Hello Roberta Buell,

Hey there! Welcome to our latest newsletter, where we bring you all the updates regarding drug reimbursement and coding for same. This year, we are discussing more about Inpatient drug proposals than we ever have. In so doing, I provide you with the most relevant and brand new information--even if it is completely boring. It still is stuff that folks ask about--so, be careful what you wish for.

In this issue, we have all 42 of the new HCPCS for Q3 2024 as well as the other HCPCS changes for next quarter, We try to bring them to you far enough in advance so you can change your charge documents in time to bill for dates of service on or after July 1. We will have OPPS (hospital outpatient) changes in our next newsletter, since they are never available until the last minute.

As we do every year, we present the proposed new ICD-10 codes for 2025, While these are proposed, our experience tells us that they do not change too much in the Final Rule, For your reading pleasure (??), we have inserted some jokes. Hopefully, you won't think they are too tasteless and, if you do, you can just read the whole list. I dare you to stay awake (unless you are a nerd like me).

Speaking of boring, there is new guidance on Part D drug negotiations with HHS. They are supposed to have bids from 15 Part D drugs, but, so far, we are only seeing 10 blockbusters in the mix. By the way, the acronym for the new drug pricing is MFP (Maximum Fair Price). We would like to thank HHS for including MF in the acronym.

But that's not all! We also have other exciting iPPS proposals for 2025 that you definitely don't want to miss, if you belong to a hospital, pharma, or are in the consulting world. Our summary is not the whole deal, just some parts that refer to drugs.

So, sit on the back porch (if you have one or even if you don't), relax, and cure your insomnia with this cray read! Btw, if the QR code in the ad above does not work for you, just click on the picture and it will take you to our web site.

PS--Nice to see and meet many of you at Asembia last week,

Da' Mistress

Here we have Third Quarter HCPCS changes to drug codes. We got some very good feedback regarding including all HCPCS changes related to drugs not just the new codes. So your wish is our command. As you probably know, these additions and other changes go into effect for dates of service on or after July 1, 2024. For the entire list of changes (and there are new G-codes), just click here.

NEW CODES

HCPC LONG DESCRIPTION

J0211 Injection, sodium nitrite 3 mg and sodium thiosulfate 125 mg (nithiodote)

J0687 Injection, cefazolin sodium (wg critical care), not therapeutically equivalent to j0690, 500 mg

J0872 Injection, daptomycin (xellia), unrefrigerated, not therapeutically equivalent to j0878 or j0873, 1 mg

J0911 Instillation, taurolidine 1.35 mg and heparin sodium 100 units (central venous catheter lock for adult patients receiving chronic hemodialysis)

J1597 Injection, glycopyrrolate (glyrx-pf), 0.1 mg

J1598 Injection, glycopyrrolate (fresenius kabi), not therapeutically equivalent to j1596, 0.1 mg

J1748 Injection, infliximab-dyyb (zymfentra), 10 mg

J2183 Injection, meropenem (wg critical care), not therapeutically equivalent to j2185, 100 mg

J2246 Injection, micafungin in sodium (baxter), not therapeutically equivalent to j2248, 1 mg

J2267 Injection, mirikizumab-mrkz, 1 mg

J2373 Injection, phenylephrine hydrochloride (immphentiv), 20 micrograms

J2468 Injection, palonosetron hydrochloride (avyxa), not therapeutically equivalent to j2469, 25 micrograms

J2470 Injection, pantoprazole sodium, 40 mg

J2471 Injection, pantoprazole (hikma), not therapeutically equivalent to j2470, 40 mg

