Hello Roberta Buell,

Since the Inauguration, the entire healthcare system seems to be in suspended animation. First, the Cabinet had to be confirmed. As you probably know, Robert Kennedy, Jr. will be the Secretary of Health and Human Services, and Dr. Mehmet Oz will be the Administrator of the Centers for Medicare and Medicaid Services ("CMS"). Additionally, thousands have been laid off from CMS, the FDA, and the National Institutes of Health. How this will impact all of us--positively or negatively--is not known just yet.

There are some immediate issues that we will have to face soon- certain waivers regarding telehealth and the Geographical Practice Cost Indices floor will expire on March 31. Most important is telehealth ending, which will end after March 31 if delivered in patients' homes with a few exceptions for behavioral health and substance abuse. If the waivers are extended, it will be part of the Budget package that was passed by the House last night. There are supposed to be further cuts to Medicare as well, but telehealth is extremely popular, so who knows? The Bill will go to the Reconciliation next.

This budget package will also keep the government open. Additionally, many physician organizations want an increase in physician fees in this package. The House’s passage of the budget resolution, which calls for $2 trillion in spending cuts plus $4.5 trillion in tax cuts and a $4 trillion increase in the debt ceiling, comes after the Senate approved its own version last Friday (Feb. 21). Because cuts to Medicaid alone are now forecasted at approximately $880 billion, increases in physician fees do not look promising at this point.

Other items in the usual workflow at CMS have slowed. For example, the HCPCS codes generally are released approximately six weeks before the end of the quarter. So far, I have seen none for April 1, 2025. In the interest of time, we are publishing the coding DECISIONS for Q2. The official spreadsheet has not been published, and in the interest of time, we wanted to provide some information. But, there may be corrections in the official quarterly release.

In addition, we provide some good news (for a pleasant change). CMS has officially published that it is standardizing the definition of COMPLEX Drug Administration, as prescribed in the Final Rule last year. As you may know, this was previously up to the individual MACs. Now, this definition is completely consistent with CPT® and does not differ between MACs. See our second article.

And, speaking of MACs, did you know that some CPT, Level III, codes are covered by Medicare? I didn't. The bad news is they are often MAC-priced. Check out our third article. We'll tell you how!

Also, don't miss Sound Bytes. It is action-packed this time with some important tidbits.

Feeling like I'm living in limbo,

Da' Mistress

Here are the ACCEPTED HCPCS drug changes for dates of service on or after April 1, 2025. See the meeting notes here. For all these projected HCPCS DRUG changes, see Buyandbill.com. for an easy-to-read version of this.

Added Codes

HCPCS Long Descriptor

A9611 Flurpiridaz f 18, diagnostic, 1 millicurie

J0281 Injection, aminocaproic acid, 1 gram

J1072 Injection, testosterone cypionate (azmiro), 1 mg

J1271 Injection, doxycycline hyclate, 1 mg

J1299 Injection, eculizumab, 2 mg

J1308 Injection, famotidine, 0.25 mg

J1808 Injection, folic acid, 0.1 mg

J1938 Injection, furosemide, 1 mg

J2351 Injection, ocrelizumab, 1 mg and hyaluronidase-ocsq

J2428 Injection, paliperidone palmitate extended release (erzofri), 1 mg

J2804 Injection, rifampin, 1 mg

J2865 Injection, sulfamethoxazole 5 mg and trimethoprim 1 m

J7521 Tacrolimus, granules, oral suspension, 0.1 mg

J9024 Injection, atezolizumab, 5 mg and hyaluronidase-tqjs

J9038 Injection, axatilimab-csfr, 0.1 mg

J9054 Injection, bortezomib (boruzu), 0.1 mg

J9161 Injection, denileukin diftitox-cxdl, 1 mcg

Q2057. Afamitresgene autoleucel up to 10 x 10^9 MAGEA4 TCR positive T-cells, per therapeutic dose

