no early symptoms of cataracts and later symptoms includes blurry vision, colors that seem faded, sensitivity to light, trouble seeing at night and double vision.
A cataract is diagnosed by a dilated eye exam and the treatment is surgery. Cataract surgery is one of the most common operations in the United States. In fact, more than half of all Americans aged eighty or older either have cataracts or have had surgery to get rid of cataracts.
Why it Matters?
Being a high-volume surgery, means scrutiny by CMS and Medicare Contractors to assure documentation in the medical record supports medical necessity of the procedure.
Recovery Audit Contractors
RAC Issue 0002 cataract removal (https://www.cms.gov/Research-Statistics-Data-and-Systems/Monitoring-Programs/Medicare-FFS-Compliance-Programs/Recovery-Audit-Program/Approved-RAC-Topics-Items/0002-Cataract-Removal-Medical-Necessity-and-Documentation-Requirements) has been an approved complex review for procedures performed in the outpatient hospital setting and ambulatory surgery centers (ASCs) since February 1, 2017. RACs will review documentation to determine if cataract surgery meets Medicare coverage criteria, meets applicable coding guidelines, and/or is medically reasonable and necessary. Applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) are included on this RAC issue webpage.
Comprehensive Error Rate Testing (CERT)
In the 2021 and 2022 CERT Medicare Fee-for-Service supplemental improper payment report, cataract removal and lens insertion is listed in Table D1: Top 20 Service Types with Highest Improper Payments: Part B (https://www.cms.gov/files/document/2021-medicare-fee-service-supplemental-improper-payment-data.pdf-0).
2021 CERT Report
The improper payment rate for this surgery was 12.7%. The CERT cited two types of errors, insufficient documentation, and incorrect coding, as being the cause of improper payments. Specifically,
the insufficient documentation project improper payment was $190,495,888 and the incorrect coding improper payment was $27,844,602.
2022 CERT Report
The improper payment rate for this surgery was 8.3%. Unlike 2021, 100% of the errors were due to insufficient documentation. The project improper payment rate was $146,067,233.
Medicare Administrative Contractors (MACs)
JE and JF MAC: Noridian
Cataract surgery has been a review target for Noridian MAC jurisdictions for a few years. Their most recent review findings were for claims with dates of service from January 1, 2023 through March 31, 2023.
Review results for jurisdictions were published April 12, 2023:
- Noridian JE error rate of 48.67%. https://med.noridianmedicare.com/web/jea/cert-review/mr/review-results
- Noridian JF error rate 45.88%. https://med.noridianmedicare.com/web/jfa/cert-review/mr/review-results
Noridian’s review results articles include top denial reasons, educational resources, and education regarding the medical necessity for cataract surgery.
Supplemental Medical Review Contractor (SMRC)
On February 16, 2022, the SMRC published a notification of their intent to review cataract surgeries performed in the physician office, outpatient hospital and specialty facility clinical access hospitals. In the background section of the notification, they note that “this type of surgery has been a topic of interest for the Office of Inspector General (OIG) for a number of years. The OIG looked into surgery in both the outpatient facility and ambulatory service center settings. CMS data reflects a potential vulnerability.”
The SMRC published review results on September 27, 2022 (https://noridiansmrc.com/completed-projects/01-302/). The error rate was 51%.
What Can You Do?
With so many entities focused on reviewing cataract surgery claims, moving forward providers should:
- Respond to ADRs in a timely manner,
- Become familiar with medical necessity indications and documentation requirements detailed in Medicare coverage documents (NCDs, LCDs, LCAs),
- Be aware of who is performing cataract surgery reviews,
- Read published review results to understand reasons for denials and ways to prevent future denials, and
- Ensure physicians performing these procedures are also aware of Medicare coverage requirements.
Beth Cobb
Did You Know?
According to the American Lung, about 10 to 30% of adults in the U.S. may have sleep apnea and your risk increases with age and weight. One relatively new treatment for this condition is Hypoglossal Nerve Stimulation (HNS).
Effective January 1, 2022, there were three new CPT codes related to implantation, revision, or removal of the HNS system. A few months later, on June 7, 2022, the first RAC approved issue in 2022 was RAC Issue 0201 (Hypoglossal Nerve Stimulation for Obstructive Sleep Apnea: Medical Necessity and Documentation Requirements). You can read more about this in a related MMP article.
The affected CPT code for RAC Issue 0201 is 64582 (open implantation of hypoglossal nerve neurostimulator array, pulse generator and distal respiratory sensor electrode or electrode array). The following table highlights the place of service, volume and claims paid in CY 2022 for this CPT code.
