This week in Medicare updates—10/5/2022
Changes to the Laboratory National Coverage Determination (NCD) Edit Software for January 2023
On September 1, CMS published Medicare Claims Processing Transmittal 11583 regarding the January 2023 quarterly update to the edit module for clinical diagnostic laboratory services.
Effective date: January 1, 2023 - Unless noted differently in requirements
Implementation date: January 3, 2023
Artificial Hearts and Related Devices - Retired
On September 1, CMS published a Notice regarding NCD 20.9 (Artificial Hearts and Related Devices) to note that effective December 1, 2020, this section has been removed from the NCD Manual as coverage of artificial hearts and related devices are now being made by the MACs.
This change was implemented via Medicare National Coverage Determinations Transmittal 10837, which was published June 11, 2021.
Reducing Medicare’s Payment Rates for Intermittent Urinary Catheters Can Save the Program and Beneficiaries Millions of Dollars Each Year
On September 6, the OIG published a Report regarding Medicare’s payments for intermittent urinary catheters and the methods available to reduce payment rates for these catheters. The OIG found that Medicare is paying way more for intermittent catheters ($407 million) than suppliers are paying to acquire these catheters ($121 million). The OIG said there is a potential for savings across all categories of catheters, and while it acknowledged that suppliers face other costs aside from simply acquisition costs, it said the difference in the acquisition costs and the Medicare payments is far too vast.
The OIG recommends Medicare lower payment rates for intermittent urinary catheters and noted that CMS has previously protected beneficiary access by using competitive bidding or an inherent reasonableness process when seeking to obtain savings for other items. CMS said it would take the OIG’s recommendation under consideration as it determines next steps.
Certain Medicare Beneficiaries Were More Likely Than Others to Use Telehealth During the First Year of the COVID-19 Pandemic
On September 7, the OIG published a Data Brief regarding telehealth use during the COVID-19 pandemic. The data brief is part of a series of OIG analyses examining the use of telehealth in Medicare and potential program integrity concerns related to telehealth during the pandemic. This data brief examines the types of beneficiaries who were more likely to use telehealth. The OIG found beneficiaries in urban areas were more likely to use telehealth, as were dually eligible, hispanic, younger, and female beneficiaries. Telehealth use was also most common in Massachusetts, Delaware, and California. It found beneficiaries almost always used telehealth from home or other non-healthcare settings.
The OIG recommends that as CMS, HHS, and Congress consider permanent changes to Medicare telehealth services, they should balance concerns about access, quality of care, cost, health equity, and program integrity. It also recommends CMS take steps to enable a successful transition from current pandemic-related flexibilities to long-term policies for the use of telehealth in urban areas and from the beneficiary’s home. In addition, the OIG recommends CMS temporarily extend the use of audio-only telehealth services and evaluate their impact, require a modifier to identify all audio-only telehealth services provided in Medicare, and use telehealth to advance health care equity.
Medicare Telehealth Services During the First Year of the Pandemic: Program Integrity Risks
On September 7, the OIG published a Data Brief as part of a series of OIG analyses examining the use of telehealth in Medicare and potential program integrity concerns related to telehealth during the pandemic. This data brief examines provider billing for telehealth services and identifies ways to safeguard Medicare from fraud, waste, and abuse. For the data brief, the OIG focused its analysis on 742,000 providers who billed for telehealth services between March 1, 2020 - February 28, 2021. The OIG developed seven measures to identify high-risk telehealth billing (such as billing for both telehealth and a facility fee for a majority of visits, billing for both fee-for-service and a Medicare Advantage plan for the same service for a high proportion of services, etc.) and set high thresholds for those measures in an aim to identify providers whose billing poses a high risk to Medicare. The OIG noted that the specificity of this analysis does not capture all concerning billing related to telehealth in Medicare and said incident-to billing is hard for them to monitor in these types of reviews but can also pose a program integrity risk.