Q5147 Injection, aflibercept-ayyh (pavblu),biosimilar, 1 mg

Q5148 Injection, filgrastim-txid (nypozi), biosimilar,1 microgram

Q5149 Injection, aflibercept-abzv (enzeevu), biosimilar, 1 mg

Q5150 Injection, aflibercept-mrbb (ahzantive), biosimilar, 1 mg

Q5151 Injection, eculizumab-aagh (epysqli), biosimilar, 2 mg

Q5152 Injection, eculizumab-aeeb (bkemv), biosimilar, 2 mg

Q9999 Injection, ustekinumab-aauz (otulfi), biosimilar, 1 mg

S4024. Air polymer-type a intrauterine foam, per study dose

Deleted codes

J1094 Injection, dexamethasone acetate, 1 mg

J1300 Injection, eculizumab, 10 mg

J1810 Injection, droperidol, and fentanyl citrate, up to 2 ml ampule

J1890 Injection, cephalothin sodium, up to 1 gram

J1940 Injection, furosemide, up to 20 mg\

J9037 Injection, belantamab mafodotin-blmf,0.5 mg

J9247 Injection, melphalan flufenamide, 1mg

Q5139 Injection, eculizumab-aeeb (bkemv), biosimilar, 10 mg

S0017 Injection, aminocaproic acid, 5 grams

S0028 Injection, famotidine 20 mg

S0032 Injection, nafcillin sodium, 2 grams

S0039. Injection, sulfamethoxazole and trimethoprim, 10 ml

Descriptor Change

J9073 Injection, cyclophosphamide (dr. reddy's), 5 mg

For a complete list, see the HCPCS Quarterly Update when it is released.

Complex Drug Administration Codes 2025

A little history lesson for all of you out there who administer drugs in your office or clinic. In 2006, when all of these admin codes changed from CPT to HCPCS Level II back to CPT, The American Medical Association left the decision about whether or not to consider a drug admin complex up to the Medicare Administrative Contractors. Moreover, when all of this was going on, there were many fewer NON-CHEMO complex drugs. But, over the years, Neurology, Gastro, Allergy, and Dermatology practices have queried how drug admin should be coded for drugs like Ocrevus®, Tysabri™, etc.

In December 2023, CMS directed A/B MACs not to make downward adjustments to claims for CPT Codes for complex therapy administration (96401-96549) based solely on the specific drug being administered. In CMS Technical Direction Letter – Transmittal 12397 (TDL), CMS directed that CPT Codes involving the administration of monoclonal, complex biological, and rheumatological therapies be paid as complex administration as long as all of the elements of these codes that are required for appropriate billing are met.

Flash forward to the Physician Fee Schedule Final Rule. CMS outlined that having every MAC decide for themself was not a good plan. So, they ruled that the CPT® definition should be the standard for billing complex administration codes. To comply with the Final Rule, CMS issued Transmittal 13012. This transmittal basically outlines the CPT guidelines for The Claims Processing Manual, Chapter 12, section 30.5, so now it reads (highlights are mine):

"A/B MACs should consider multiple factors when determining if the level of intensity for a complex drug administration service has been met, rather than just the drug name alone. Chemotherapy administration is considered highly complex and requires a physician or qualified health professional to work and monitor well beyond the level of the therapeutic, prophylactic, and diagnostic injections and infusions code series (96360-96379) due to the high incidence of potentially adverse reactions for the patient. This service typically requires direct supervision from qualified health professionals and/or clinical staff with advanced practice training in the special considerations of preparation, dosage, and disposal, and it often involves frequent monitoring of the patient and conferring with a physician."

Spelling this out for those of you who cannot decipher CMS Manual language, here are the elements that contribute to complex drug administration:

• Drug is riskier than in therapeutic and hydration infusions so they require supervision and monitoring of the infusion;
• Drug may require changes in dosing due to toxicity;
• Drug can cause adverse events, also necessitating monitoring;
• Staff administering has advanced training; and,
• There are special considerations for the preparation, dosing, and disposal of drug(s) administered.

For more information, see Claims Processing Manual, Chapter 12, Section 30.5.

Category III CPT Codes: Useful or No?

In my infinite silliness, I completely ignored these Level III codes until 2023, when I learned that harvesting, dispatching, and administering CAR-Ts were Level III's. As it happens, some payers paid these codes before receiving Level I codes last month. So, let us tell you a little more about them. If you are wondering what Level II CPT codes are, you use these for quality measurement in MIPS and some for HEDIS measures in hospitals. Onto Level III...

Category III Codes

Category III CPT codes are temporary for emerging technology, services, and procedures, making them more valuable than Level II codes. These codes are intended to track usage and the data collected. Although coverage and payment for the performance of a procedure with a Category III code is not common among the majority of payers when initially released, physicians and other providers are required to use the most appropriate code to describe the service provided. Thus, reporting a Category III code for a service accurately described by the code is appropriate. In the long run, the determination for coverage should be based upon clinical evidence and medical necessity, and not the CPT code category. Reporting should be used to substantiate widespread usage in the Food and Drug Administration (FDA) approval process. However, Category III codes are not automatically designated for Level I services or procedures, as the CPT Editorial Panel initially determined they did not meet the requirements for a Category I code and designated a Level III code.

