Tag: Centers for Medicare and Medicaid Services (CMS)

CMS Posts 2023 Public Use File

On November 23, 2022, CMS posted the 2023 Ambulance Fee Schedule Public Use Files. These files contain the amounts that will be allowed by Medicare in the calendar year 2023 for the various levels of ambulance service and mileage. These allowable reflect an 8.7% inflation adjustment over the calendar 2022 rates. The 2023 Ambulance Fee Schedule Public Use File can be downloaded from the CMS website by clicking here.

Please note that these files reflect the Medicare allowable based on current federal law.  Accordingly, the 2023 Public Use Files do not include the current add-ons (i.e., 2% for urban, 3% for rural, and the super-rural bonus), as these add-ons are currently scheduled to expire on December 31, 2022.

The AAA is actively working with congressional offices to not only extend but hopefully increase, the Medicare ambulance add-ons by the end of the year. If you have not already written to your members of Congress about extending the add-ons at increased levels, please do so today by using the AAA online advocacy tool by clicking here.

Unfortunately, in recent years, CMS has elected to release its Public Use Files without state and payment locality headings. As a result, in order to look up the rates in your service area, you would need to know the CMS contract number assigned to your state. This is not something the typical ambulance service would necessarily have on hand. For this reason, the AAA will be publishing a reformatted version of the CMS Medicare Ambulance Fee Schedule that includes the state and payment locality headings. The reformatted fee schedule will be available on the AAA website in the coming days.

The AAA will also be publishing an updated version of its Medicare Rate Calculator, which we expect to have available on our website once we have a better sense of the timing of the extension of the add-ons.

CMS Update-CY 2023 Final Ambulance Fee Schedule

Member Advisory:  CMS Issues CY 2023 Final Ambulance Fee Schedule Rule Updated Data Ground Ambulance Data Collection System

by Kathy Lester, JD, MPH

CMS has released the “CY 2023 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicare and Medicaid Provider Enrollment Policies, Including for Skilled Nursing Facilities; Conditions of Payment for Suppliers of Durable Medicaid Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS); and Implementing Requirements for Manufacturers of Certain Single-dose Container or Single-use Package Drugs to Provide Refunds with Respect to Discarded Amounts” (Final Rule).  The Final Rule includes proposals affecting ground ambulance services in terms of medical necessity requirements and documentation requirements, as well as to the ground ambulance cost collecting tool.

I.           Medical Necessity and Documentation Requirements for Nonemergency, Scheduled, Repetitive Ambulance Services

              CMS finalizes the modifications to the documentation requirements codified in regulation pertaining to the medical necessity and documentation requirements for nonemergency, scheduled, repetitive ambulance services, such as those to/from dialysis facilities.  The Final Rule clarifies that the Physician Certification Statement (PCS), and additional documentation from the beneficiary’s medical record, may be used to support a claim that transportation by ground ambulance is medically necessary.  It also notes that the PCS and additional documentation must provide detailed explanations that: (1) are consistent with the beneficiary’s current medical condition; and (2) explain the beneficiary’s need for transport by an ambulance.  Coverage includes observation or other services rendered by qualified ambulance personnel.  It maintains the following requirements:

  • In all cases, the provider or supplier must keep appropriate documentation on file and, upon request, present it to CMS;
  • The ambulance service must meet all program coverage criteria including vehicle and staffing requirements; and
  • A signed PCS does not alone demonstrate that transportation by ground ambulance was medically necessary.

             CMS declines to “confine this regulatory clarification to the RSNAT prior authorization program, as there may be non-emergent, scheduled, repetitive ambulance transport services outside of that program that would be affected.” (Display Copy 1756)  CMS also does not provide further clarification about what it means by the term “additional documentation” because it believes that “the data elements needed will vary depending upon the beneficiary’s specific conditions and needs.” (Id.)  CMS also states that “[t]his proposal does not establish new obligations for documentation; rather, it merely clarifies existing requirements.” (Id. at 1757).  In response to a comment, CMS also writes, “In addition, our pre-proposal language and proposed regulatory language both reflect that the presence of a PCS alone is not sufficient to demonstrate medical necessity, and, therefore, must be supported by medical documentation.” (Id.)  CMS also declined to extend authorization to nurse practitioners and physicians’ assistants, stating that to do so would be outside of the scope of the rule.

II.         Ground Ambulance Data Collection Instrument

            CMS finalizes the proposed changes to the ground ambulance data collection instrument and instructions with a few additional modifications in response to comments.  They fall within four areas:  (1) editorial changes for clarity and consistency; (2) updates to reflect the web-based system; (3)  clarifications responding to feedback from questions from interested parties and testing; and (4) typos and technical corrections.  The updated instrument that includes all of the CY 2023 proposed changes to review and provide comments on is posted on the CMS website at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AmbulanceFeeSchedule/Downloads/Medicare-Ground-Ambulance-Data-Collection-System-Instrument.pdf.

            One of these modification is to Section 5, Question 3c, which now reads: Does your organization respond to calls with another non- transporting agency such as a local fire department that is not part of your organization? After the question, the following instructions will be provided: This includes joint responses with other ground ambulance organizations as well as cases where a fire, police, or other public safety department responses to calls for service with your organization. Only consider cases where your ground ambulance does or would have transported the patient, if necessary.

            The Final Rule notes that the system already includes an “autosave” feature that saves responses as they are entered. The system also allows the same user to enter information at different times, and/or multiple users to enter information at different times. The system also already includes many validation and error checking steps that are automatically applied as respondents enter information. CMS also noted that it has no plans to adopt additional import functionality prior to the launch of the system, but that it will continue to explore the option of an API.  CMS also indicates that the final written tool and web-based platform will align before the system goes live.  A print function will also be available for the online submissions.

            CMS indicates that the data from the collection system will be made available to the public through posting on the CMS website at least every 2 years.  Summary results will be posted by the last quarter.  The data collected under the ground ambulance data collection system will be publicly available beginning in 2024.

            CMS also indicates that it will not require a ground ambulance organization to fill the data entry submitter and data certifier roles with different individuals.

            CMS has also provided additional guidance, including FAQs available at:  https://www.cms.gov/Medicare/Medicare-Fee-for-Service- Payment/AmbulanceFeeSchedule/Downloads/Medicare-Ground-Ambulance-FAQs.pdf.

            CMS also finalizes its proposal for an automated process for submitting a hardship exemption request and informal review request.

III.        Origin and Destination Requirements Under the Ambulance Fee Schedule

            In the Final Rule, CMS also responds to comments it received on the Interim Final Rule that expanded the origin and destination requirements.  It finalizes the interim final policy that the expanded list of covered destinations for ground ambulance transports including, but are not limited to, any location that is an alternative site determined to be part of a hospital, CAH or SNF, community mental health centers, FQHCs, RHCs, physician offices, urgent care facilities, ASCs, any location furnishing dialysis services outside of an ESRD facility when an ESRD facility is not available, and the beneficiary’s home.  The policy will be In effect for the duration of the PHE for the COVID-19 only.

CMS Announces Providers Selected for Year 3 & 4 Cost Data Collection

Centers for Medicare & Medicaid Services Announces Year 3 and Year 4 Medicare Ground Ambulance Data Collection System Selected Providers and Suppliers

The Centers for Medicare & Medicaid Services (CMS) has released the ground ambulance suppliers and providers selected for Years 3 and 4 of the Medicare ground ambulance data collection system.  The list of the selected providers and suppliers is available on the CMS website.  These providers and suppliers will be asked to collect data during their budget year starting in 2023 and to report the data within five months of the close of that year.

Providers and suppliers who are selected should respond to the notification letter sent by Medicare Administrative Contractors (MAC).  Organizations may select a calendar year or fiscal year start date for the data collection period.  Data will be submitted for a continuous 12-month period using the Medicare Ground Ambulance Data Collection Instrument: English (PDF).

The AAA continues to provide educational support for ground ambulance services to help them collect and report these data.  In addition to in-person sessions, the AAA offers webinars on demand.

It is important that all ground ambulance providers and suppliers collect and report data through this program.  The Congress intends to use the information to help reform Medicare ambulance fee schedule.

CMS | CY 2023 Medicare Physician Fee Schedule Final Rule

From CMS on November 1, 2022

On November 01, 2022, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that includes updates and policy changes for Medicare payments under the Physician Fee Schedule (PFS), and other Medicare Part B issues, effective on or after January 1, 2023.