Overall, the OIG identified 1,714 providers whose telehealth billing seems to pose a high risk to Medicare. These providers received a total of $127.7 million in Medicare fee-for-service payments. The OIG said more than half of the high-risk providers are part of a medical practice where at least one other provider’s billing also seemed to pose a high risk to Medicare, suggesting that certain practices are encouraging a certain type of billing among their providers. The OIG recommends CMS strengthen monitoring and targeted oversight of telehealth services, provide additional education to providers on appropriate billing for telehealth services, improve transparency of incident-to services when clinical staff primarily delivered the telehealth service, identify telehealth companies that bill Medicare, and follow up on providers identified in the report. CMS concurred with recommendations to follow up with providers identified in the report but did not indicate whether it concurred with any other recommendations.
October 2022 Integrated Outpatient Code Editor (I/OCE) Specifications Version 23.3
On September 9, CMS published Medicare Claims Processing Transmittal 11593 regarding the October update to the I/OCE.
Effective date: October 1, 2022
Implementation date: October 3, 2022
October 2022 Update of the Hospital Outpatient Prospective Payment System (OPPS)
On September 9, CMS published Medicare Claims Processing Transmittal 11594 regarding the October update to the OPPS. Changes include new COVID-19 CPT Vaccines and Administration codes, status indicator revisions for bone density studies, skin substitute coding changes, and more.
On September 13, CMS published MLN Matters 12885 to accompany the transmittal.
Effective date: October 1, 2022
Implementation date: October 3, 2022
Updated EUA for Pfizer, Moderna Vaccines
On September 12, CMS updated its COVID-19 Toolkit to note that the FDA revised the Emergency Use Authorization (EUA) for the Pfizer and Moderna COVID-19 vaccine on August 31 to authorize use for the bivalent formulations of the vaccines as a booster dose. CMS noted that patients may refer to this as the “updated COVID-19 vaccines.”
CMS added information about coding for the bivalent vaccines to its COVID-19 Vaccines and Monoclonal Antibodies page. Payment remains the same ($40 per dose) for the bivalent doses as it does for other doses. CMS published a News Alert about the bivalent doses on the same date.
Analysis of Coverage with Evidence Development Criteria
On September 12, CMS published an Announcement saying it will convene the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) to examine the requirements for clinical studies submitted for CMS coverage under Coverage with Evidence Development (CED). CMS noted that it has been almost eight years since it last evaluated and codified criteria for CED.
The meeting will be held on December 7.
Medicare Advantage Compliance Audit of Specific Diagnosis Codes that Regence Blue Cross Blue Shield of Oregon Submitted to CMS
On September 13, the OIG published a Review of whether select diagnosis codes that Regence Blue Cross Blue Shield of Oregon submitted to CMS for use in the risk adjustment program complied with federal requirements. The OIG conducted the audit by sampling 179 unique enrollee-years with high-risk diagnosis codes for which Regence received higher payments for 2015 and 2016. The OIG found that diagnosis codes for 111 of the 179 enrollee-years did not comply with federal requirements because there was not sufficient support for those codes in the medical records. The OIG estimated that based on the results of the sample, Regence received at least $1.8 million in net overpayments in 2015 and 2016.
The OIG recommended that Regence refund the federal government for the $1.8 million in net overpayments, identify and return similar overpayments, and continue its examination of its policies and procedures to identify areas where improvements can be made to ensure diagnosis codes at high risk for being miscoded comply with federal requirements. Regence disagreed with the OIG’s findings and recommendations, but the OIG maintained that its findings and recommendations were correct.
Annual Clotting Factor Furnishing Fee Update 2023
On September 13, CMS published Medicare Claims Processing Transmittal 11596, which rescinds and replaces Transmittal 11567, dated August 18, to remove the Durable Medical Equipment MACs from business requirement 12860.2. The original transmittal was published regarding the annual update to the clotting factor furnishing fee, which will be $0.250 per unit in 2023.
Effective date: January 1, 2023
Implementation date: January 3, 2023
Updated OIG Work Plan
On September 15, the OIG updated its Work Plan with the following new items:
Opioid Overdoses and the Limited Treatment of Opioid Use Disorder Continue to be Concerns for Medicare Beneficiaries
On September 15, the OIG published a Data Brief regarding opioid use, access to treatment for beneficiaries with opioid use disorder, and access to naloxone among Medicare Part D beneficiaries in 2021. The OIG found that about 50,400 Part D beneficiaries experienced an opioid overdose in 2021, but that number is likely higher because it does not account for any beneficiaries who overdosed but did not receive medical care that was billed to Medicare. The number of prescribers ordering opioids for large numbers of beneficiaries at serious risk stayed steady with previous years, and over one million Medicare beneficiaries had a diagnosis of opioid use disorder in 2021. Fewer than 1 in 5 of the one million Medicare beneficiaries with that diagnosis received medication to treat their disorder.