To expedite the availability of CPT Category III codes and to reflect the need to establish

tracking mechanisms more quickly, the new CPT Category III codes are released semiannually via electronic distribution on the AMA CPT Web site (www.ama-assn.org/go/cpt ). CPT Level I codes, with few exceptions, are released once per year. The codes are effective six months after they are first posted. (Category III codes posted in July become effective the following January 1, and Category III codes posted in January become effective the following July 1.) 

Unlike Category II, there is a pathway for Level III codes to become Level I. According to the CPT process, Category III codes are to be archived five years from publication in the CPT codebook if they have not been accepted for placement in the Category I section of CPT. If it is demonstrated that a Category III code is still needed, it will be retained. By the way, the publication date is when the information is printed in the CPT codebook, not when it appears on the AMA website.

Although coverage and payment for the performance of a procedure with a Category III code is not common among the majority of payers when initially released, physicians are required to use the most appropriate code to describe the service provided. Reporting of a Category III code for a service accurately described by the code is appropriate. In the long run, the determination for coverage should be based upon clinical evidence and medical necessity, and not the CPT code category.

However, when a Level III code portrays something not currently reportable, it can be paid by Medicare and Commercial payers. Before proceeding with the performance of a procedure with a Category III code, it is important to determine if the reimbursement covers the cost of the device/procedure. When Medicare covers a Level III, it is MAC-priced, which may mean the claim will be manually reviewed. But, it will be paid if it is appropriate for the condition and medically necessary for the beneficiary.

Level III Example

I'm frequently asked if there are really codes below Level I that are actually paid. As previously mentioned, because there are no relative values for these codes, they are MAC-priced and/or a contracted price for commercial and Medicare Advantage payers. Let's take an example. Check out this Level III code descriptor:

0794T---Patient-specific, assistive, rules-based algorithm for ranking pharmaco-oncologic treatment options based on the patient's tumor-specific cancer marker information obtained from prior molecular pathology, immunohistochemical, or other pathology results which have been previously interpreted and reported separately

This activity is not represented in any other code in Level I. There are actual guidelines for it in CPT. It is covered by Medicare and is MAC-priced. So, should you report it? Well, it will sunset on January 1, 2029. So, if you want to be able to get paid for this as a Level I, it might be a good idea to bill it. Also, it might be a plan to contract with your commercial plans as well.

For more information on Level III coding, click here.