The calendar year (CY) 2023 PFS final rule is one of several rules that reflect a broader Administration-wide strategy to create a more equitable health care system that results in better accessibility, quality, affordability, and innovation.

Background on the Physician Fee Schedule

Since 1992, Medicare payment has been made under the PFS for the services of physicians and other billing professionals. Physicians’ services paid under the PFS are furnished in various settings, including physician offices, hospitals, ambulatory surgical centers (ASCs), skilled nursing facilities and other post-acute care settings, hospices, outpatient dialysis facilities,

clinical laboratories, and beneficiaries’ homes. Payment is also made to several types of suppliers for technical services, most often in settings for which no institutional payment is made.

For most services furnished in a physician’s office, Medicare makes payment to physicians and other professionals at a single rate based on the full range of resources involved in furnishing the service. In contrast, PFS rates paid to physicians and other billing practitioners in facility settings, such as a hospital outpatient department (HOPD) or an ASC, reflect only the portion of the resources typically incurred by the practitioner in the course of furnishing the service.

For many diagnostic tests and a limited number of other services under the PFS, separate payment may be made for the professional and technical components of services. The technical component is frequently billed by suppliers, like independent diagnostic testing facilities and radiation treatment centers, while the professional component is billed by the physician or practitioner.

Payments are based on the relative resources typically used to furnish the service. Relative value units (RVUs) are applied to each service for work, practice expense, and malpractice expense. These RVUs become payment rates through the application of a conversion factor. Geographic adjusters (geographic practice cost index) are also applied to the total RVUs to account for variation in practice costs by geographic area. Payment rates are calculated to include an overall payment update specified by statute.

CY 2023 PFS Ratesetting and Conversion Factor

CMS is finalizing a series of standard technical proposals involving practice expense, including the implementation of the second year of the clinical labor pricing update. We also included a comment solicitation seeking public input as we develop a more consistent, predictable approach to incorporating new data in setting PFS rates. Per statutory requirements, we are also updating the data that we use to develop the geographic practice cost indices (GPCIs) and malpractice RVUs.

With the budget neutrality adjustments, which are required by law to ensure payment rates for individual services don’t result in changes to estimated Medicare spending, the required statutory update to the conversion factor for CY 2023 of 0%, and the expiration of the 3% supplemental increase to PFS payments for CY 2022, the final CY 2023 PFS conversion factor is $33.06, a decrease of $1.55 to the CY 2022 PFS conversion factor of $34.61.

Evaluation and Management (E/M) Visits

As part of the ongoing updates to E/M visit codes and related coding guidelines that are intended to reduce administrative burden, the AMA CPT Editorial Panel approved revised coding and updated guidelines for Other E/M visits, effective January 1, 2023. Similar to the approach we finalized in the CY 2021 PFS final rule for office/outpatient E/M visit coding and documentation, we finalized and adopted most of these AMA CPT changes in coding and documentation for Other E/M visits (which include hospital inpatient, hospital observation, emergency department, nursing facility, home or residence services, and cognitive impairment assessment) effective January 1, 2023. This revised coding and documentation framework includes CPT code definition changes (revisions to the Other E/M code descriptors), including:

  • New descriptor times (where relevant).
  • Revised interpretive guidelines for levels of medical decision making.
  • Choice of medical decision making or time to select code level (except for a few families like emergency department visits and cognitive impairment assessment, which are not timed services).
  • Eliminated use of history and exam to determine code level (instead there would be a requirement for a medically appropriate history and exam).

We finalized the proposal to maintain the current billing policies that apply to the E/Ms while we consider potential revisions that might be necessary in future rulemaking. We also finalized creation of Medicare-specific coding for payment of Other E/M prolonged services, similar to what CMS adopted in CY 2021 for payment of Office/Outpatient prolonged services. These services will be reported with three separate Medicare-specific G codes.

Split (or Shared) E/M Visits

For CY 2023, we finalized  a year-long delay of the split (or shared) visits policy we  established in rulemaking for 2022.  This policy determines which professional should bill for a shared visit by defining the “substantive portion,” of the service as more than half of the total time. Therefore, for CY 2023, as in CY 2022, the substantive portion of a visit is comprised of any of the following elements:

  • History.
  • Performing a physical exam.
  • Medical Decision Making.
  • Spending time (more than half of the total time spent by the practitioner who bills the visit).

As finalized, clinicians who furnish split (or shared) visits will continue to have a choice of history, or physical exam, or medical decision making, or more than half of the total practitioner time spent to define the “substantive portion” instead of using total time to determine the substantive portion, until CY 2024.

Telehealth Services

For CY 2023, we are finalizing a number of policies related to Medicare telehealth services, including making several services that are temporarily available as telehealth services for the PHE available at least through CY 2023 in order to allow additional time for the collection of data that may support their inclusion as permanent additions to the Medicare Telehealth Services List. We finalized our proposal to extend the duration of time that services are temporarily included on the telehealth services list during the PHE for at least a period of 151 days following the end of the PHE, in alignment with the Consolidated Appropriations Act, 2022 (CAA, 2022).

We confirmed our intention to implement the telehealth provisions in sections 301 through 305 of the CAA, 2022, via program instruction or other subregulatory guidance to ensure a smooth transition after the end of the PHE. These policies, such as allowing telehealth services to be furnished in any geographic area and in any originating site setting (including the beneficiary’s home); allowing certain services to be furnished via audio-only telecommunications systems; and allowing physical therapists, occupational therapists, speech-language pathologists, and audiologists to furnish telehealth services, will remain in place during the PHE for 151 days after the PHE ends. The CAA, 2022, also delays the in-person visit requirements for mental health services furnished via telehealth until 152 days after the end of the PHE.

We finalized the proposal to allow physicians and practitioners to continue to bill with the place of service (POS) indicator that would have been reported had the service been furnished in-person.  These claims will require the modifier “95” to identify them as services furnished as telehealth services. Claims can continue to be billed with the place of service code that would be used if the telehealth service had been furnished in-person through the later of the end of CY 2023 or end of the year in which the PHE ends.

The Telehealth Originating Site Facility Fee has been updated for CY 2023, which can be found with the list of Medicare Telehealth List of Services at the following website:  https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/Telehealth-Codes

Behavioral Health Services 

In light of the current needs among Medicare beneficiaries for improved access to behavioral health services, CMS has considered regulatory revisions that may help to reduce existing barriers and make greater use of the services of behavioral health professionals, such as licensed professional counselors (LPCs) and Licensed Marriage and Family Therapists (LMFTs). Therefore, CMS is finalizing the proposal to add an exception to the direct supervision requirement under our “incident to” regulation at 42 CFR 410.26 to allow behavioral health services to be provided under the general supervision of a physician or non-physician practitioner (NPP), rather than under direct supervision, when these services or supplies are furnished by auxiliary personnel, such as LPCs and LMFTs, incident to the services of a physician (or NPP). CMS is also clarifying that any service furnished primarily for the diagnosis and treatment of a mental health or substance use disorder can be furnished by auxiliary personnel under the general supervision of a physician or NPP who is authorized to furnish and  bill for services provided incident to their own professional services. CMS believes that this change will facilitate access and extend the reach of behavioral health services. Finally, CMS  indicated in the final rule that we intend to address payment for new codes that describe caregiver behavioral management training in CY 2024 rulemaking.

In the 2022 CMS Behavioral Health Strategy (https://www.cms.gov/cms-behavioral-health-strategy), CMS included a goal to improve access to, and quality of, mental health care services and included an objective to “increase detection, effective management, and/or recovery of mental health conditions through coordination and integration between primary and specialty care providers.” In CY 2017 and 2018 PFS rulemaking, CMS received comments that initiating visit services for behavioral health integration (BHI) should include in-depth psychological evaluations delivered by a clinical psychologist (CP), and that CMS should consider allowing professionals who were not eligible to report the approved initiating visit codes to Medicare to serve as a primary hub for BHI services. Considering the increased needs for mental health services and feedback we have received, we are finalizing our proposal to create a new General BHI code describing a service personally performed by CPs or clinical social workers (CSWs) to account for monthly care integration where the mental health services furnished by a CP or CSW are serving as the focal point of care integration. CMS is also finalizing the proposal to allow a psychiatric diagnostic evaluation to serve as the initiating visit for the new general BHI service.