Place of Service |
Procedure Volume |
SumCPT Paid |
Inpatient Hospital |
113 |
$28,771.66 |
Outpatient Hospital |
5,962 |
$2,702,754.78 |
Ambulatory Surgery Center (ASC) |
958 |
$4,486,802.84 |
Overall Totals |
7,033 |
$7,218,329.28 |
Data Source: RealTime Medicare Data (RTMD) CY 2022 Medicare Fee-For-Service nationwide paid claims. |
Why It Matters?
Medicare Administrative Contractors (MACs) have published Local Coverage Determinations (LCDs) and related coding and billing articles for this procedure. Currently, two of the indications are a body mass index (BMI) less than 35 kg/m2, and a polysomnography (PSG) demonstrating an apnea-hypopnea index (AHI) of 15 to 65 events per hour within 24 months of initial consultation for HNS implant.
In the U.S. Food & Drug Administration’s June 9, 2023 FDA Roundup, they announced they have approved an expanded indication for the Inspire Medical Systems’ Inspire Upper Airway Stimulation (UAS) System to include an updated AHI and BMI threshold.
“The safety and effectiveness data available now increased the AHI baseline to 100 and a BMI level of 40 for adults with moderate to severe Obstructive Sleep Apnea (OSA).”
What Can I Do?
With this device being on the RAC approved issue list you should:
- Be mindful of the timing of the FDA’s expanded indications in the event you receive a request for records for dates of service on or after June 9, 2023.
- Watch for updated indication information in your MACs related LCD.
- Share this information with key stakeholders.
Resources
American Lung Association article Learn About Sleep Apnea at https://www.lung.org/lung-health-diseases/lung-disease-lookup/sleep-apnea/learn-about-sleep-apnea
FDA Roundup: June 9, 2023: https://www.fda.gov/news-events/press-announcements/fda-roundup-june-9-2023
Beth Cobb
Coverage Updates
May 9, 2023: U.S. Preventive Services Task Forces (USPSTF) Posts Draft Recommendation Statement for Screening Breast Cancer
The USPSTF issued a draft recommendation indicating that science now shows all women should get screened for breast cancer every other year starting at age 40. This recommendation applies to women at average risk of breast cancer and includes people with a family history of breast cancer, and people who have other risk factors, such as dense breasts. https://uspreventiveservicestaskforce.org/uspstf/sites/default/files/file/supporting_documents/breast-cancer-screening-draft-rec-bulletin.pdf
Compliance Education Updates
MLN Fact Sheet: Clinical Laboratory Fee Schedule
This fact sheet has been updated to include the CY 2023 specimen collection amounts and flat-rate travel allowance. https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/clinical-laboratory-fee-schedule-fact-sheet-icn006818.pdf
MLN Fact Sheet: Skilled Nursing Facility 3-Day Rule Billing
The end of the COVID-19 PHE brought an end to the 3-day prior hospitalization waiver. CMS has updated this MLN Fact Sheet to remove language related to this waiver. For Case Managers hired during the pandemic, this is a must read to help understand what is required for your Medicare Fee-for-Service beneficiary to qualify for admission to a Skilled Nursing Facility. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/SNF3DayRule-MLN9730256.pdf
COVID-19 Updates
May 19, 2023: End of COVID-19 PHE FAQs Updates
Learn about updates to the Frequently Asked Questions: CMS Waivers, Flexibilities, and the End of the COVID-19 Public Health Emergency (questions 21-23 on page 9). For example, CMS answers the question, can hospitals bill for outpatient physical therapy (PT), occupational therapy (OT), speech language therapy (SLF) services, Diabetes Self-Management Training (DSMT), or Medical Nutrition Therapy (MNT) provided to beneficiaries in their homes through telecommunication technology by hospital-employed staff?
May 25, 2023: FDA Approved Oral Antiviral Paxlovid for Treatment of Mild to Moderate COVID-19
This drug is for use in adults at high risk for progression to severe CODI-19, including hospitalization and death. Approved during the COVID-19 PHE, Patrizia Cavazzoni, M.D., director for the FDA’s Center for Drug Evaluation and Research notes that “Today’s approval demonstrates that Paxlovid has met the agency’s rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19.” https://content.govdelivery.com/accounts/USFDA/bulletins/35c86d9
Other Updates
Comprehensive Error Rate Testing (CERT) Review Contractor: Same Company, New Name
The CERT review contractor, formerly known as NCI Information Systems, Inc. has changed their company name to Empower AI, Inc. Their email domain is @empower.ai.