SOUND BYTES

CMS posted an updated list of billing and payment codes (PDF) for orphan drugs that qualify for a 26% increased applicable percentage in terms of WASTE TRACKING for calendar quarters in 2023. For most other drugs, the percentage for fines is 10%. To qualify, a drug must meet all 3 of the following requirements: (1) Designated as an orphan drug under section 526 of the Federal Food, Drug, and Cosmetic Act; (2) Approved by the FDA exclusively for indications within the designated rare disease or condition; and, (3) Furnished to fewer than 100 unique beneficiaries per calendar year...Fierce Healthcare reporting-- federal judge sided with the Federal Trade Commission (FTC) in a case against the nation’s three largest pharmacy benefit managers (PBMs), declining to halt the lawsuit. The case is now expected to move forward following the Feb. 19 court ruling. The FTC announced last September that it was suing the “big three” PBMs, alleging they colluded to raise the price of insulin through “discounts” that pass additional costs to patients. The companies being sued include Caremark, Express Scripts, and Optum RX—owned by CVS Health, Cigna, and UnitedHealth Group, respectively. Allegations of price-fixing and collusion were also levied against the group purchasing organizations (GPOs) for each PBM, all of which fall under the same parent companies. The FTC alleged that this vertical integration allows the drug distributors to rig the “pharmaceutical supply chain competition” in their favor, forcing patients to pay more for life-saving medication...On February 18, 2025, the First Circuit adopted the "but-for" causation standard as a threshold for proving a False Claims Act (FCA) claim based on an Anti-Kickback Statute (AKS) violation in the case of United States v. Regeneron Pharmaceuticals Inc. This decision aligns the First Circuit with the Sixth and Eighth Circuits, holding that FCA liability requires that a kickback be the but-for cause of a claim. The reason this is BIG News is that it makes it harder to prosecute False Claims based on the Anti-Kickback Statute. Why? "But for" requires only a “causal link” between the alleged kickback and subsequent claim (s). In the Regeneron case, the government thought a Copay program caused false claims. But, the government does not pay the copays, so this could not have produced false claims.  This case may go to the Supremes, but for (!!) now, cases must consider this causal link...The Class action lawsuit against UnitedHealth's AI claim denials will advance, although parts have been dropped. The plaintiffs have accused the insurer of using artificial intelligence algorithms to deny claims illegally. A federal judge has dismissed five out of seven counts in a class action lawsuit against UnitedHealth Group but will allow it to continue, with the suit claiming that UHG, UnitedHealthcare and naviHealth denied claims by using an artificial intelligence program instead of medical professionals in Medicare Advantage plans. The plaintiffs are members who were denied benefit coverage. They claim in the lawsuit that the use of AI to evaluate claims for post-acute care resulted in denials, which in turn led to worsening health for the patients and in some cases resulted in death. They said the AI program developed by UnitedHealth subsidiary naviHealth, NH Predict, would sometimes supersede physician judgment and has a 90% error rate, meaning nine of 10 appealed denials were ultimately reversed. The plaintiffs also allege that UnitedHealthcare breached its insurance contract, which stipulated that it would cover medically necessary healthcare services and that coverage decisions be made by clinical staff. and the claims would have been billed anyway...CMS announces 50 new ICD-10-PCS codes (PDF), effective April 1, 2025. The April 1, 2025, procedure code update files are now available. Use these codes for discharges occurring from April 1, 2025 – September 30, 2025, and for patient encounters occurring from April 1, 2025 -September 30, 2025. CDC announces no new ICD-10-CM codes effective April 1, 2025. The April 1, 2025, diagnosis code update files, which address revisions and typographical errors, are now available. Use these files for discharges occurring from April 1, 2025, to September 30, 2025, and for patient encounters occurring from April 1, 2025, to September 30, 2025...Two months after delaying the expiration of COVID-era telehealth prescribing rules, the Drug Enforcement Administration (DEA) has released a regulatory framework to keep these rules in place permanently. During the COVID-19 pandemic, flexibilities were introduced to allow providers to prescribe controlled substances such as Adderall, benzodiazepines, sleep medications, and certain painkillers via telehealth visits. Prior to COVID, prescribing controlled substances required an in-person visit, along with additional limitations. The new rule authorizes the prescription of controlled substances classified up to Schedule II without the need for an in-person visit. The DEA is also adding buprenorphine to the list of approved substances, a drug that is gaining popularity as a less addictive alternative to opioids. It is also used to treat opioid addiction. The framework was published in the Federal Register on Jan. 17 and will become effective 30 days later...Claims adjudication costs healthcare providers more than $25.7 billion, according to a new national survey of hospitals, health systems and post-acute care providers conducted by Premier, Inc. This figure represents a 23 percent increase over the $19.7 billion in costs reported in the previous year. Claims move into the adjudication process after payers issue an initial denial on the submission. While denial rates remained consistent at nearly 15 percent, according to survey data, they ranged as high as 49 percent in certain instances. In addition, the administrative costs associated with fighting them increased dramatically – from $43.84 per claim in 2022 to $57.23 in 2023. Additional costs primarily resulted from added labor, responsible for 90 percent of claims processing expenses incurred by providers...The U.S. Department of Justice (DOJ) is investigating potential illegal activity at UnitedHealth Group, related to the insurer’s billing practices (again), according to a report published Friday by the Wall Street Journal.Per the outlet, UnitedHealth is being probed for upcoding Medicare Advantage claims. Specifically, the DOJ is looking into whether the insurer is responsible for billing the Centers for Medicare & Medicaid Services (CMS) for patient diagnoses not applicable to the actual care (color me shocked) in an effort to boost monthly payments ("PMPM") received through the program. The Wall Street Journal cites sources familiar with the case for its coverage. According to reporters, the DOJ has spoken with providers about the alleged upcoding, which could have led to the insurer pocketing billions of extra reimbursement dollars. The Wall Street Journal also reported that the Department of Health and Human Services Office of Inspector General (OIG) is supporting the DOJ investigation. However, neither agency has released a statement. UnitedHealth quickly responded, issuing its own statement Friday morning, calling the claims made by the Wall Street Journal "misinformation" and adding that the outlet has a history of misleading the public about the Medicare Advantage program...According to Drug Channels, for 2025, 40% of the plans in 39 states have copay accumulators—although you may not be able to figure it out. That is because plans mostly do not list the accumulators on web sites, according to a report by the AIDS Institute.

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.