In positive trends, the number of Part D beneficiaries who received opioids in 2021 decreased to almost a quarter of beneficiaries, and fewer Part D beneficiaries were identified as receiving high amounts of opioids or at serious risk than in previous years. The number of Part D beneficiaries receiving naloxone increased from previous years.
Comment Request: Financial Statement of Debtor; more
On September 15, CMS published a Comment Request in the Federal Register regarding the following information collections:
-
Financial Statement of Debtor
-
Elimination of Cost-Sharing for Full Benefit Dual-Eligible Individuals Receiving Home and Community-Based Services
-
Provider Network Coverage Data Collection
-
Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery
-
Social Security Office (SSO) Report of State Buy-In Problem
Comments are due by November 14.
Quarterly Update to the National Correct Coding Initiative (NCCI) Procedure-to-Procedure (PTP) Edits, Version 29.0, Effective January 1, 2023
On September 15, CMS published Medicare Claims Processing Transmittal 11599 regarding a reminder that the quarterly update for the NCCI PTP edits will be available via the CMS Virtual Data Center on or about November 17, 2022.
Effective date: January 1, 2023
Implementation date: January 3, 2023
Annual Update of the HCPCS Codes Used for Home Health Consolidated Billing Enforcement
On September 15, CMS published Medicare Claims Processing Transmittal 11601 to provide the January 2023 update to the list of HCPCS codes used to enforce consolidated billing of home health services.
Effective date: January 1, 2023
Implementation date: January 3, 2023
Chronic Care Management Services
On September 19, CMS revised an MLN Booklet regarding chronic care management services. Revisions include changes to billing policies for rural health clinics/federally qualified health centers, the addition of five codes to report staff-provided principal care management services under physician supervision, and the replacement of code G2058 with 99439.
Advisory Opinion No. 22-18
On September 20, the OIG published an Advisory Opinion regarding whether the OIG would impose sanctions under the federal anti-kickback statute and prohibition on beneficiary inducements civil monetary penalty due to an arrangement in which a Medigap plan would contract with a preferred hospital organization (PHO) and would have network hospitals under the PHO provide discounts to the Medigap plan on policyholders’ Part A inpatient deductibles. The discount would be established in advance and would be applied uniformly to all policyholders for at least one year. The Medigap plan would then offer a $100 premium credit to policyholders who select a network hospital under the PHO for a Part A covered inpatient stay. This credit would apply to the next premium payment due to the policyholder’s Medigap plan after the inpatient stay. The Medigap plan would also pay the PHO a monthly, percentage-based administrative fee to compensate the PHO for establishing the hospital network and arranging for network hospitals to discount the Part A inpatient deductible.
The OIG determined that all three streams of remuneration in this agreement would implicate the anti-kickback statute, and the premium credit from the Medigap plans to the policyholders would implicate the beneficiary inducements civil monetary penalty. However, the OIG said it would not impose sanctions in this case due to a low risk of fraud and abuse. The OIG said several elements of the arrangement factored into its decision, and it discussed these factors in depth in the Opinion.
Medicare Part B Overpaid and Beneficiaries Incurred Cost-Share Overcharges of Over $1 Million for the Same Professional Services
On September 20, the OIG published a Review of whether Part B payments to critical access hospitals (CAH) for professional services and payments made to health care practitioners for the same services complied with federal requirements. The OIG was particularly concerned because prior survey work showed Medicare was paying both CAHs and health care practitioners for the same professional services. The OIG found that of the 40,026 claims reviewed, CAHs and health care practitioners each submitted an equal number of claims but only one claim for each date of service complied with federal requirements. As a result, MACs paid providers $907,438 more than they should have and beneficiaries had to pay $281,321 more than they should have. The OIG attributed the overpayments to CMS’ lack of claim system edits to prevent and detect duplicate professional services claims for the same date of service, beneficiary, and procedure.