You can learn more about changes to the CERT Contractors (Review Contractor and Statistical Contractor) in a related Palmetto GBA article at https://www.palmettogba.com/palmetto/jja.nsf/DID/M5PPHI24YK#ls
May 4, 2023 MLN Connects: May is National Mental Health Month
CMS notes in the May 4th edition of MLN connects that 20% of Americans experience mental illness each year and disproportionately affects racial and ethnic minority groups. I encourage you to read this edition of MLN Connects to learn about appropriate preventive services covered by Medicare (i.e., Depression Screening) and additional mental health resources made available by CMS. https://www.cms.gov/outreach-and-education/outreach/ffsprovpartprog/provider-partnership-email-archive/2023-05-04#_Toc134022248
May 24, 2023: Inpatient Rehabilitation Review Choice Demonstration and Targeted Probe and Educate
Palmetto GBA clarifies that this demonstration is for IRF providers that are physically located in and bill to the state of Alabama. Also, any current TPE reviews in process prior to June 1, 2023, will continue the normal medical review course until completion. https://www.palmettogba.com/palmetto/jja.nsf/DID/M8URLP6DJM#lsBeth Cobb
Medicare Transmittals & MLN Articles
April 27, 2023: MLN MM12889: New Fiscal Intermediary Shared System Edit to Validate Attending Provider NPI
This MLN article issued October 6, 2022 has been revised to add information to explain how to verify attending physician information. https://www.cms.gov/files/document/mm12889-new-fiscal-intermediary-shared-system-edit-validate-attending-provider-npi.pdf
May 4, 2023: MLN MM13195: Clinical Laboratory Fee Schedule & Laboratory Services Reasonable Charge Payment: Quarterly Update
This article includes information the COVID-19 PHE expiration, the next Clinical Laboratory Fee Schedule data reporting period, the general specimen collection fee increase, and new and discontinued HCPCS codes. https://www.cms.gov/files/document/mm13195-clinical-laboratory-fee-schedule-laboratory-services-reasonable-charge-payment-quarterly.pdf
May 4, 2023: MLN MM13180: Home Dialysis Payment Adjustment & Performance Payment Adjustment for ESRD Treatment Choices Model: Updated Process
Billing staff for physicians and End Stage Renal Disease (ESRD) facilities assigned to the ESRD Treatment Choices (ETC) Model should know about adjustments to claim lines on type of bill 072X with condition codes 74 or 76. They also need to know about monthly capitation payment (MCP) claims on claim lines with CPT codes 90957-90962 and 90965-90966. https://www.cms.gov/files/document/mm13180-home-dialysis-payment-adjustment-performance-payment-adjustment-esrd-treatment-choices-model.pdf
May 16, 2023: MLN MM13071: Travel Allowance Fees for Specimen Collection: 2023 Updates
Initially released January 9, 2023, this article was revised May 16, 2023 to delete the phrase “including Medicare Advantage” from the Travel Allowance Policy section of this article. https://www.cms.gov/files/document/mm13071-travel-allowance-fees-specimen-collection-2023-updates.pdf
May 17, 2023: MLN MM13064: Updating Medicare Manual with Policy Changes in the CY 2020 & CY 2023 Final Rules
Billing staff for physicians, hospitals, suppliers, and other providers billing MACs for services provided to Medicare patients need to be aware of the updated billing instructions for nursing facility visits code family, hospital inpatient or observation care code family, and substantive portion of a split, or shared, visit. https://www.cms.gov/files/document/mm13064-updating-medicare-manual-policy-changes-cy-2020-cy-2021-final-rules.pdf
May 18, 2023: Transmittal 12047: Educational Instructions for the Implementation of the Medicare Payment Provisions for Dental Services as Finalized in the CY 2023 Physician Fee Schedule (PFS) Final Rule
The Change Request (CR 13190) provides further clarity to and directs the A/B MACs to develop educational materials to aid in the implementation of the Medicare payment policies for dental services as described in Section II.L of the CY 2023 PFS final rule. This guidance is intended to facilitate a consistent application of the payment policy nationally, with MACs providing payment for more types of dental services associated with a broader set of medical services than before CY 2023. https://www.cms.gov/files/document/r12047bp.pdf
May 19, 2023: MLN MM13192: HCPCS Codes Used for Skilled Nursing Facility Consolidated Billing Enforcement: July 2023 Quarterly Update
Information in this MLN article includes updates to the list of HCPCS codes subject to the CB provision of the SNF prospective payment system (PPS) as well as additions and deletions of certain chemotherapy and vaccine codes from the Medicare Part B SNF files. https://www.cms.gov/files/document/mm13192-hcpcs-codes-used-skilled-nursing-facility-consolidated-billing-enforcement-july-2023.pdf
May 23, 2023: MLN MM13210: Hospital Outpatient Prospective Payment System: July 2023 Update
This article describes coding changes and policy effective July 1, 2023, for the hospital OPPS including payment system updates and new codes for COVID-19, drugs, biologicals, and radiopharmaceuticals, devices and other items and services. https://www.cms.gov/files/document/mm13210-hospital-outpatient-prospective-payment-system-july-2023-update.pdf
May 23, 2023: MLN SE22001: Mental Health Visits via Telecommunications for Rural Health Clinics & Federally Qualified Health Centers
First released March 30, 2022, in this fourth iteration, CMS revised the article to show a legislative change about in-person visits and added modifier 93 for reporting audio-only mental health visits. For RHCs and FQHCs, CMS will not require in-person visits until January 1, 2025. https://www.cms.gov/files/document/se22001-mental-health-visits-telecommunications-rural-health-clinics-federally-qualified-health.pdf
May 25, 2023: MLN MM13216: Ambulatory Surgical Center Payment System: 2023 Update
CMS advises that providers make sure your billing staff know about payment system updates, including new drug biological and procedure codes, an ASC Payment Indicator (PI) correction for CPT code 0698T, and additional skin substitute products. https://www.cms.gov/files/document/mm13216-ambulatory-surgical-center-payment-system-july-2023-update.pdfBeth Cobb
The CMS Review Choice Demonstration for Inpatient Rehabilitation Facility (IRF) Services is set to begin in Alabama in August 2023. You can read more about the program and choices that Alabama IRF providers will need to make in a related article in this week’s newsletter.
