Hello Roberta Buell,

It seems that, whenever I write a newsletter, we are in some kind of period of transition. Right now, we are in this midst of a change in Administration. What this means is that all the policies described below (except the last article about coding) may be subject to change. Sorry about that, but this is what happens every four years.

One thing that happened as the Biden Administration on their way out the door was that they named the next 15 drugs open for negotiation in 2026. The drugs selected for the second round of negotiations are Ozempic/Rybelsus/Wegovy, Trelegy Ellipta, Xtandi, Pomalyst, Ibrance, Ofev, Linzess, Calquence, Austedo/Austedo XR, Bre Ellipta, Tradjenta, Xifaxan, Vraylar, Janumet/Janumet XR and Otezla. In accordance with the final guidance for the second cycle of the Drug Price Negotiation Program, drug companies with a selected drug will have until Feb. 28 to decide if they will participate in negotiations. In negotiating with participating manufacturers, the Centers for Medicare and Medicaid Services said it will consider the selected drug's clinical benefit, the extent to which it addresses unmet medical needs, and its impact on specific populations, including people who rely on Medicare. Other considerations include costs associated with research and development as well as production and distribution for the selected drugs.

Everyone is looking for guidance on Telehealth. There are still many unanswered questions about how this works and what will happen down the road. But, we review what's going on with it and a few other things that went down at the end of the year--in case you missed it. The other thing that didn't happen in December was the Fourth Quarter Hospital Outpatient Prospective Payment System memo did not get released until January, so we cover that for you.

Less definite are the Medicare Advantage and Part D Rules for 2026 which were proposed at the end of the Biden Administration. While some aspects of this proposal will remain, not all will. The Trump Administration has already cut the programs in place to test out other strategies to further lower drug prices. Keep your eyes and ears open.

We also are hearing that CAR-Ts are migrating out in Community Oncology. The Part B coding and billing is complicated, but once you get the hang of it, it's not so bad.

Finally, if you want to hear about what we think Trump will do to/for healthcare, try our podcasts. They are for you AND your patients. Check it out! You can find it on Spotify Avoid Staying Sick & Going Broke | Podcast on Spotify Or Apple Avoid Staying Sick & Going Broke Podcast - Apple Podcasts.

Happy New Year!!!!

Da' Mistress

Some big things happened (or didn't) while you were away for Xmas, Chanukah, Quansa, New Years, and otherwise partying season. The first thing discussed below is the American Relief Act which was supposed to put a patch on physician payment--which it didn't. The OPPS changes for Q1 were not released until January 10, 2025--so we are summarizing it for you in the next article

The American Relief Act

At the close of 2024, US Congress passed a short-term extension of Medicare telehealth flexibilities as part of the American Relief Act, 2025 (ARA). The Medicare telehealth waivers, originally enacted as part of the COVID-19 public health emergency (PHE) and subsequently extended through legislation, were set to end on December 31, 2024. These flexibilities, along with the Acute Hospital Care at Home waiver program, are now set to expire March 31, 2025. The ARA failed to extend other waivers, such as the temporary safe harbor for high-deductible health plans (HDHPs) to provide first-dollar coverage of telehealth without interfering with health savings account (HSA) eligibility. While the short-term extension provides continued access to telehealth for Medicare patients, stakeholders should continue to engage with Congress for a more permanent solution.

First and foremost, there was NO FIX to the cut in physician pay. This means we have to wait until mid-March to see if there will be any kind of fix this year at all. Tax cuts may be on the horizon--so these cuts may stand for all of 2025.