Chronic Pain Management and Treatment Services 

We finalized new HCPCS codes, G3002 and G3003, and valuation for chronic pain management and treatment services (CPM) for CY 2023. We believe the CPM HCPCS codes will improve payment accuracy for these services, prompt more practitioners to welcome Medicare beneficiaries with chronic pain into their practices, and encourage practitioners already treating Medicare beneficiaries who have chronic pain to spend the time to help them manage their condition within a trusting, supportive, and ongoing care partnership.

The finalized codes include a bundle of services furnished during a month that we believe to be the starting point for holistic chronic pain care, aligned with similar bundled services in Medicare, such as those furnished to people with suspected dementia or substance use disorders. We have finalized the CPM codes to include the following elements in the code descriptor: diagnosis; assessment and monitoring; administration of a validated pain rating scale or tool; the development, implementation, revision, and/or maintenance of a person-centered care plan that includes strengths, goals, clinical needs and desired outcomes; overall treatment management; facilitation and coordination of any necessary behavioral health treatment; medication management; pain and health literacy counseling; any necessary chronic pain related crisis care; and ongoing communication and coordination between relevant practitioners furnishing care, such as physical and occupational therapy, complementary and integrative care approaches, and community-based care, as appropriate.

Opioid Treatment Programs (OTPs)

In order to stabilize the price for methadone for CY 2023 and subsequent years, CMS is finalizing the proposal to revise our methodology for pricing the drug component of the methadone weekly bundle and the add-on code for take-home supplies of methadone. As proposed, CMS will base the payment amount for the drug component of HCPCS codes G2067 and G2078 for CY 2023 and subsequent years on the payment amount for methadone in CY 2021 and update this amount annually to account for inflation using the PPI for Pharmaceuticals for Human Use (Prescription).

Additionally, based on the severity of needs of the patient population diagnosed with opioid use disorder (OUD) and receiving services in the OTP setting, CMS is finalizing the proposal to modify the payment rate for the non-drug component of the bundled payments for episodes of care to base the rate for individual therapy on a crosswalk to a code describing a 45-minute session, rather than the current crosswalk to a code describing a 30-minute session. This will increase overall payments for medication-assisted treatment and other treatments for OUD, recognizing the longer therapy sessions that are usually required.

CMS is also finalizing the proposal to allow the OTP intake add-on code to be furnished via two-way audio-video communications technology when billed for the initiation of treatment with buprenorphine, to the extent that the use of audio-video telecommunications technology to initiate treatment with buprenorphine is authorized by the Drug Enforcement Administration (DEA) and Substance Abuse and Mental Health Services Administration (SAMHSA) at the time the service is furnished. CMS is also finalizing the proposal to permit the use of audio-only communication technology to initiate treatment with buprenorphine in cases where audio-video technology is not available to the beneficiary, and all other applicable requirements are met.

Additionally, CMS is allowing periodic assessments to be furnished audio-only when video is not available for the duration of CY 2023, to the extent that it is authorized by SAMSHA and DEA at the time the service is furnished.

Additionally, CMS is clarifying that OTPs can bill Medicare for medically reasonable and necessary services furnished via mobile units in accordance with SAMHSA and DEA guidance. CMS is finalizing the proposal that locality adjustments for services furnished via mobile units would be applied as if the service were furnished at the physical location of the OTP registered with DEA and certified by SAMHSA.

Audiology Services

CMS finalized a policy to allow beneficiaries direct access to an audiologist without an order from a physician or NPP for non-acute hearing conditions.  The finalized policy will use a new modifier ─ instead of using a new HCPCS G-code as we proposed ─ because we were persuaded by the commenters that a modifier would allow for better accuracy of reporting and reduce burden for audiologist. The service(s) can be billed using the codes audiologists already use with the new modifier, and include only those personally furnished by the audiologist. The finalized direct access policy will allow beneficiaries to receive care for non-acute hearing assessments that are unrelated to disequilibrium, hearing aids, or examinations for the purpose of prescribing, fitting, or changing hearing aids.  This modification in our finalized policy necessitates multiple changes to our claims processing systems, which will take some time to fully operationalize, but audiologists may use modifier AB, along with the finalized list of 36 CPT codes, for dates of service on and after January 1, 2023.

CMS finalized the proposal to permit audiologists to bill for this direct access (without a physician or practitioner order) once every 12 months per beneficiary.  Medically reasonable and necessary tests ordered by a physician or other practitioner and personally provided by audiologists will not be affected by the direct access policy, including the modifier and frequency limitation.

Dental and Oral Health Services

Medicare payment for dental services is generally precluded by statute.  However, Medicare currently pays for dental services in a limited number of circumstances, specifically when that service is an integral part of specific treatment of a beneficiary’s primary medical condition. Some examples include reconstruction of the jaw following fracture or injury, tooth extractions done in preparation for radiation treatment for cancer involving the jaw, or oral exams preceding kidney transplantation. CMS proposed to clarify and codify certain aspects of the current Medicare fee-for-services payment policies for dental services. CMS also proposed and sought comment on payment for other dental services that were inextricably linked to, and substantially related and integral to, the clinical success of, an otherwise covered medical service, such as dental exams and necessary treatments prior to organ transplants, cardiac valve replacements, and valvuloplasty procedures. Effective for CY 2023, CMS 1) finalized our proposal to clarify and codify certain aspects of the current Medicare FFS payment policies for dental services when that service is an integral part of specific treatment of a beneficiary’s primary medical condition, and 2) other clinical scenarios under which Medicare Part A and Part B payment can be made for dental services, such as dental exams and necessary treatments prior to, or contemporaneously with, organ transplants, cardiac valve replacements, and valvuloplasty procedures. We are also finalizing payment for dental exams and necessary treatments prior to the treatment for head and neck cancers starting in CY 2024, and finalizing a process in CY 2023 to review and consider public recommendations for Medicare payment for dental service in other potentially analogous clinical scenarios. Finally, we are working to address commenters’ thoughtful feedback and questions regarding the operational aspects of billing and claims processing for these services.

Skin Substitutes

CMS proposed several changes to the policies for skin substitute products to streamline the coding, billing, and payment rules and to establish consistency with these products across the various settings. Specifically, CMS proposed to change the terminology of skin substitutes to ‘wound care management products’, and to treat and pay for these products as incident to supplies under the PFS beginning on January 1, 2024.  After reviewing comments on the proposals, we understand that it would be beneficial to provide interested parties more opportunity to comment on the specific details of changes in coding and payment mechanisms prior to finalizing a specific date when the transition to more appropriate and consistent payment and coding for these products will be completed. We plan to conduct a Town Hall in early CY 2023 with interested parties to address commenters’ concerns as well as discuss potential approaches to the methodology for payment of skin substitute products under the PFS. We will take into account the comments we received in response to CY 2023 rulemaking and feedback received in association with the Town Hall in order to strengthen proposed policies for skin substitutes in future rulemaking.

Colorectal Cancer Screening

For CY 2023, we are finalizing, as proposed, two updates to expand our Medicare coverage policies for colorectal cancer screening in order to align with recent United States Preventive Services Task Force and professional society recommendations. First, we are expanding Medicare coverage for certain colorectal cancer screening tests by reducing the minimum age payment and coverage limitation from 50 to 45 years. Second, we are expanding the regulatory definition of colorectal cancer screening tests to include a complete colorectal cancer screening, where a follow-on screening colonoscopy after a Medicare covered non-invasive stool-based colorectal cancer screening test returns a positive result. A functional outcome of our policy for a complete colorectal cancer screening will be that, for most beneficiaries, cost sharing will not apply for either the initial stool-based test or the follow-on colonoscopy. Both of these policies reflect our desire to expand access to quality care and to improve health outcomes for patients through prevention and early detection services, as well as through effective treatments. Our revised colorectal cancer screening policies directly advance our health equity goals by promoting access for much needed cancer prevention and early detection in rural communities and communities of color that are especially impacted by the incidence of colorectal cancer. Our policies also directly support President Biden’s Cancer Moonshot Goal to cut the death rate from cancer by at least 50 percent over the next 25 years and addresses his recent proclamation of March 2022 as National Colorectal Cancer Awareness Month.