The OIG recommends CMS direct the MACs to recover payments from CAHs for which the health care practitioners had not reassigned their billing rights to the CAHs and recover the cost-sharing overcharges for Medicare beneficiaries within the 4-year reopening period, direct MACs to recover the payments from healthcare practitioners for the claims for which the practitioners had reassigned their billing rights to the CAHs and recover the beneficiary cost-sharing overcharges within the 4-year reopening period, and develop system edits or alternative means to prevent and detect overpayments for professional service payments. CMS concurred with all recommendations except the system edits/alternative means to prevent and detect overpayments for these types of services. CMS provided a variety of reasons within the report for not concurring with that recommendation, and the OIG provided suggestions as to how CMS could better monitor this issue.
CMS’ System Edits Significantly Reduced Improper Payments to Acute Care Hospitals After May 2019 for Outpatient Services Provided to Beneficiaries Who Were Inpatients of Other Facilities
On September 23, the OIG published a Review of whether Medicare appropriately paid acute care hospitals for outpatient services provided to beneficiaries who were inpatients of other facilities (such as long-term care hospitals, inpatient rehabilitation facilities, etc.). This review was conducted as a follow-up to a previous audit which had found $51.6 million in improper payments for these scenarios. In this audit, the OIG found that Medicare inappropriately paid acute care hospitals $39.3 million for outpatient services provided to beneficiaries who were inpatients of other facilities. However, the vast majority of that total ($32.5 million) was paid before CMS modified system edits to prevent these payments in May 2019.
The OIG recommends CMS direct the Medicare contractors to recover the portion of the $39.3 million in improper payments within the four-year reopening period, instruct acute care hospitals to refund beneficiaries for deductible and coinsurance amounts that may have been incorrectly collected, direct the contractors to recover any improper payments after the audit period, and continue to review system edits to determine whether any refinements are necessary to prevent future overpayments like these. CMS concurred with all but one recommendation and said it will review data submitted for the audit period to consider how best to address any remaining improper payments made after the audit period.
October 2022 Update of the Ambulatory Surgical Center (ASC) Payment System
On September 23, CMS published Medicare Claims Processing Transmittal 11610 regarding the October 2022 update of the ASC payment system. Updates include payment indicator changes for bone (mineral) density studies, a note about device offset payments for CPT code 20950, 10 new HCPCS codes for drugs and biologicals, and more.
On September 26, CMS published MLN Matters 12915 to accompany the transmittal.
Effective date: October 1, 2022
Implementation date: October 3, 2022
FY 2023 Dialysis Facility Outcomes List
On September 23, CMS published a Memorandum to state survey agency directors regarding the annual release of the Dialysis Facility Outcomes List. The list establishes the tier 2 survey workload for state agencies, and it includes the percent of prevalent patients waitlisted (PPPW) measure in its methodology for the first time this year. The memo details the background of the list, discussion about measures, survey considerations, and more.
Effective date: Immediately. Please communicate to all appropriate staff within 30 days.
CMS Announces Resources and Flexibilities in Response to Hurricane Fiona in Puerto Rico
On September 21, CMS published a Press Release on actions it is taking to support Hurricane Fiona recovery efforts in Puerto Rico. These actions include steps to ensure dialysis patients can obtain services, waived requirements to help ensure access to certain DMEPOS items, and more. Providers should review the press release and CMS’ non-COVID emergency website for more details.
Biden-Harris Administration Makes More Medicare Nursing Home Ownership Data Publicly Available
On September 26, CMS published a Press Release to announce the release of additional data to the public to provide more information about ownership of all Medicare-certified nursing homes. CMS first released public data in April on mergers, acquisitions, consolidations, and changes of ownership for hospitals and nursing homes enrolled in Medicare.
Final Decision Memo: Cochlear Implantation
On September 26, CMS published a Final Decision Memo regarding a revision to NCD 50.3, Cochlear Implantation, to expand coverage by changing the definition of limited benefit from amplification to define it as test scores of less than or equal to 60% correct on recorded tests of open-set sentence cognition when the patient meets specific coverage criteria. CMS also finalized coverage of cochlear implants for beneficiaries who might not meet the coverage criteria but are participating in an FDA-approved investigational device exemption clinical trial or when provided as a routine cost in clinical trials under section 310.1 of the NCD manual.