Historically, prior to the Pandemic, Medicare has provided coverage for telehealth services in instances where patients would otherwise be geographically distant from approved providers (e.g., physicians, nurse practitioners, and clinical psychologists)--this is called an 'underserved' area. Section 1834(m) of the Social Security Act provides that telehealth services are only covered if the beneficiary is seen:

• At an approved “originating site” (e.g., physician office, hospital, or skilled nursing facility) that is located within a rural health professional shortage area that is either outside of a metropolitan statistical area (MSA), in a rural census tract, or in a county outside of an MSA
• By an approved provider
• For a defined set of services that are listed
• Using certain telecommunications technologies.
• Many of these Medicare restrictions regarding coverage and payment for telehealth services were waived via authority delegated in the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Congress subsequently extended the waivers in other pieces of legislation, including the Consolidated Appropriations Act (CAA) 2022 and CAA 2023, with the flexibilities most recently set to expire on December 31, 2024.

The ARA extended the following Medicare flexibilities through March 31, 2025--at which time we HOPE these will be extended until AT LEAST 12/31/2025:

• Geographic restrictions and originating sites. Patients’ homes will continue to serve as eligible originating sites for all telehealth services (ARA § 3207(a)(2)). Geographic restrictions also remain waived (ARA § 3207(a)(1)).
• Eligible practitioners. The expanded definition of the term “practitioner” will continue to apply. The expanded definition includes qualified occupational therapists, physical therapists, speech-language pathologists, and audiologists.
• Audio-only. Audio-only telehealth services remain eligible for reimbursement. This is a problem, kiddies. Why? As you know, the telephone call codes were deleted. So, how do you report Audio-only telehealth? Different coders have differing opinions--but one thing is for sure: there is no specific guidance from CMS.
• There are coders who say to to use to use 98016 which is actually for a brief check-in and has certain visit restrictions such as the patient cannot have been seen in the last 7 days AND this check in must be patient initiated.
• The Final Regs originally stated that, for telephone services in 2025, you would:
• Use the CPT or HCPCS code that best describes the service
• Append CPT modifier 93 to the claim
• Document that the physician has audio-video available, but the patient preferred audio-only or was unable to use audio-video
• Federally qualified health centers and rural health centers should use modifier FQ, 93, or both where appropriate
• There is no official Medicare guidance, but I go with the second option, unless you hear otherwise.
• Extending telehealth services for federally qualified health centers (FQHCs) and rural health clinics (RHCs). The US Department of Health and Human Services will cover telehealth services furnished via FQHCs and RHCs to eligible individuals.
• In-person requirements for mental health. The in-person requirement for mental health care to be reimbursed under Medicare has been delayed until April 1, 2025.
• Telehealth for hospice. Telehealth can continue to be used for the required face-to-face encounter prior to the recertification of a patient’s eligibility for hospice care.
• The ARA also extended the Acute Hospital Care at Home waiver program through March 31, 2025. In the midst of the PHE, the Centers for Medicare & Medicaid Services (CMS) used its PHE flexibilities to issue waivers to certain Medicare hospital conditions of participation (CoPs). These waivers, along with the PHE-related telehealth flexibilities, allowed Medicare-certified hospitals to furnish inpatient-level care in patients’ homes. Addressing hospital bed capacity during the pandemic was a high priority for CMS. These waivers and flexibilities, collectively referred to as the AHCAH Initiative, included:
• Also, the ever-repealed GPCI floor is reinstated until 3/31/2025 as authorized Section 3206 of the American Relief Act, 2025. Fee schedules have been adjusted for this.

Other than these provisions, nothing else changed for 2025--until the Trump Administration is fully installed.

While many of us were probably super busy during the holidays, CMS apparently was too since they did not release the OPPS (Medicare Outpatient Prospective Payment System) changes for Q1 until early January. The Transmittal 13032, Change Request 13933 was issued January 10 and the following are the portions related to drugs, effectively January 1, 2025