Requiring Manufacturers of Certain Single-Dose Container or Single-Use Package Drugs to Provide Refunds with Respect to Discarded Amounts

Section 90004 of the Infrastructure Investment and Jobs Act (Pub. L. 117-9, November 15, 2021) amended section 1847A of the Act adding provisions that require manufacturers to provide a refund to CMS for certain discarded amounts from a refundable single-dose container or single-use package drug. The refund amount is the amount of discarded drug that exceeds an applicable percentage, which is required to be at least 10%, of total allowed charges for the drug in a given calendar quarter. The proposals to implement section 90004 of the Infrastructure Act included: how discarded amounts of drugs are determined; a definition of which drugs are subject to refunds (and exclusions); when and how often CMS will notify manufacturers of refunds; when and how often payment of refunds from manufacturers to CMS is required; refund calculation methodology (including applicable percentages); a dispute resolution process; and enforcement provisions. This refund applies to refundable single-dose container or single-use package drugs beginning January 1, 2023.

CMS is finalizing as proposed the definition of a refundable single-dose container or single-use package drug as a drug or biological for which payment is made under Part B and that is furnished from a single-dose container or single-use package. CMS is finalizing exclusions to this definition as required by statute for drugs that are either radiopharmaceuticals or imaging agents, drugs that require filtration during the drug preparation process, and drugs approved on or after the date of enactment of the Infrastructure Act (that is, November 15, 2021) for which payment under Part B has been made for fewer than 18 months.

For drugs with unique circumstances, CMS solicited comment on whether an increased applicable percentage would be appropriate for drug that is reconstituted with a hydrogel and administered via ureteral catheter or nephrostomy tube into the kidneys; in this circumstance, there is substantial amount of reconstituted hydrogel that adheres to the vial wall during preparation and not able to be extracted from the vial for administration. Based on comments received, CMS is finalizing an increased applicable percentage of 35 percent for this drug.

CMS also solicited comments on whether there are other drugs with unique circumstances that may warrant an increase in the applicable percentage.  As a result of public comments, CMS plans to collect additional information about drugs that may have unique circumstances along with what increased applicable percentages might be appropriate for each circumstance.  CMS will revisit additional increased applicable percentages through future notice and comment rulemaking.

CMS is finalizing requirements for the use of the JW modifier, for reporting discarded amounts of drugs, and the JZ modifier, for attesting that there were no discarded amounts. CMS is finalizing that providers will be required to report the JW modifier beginning January 1, 2023 and the JZ modifier no later than July 1, 2023 in all outpatient settings. In the proposed rule, CMS proposed that an initial invoice for the refund to be sent to manufacturers in October 2023.  However, we believe it would be beneficial to create system efficiencies related to the reconciliation and invoicing system of the discarded drug refunds and the new inflation rebate programs under the Inflation Reduction Act, and so we are not finalizing the timing of the initial report to manufacturers or date by which the first refund payments are due. We are, however, finalizing that we will issue a preliminary report on estimated discarded drug amounts based on claims from the first two calendar quarters of 2023 no later than December 31, 2023 and will revisit the timing of the first report in future rulemaking.

Preventive Vaccine Administration Services

In this rule, CMS finalized refinements to the payment amount for preventive vaccine administration under the Medicare Part B vaccine benefit, which includes the influenza, pneumococcal, hepatitis B, and COVID-19 vaccine and their administration. CMS finalized the proposal to annually update the payment amount for vaccine administration services based upon the increase in the MEI, and to adjust for the geographic locality based upon the geographic adjustment factor (GAF) for the PFS locality in which the preventive vaccine is administered. CMS also finalized the proposal to continue the additional payment for at-home COVID-19 vaccinations for CY 2023.

Additionally, in light of the distinction between a PHE declared under section 319 of the Public Health Service Act (PHS Act) and an Emergency Use Authorization (EUA) declaration under section 564 of the Food, Drug, and Cosmetic Act (FD&C Act), and the possibility that they will not terminate at precisely the same time, CMS is clarifying the policies finalized in the CY 2022 PFS final rule regarding the administration of COVID-19 vaccine and monoclonal antibody products, to reflect that those policies will continue through the end of the calendar year in which the EUA declaration for drugs and biological products is terminated. Lastly, CMS is finalizing the proposal to  permanently cover and pay for covered monoclonal antibody products used as pre-exposure prophylaxis for prevention of COVID-19 under the Medicare Part B vaccine benefit.

Updated Medicare Economic Index (MEI) for CY 2023

We proposed to rebase and revise the MEI for CY 2023 and solicited comments regarding the future use of the 2017-based MEI weights in PFS ratesetting and the GPCIs. The proposed method for determining the 2017-based MEI relies on estimating base year expenses from publicly available data from the U.S. Census Bureau NAICS 6211 Offices of Physicians. The proposed methodology allows for the use of data that are more reflective of current market conditions of physician ownership practices, rather than only reflecting costs for self-employed physicians, and also would allow for the MEI to be updated on a more regular basis since the proposed data sources are updated and published on a regular basis.

Finalizing the use of the 2017-based MEI cost weights to set PFS rates would not change overall spending on PFS services, but would result in significant distributional changes to payments among PFS services across specialties and geographies. In consideration of our ongoing efforts to update the PFS payment rates with more predictability and transparency, and in the interest of ensuring payment stability, we proposed not to use the updated MEI cost share weights to set PFS payment rates for CY 2023. However, we solicited comments on the potential use of the proposed updated MEI cost share weights to calibrate payment rates and update the GPCI under the PFS in the future.

We finalized the proposed rebasing and revising of the 2017-based MEI with some technical revisions to the proposed method based on public comments.  The final CY 2023 MEI update is 3.8 percent based on the most recent historical data available. As noted above, the rebased and revised MEI weights were not used in CY 2023 PFS ratesetting.

Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)

Chronic Pain Management and Behavioral Health Services

We are finalizing the addition of chronic pain management and behavioral health integration services to the RHC and FQHC specific general care management HCPCS code, G0511, which aligns with changes made under the PFS for CY 2023. Since the requirements for the chronic pain management and behavioral health integration services are similar to the requirements for the general care management services furnished by RHCs and FQHCs (which are the current services for which RHCs and FQHCs can use HCPCS code G0511) the payment rate for HCPCS code G0511 will continue to be the average of the national non-facility PFS payment rates for the RHC and FQHC care management and general behavioral health codes (CPT codes 99484, 99487, 99490, and 99491) and PCM codes (CPT codes 99424 and 99425) Payment will be updated annually based on the PFS amounts for these codes, which is how these updates are made currently.

Telehealth Services

We announced that we are implementing the telehealth provisions in the Consolidated Appropriations Act, 2022 (CAA, 2022) via program instruction or other subregulatory guidance to ensure a smooth transition after the end of the PHE. The CAA, 2022 extends certain flexibilities in place during the PHE for 151 days after the PHE ends, including allowing payment for RHCs and FQHCs for furnishing telehealth services as distant site practitioners (though note that mental health visits can be furnished virtually on a permanent basis) under the payment methodology established for the PHE, allowing telehealth services to be furnished in any geographic area and in any originating site setting, including the beneficiary’s home, and allowing certain services to be furnished via audio-only telecommunications systems. The CAA, 2022 also delays the in-person visit requirements for mental health visits via telecommunications technology, including those furnished by RHCs and FQHCs, until 152 days after the end of the PHE.

Conforming Technical Changes to the In-Person Requirements for Mental Health Visits

We finalized conforming regulatory text changes in accordance with section 304 of the CAA, 2022 to amend paragraph (b)(3) of 42 CFR 405.2463, “What constitutes a visit,” and paragraph (d) of 42 CFR 2469, “FQHC supplemental payments,” to include the delay of the in-person requirements for mental health visits furnished by RHCs and FQHCs through telecommunication technology under Medicare until the 152nd day after the COVID-19 PHE ends.

Specified Provider-Based RHC Payment Limit Per-Visit

Subsequent to the publication of the CY 2022 PFS final rule, which implemented changes to the RHC payment limit as required by the Consolidated Appropriations Act, 2021, interested parties requested clarification regarding the timing of cost reports used to set the RHC payment limit. We finalized the clarification that a 12-consecutive month cost report should be used to establish a specified provider-based RHC’s payment limit per visit. We believe 12-consecutive months of cost report data accurately reflects the costs of providing RHC services and will establish a more accurate base from which the payment limits will be updated going forward.