J3247 Injection, secukinumab, intravenous, 1 mg

J3263 Injection, toripalimab-tpzi, 1 mg

J3393 Injection, betibeglogene autotemcel, per treatment

J3394 Injection, lovotibeglogene autotemcel, per treatment

J7171 Injection, adamts13, recombinant-krhn, 10 iu

J7355 Injection, travoprost, intracameral implant, 1 microgram

J8611 Methotrexate (jylamvo), oral, 2.5 mg

J8612 Methotrexate (xatmep), oral, 2.5 mg

J9361 Injection, efbemalenograstim alfa-vuxw, 0.5 mg

Q5137 Injection, ustekinumab-auub (wezlana), biosimilar, subcutaneous, 1 mg

Q5138 Injection, ustekinumab-auub (wezlana), biosimilar, intravenous, 1 mg

DiSCONTINUED CODES

HCPC LONG DESCRIPTION

C9113 Injection, pantoprazole sodium, per vial

C9166 Injection, secukinumab, intravenous, 1 mg

C9167 Injection, adamts13, recombinant-krhn, 10 iu

C9168 Injection, mirikizumab-mrkz, 1 mg

J2780 Injection, ranitidine hydrochloride, 25 mg

J9371 Injection, vincristine sulfate liposome, 1 mg

S0164 Injection, pantoprazole sodium, 40 mg

LONG DESCRIPTOR CHANGES

HCPC LONG DESCRIPTION

J0134 Injection, acetaminophen (fresenius kabi), not therapeutically equivalent to j0131, 10 mg

J0136 Injection, acetaminophen (b braun), not therapeutically equivalent to j0131, 10 mg

J0137 Injection, acetaminophen (hikma), not therapeutically equivalent to j0131, 10 mg

J0173 Injection, epinephrine (belcher), not therapeutically equivalent to j0171, 0.1 mg

J0401 Injection, aripiprazole (abilify maintena), 1 mg

J0651 Injection, levothyroxine sodium (fresenius kabi), not therapeutically equivalent to j0650, 10 mcg

J0652 Injection, levothyroxine sodium (hikma), not therapeutically equivalent to j0650, 10 mcg

J0873 Injection, daptomycin (xellia), not therapeutically equivalent to j0878 or j0872, 1 mg

J0893 Injection, decitabine (sun pharma), not therapeutically equivalent to j0894, 1 mg

J1574 Injection, ganciclovir sodium (exela), not therapeutically equivalent to j1570, 500 mg

J1806 Injection, esmolol hydrochloride (wg critical care), not therapeutically equivalent to j1805, 10 mg

J1921 Injection, labetalol hydrochloride (hikma), not therapeutically equivalent to j1920, 5 mg

J2021 Injection, linezolid (hospira), not therapeutically equivalent to j2020, 200 mg

J2184 Injection, meropenem (b. braun), not therapeutically equivalent to j2185, 100 mg

J2251 Injection, midazolam hydrochloride (wg critical care), not therapeutically equivalent to j2250, per 1 mg

J2272 Injection, morphine sulfate (fresenius kabi), not therapeutically equivalent to j2270, up to 10 mg

J2281 Injection, moxifloxacin (fresenius kabi), not therapeutically equivalent to j2280, 100 mg

J2599 Injection, vasopressin (american regent), not therapeutically equivalent to j2598, 1 unit

J2806 Injection, sincalide (maia), not therapeutically equivalent to j2805, 5 micrograms

J3244 Injection, tigecycline (accord), not therapeutically equivalent to j3243, 1 mg

J3371 Injection, vancomycin hcl (mylan), not therapeutically equivalent to j3370, 500 mg

J3372 Injection, vancomycin hcl (xellia), not therapeutically equivalent to j3370, 500 mg

J9046 Injection, bortezomib (dr. reddy's), not therapeutically equivalent to j9041, 0.1 mg

J9172 Injection, docetaxel (ingenus), not therapeutically equivalent to j9171, 1 mg

J9258 Injection, paclitaxel protein-bound particles (teva), not therapeutically equivalent to j9264, 1 mg

J9259 Injection, paclitaxel protein-bound particles (american regent), not therapeutically equivalent to j9264, 1 mg

J9294 Injection, pemetrexed (hospira), not therapeutically equivalent to j9305, 10 mg

J9296 Injection, pemetrexed (accord), not therapeutically equivalent to j9305, 10 mg

J9314 Injection, pemetrexed (teva), not therapeutically equivalent to j9305, 10 mg

J9322 Injection, pemetrexed (bluepoint), not therapeutically equivalent to j9305, 10 mg

J9393 Injection, fulvestrant (teva), not therapeutically equivalent to j9395, 25 mg