• New HCPCS Codes getting Pass-Through Status 1/1/2025:
• C9173, Injection, filgrastim-txid (nypozi,), 1 mic
• J0870, Imelstat, 1 mg
• Existing HCPCS gaining Pass-Through Status as of 1/1/2025
• A9697, Injection, carboxydextran-coated superparamagnetic iron oxide, per study dose
• J0175, Injection, donanemab-azbt, 2 mg
• J2468, Injection, palonosetron hydrochloride (posfrea), 25 micrograms
• J2601, Injection, vasopressin (baxter), 1 unit
• J9329, Injection, tislelizumab-jsgr, 1 mg,
• HCPCS Codes for drugs losing Pass-Through status after 12/31/2024
• A9595, Piflufolastat f-18, diagnostic, 1 millicurie
• J0219, Injection, avalglucosidase alfa-ngpt, 4 mg
• J0491, Injection, anifrolumab-fnia, 1 mg
• J9021, Injection, asparaginase, recombinant, (rylaze), 0.1 mg
• J9071, Injection, cyclophosphamide, (auromedics), 5 mg
• HCPCS Codes deleted as of 1/1/2025
• 90654, Influenza virus vaccine, trivalent (IIV3), split virus, preservative-free, for intradermal use
• 90630, Influenza virus vaccine, quadrivalent (IIV4), split virus, preservative free, for intradermal use
• J0135, injection, adalimumab, 20 mg
• J0570 Buprenorphine implant, 74.2 mg
• J2796, Injection,romiplostim, 10 micrograms
• J2806, Injection, sincalide (maia), not therapeutically equivalent to j2805, 5 micrograms
• J9058, Injection, bendamustine hydrochloride (apotex), 1 mg
• J9059, Injection, bendamustine hydrochloride (baxter), 1 mg
• J9259, Injection, paclitaxel protein-bound particles (american regent), not therapeutically equivalent to j9264, 1 mg
• Q0516 Pharmacy supplying fee for hiv pre-exposure prophylaxis fda approved prescription oral drug, per 30-days
• Q0517 Pharmacy supplying fee for hiv pre-exposure prophylaxis fda approved prescription oral drug, per 60-days
• Q0518 Pharmacy supplying fee for hiv pre-exposure prophylaxis fda approved prescription oral drug, per 90-days
• Q0519 Pharmacy supplying fee for hiv pre-exposure prophylaxis fda approved prescription injectable drug, per 30-days
• Q0520 Pharmacy supplying fee for hiv pre-exposure prophylaxis fda approved prescription injectable drug, per 60-days
• Q5131 Injection, adalimumab-aacf (idacio), biosimilar, 20 mg
• Q5132 Injection, adalimumab-afzb (abrilada), biosimilar, 10 mg
• HCPCS Code changing Payment Status Indicator to E1 as of January 1, 2025
• J9198 Injection, gemcitabine hydrochloride, (infugem), 100 mg
• HCPCS Codes Changing Payment Status Retroactive to October 1, 2024
• J9059. Injection, bendamustine hydrochloride (baxter), 1 mg (K Status)
• J9072  Injection, cyclophosphamide (dr. reddy's), 5 mg (E2 Status)
• J9329  Injection, tislelizumab-jsgr, 1mg (K Status)
• Q5131.Injection, adalimumab-aacf (idacio), biosimilar, 20 mg (K Status)
• HCPCS Codes with New Long Descriptors as of January 1, 2025. The new ones are
• 90661 Influenza virus vaccine, trivalent (ccIIV3), derived from cell cultures, subunit, antibiotic free, 0.5 mL dosage, for intramuscular use
• J2468. Injection, palonosetron hydrochloride (posfrea), 25 micrograms
• J9033 Injection, bendamustine hydrochloride, 1 mg
• J9072. Injection, cyclophosphamide (avyxa), 5 mg
• Previously Bundled Radiopharmaceuticals paid separately as January 1, 2025
• A9515 Choline C 11, diagnostic, per study dose
• A9521 technetium tc-99m exametazime, diagnostic, per study dose, up to 25 millicuries
• A9542 indium in-111 ibritumomab tiuxetan, diagnostic, per study dose, up to 5 millicurie
• A9547. indium in-111 oxyquinoline, diagnostic, per 0.5 millicurie
• A9548. indium in-111 pentetate, diagnostic, per 0.5 millicurie
• A9557. technetium tc-99m bicisate, diagnostic, per study dose, up to 25 millicuries
• A9568. technetium tc-99m arcitumomab, diagnostic, per study dose, up to 25 millicuries

For more information about ALL OPPS Changes for January 1, 2025, see the Transmittal.