Clinical Laboratory Fee Schedule (CLFS):

In accordance with section 4(b) of the Protecting Medicare and American Farmers from Sequester Cuts Act, we are finalizing certain conforming changes to the data reporting and payment requirements at 42 CFR part 414, subpart G. Specifically, we are finalizing revisions to § 414.502 to update the definitions of both the “data collection period” and “data reporting period,” specifying that for the data reporting period of January 1, 2023 through March 31, 2023, the data collection period is January 1, 2019 through June 30, 2019. We are also finalizing revisions to § 414.504(a)(1) to indicate that initially, data reporting begins January 1, 2017 and is required every 3 years beginning January 2023. In addition, we are finalizing conforming changes to our requirements for the phase-in of payment reductions to reflect the amendments in section 4(b) of this law. Specifically, we are finalizing revisions to § 414.507(d) to indicate that for CY 2022, payment may not be reduced by more than 0% as compared to the amount established for CY 2021, and for CYs 2023 through 2025, payment may not be reduced by more than 15% as compared to the amount established for the preceding year.

Additionally, after consideration of public comments and further analysis, we are finalizing an increase to the nominal fee for specimen collection based on the Consumer Price Index for all Urban Consumers (CPI-U).  Therefore, for CY 2023, the general specimen collection fee will increase from $3 to $8.574 and as required by PAMA, we will increase this amount by $2 for those specimens collected from a Medicare beneficiary in a SNF or by a laboratory on behalf of an HHA, which will result in a $10.57 specimen collection fee for those beneficiaries . In addition, we are finalizing a policy to update this fee amount annually by the percent change in the CPI-U.  We are also finalizing our proposals to codify and clarify various laboratory specimen collection fee policies in § 414.523(a)(1). This is because the policies implementing the statutory requirements under section 1833(h)(3)(A) of the Act for the laboratory specimen collection fee, which are currently described in the Medicare Claims Processing Manual Pub. 100-04, chapter 16, § 60.1., did not have corresponding regulations text and some of the manual guidance is no longer applicable.

Lastly, in light of questions we have received from interested parties, we are finalizing as proposed to codify in our regulations, and make certain modifications and clarifications to, the Medicare CLFS travel allowance policies. We are finalizing the addition of § 414.523(a)(2) “Payment for travel allowance” to reflect the requirements for the travel allowance for specimen collection. Specifically, in accordance with section 1833(h)(3)(B) of the Act, we are finalizing to include in our regulations the following requirements for the travel allowance methodology: (1) a general requirement, (2) travel allowance basis requirements, and (3) travel allowance amount requirements.

Medicare Ground Ambulance Data Collection System

CMS is finalizing a series of changes to the Medicare Ground Ambulance Data Collection System. First, we are finalizing our proposal to update our regulations at § 414.626(d)(1) and (e)(2) to provide the necessary flexibility to specify how ground ambulance organizations should submit the hardship exemption requests and informal review requests, including to our web-based portal once that portal is operational. Second, we are finalizing our proposed changes and additional clarifications  to the Medicare Ground Ambulance Data Collection Instrument. The changes and clarifications aim to reduce burden on respondents, improve data quality, or both. We grouped  these changes and clarifications into four broad categories: editorial changes for clarity and consistency; updates to reflect the web-based system; clarifications responding to feedback from questions from interested parties and testing; and typos and technical corrections.

Origin and Destination Requirements Under the Ambulance Fee Schedule

CMS is finalizing our interim final policy (85 FR 19276) that the expanded list of covered destinations for ground ambulance transports was for the duration of the COVID-19 PHE only.  These destinations include, but are not limited to, any location that is an alternative site determined to be part of a hospital, critical access hospital(CAH)or skilled nursing facility (SNF), community mental health centers, Federally qualified health centers, rural health clinics, physician offices, urgent care facilities, ambulatory surgical centers, any location furnishing dialysis services outside of an end-stage renal disease (ESRD) facility when an ESRD facility is not available, and the beneficiary’s home.

When the COVID-19 PHE ends, our regulations will reflect the long-standing ambulance services coverage for the following destinations only: hospital; CAH; SNF; beneficiary’s home; and dialysis facility for an ESRD patient who requires dialysis. In addition to these long-standing covered destinations, rural emergency hospitals (REH) will also be an allowed destination, in accordance with the Consolidated Appropriations Act, 2021, effective with services on or after January 1, 2023.

For a fact sheet on the CY 2023 Quality Payment Program changes, please visit (clicking link downloads zip file): https://qpp-cm-prod-content.s3.amazonaws.com/uploads/2136/2023%20Quality%20Payment%20Program%20Final%20Rule%20Resources.zip

For a fact sheet on the Medicare Shared Savings Program changes, please visit:  https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2023-medicare-physician-fee-schedule-final-rule-medicare-shared-savings-program

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CMS Announces 2023 Ambulance Inflation Factor

On October 14, 2022, CMS issued Transmittal 11642 (Change Request 12948), which announced the Medicare Ambulance Inflation Factor (AIF) for the calendar year 2023.

The AIF is calculated by measuring the increase in the consumer price index for all urban consumers (CPI-U) for the 12-month period ending with June of the previous year.  Starting in the calendar year 2011, the change in the CPI-U is now reduced by a so-called “productivity adjustment”, which is equal to the 10-year moving average of changes in the economy-wide private nonfarm business multi-factor productivity index (MFP).  The MFP reduction may result in a negative AIF for any calendar year.  The resulting AIF is then added to the conversion factor used to calculate Medicare payments under the Ambulance Fee Schedule.

For the 12-month period ending in June 2022, the Federal Bureau of Labor Statistics (BLS) has calculated that the CPI-U increased by 9.1%.  CMS further indicated that the CY 2023 MFP would be 0.4%.  Accordingly, CMS indicated that the Ambulance Inflation Factor for the calendar year 2023 will be 8.7%. 

This is the largest inflation update since the implementation of the current Medicare Ambulance Fee Schedule in April 2002.  The increase from last year’s 5.1% increase is also the single largest year-over-year increase on record.

CMS End of PHE Roadmap

CMS Prepares Providers and Suppliers for the End of the Public Health Emergency:

CMS Issues Updates on the End of Emergency Waivers and Flexibilities Issued during the PHE

By Kathy Lester, J.D., M.P.H.

 

Even though it appears that the Biden-Harris Administration will extend the COVID-19 Public Health Emergency (PHE) for at least another 90 days, CMS has begun the process of preparing for the termination of waivers and flexibilities that have been in effect during the pandemic.  During the PHE, the American Ambulance Association has worked closely with CMS and Congress to make sure that ground ambulance services were prioritized and provided with waivers and flexibilities to support their integral role as a front-line medical response during the pandemic.

 

CMS announced its roadmap for the end of the PHE on August 18.  The roadmap includes a summary of the policies that will terminate at the end of the PHE, but also notes that CMS intends to keep some policies in place even after the PHE ends. Examples of policies that will continue after the PHE is allowed to expire include certain morbidity and mortality reporting requirements on long-term care facilities and certain telehealth services expanded by Congress.

 

In its announcement, CMS indicated particular concern about patient safety.  “As mentioned by Lee A. Fleisher, M.D.; Michelle Schreiber, M.D.; Denise Cardo, M.D.; and Arjun Srinivasan, M.D., in February 17, 2022, New England Journal of Medicine Perspective, ‘Safety has also worsened for patients receiving post-acute care, according to data submitted to the Centers for Medicare and Medicaid Services (CMS) Quality Reporting Programs…’”

 

As part of this announcement, CMS released a fact sheet detailing the current status of the Medicare waivers and flexibilities for ambulance providers and suppliers.  Some of the policies highlighted in this fact sheet include:

 

  • Vaccine Reimbursement Rates: CMS will continue to pay approximately $40 per dose for administering COVID-19 vaccines in outpatient settings for Medicare beneficiaries through the end of the calendar year that the COVID-19 PHE ends.  Effective January 1 of the year following the year that the COVID-19 PHE ends, CMS will set the payment rate for administering COVID-19 vaccines to align with the payment rate for administering other Part B preventive vaccines.  CMS plans to continue to pay a total payment of approximately $75 per dose to administer COVID-19 vaccines in the home for certain Medicare patients through the end of the calendar year that the COVID-19 PHE ends.

 

  • Alternative Destination: CMS indicates that it will include this issue in future rulemaking.

 

  • Treat in Place: CMS indicates that the waiver will end with the end of the PHE.

 

  • Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) Prior Authorization: CMS notes that it has already returned to the full model operations including post-payment reviews of claims submitted during the PHE.

 

  • Signature Requirements: Absent indications of potential fraud and abuse, CMS will not review claims for dates of service during the COVID-19 PHE for compliance with the signature requirements.