Q2055 Idecabtagene vicleucel, up to 510 million autologous b-cell maturation antigen (bcma) directed car-positive t cells, including leukapheresis and dose preparation procedures, per therapeutic dose

As part of the Inpatient Proposed Rule, CMS proposed hundreds of ICD-10-CM code changes in the 2025 Hospital Inpatient Prospective Payment System, published April 10, including:

252 new codes

13 revised codes

36 invalidated codes

Remember that this is a PROPOSED rule, so there may be further changes. My experience tells me that most of the time, these last minute changes are additions. But, we will get back to you on that.

Highlights of the proposed additions include codes to report the following conditions or to report them with additional specificity. iI there is a DASH on the end of the code, it means I have abbreviated the code, so look at the list! which you can get right here. Please pardon any and all jokes on my part, but really, without jokes, why would you read this stuff?

• Cancer: For some strange reason, CDC (they are in charge of ICD-10) decided to make lymphoma coding like leukemia coding. So, they added remission status to codes in the following code sets, effective October 1. Many of these remission status codes end in "A". Also, for cancer practices and clinics, see the Z-codes for some exciting news.
• C81.-
• C82.-
• C83.-
• C84.-
• C85.-
• C86.-
• C88.-
• Blood and blood organs: As you may remember, there are always new anemia codes. This year is no exception:
• D61.03 will be used for Franconi anemia
• That's all, folks
• Endocrine/Diabetes: Since diabetes is abundant in our society as well as world-wide. So, here are some additions to diabetes coding:
• E10.A- for Diabetes Type 1, Stages 1 and 2
• E16.A- Hypoglycemia, Levels 1-3
• E66.8- Obesity, Class 1-3, Other
• E88.82 Obesity due to disruption of MC4R pathway
• E74.8- Citrate disorder
• Carcinoid: Added the heart for 2025:
• E34.01 Carcinoid heart syndrome
• E34.09 Other carcinoid syndrome
• Head Cases: Since COVID, it seems that everyone has a few screws loose. So, of course, there must be codes for these disorders:
• F50.- Every kind of eating disorder imaginable, including Pica (swallowing non-food items)
• Nervous System: More classification of diseases of the nerves:
• G40.84- KCNQ2-related epilepsy
• G90.8- Serotonin syndrome
• G93.45 Developmental and epileptic encephalopathy
• Cardiovascular: Only one code set added this year: I26.- For various emboli of all shapes and sizes
• The Nose: Okay, here is a code set that most likely involves nasal drug use--J34.82-, Nasal Valve Collapse of various types and unspecified.
• The Butt of Jokes: I would have liked to have called it something else, but, you know, there are some sensitive people out there. Here are some 2025 code sets that are bringing up the rear:
• K60.3- Anal fistulae of various types
• K60.4- Rectal fistulae of various types
• K60.5- Anorectal fistulae
• Skin: New coding for skin problems include:
• L29.8- Pruritis, Cholestatic and NOC
• L66.- Lichen planopilaris, unspecified along with many other ways to lose your hair
• Musculoskeletal issues: A relatively short list for this category includes:
• M51.3- Other intervertebral disc degeneration lumbar and lumbarsacral
• M62.85 Dysfunction of the multifidus muscles, lumbar region
• M65.9- Unspecified synovitis and tensynovitis
• Born this way which are actually congenital issues, but life is not complete without a Lady Gaga reference:
• Q23.8- Congenital mitral and aortic valve
• Q87.86 Kleefstra syndrome
• Symptoms Does not have a lot of proposed action for 2025. Only one code proposed for 2025 and that is R41.45 for Anosognosia (it means you do not know if you are crazy and aren't just in denial)
• Poisoning and/or adverse events which this year is a bit focused on checkpoint inhibitors:
• T45.AX- Poisoning, adverse events, or underdosing by immune checkpoint inhibitors
• T81.32- Disruption or dehiscence of wound closure (literally spilling your guts)
• A Boatload of Z-codes (and some of these are long awaited) as these will say a lot more about tumors:
• Z15.1 Genetic susceptibility to epilepsy
• Z15.2 Genetic susceptibility to obesity
• Z17.2- Progesterone receptor positive and negative status
• Z17.3- Human epidermal growth factor receptor 2 positive and negative status
• Z17.4- Hormone receptor positive/negative with human epidermal growth factor receptor 2 positive/negative status
• Z51.A- Encounter for sepsis
• Z59.71 Insufficient insurance--this is a secondary diagnosis for everyone in the U.S.
• Z59.72 Insufficient welfare (SDoH0
• Z67.A- Duffy sign status
• Z68.5- Pediatric high BMI
• Z83.72 Family history of adenomatous polyposis
• Z86.01- Personal history of various colon polyps
• Z92.26 Personal history of immune checkpoint inhibitor therapy