On January 10, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, which makes proposals to update program policies for Medicare Advantage (MA) and Part D beginning in 2026. CMS also issued its Draft CY 2026 Part D Redesign Program Instructions, which center on implementing provisions of the Inflation Reduction Act of 2022 (IRA) related to the Part D benefit for 2026. A press release, along with fact sheets for the Advance Notice and Part D Redesign Program Instructions, were also released.

Public comments on the Advance Notice and Draft Part D Redesign Program Instructions must be submitted by 11:59 PM Eastern Time on Monday, February 10, 2025. The CY 2026 Rate Announcement and the CY 2026 Part D Redesign Program Instructions will be published no later than April 7, 2025.

Remember that we have a new Administration, so all or some of this could be toast when the rules are finalized in March or April.

Here are some of the highlights (using the term loosely:

Payment Impact on Medicare Advantage Organizations

In the Advance Notice, CMS projects that payments to MA plans will increase by 4.33 percent (What?) from 2025 to 2026—which represents a $21 billion increase in expected payments to MA plans next year. CMS estimates that payments to MA plans in 2026 will total $590.9 billion.

The proposed increase in payments is based on several factors, including cost growth rates, changes to MA plan Star Ratings, continued phase in of the new risk adjustment model, and MA risk score trends. The estimated growth rate considers demographic changes in MA enrollment, including projected increases in the Medicare population.

The Advance Notice estimates represent the average increase in payments to MA plans and actual payments will vary from plan to plan according to actuarial and contracting factors.

MA Risk Adjustment Changes

CMS intends to complete the three-year phase-in of the MA risk adjustment model that was first published in the CY 2024 Rate Announcement (remember this proposal is for 2026). Specifically, CMS proposes to calculate 100 percent of the risk scores using the new MA risk adjustment model, referred to as the 2024 hierarchical condition categories ("CMS-HCC") framework. CMS maintains that the changes to the methodology for calculating risk have improved the predictive accuracy of the model while ensuring risk-adjusted payments to MA plans are accurate.

In addition, CMS has been working to calibrate the risk adjustment model based on MA encounter data, and CMS proposes to begin phasing in an encounter-based MA risk adjustment model as soon as CY 2027 as opposed to a population basis.

CMS also proposes to apply the statutory minimum MA coding pattern difference adjustment factor of 5.90 percent for CY 2026. Let me tell you why this is outrageous. This coding allowance deducts 5.9% for overcoding, but estimates are that overcoding is more like approximately 20%, leading to a $50 billion windfall. This has been going on for years,

Technical Adjustment to Cost Calculations Related to Medical Education Costs

CMS plans to complete the three-year phase-in of technical adjustments to the per capita cost calculations related to indirect and direct medical education costs associated with services delivered to MA beneficiaries. This technical adjustment—finalized in the CY 2024 Rate Announcement—has reduced growth rates for MA plans because of the removal of MA-related medical education costs from the benchmarks.

MA Star Ratings

The Star Ratings have produced several lawsuits over the past year. CMS reiterates its continued focus on creating metrics that center on clinical care, patient outcomes, and improved patient experiences and are aligned across CMS programs. In addition, CMS is soliciting initial feedback on both substantive measure specification updates as well as comments on new measure concepts. CMS also is seeking stakeholder feedback on modifications to the Health Equity Index, including adding social risk factors and geography (urban or rural) to the reward factor.