COVID-19 Focused Infection Control Survey Tool for Acute and Continuing Care Providers and Suppliers
On September 26, CMS revised a Memorandum to state survey agency directors regarding survey processes and visitation restrictions. Survey agencies and accreditation organizations are returning to standard survey processes and are no longer required to use a special focused infection control survey tool, as CMS is rescinding most of the survey flexibilities introduced during the PHE. CMS is also not issuing updated guidance on visitation, so facilities should continue to adhere to basic infection prevention and control principles for COVID-19.
CMS Rescinds Enforcement Discretion for SARS-CoV-2 Tests on Asymptomatic Individuals
On September 26, CMS published a Memorandum to state survey agency directors to rescind the December 7, 2020 guidance regarding an enforcement discretion under CLIA for the use of SARS-CoV-2 tests on asymptomatic individuals outside of the test’s authorization.
Effective date: The rescission of this policy is effective immediately. The policy should be communicated to all survey and certification staff and managers immediately. Laboratories will be granted 30 days for the date of this memorandum to come into compliance.
Medicare Payment Systems
On September 26, CMS revised its Medicare Payment Systems Educational Tool to update each payment system with regulatory changes finalized through the recent rule-making cycles.
FY 2023 ICD-10-CM Table of Drugs and Chemicals Errata
On September 26, the CDC published a Table regarding a correction to the ICD-10-CM Table of Drugs due to an inadvertent error. Poisoning by methamphetamine, assault (including synonyms), should be coded to T43.653.
CMS Announces Resources and Flexibilities in Response to Hurricane Ian in Florida and South Carolina
On September 27 and October 3, CMS published Press Releases on actions it is taking to support Hurricane Ian recovery efforts in Florida and South Carolina. These actions include steps to ensure dialysis patients can obtain services, waived requirements to help ensure access to certain DMEPOS items, and more. Providers should review the press releases and CMS’ non-COVID emergency website for more details.
2022 Medicare Parts A & B Premiums and Deductibles
On September 27, CMS published a Press Release regarding the 2023 Medicare Parts A & B premiums, deductibles, and coinsurance amounts. The Part B amounts decreased from 2022 to 2023, as a contingency margin was built in for 2022 due to projected Part B spending for Aduhelm, which ended up resulting in less spending than expected. The standard 2023 amounts are:
-
Part A inpatient hospital deductible - $1600
-
Part A daily coinsurance (61st - 90th day) - $400
-
Part A daily coinsurance (lifetime reserve days) - $800
-
Part B monthly premium - $164.90
-
Part B annual deductible - $226
-
Skilled nursing facility coinsurance - $200
CMS published these rate notices in the Federal Register on September 29 via separate notices for the CY 2023 Inpatient Hospital Deductible and Hospital and Extended Care Services Coinsurance Amounts, the CY 2023 Part A Premiums for the Uninsured Aged and Certain Disabled Individuals Who Have Exhausted Other Entitlements, and the CY 2023 Part B Monthly Actuarial Rates, Premium Rates, and Annual Deductible.
Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2020 Average Sales Prices (ASP)
On September 28, the OIG published a Data Snapshot quantifying savings for Medicare and beneficiaries due to CMS’ price-substitution policy for Part B drugs in 2020. Under the price substitution policy, CMS substitutes the ASP-based payment amount for Part B drugs with a lower calculated rate if the ASP for a drug exceeds the average manufacturer’s price (AMP) by 5% in the two previous quarters or in three of the previous four quarters. The OIG found the CMS did not correctly implement price reductions for some eligible drugs because CMS had applied an incorrect payment amount when creating the adjustment. While the OIG alerted CMS about the incorrect payment amount when it was initially discovered in February 2022, CMS said it would not retroactively reduce payment amounts for the drugs paid prior to the pricing correction, which was applied in March 2022. CMS therefore missed out on savings that should have totaled $2.8 million over the course of a year but instead amounted to only $8,158. The OIG said CMS could also generate additional savings if it would expand the price substitution criteria to include drugs that exceeded the 5% threshold in a single quarter.