The conditions with proposed code revisions include degenerative myopia with associated ocular conditions, rumination disorder of infancy and childhood, and irritable bowel syndrome, unspecified. Check these out right here (Table 6)

Many of the proposed code invalidations consist of removing codes and turning them into subcategories to make room for more specified code additions. For example, current ICD-10-CM code F50.01 (anorexia nervosa, restricting type) would be deleted and changed into subcategory F50.01- to make way for proposed codes:

F50, 010, anorexia nervosa, restricting type, mild

F50.011, anorexia nervosa, restricting type, moderate

F50.012, anorexia nervosa, restricting type, severe

F50.013, anorexia nervosa, restricting type, extreme

F50.014, anorexia nervosa, restricting type, in remission

Other proposed invalidations include codes for disruption of internal operation (surgical) wound, T-cell lymphoma--again remission status, and personal history of colonic polyps.

Revenue integrity professionals can view the entire list of proposed 2025 ICD-10-CM code updates in Tables 6A-6J of the rule. CMS encourages community members to comment on these proposed changes until June 10 at 5 p.m. Eastern. Accepted changes will be included in the 2025 ICD-10-CM code set and will be implemented October 1.

The Biden administration recently rolled out its draft guidance for the next cycle of drug price negotiations, despite many lawsuits and knashing ot teeth from the pharmaceutical industry. The guidance lays out the Centers for Medicare & Medicaid Services’ requirements and parameters for the second cycle of negotiations in the Medicare Drug Price Negotiation Program. So far, Ten Medicare Part D drugs will be selected for the second negotiation round. This list will be updated "over time". The agency is expected to announce the list of Medicare Part D drugs no later than February 1, 2025. Those agreed to negotiated prices called the Maximum Fair Price ("MFN") will go into effect on 1/1/26.

Please send comments pertaining to this draft guidance to this email with the subject line “Medicare Drug Price Negotiation Program Draft Guidance.” Comments received by 11:59 PM Pacific Time (PT) on July 2, 2024 will be considered

The CMS said the plan builds on policies from the revised guidance of the first cycle of negotiation, which is ongoing. The CMS also noted that it “may make additional adjustments in the final guidance.”The agency is currently on track to set the prices for all NDCs of 10 Medicare Part D drugs from companies including Johnson & Johnson, Bristol-Myers Squibb, and Novartis beginning in 2026. The HHS in April announced it responded to manufacturers’ counteroffers to Medicare’s initial offers of maximum fair prices ("MFN") for these10 drugs in the first round.

This draft guidance, which is not subject to the same process rules as most Medicare proposals, also sets forth additional policies regarding manufacturer effectuation of the MFP in 2026 and 2027, and specifies the requirements that will be applicable to manufacturers of drugs that are selected for negotiation and the procedures that may be apply to these stakeholders--manufacturers, Medicare Part D plan sponsors (both Prescription DrugPlans (PDPs) and Medicare Advantage Prescription Drug (MA-PD) Plans), pharmacies, mail order services, and other dispensing entities that dispense drugs covered under Medicare Part D. CMS will issue final guidance later this year setting forth CMS’ final policies on the issues discussed in this draft guidance.