Medicare Part D Provisions

The CY 2026 Advance Notice and the CY 2026 Draft Part D Redesign Program Instructions include several payment and benefit updates as required in the Inflation Reduction Act (IRA) of 2022. The CY 2026 updates include:

• The CY 2026 annual out-of-pocket cost threshold for Part D covered drugs is $2,100, which is the original out-of-pocket cap of $2,000 adjusted for the annual percentage increase in average expenditures for Part D covered drugs
• Establishment of the selected drug subsidy program
• Changes to the liability of enrollees, plan sponsors, drug manufacturers, and CMS in the standard Part D benefit design, specifically to account for the start of the Medicare Drug Price Negotiation Program in 2026 (see more info on this above)
• Guidance on the successor regulation exception to the IRA’s formulary inclusion requirement for selected drugs under the Medicare Drug Price Negotiation Program
• Other previously implemented IRA reforms will continue in CY 2026, including no cost sharing for Medicare beneficiaries for Part D covered drugs in the catastrophic phase, which begins after the annual out-of-pocket threshold of $2,100 is reached; a $35 monthly cap on enrollee cost sharing for insulin; no cost sharing for adult vaccines recommended by the Centers for Disease Control and Prevention’s (CDC’s) Advisory Commission on Immunization Practices and covered under Part D; and the requirement for Part D plans to offer the Medicare Prescription Payment Plan to beneficiaries. Again, all or some of this could go bye-bye.

Administration Change Possibilities

Like the policy and technical changes included in the MA proposed rule, the CMS Advance Notice payment updates will be finalized under the incoming Trump Administration. MA plans should expect that the new leadership at the US Department of Health and Human Services and CMS will closely examine and take a fresh look at the proposed payment and policy changes. For example, officials in the Trump Administration could seek to delay the phase in of the risk adjustment changes as well as the technical adjustment regarding medical education costs. Even some IRA changes could possibly go away.

Stay Tuned.

I have seen awfully hard coding in my time (looking at you, Interventional Radiology), but we are seeing CAR-Ts migrating from the hospital to the office setting and the coding/billing is totally weird. That's the bad news. The good news is that we are seeing Community claims being paid, so somebody out there actually knows what they are doing--Congrats!

We suspect some of the rest of you will want to bill these innovative drugs when they come your way, so here is the scoop...remember this is Part B only; all others can be found in this comprehensive guide.

Cell Harvesting and Delivery Activities

Until January 1, 2025, these were Level III HCPCS and were paid by a number of payers. The new 2025 codes are:

• 38225 – Chimeric antigen receptor T-cell (CAR-T) therapy; harvesting of blood-derived T lymphocytes for development of genetically modified autologous CAR-T cells, per day

• 38226 – …preparation of blood-derived T lymphocytes for transportation (eg, cryopreservation, storage)

• 38227 – …receipt and preparation of CAR-T cells for administration

These codes have a "B" status for Medicare, so they are bundled and not paid. Check with your private payers regarding reimbursement. As we said, some were paying the old codes.

Place of Service

For Part B (outpatient claims), HCPCS codes (always Q-codes) for CAR T-cell products will only be paid in POS 11 (office) or 49 (independent clinic). Any other place of service will be denied if they are billed as we describe in the next sections. Again, hospital claims are different.

To give CAR-Ts your office needs to be FDA REMS approved. To denote this you must use a -KX Modifier. When a provider submits a KX HCPCS modifier on CAR T-cell therapy services, they are acknowledging the service is being submitted by or performed in an FDA REMS approved facility. Claims billed without the KX HCPCS modifier will be denied.

Number of Units

Here comes the trickiest part.

Effective for DOS on and after January 1, 2022, when entering the dollar amount for the charge of a service, providers are limited to a maximum of $99,999.99 per claim because $100,000.00 would exceed the CMS-1500 field size.