 

  • Appeal Flexibilities: CMS will allow some of the flexibilities related to the timing of appears to continue consistent with existing authority for appeals once the PHE ends.

 

The AAA will continue to monitor the PHE and any changes in the waivers and flexibilities specific to ground ambulance services.  We encourage members to reach out to our team if concerns or questions arise as CMS winds down the PHE.

CMS Ambulance Open Door Forum Summary

On August 18, 2022, the Centers for Medicare and Medicaid Services (CMS) held its most recent Ambulance Open Door Forum (ODF). As is typically the case, CMS started the ODF with a series of announcements, before opening the call to questions from the ambulance industry.

 

The first announcement related to proposed changes to the regulations governing the medical necessity requirements for non-emergency, scheduled, repetitive ground ambulance services. Specifically, CMS is proposing to modify the so-called “special rule” for repetitive, scheduled non-emergency services (set forth in the regulations at 42 C.F.R. §410.40(e)(2)(ii)). CMS indicated that these proposed changes would provide necessary and ensure the consistent application of the documentation requirements by its contractors. The proposed change would add language indicating that both the Physician Certification Statement and “additional documentation from the beneficiary’s medical record” could be used to support medical necessity for the ambulance transport. The new language would further indicate that these documents must provide detailed explanations that are consistent with the beneficiary’s current medical condition. On the ODF, CMS encouraged the industry to submit comments on these proposed changes. However, CMS indicated that, because these changes were the subject of ongoing rulemaking, it would not be able to answer any questions on the ODF.

 

The second announcement related to the proposed changes to the Medicare Ground Ambulance Data Collection System (GADCS) included in the July 2022 Proposed Rule. CMS and its contractor, the Rand Corporation, went through a detailed PowerPoint presentation that summarized these proposed changes. That PowerPoint presentation can be accessed by clicking here.

 

As part of its discussion of the GADCS, CMS also announced the implementation of an automated process for requesting hardship exemptions and informal review of determinations that an ambulance provider is subject to a financial penalty for failing to properly submit its cost data.

 

The final announcement related to ambulance services furnished by Rural Emergency Hospitals (REHS). In the FY 2023 Outpatient Hospital Proposed Rule, CMS is proposing to codify in its regulations the statutory requirement that ambulance services furnished by entities that are owned and operated by REHS will be paid under the Medicare Ambulance Fee Schedule. CMS is also proposing to revise the origin and destination requirements to include REHS as both a covered origin and covered destination for ambulance services.

 

The ODF concluded with a brief Q&A period. All of the questions posed to CMS related to the GADCS.  One of the questions placed to CMS was whether it would permit ambulance suppliers to prospectively seek a hardship exemption, i.e., to permit an ambulance supplier to ask now that it be relieved of the financial penalties for failing to report its cost data. The person posing the question specifically referenced ambulance suppliers impacted by the severe flooding in the State of Kentucky. CMS confirmed that an ambulance supplier had to be notified that it was subject to a financial penalty before it was eligible to seek a hardship exemption.

CMS Medicare, Medicaid, and CHIP Enrollment

Centers for Medicare & Medicaid Services

Today, the Centers for Medicare & Medicaid Services (CMS) released the latest enrollment figures for Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP). These programs serve as key connectors to care for more millions of Americans.

Medicare

As of May 2022, 64,553,288 people are enrolled in Medicare. This is an increase of 103,837 since the last report.

34,893,853 are enrolled in Original Medicare.

29,659,435 enrolled in Medicare Advantage or other health plans. This includes enrollment in Medicare Advantage plans with and without prescription drug coverage.

50,086,253 are enrolled in Medicare Part D. This includes enrollment in stand-alone prescription drug plans as well as Medicare Advantage plans that offer prescription drug coverage.

About 12 million individuals are dually eligible for Medicare and Medicaid, so are counted in the enrollment figures for both programs.

Detailed enrollment data can be viewed here: https://data.cms.gov/summary-statistics-on-beneficiary-enrollment/medicare-and-medicaid-reports/medicare-monthly-enrollment

Medicaid and Children’s Health Insurance Program (CHIP)

As of May 2022, 88,978,791 of people are enrolled in Medicaid and CHIP. This is an increase of 677,711 since the last report.

81,904,569 are enrolled in Medicaid

7,074,222 are enrolled in CHIP

For more information on Medicaid/CHIP enrollment, including enrollment trends, visit https://www.medicaid.gov/medicaid/program-information/medicaid-chip-enrollment-data/medicaid-and-chip-enrollment-trend-snapshot/index.html

Every day, CMS ensures that people across the U.S. have coverage that works. See the latest coverage totals across all CMS programs at https://www.cms.gov/pillar/expand-access. This information is updated on a monthly basis. Enrollment data for CMS programs are compiled on different timelines owing to the unique nature of each program.

CMS Ambulance Open Door Forum scheduled for Thursday, August 18

CMS Open Door Forum
The next CMS Ambulance Open Door Forum scheduled for:

Date:  Thursday, August 18, 2022

Start Time:  2:00pm-3:00pm PM Eastern Time (ET);

Please dial-in at least 15 minutes before call start time.

Conference Leaders: Jill Darling, Maria Durham

**This Agenda is Subject to Change**

  1. Opening Remarks

Chair- Maria Durham, Director, Division of Data Analysis and Market Based Pricing

Moderator – Jill Darling (Office of Communications)

  1. Announcements & Updates
  1. Medicare Ground Ambulance Data Collection System: Proposed Changes in the CY 2023 Physician Fee Schedule (PFS) Proposed Rule

Slide presentation is available at: https://www.cms.gov/Center/Provider-Type/Ambulances-Services-Center, under Spotlights, Upcoming Events

2. CY 2023 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical  Center (ASC) Payment System Proposed Rule: https://www.federalregister.gov/documents/2022/07/26/2022-15372/medicare-program-hospital-outpatient-prospective-payment-and-ambulatory-surgical-center-payment

Proposals Regarding Rural Emergency Hospitals Ambulance Services

III. Open Q&A

**DATE IS SUBJECT TO CHANGE**

Next Ambulance Open Door Forum: TBA

ODF email: AMBULANCEODF@cms.hhs.gov

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This Open Door Forum is open to everyone, but if you are a member of the Press, you may listen in but please refrain from asking questions during the Q & A portion of the call. If you have inquiries, please contact CMS at Press@cms.hhs.gov. Thank you.

Open Door Participation Instructions:

This call will be Conference Call Only.

To participate by phone:

Dial: 1-888-455-1397 & Reference Conference Passcode: 5109694

Persons participating by phone do not need to RSVP. TTY Communications Relay Services are available for the Hearing Impaired.  For TTY services dial 7-1-1 or 1-800-855-2880. A Relay Communications Assistant will help.

Instant Replay: 1- 866-469-7806; Conference Passcode: No Passcode needed

Instant Replay is an audio recording of this call that can be accessed by dialing 1-866-469-7806 and entering the Conference Passcode beginning 1 hours after the call has ended. The recording is available until August 20, 2022, 11:59PM ET.

For ODF schedule updates and E-Mailing List registration, visit our website at http://www.cms.gov/OpenDoorForums/.

Were you unable to attend the recent Ambulance ODF call? We encourage you to visit our CMS Podcasts and Transcript webpage where you can listen and view the most recent Ambulance ODF call. The audio and transcript will be posted to: https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts.html.

CMS provides free auxiliary aids and services including information in accessible formats. Click here for more information. This will point partners to our CMS.gov version of the “Accessibility & Nondiscrimination notice” page. Thank you.

CMS | Ambulance Ground Transport: Comparative Billing Report in April

From CMS on April 21, 2022

In late April, CMS will issue a Comparative Billing Report (CBR) on Medicare Part B claims for ambulance ground transport. Use the data-driven report to compare your billing practices with those of peers in your state and across the nation.

CBRs aren’t publicly available. Look for an email from cbrpepper.noreply@religroupinc.com to access your report. Update your email address in the Provider Enrollment, Chain, and Ownership System to ensure delivery.

For More Information:

Wall Time Toolkit

Extended ambulance patient offload times (APOT), or “wall times,” at hospitals are causing long waits for 911 and interfacility patients and exacerbating the EMS workforce shortage. Ambulance services across the country are continually trying to meet demand with fewer resources; when EMS providers are kept out of service for extended periods of time because they are unable to transfer patient care at the hospital, wait times for both 911 and inter-facility patients increase and both emergency and non-emergency calls pile up. 