Changes to Beneficiary Coinsurance for Additional Procedures Furnished During the Same Clinical Encounter as Certain Colorectal Cancer Screening Tests
On September 29, CMS published One-Time Notification Transmittal 11622, which rescinds and replaces Transmittal 11374, dated April 22, to add business requirements 12656.4 through 12656.7. These new business requirements will add the Other Amount Indicator “B2” for coinsurance reduction amount to the claim, modify edits that affect the coinsurance reduction amount, and report the applied coinsurance amount in the coinsurance field. The original transmittal was published regarding the implementation of a gradual reduction in coinsurance for certain colorectal cancer screening procedures as mandated by the Consolidated Appropriations Act of 2021.
CMS revised MLN Matters 12656 on the same date to accompany the transmittal.
Effective date: January 1, 2022
Implementation date: October 3, 2022 - Coding; January 3, 2023 - Testing and Full Implementation
First Biannual HCPCS Level II Final Coding, Benefit Category, and Payment Determinations
On September 29, CMS published the HCPCS Level II Coding, Benefit Category, & Payment Determinations document, which is the first time they have published what will be a biannual update. The document contains the benefit category and payment determinations for non-drug and non-biological items assigned a new HCPCS Level II code effective January 1, 2020 to April 1, 2022. It also contains the final coding, benefit category, and payment determinations for HCPCS Level II applications processed in CMS’ B1 2022 coding cycle for non-drug and non-biological items and services.
Medicare Advantage Compliance Audit of Specific Diagnosis Codes that BlueCross BlueShield of Tennessee (BCBST) Submitted to CMS
On September 30, the OIG published a Review of whether select diagnosis codes that BCBST submitted to CMS for use in the risk adjustment program complied with federal requirements. The OIG conducted the audit by sampling 270 enrollee-years with high-risk diagnosis codes for which BCBST received higher payments for 2016-2017. The OIG found that the medical records for 210 of the 270 sampled enrollee-years did not support the diagnosis codes, and the OIG estimated that BCBST received $7.8 million in overpayments for 2016 and 2017.
The OIG recommended that BCBST refund the federal government for the $7.8 million in overpayments, identify similar instances of noncompliance and refund the federal government accordingly, and continue its examination of existing compliance procedures to identify areas where improvements can be made to ensure high-risk diagnosis codes comply with federal requirements.
Medicare Advantage Compliance Audit of Diagnosis Codes that Inter Valley Health Plan Inc. Submitted to CMS
On September 30, the OIG published a Review of whether select diagnosis codes that Inter Valley Health Plan submitted to CMS for use in the risk adjustment program complied with federal requirements. The OIG conducted the audit by sampling 200 enrollees with at least one diagnosis code that mapped to an HCC for 2015. This resulted in 1,553 HCCs associated with these enrollees. The OIG found that 142 of the 1,553 HCCs were not supported in the medical record. The OIG also found that there were an additional 12 HCCs for which the medical records supported diagnosis codes that Inter Valley should have submitted to CMS but did not. Therefore, the risk scores for these sampled enrollees should have been based on 1,446 HCCs instead of 1,553, and Inter Valley received at least $5.3 million in net overpayments for these sampled enrollees.
The OIG recommended that Inter Valley refund the federal government for the $5.3 million in net overpayments and improve its policies and procedures to prevent, detect, and correct noncompliance with federal requirements for diagnosis codes used in risk-adjusted payment calculations. Inter Valley did not concur with the findings and submitted additional medical record documentation that it believed validated the specified HCCs. The OIG revised some of its original findings and recommendations after reviewing the additional documentation.
Adjustment to the Amount in Controversy Threshold Amounts for CY 2023
On September 30, CMS published a Notice in the Federal Register to announce the annual adjustment in the amount in controversy threshold amounts. The CY 2023 amount in controversy thresholds are $180 for ALJ hearings and $1,850 for judicial review.
The annual adjustment takes effect on January 1, 2023.
Revisions to State Operation Manual (SOM), Appendix PP Guidance to Surveyors for Long Term Care Facilities
On September 30, CMS published State Operations Provider Certification Transmittal 207 regarding revisions to information about food director qualification and physical environment (specifically the fire safety evaluation system).
Effective date: September 30, 2022
Implementation date: October 1, 2022