In most cases, the total payment for the CAR T-cell products will be divided by 10 and the provider will need to bill in 0.1-unit fractions. The provider will need to bill a total of 10 fractional units to reach the total Medicare allowed payment amount or one (1) complete unit, except as follows:

• Providers billing $499,999.99 or less would submit five claims for 0.2 fractional units per claim, for one (1) complete unit.
• For claims priced over $500,000.00, providers would bill 10 claims for 0.1 fractional units per claim.
• The total units for fractions billed shall not exceed one (1) unit.
• All claims for fractional units shall be billed with HCPCS modifier LU (fractionated payment CAR T-cell therapy).
• CPT® modifier 76 (repeat service) should also be used to bill for all subsequent fractional unit claims, but not the first one.
• Claims for fractional units billed without HCPCS modifier LU will be denied.

Let's take an example:

CAR T-cell product allowed payment per a total of one unit (1.0) is $445,000:

Claim 1 — 0.2 units = $89,000.06

Claim 2 — 0.2 units = $89,000.00

Claim 3 — 0.2 units = $88,999.99

Claim 4 — 0.2 units = $88,999.98

Claim 5 — 0.2 units = $88,999.97

Note: Each fractional unit would be billed on a separate claim--same thing when billing. Contractors shall only pay up to one (1.0) unit per HCPCS code. Anything above one (1.0) unit will be denied. Don't forget that on Claims 2-5 would necessitate Modifiers KX, LU, and 76, while the first one will only require KX and LU.

When Dosage Exceeds Code Descriptor

When the dose exceeds the code descriptor for CAR T-cell products, use HCPCS code J3490, J3590 or J9999 for the exceeded dosage. The provider would bill a total of one (1.0) unit of the Q code plus a total of one (1.0) unit of the J code and include the CAR T-cell product name and the exceeded dosage in Block 19 of the 1500 claim form or its electronic equivalent.

Example: Q2041 (Axicabtagene ciloleucel, up to 200 million autologous anti-CD19 CAR positive T-cells.)

If the provider gives 300 million cells, they will bill:

• Q2041 for 0.1 fraction $42,294.00 x10 for 200 million cells (total $422,940.00)
• J9999 for 0.2 fractions $42,294.00 x5 for 100 million cells (total $211,470.00)
• Note: The FDA labels for CAR T-cell products state the maximum number of cells to be infused. The HCPCS code descriptors for Q2041, Q2042, Q2053, Q2054, Q2055 and Q2056 all align with the FDA label maximum number of cells to be infused. If a provider exceeds the HCPCS code descriptor number of cells, this is off label use. This should be extremely rare, which may be a good thing since these will most probably be reviewed and then denied, unless there is something extraordinary.

CAR-T Admin

Probably the easiest part of all of this:

38228 Chimeric antigen receptor T-cell (CAR-T) therapy; CAR-T cell administration, autologous (CMS National Non-Facility Allowable $280.12), effective January 1, 2025.

Notice this is not a time based code.

Summary

Here are the important concepts described herein:

• Fractional Billing--Due to the high cost of CAR-T billing, providers must divide the total cost by 5 or 10 and bill in 0.2 or 0.1- claim fractions to equal 1.0
• Modifier LU-- When billing with fractional amounts, use LU to signify fractionalized billing for CAR-T billing
• Modifier KX--This modifier signifies that the billing practice is a REMS-approved facility
• Modifier 76--This modifier, usually used for surgery, is used on subsequent claims (to the first one) for fractionalized billing
• 38228--New(ish) code for CAR-T administration.

For more information, see this Medlearn Matters or, for a more comprehensive view, see the Palmetto web site.

.

This newsletter is a brief interpretation of information. It may be subject to typos, misinterpretation, and misapplication. This company and its parent assume no liability for the content herein. Moreover, this is not consultative or legal advice. Billing of claims and payment thereof is individual to payers and circumstance. Providers should check with each payer prior to billing. This information is time-sensitive and may change at any time. Please ensure that you constantly check for new information. CPT is a trademark of the American Medical Association, All Rights Reserved.