CMS recognized the statutory requirement that manufacturers need offer only the lesser of the MFP or the 340B ceiling price to 340B covered entities, not both. CMS noted that it will “examin[e] options with respect to identification of 340B units in consultation with [the Health Resources and Services Administration (HRSA)] and interested parties. In addition to any policies or procedures that CMS may adopt in this regard, CMS indicated that it would work with HRSA to ensure the MFP is made available where appropriate in a non-duplicated amount to the 340B ceiling price.”

As far as patients are concerned, the fact sheet on the negotiation process describes formularies as follows. As required by law, Medicare prescription drug plans, including standalone Part D plans and Medicare Advantage-prescription drug plans, must include on their formularies the selected drugs for which CMS and the participating drug company have agreed to a maximum fair price. CMS will use its comprehensive formulary review process for Medicare prescription drug plans to assess any practices that may undermine access to selected drugs for people with Medicare

The CMS will engage with a Medicare Transaction Facilitator (MTF) to ease the exchange of data between pharmaceutical supply chain entities to verify eligibility of an individual who is dispensed a selected drug for its negotiated maximum fair price. The agency is soliciting comment on options for the MTF. The agency is asking the public to weigh in on two payment facilitation options, neither of which seems so great to me:.

• The first has the MTF collecting dispensing entities’ banking information and providing it to manufacturers.
• The second, meanwhile, has the MTF receiving aggregated refund amounts from manufacturers and passing them through to dispensing entities.

The following is a brief summary of the MTF data flow process for verifying eligibility for the MFP:

• A plan sponsor approves a claim from a dispensing entity based on confirmation of beneficiary enrollment in Medicare and that the drug is covered.
• The plan sponsor approving the claim submits data to CMS’s Drug Data Processing System (DDPS), which provides a second round of validation.
• DDPS sends the data to the MTF, which prepares certain claims level data, described below, to be sent to the manufacturer.
• The MTF sending/manufacturer receiving the claims level data starts the 14-day prompt MFP payment window described below.
• The manufacturer pays the MFP and submits payment-related data to the MTF within the 14-day prompt MFP payment window.

A CMS fact sheet said the agency is also seeking comments on whether three negotiation meetings are needed. The fact sheet also said the agency wanted comments on whether it would be preferable to contemplate an additional written offer to be made in lieu of one or more meetings.

Since June 2023, several drugmakers (and other interested parties) such as Merck and AstraZeneca launched lawsuits challenging the program under various legal precedents, including unconstitutionality under the Fifth Amendment and violation of the Administrative Procedure Act. The AstraZeneca suit ended after the court granted summary judgment in favor of the administration in early March. AstraZeneca has not yet filed an appeal. The drug price negotiation program has now initially survived three legal challenges brought against it, some of which are under appeal, and other lawsuits remain ongoing.

The offer/counteroffer process is scheduled to continue until August 1, 2024, when again final prices will be announced. As we said, the negotiated prices will not go into effect until 2026. Litigation is also expected to continue. Many interested parties will continue to watch as the IRA’s Medicare drug price negotiation program, and its legal challenges unfold.

Again, the first negotiation period is scheduled to end August 1 and maximum fair prices will be announced September 1. The maximum fair prices will go into effect January. 1, 2026. The CMS plans to publish guidance for the second negotiation round in fall 2024.

NTAP and Drug Shortage Revisions Proposed for 2025

As we said previously, on April 10, the Centers for Medicare & Medicaid Services (CMS) released the Inpatient Prospective Payment System (IPPS) proposed rule (CMS-1808-P) for FY 2025. This rule updates payment policies and payment rates for acute care inpatient hospital services furnished under Medicare. In addition, this year’s rule addresses drug shortages by proposing to make a separate payment to small, independent hospitals to establish and maintain a buffer stock of essential medicines. Also included in the rule are policies to address health equity by capturing data on homelessness--finally the SDoH ICD-10 codes count--and providing additional funding for graduate medical education (GME) slots fto get more physicians out in the rural areas. CMS has also prepared a fact sheet that highlights some of the major policies proposed in the rule.