We recognize that the issue of extended wall times is not new, but an existing problem exacerbated by the ongoing battle with COVID-19 across the country. Increased wall times are a symptom of a much larger problem for which there is no easy solution.

This toolkit will provide an overview of EMTALA, highlight the intersection between EMTALA and APOT, and address some frequently asked questions along with links to resources and examples of how services are addressing this issue across the country.

EMTALA – Emergency Medical Treatment and Labor Act
Summary of Major Provisions

  • The Emergency Medical Treatment and Labor Act (EMTALA) is a federal law that was enacted as part of the Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1985 (42 U.S.C. §1395dd).
  • EMTALA provides that when an individual comes to an emergency department, he/she/they must be stabilized and treated, regardless of their insurance status or ability to pay.
  • EMTALA is often referred to as the “anti-dumping” law and was designed to prevent hospitals from transferring uninsured or Medicaid patients to another hospital without, at a minimum, providing a medical screening examination to ensure they were stable for transfer.
  • EMTALA requires the hospital to provide a screening examination to determine if an emergency medical condition exists and, if so, provide stabilizing treatment to resolve the patient’s emergency medical condition.
  • EMTALA requires Medicare-participating hospitals with emergency departments to screen and treat the emergency medical conditions of patients in a non-discriminatory manner to anyone, regardless of their ability to pay, insurance status, national origin, race, creed, or color.

EMTALA & Ambulance Patient Offloading Times (APOT)

  • EMS agencies have been struggling with extended Emergency Department patient offload times. This has been exacerbated over the last few years of the COVID-19 pandemic.
  • This has impacted the ability of EMS agencies to provide services and respond to ambulance service requests. Additionally, it is impacting many public safety agencies that are responding to medical emergencies.
  • Centers for Medicare & Medicaid Services (CMS) issued a memorandum on extended ambulance patient offload times and EMTALA in July 2006.
    • In the memorandum, CMS noted “Many of the hospital staff engaged in such practice believe that unless the hospital “takes responsibility” for the patient, the hospital is not obligated to provide care or accommodate the patient”
    • CMS stated that this practice may result in a violation of the Emergency Medical Treatment and Labor Act (EMTALA) and “raises serious concerns for patient care and the provision of emergency services in a community.”
    • Additionally, CMS notes that this practice may also result in a violation of 42 CFR 482.55, the Conditions of Participation for Hospitals for Emergency Services, which requires that a hospital meet the emergency needs of patients in accordance with acceptable standards of practice.
    • EMTALA defines[1] when a patient “presents” at an emergency department in the following way:

(1) Has presented at a hospital’s dedicated emergency department, as defined in this section, and requests examination or treatment for a medical condition, or has such a request made on his or her behalf. In the absence of such a request by or on behalf of the individual, a request on behalf of the individual will be considered to exist if a prudent layperson observer would believe, based on the individual’s appearance or behavior, that the individual needs examination or treatment for a medical condition;

(2) Has presented on hospital property, as defined in this section, other than the dedicated emergency department, and requests examination or treatment for what may be an emergency medical condition, or has such a request made on his or her behalf. In the absence of such a request by or on behalf of the individual, a request on behalf of the individual will be considered to exist if a prudent layperson observer would believe, based on the individual’s appearance or behavior, that the individual needs emergency examination or treatment;

(3) Is in a ground or air ambulance owned and operated by the hospital for purposes of examination and treatment for a medical condition at a hospital’s dedicated emergency department, even if the ambulance is not on hospital grounds. However, an individual in an ambulance owned and operated by the hospital is not considered to have “come to the hospital’s emergency department” if –

(i) The ambulance is operated under communitywide emergency medical service (EMS) protocols that direct it to transport the individual to a hospital other than the hospital that owns the ambulance; for example, to the closest appropriate facility. In this case, the individual is considered to have come to the emergency department of the hospital to which the individual is transported, at the time the individual is brought onto hospital property;

(ii) The ambulance is operated at the direction of a physician who is not employed or otherwise affiliated with the hospital that owns the ambulance; or

(4) Is in a ground or air nonhospital-owned ambulance on hospital property for presentation for examination and treatment for a medical condition at a hospital’s dedicated emergency department. However, an individual in a nonhospital-owned ambulance off hospital property is not considered to have come to the hospital’s emergency department, even if a member of the ambulance staff contacts the hospital by telephone or telemetry communications and informs the hospital that they want to transport the individual to the hospital for examination and treatment. The hospital may direct the ambulance to another facility if it is in “diversionary status,” that is, it does not have the staff or facilities to accept any additional emergency patients. If, however, the ambulance staff disregards the hospital’s diversion instructions and transports the individual onto hospital property, the individual is considered to have come to the emergency department.

[1] 42 CFR § 489.24(b) – Special responsibilities of Medicare hospitals in emergency cases.

APOT Strategies

  • EMS agencies who are experiencing extended ambulance patient offload times should engage the hospital leadership to collaborate to identify possible solutions. Often, we assume that the hospital leadership is aware that the EMS crews are being held for extended periods of time. Also, the hospital may not understand how APOT is impacting your organization and the overall EMS and public safety response.  Emphasize that EMS is one piece of a larger EMS system.
  • EMS agencies should consider educating or reminding the hospital leadership about their obligations under EMTALA.
  • Consider placing a transfer coordinator or another member of your staff to stay with patients during the transition between EMS and ED care. The EMS agency is under no obligation to do this and could set a precedent or expectation by the hospital that extended APOT is the EMS agency’s responsibility.  However, it may serve to free up valuable EMS resources.

EMTALA & APOT Frequently Asked Questions

  1. Are EMS personnel required to remain with the patient until an emergency department personnel “accept” report or “takes over care” of the patient?

Answer: No, the EMS crew is not legally required to remain with the patient until the hospital personnel take a report or take over patient care.  As the EMTALA provisions above cite, the EMS crew may choose to remain with the patient but, as soon as that patient arrives on hospital property or enters the emergency department, the hospital is legally responsible for the patient.

  1. What if the patient’s condition requires constant attention and the patient cannot be left alone without causing the patient harm?

Answer:  If the patient’s condition dictates that the patient cannot be safely left alone, the crew would have an ethical obligation to continue to care for the patient until care can be safely transferred to the appropriate caregiver. The EMS crew should continue to provide patient care and should contact a supervisor or Officer in Charge (OIC) at their agency to inform them of the situation and request assistance with facilitating the transfer of care.

  1. What do I do if the emergency department staff fail/refuse to take a report or take over care of the patient?

Answer:  The EMS crew should attempt to provide a verbal report to an emergency department staff member if possible.  If no one is available, or the hospital staff will not make someone available to take a verbal report, the crew should tell an ED staff member that the EMS crew will be leaving the patient, where the patient was left and the patient’s general condition.  EMS providers should document how long they waited after arriving at the ED, where they left the patient, which ED staff member they notified, and the patient’s condition when they left in their patient care report.  EMS providers should be sure to leave a copy of their patient care report or an abbreviated patient care report with the hospital staff or with the patient.

In some states, extended APOT may be reportable to the state-level oversight agency, such as the state EMS Office or the Department of Public Health.

If hospitals are unresponsive to the initial conversation, you could also consider escalating the issue to your State Survey Agency, the agency primarily charged with taking EMTALA complaints.

We have created a draft letter for use in communicating with your State Survey Agency; be sure to update the draft letter to include specific examples and data that illustrate the particular issues your service is facing and the steps you’ve taken to try and resolve the issue so far.

  1. Can I be accused of patient abandonment if I leave a patient in the ED without a member of the ED staff taking over the care of the patient?

Answer:  Because the legally becomes the hospital’s responsibility upon arrival on hospital property or upon arrival in the ED, it is highly unlikely that a claim of abandonment could be sustained.  The most important thing EMS providers can do is to exercise reasonable care of the patient before, upon, and after arrival at the ED.  EMS providers who reasonably attempt to furnish a report to the ED staff or who ensure that the patient can be safely left at the ED with either an abbreviated or full patient care report will likely be protected from liability.

Additional Resources

Best Practices for Mitigating Ambulance ED Delays webinar

California Emergency Medical Services Authority Ambulance Patient Offload Time (APOT) webpage

CMS Regional Office Directory

Statewide Method of Measuring Ambulance Patient Offload Times

State Survey Agency Directory
This is the agency primarily charged with receiving EMTALA complaints.