This article looks back at past IRF claims reviews and resources available to providers on Palmetto GBA’s website, the Medicare Administrative Contractor (MAC) for Alabama.
Prior IRF Claims Reviews
Office of Inspector General (OIG)
In September 2018, the OIG published the report “Many Inpatient Rehabilitation Facility Stays Did Not Meet Medicare Coverage and Documentation Requirements” (A-01-15-00500). The audit covered $6.75 billion in Medicare payments to 1,139 IRFs nationwide for 370,872 IRF stays. The objective was to determine if IRFs complied with Medicare coverage and documentation requirements for claims for services provided in 2013. Based on sample results, the OIG estimated that Medicare paid IRF’s $5.7 billion for care to beneficiaries that was not reasonable and necessary.
The OIG noted errors occurred because many IRFs did not have adequate internal controls to prevent inappropriate admissions; Medicare Part A FFS lacked a prepayment review for IRF admissions and CMS’ extensive educational efforts and post payment reviews were unable to control an increasing improper payment rate reported by CERT.
https://oig.hhs.gov/oas/reports/region1/11500500.asp
Supplemental Medical Review Contractor (SMRC)
Based on the 2018 OIG report findings, CMS tasked Noridian, the current SMRC, to complete a review of Medicare Part A IRF claims for CY 2018 claims. Noridian published their review results in October 2021 and reported a 33% error rate. I encourage you to read their review results as it includes common reasons for denial and references and resources.
https://noridiansmrc.com/completed-projects/01-025/
Comprehensive Error Rate Testing (CERT)
The OIG noted in the above 2018 report the CERT program found that the error rate for IRFs had increased, ranging from 9 percent in 2012 to a high of 62 percent in 2016. Although the error rate has decreased in subsequent years, the Improper Payment Rate remained high at 19.3 percent in 2022 with close to $7M projected improper payments.
Active OIG Work Plan Item: Inpatient Rehabilitation Facility Nationwide Audit
In this active issue description, the OIG notes that in fiscal year 2021, Medicare paid approximately $8.7 billion for 373,000 IRF stays nationwide. The CERT has consistently found high error rates, and their Hospital Compliance audits also frequently include IRF claims and have similarly found high error rates.
“In response to these findings, IRF stakeholders have stated that Medicare audit contractors and OIG have misconstrued the IRF coverage regulations. To better understand which claims IRFs believe are properly payable by Medicare, OIG needs more information from the IRF stakeholders. We plan to determine whether there are areas in which CMS can clarify Medicare IRF claims payment criteria. In addition, we will follow up on recommendations from our prior IRF audit, A-01-15-00500. We believe data and input from IRF stakeholders are critical to identifying any specific areas that might require clarification and will result in more meaningful recommendations and a greater positive impact on the program.”
https://oig.hhs.gov/reports-and-publications/workplan/summary/wp-summary-0000729.asp
Palmetto GBA IRF Education Resources
IRF Avoiding Common Billing Issues Module
Palmetto notes their goal with this module is to ensure providers are in compliance with Medicare coverage, coding, and billing rules so that payments will not be delayed.
https://www.palmettogba.com/palmetto/jja.nsf/DID/HBEIF25RPF#ls
Did You Miss It? Jurisdictions J, M Current Year 2023 IRF Webinar
Palmetto has made available a webinar on demand where Palmetto discusses IRF documentation requirements, Targeted Probe and Educate (TPE), CERT and the FY 2023 IRF Final Rule.
https://www.palmettogba.com/palmetto/jja.nsf/DID/000GWG3K8O#ls
Inpatient Rehabilitation Facility (IRF) Resources
This Palmetto GBA article provides links to the CMS IRF Prospective Payment System educational tool and a Medicare Learning Network web-based training course that includes information about IRF services, documentation requirements and the CERT program.
Moving Forward
If you are an IRF provider, I encourage you to share this information with key stakeholders.Beth Cobb
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