The FY 2025 IPPS Proposed Rule contains several key proposals that, if finalized, would improve processes for manufacturers seeking to apply for NTAP for their technologies by:

• Adjusting the timeframe for a product’s “Newness” cutoff period from April 1 to October 1--To qualify for a NTAP, a technology must satisfy three criteria: (1) Newness, (2) Cost, and (3) Substantial Clinical Improvement. A technology is considered “new” for two-to-three years after becoming available on the market (typically this is the date of FDA approval, although CMS has allowed for a later date in rare launch circumstances). CMS uses a six-month window, before and after the start date of the fiscal year, to decide whether NTAP payments should be extended to a third year; a therapy will receive three years of payments if the three-year anniversary date of its market entry is in. the second half of CMS’s fiscal year, or after April 1. In the FY 2024 IPPS Final Rule, CMS began requiring most NTAP applicants to have FDA approval by May 1 of the year preceding the fiscal year for which the application is being considered (e.g., an applicant for FY 2026 must have FDA approval by May 1, 2025). To address this limitation on the number of products eligible for a third year of NTAP, starting in FY 2026, CMS is proposing to change the April 1 cutoff date to October 1 for determining when an applicant technology would be within its 2-3-year newness period. For applicant therapies approved in this current cycle (FY 2025), payments can be extended to a third year if a product’s three-year anniversary date for market entry in the U.S. is on or after October 1, rather than April 1. As a result of this policy, more new technologies will be eligible for three years of NTAP.
• Proposing that applicants in a “hold status” with the FDA will no longer be considered inactive for NTAP eligibility purposes. CMS acknowledges that applications for FDA marketing authorization might go in or out of hold status throughout the FDA application process for many reasons. Due to this variability, CMS proposes to modify its policy regarding hold status, starting with applicants for FY 2026. If finalized, technologies that apply for NTAP for FY 2026 will not be considered “inactive”—and, therefore, will be eligible for NTAP consideration—if the applicant has a hold status with FDA. However, CMS will still consider applications that are withdrawn, the subject of a Complete Response Letter, or the subject of a final decision from FDA to refuse to approve the application to be “inactive” and, therefore, ineligible for NTAP.
• Increasing the add-on payment amount to 75% for certain gene therapies that treat sickle-cell disease (SCD). CMS in the FY 2025 IPPS Proposed Rule reiterates these considerations and proposes to increase the NTAP add-on percentage to 75% for certain gene therapies to treat sickle-cell disease (SCD), starting with any therapies approved for FY 2025. 

CMS is proposing to establish a separate IPPS payment for small (100 beds or fewer), independent hospitals for the additional resource costs of voluntarily establishing and maintaining access to a six-month buffer stock of essential medicines beginning with the October 1, 2024, cost reporting period. CMS believes that this policy will support rural hospitals as many meet the criteria of being small and independent. 493 hospitals potentially would be eligible for the proposed payment based on FY 2021 cost report data and 255 of those hospitals were classified as rural.

Proposals include:

• This proposed payment for a buffer stock would not be budget neutral. The payment could be provided biweekly or as a lump sum when cost reports are settled. The payment amounts would be determined by the Medicare Administrative Contractor based on the information provided in a new supplemental cost reporting form.
• Additionally, CMS is proposing to provide this separate payment to establish a new buffer stock for any essential medicine listed as “currently in shortage” on the Food and Drug Administration’s (FDA) Drug Shortage Database. Should a hospital already have established a buffer stock of an essential medicine prior to it going into shortage, the hospital would be eligible for the separate payment even if the buffer stock were to drop to less than six months as that stock is drawn down under this proposal. In the event a buffer stock supply was to drop to less than six months for a reason other than an FDA-recognized shortage, the separate payment would be adjusted based on the proportion of the cost reporting period that a six-month buffer stock was maintained.
• For the purposes of this proposal, the 86 medicines included in this list (See Appendix A) would be deemed as essential medicine. The agency believes that the medicines on this list are either critical for minimum patient care in acute settings or important for acute care with no comparable alternatives available. Should this list be updated, all medicines on the updated list would be eligible under this buffer stock policy. The only chemotherapies included on this list are tacrolimus and mycophenolate mofetil (where are carboplatin and cisplatin?).

For more information regarding ALL the Inpatient Proposals, read the Fact Sheet!

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