Wall time Collaborative a partnership to reduce ambulance patient off-load delays
presentation from 2013

In the News:

EMS crews forced to wait hours to drop patients at overwhelmed hospitals

TODAY | CCIIO Open Door Forum No Surprises Act

Centers for Medicare & Medicaid Services Center for Consumer Information and Insurance Oversight

Special Open Door Forum: Provider Requirements under the No Surprises Act
Wednesday December 8, 2021 | 2:00-3:00 pm Eastern Time
Conference Call Only
Participant Dial-In Number: 1-888-455-1397
Conference ID #: 8604468

 

The Center for Consumer Information and Insurance Oversight (CCIIO) and the CMS Office of Communication will host an orientation to provider requirements under the No Surprises Act.

Starting January 1, 2022, consumers will have new billing protections when getting emergency care, non-emergency care from out-of-network providers at in-network facilities, and air ambulance services from out-of-network providers. Through new rules aimed to protect consumers, excessive out-of-pocket costs will be restricted, and emergency services must continue to be covered without any prior authorization, and regardless of whether or not a provider or facility is in-network.

On July 1, 2021, the “Requirements Related to Surprise Billing; Part I,” interim final rule was issued to restrict surprise billing for patients in job-based and individual health plans who get emergency care, non-emergency care from out-of-network providers at in-network facilities, and air ambulance services from out-of-network providers.

On September 30, 2021, a second interim final rule was issued and is open for public comment. The “Requirements Related to Surprise Billing; Part II” rule provides additional protections against surprise medical bills, including:

  • Establishing an independent dispute resolution process to determine out-of-network payment amounts between providers (including air ambulance providers) or facilities and health plans.
  • Requiring good-faith estimates of medical items or services for uninsured (or self-paying) individuals.
  • Establishing a patient-provider dispute resolution process for uninsured (or self-paying) individuals to determine payment amounts due to a provider or facility under certain circumstances.
  • Providing a way to appeal certain health plan decisions.

Together, these lay the groundwork to provide consumers with protection against surprise billing, starting in 2022. Learn more about how these rules help consumers.

Here is the link to our No Surprises page that has the slides: https://www.cms.gov/nosurprises/Policies-and-Resources/Provider-requirements-and-resources

We look forward to your participation.

Special Open Door Participation Instructions:

Participant Dial-In Number: 1-888-455-1397

Conference ID #: 8604468

Note: TTY Communications Relay Services are available for the Hearing Impaired. For TTY services dial 7-1-1 or 1-800-855-2880. A Relay Communications Assistant will help. 

A transcript and audio recording of this Special ODF will be posted to the Podcast and Transcripts website at https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts.html for downloading.

For automatic emails of Open Door Forum schedule updates (E-Mailing list subscriptions) and to view Frequently Asked Questions please visit our website at http://www.cms.gov/OpenDoorForums/.

Thank you for your interest in CMS Open Door Forums.

CMS | Ambulance Open Door Forum Dec 9

The next CMS Ambulance Open Door Forum scheduled for:

Date:  Thursday, December 9, 2021

Start Time:  2:00pm-3:00pm PM Eastern Time (ET);

Please dial-in at least 15 minutes before call start time.

To participate by phone:

Dial: 1-888-455-1397 & Reference Conference Passcode: 8604468

Conference Leaders: Jill Darling, Maria Durham

**This Agenda is Subject to Change**

  1. Opening Remarks

Chair- Maria Durham, Director, Division of Data Analysis and Market Based Pricing

Moderator – Jill Darling (Office of Communications)

Announcements & Updates

  1. Emergency Triage, Treat, and Transport (ET3) Model Update
  2. Upcoming Implementation Dates of the Repetitive, Scheduled Non-Emergent Ambulance Transport Prior Authorization Model
  3. Ground Ambulance & Patient Billing Advisory Committee Member Nomination Period
  1. CY 2022 Ambulance Inflation Factor (AIF) Change Request 12488, Transmittal 11044
  2. Medicare Ground Ambulance Data Collection System CY 2022 Physician Fee Schedule Final Rule

III. Open Q&A

**DATE IS SUBJECT TO CHANGE**

Next Ambulance Open Door Forum: TBA

ODF email: AMBULANCEODF@cms.hhs.gov

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This Open Door Forum is open to everyone, but if you are a member of the Press, you may listen in but please refrain from asking questions during the Q & A portion of the call. If you have inquiries, please contact CMS at Press@cms.hhs.gov. Thank you.

Open Door Participation Instructions:

This call will be Conference Call Only.

To participate by phone:

Dial: 1-888-455-1397 & Reference Conference Passcode: 8604468

Persons participating by phone do not need to RSVP. TTY Communications Relay Services are available for the Hearing Impaired.  For TTY services dial 7-1-1 or 1-800-855-2880. A Relay Communications Assistant will help.

Instant Replay: 1-800-856-2271; Conference Passcode: No Passcode needed

Instant Replay is an audio recording of this call that can be accessed by dialing 1-800-856-2271 and entering the Conference Passcode beginning 1 hours after the call has ended. The recording is available until December 11, 2021, 11:59PM ET.

For ODF schedule updates and E-Mailing List registration, visit our website at http://www.cms.gov/OpenDoorForums/.

Were you unable to attend the recent Ambulance ODF call? We encourage you to visit our CMS Podcasts and Transcript webpage where you can listen and view the most recent Ambulance ODF call. Please allow up to three weeks to get both the audio and transcript posted to: https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts.html.

CMS provides free auxiliary aids and services including information in accessible formats. Click here for more information. This will point partners to our CMS.gov version of the “Accessibility & Nondiscrimination notice” page. Thank you.

CCIIO Open Door Forum No Surprises Act

From CMS on December 3, 2021

Centers for Medicare & Medicaid Services Center for Consumer Information and Insurance Oversight

Special Open Door Forum: Provider Requirements under the No Surprises Act
Wednesday December 8, 2021 | 2:00-3:00 pm Eastern Time
Conference Call Only
Participant Dial-In Number: 1-888-455-1397
Conference ID #: 8604468

 

The Center for Consumer Information and Insurance Oversight (CCIIO) and the CMS Office of Communication will host an orientation to provider requirements under the No Surprises Act.

Starting January 1, 2022, consumers will have new billing protections when getting emergency care, non-emergency care from out-of-network providers at in-network facilities, and air ambulance services from out-of-network providers. Through new rules aimed to protect consumers, excessive out-of-pocket costs will be restricted, and emergency services must continue to be covered without any prior authorization, and regardless of whether or not a provider or facility is in-network.

On July 1, 2021, the “Requirements Related to Surprise Billing; Part I,” interim final rule was issued to restrict surprise billing for patients in job-based and individual health plans who get emergency care, non-emergency care from out-of-network providers at in-network facilities, and air ambulance services from out-of-network providers.

On September 30, 2021, a second interim final rule was issued and is open for public comment. The “Requirements Related to Surprise Billing; Part II” rule provides additional protections against surprise medical bills, including:

  • Establishing an independent dispute resolution process to determine out-of-network payment amounts between providers (including air ambulance providers) or facilities and health plans.
  • Requiring good-faith estimates of medical items or services for uninsured (or self-paying) individuals.
  • Establishing a patient-provider dispute resolution process for uninsured (or self-paying) individuals to determine payment amounts due to a provider or facility under certain circumstances.
  • Providing a way to appeal certain health plan decisions.

Together, these lay the groundwork to provide consumers with protection against surprise billing, starting in 2022. Learn more about how these rules help consumers.

Here is the link to our No Surprises page that has the slides: https://www.cms.gov/nosurprises/Policies-and-Resources/Provider-requirements-and-resources

We look forward to your participation.

Special Open Door Participation Instructions:

Participant Dial-In Number: 1-888-455-1397

Conference ID #: 8604468

Note: TTY Communications Relay Services are available for the Hearing Impaired. For TTY services dial 7-1-1 or 1-800-855-2880. A Relay Communications Assistant will help. 

A transcript and audio recording of this Special ODF will be posted to the Podcast and Transcripts website at https://www.cms.gov/Outreach-and-Education/Outreach/OpenDoorForums/PodcastAndTranscripts.html for downloading.

For automatic emails of Open Door Forum schedule updates (E-Mailing list subscriptions) and to view Frequently Asked Questions please visit our website at http://www.cms.gov/OpenDoorForums/.

Thank you for your interest in CMS Open Door Forums.