ANALYSIS OF 2021 PART B DRUG DISCARDED UNITS IN LIGHT OF NEWLY RELEASED GUIDANCE IN CY 2023 MEDICARE PHYSICIAN FEE SCHEDULE PROPOSED RULE

July 14, 2022 BACK TO RESOURCES

Part B Discarded Drug Units for 2021

The Centers for Medicare and Medicaid Services (CMS) requires all providers and suppliers to report the “JW” HCPCS modifier on Part B drug claims for discarded drugs and biologicals beginning January 1, 2017. CMS reports aggregate discarded units, also referred to as “wastage,” through the Medicare Part B Discarded Drug Units Dashboard. Beginning in 2023, as required by the Infrastructure Investment and Jobs Act,1 manufacturers must provide a refund to the federal government for discarded units that are in excess of 10% of the total allowed amount for Part B drugs.

CMS is required to implement this policy through notice and comment rulemaking2 and included implementation and operationalization guidance for the discarded unit policy in the CY 2023 Medicare Physician Fee Schedule (MPFS) proposed rule.3 To help manufacturers and stakeholders prepare, ADVI SAVEs analyzed CY 2021 Medicare FFS Part B drug claims to determine which drugs may be at risk for owing a rebate on discarded units.

 

 

In the 2020 Part B Discarded Drug Units Dashboard, CMS identified 39 drugs that have a discarded unit’s percentage above 10%. This is nearly double the number of drugs above the threshold since CMS started tracking discarded units in 2017 (see Figure 1).4 In 2020, an additional 15 drugs had a discarded unit’s percentage between 8.0-10.0% nearing the penalty threshold.

In replicating CMS’ methodology for claims in 20215, ADVI SAVEs found 51 drugs with a discarded units percentage greater than 10% (listed in Table 1 below) and 10 additional drugs with a discarded percentage between 8-10% (Table 2 below). There are thirteen new drugs with discarded units above 10% in 2021; six of them were not on the market in 2020. Additionally, three drugs were above the 10% threshold in 2020 have now dropped below in 20216.

Table 1 – Part B Drugs with Discarded Units Above 10% Threshold7

HCPCS

Brand Name

Generic Name

2021 Total Allowed Amount

2021 Total Allowed Amount for Units Discarded

2021 Discarded Units as % of Total Allowed Amount

2020 CMS Discarded Units as % of Total Allowed Amount

Newly Above Discarded Unit Threshold in 2021

Q9965 Omnipaque Iohexol

$2,288,078

$1,547,573

67.6%

23.4%

J7342 Otiprio Ciprofloxacin

$4,560

$2,429

53.3%

n/a8

Yes

J9281 Jelmyto Mitomycin

$26,599,582

$10,006,372

37.6%

n/a6

Yes

J9262 Synribo Omacetaxine Mepesuccinate

$220,987

$68,454

31.0%

20.0%

J9043 Jevtana Cabazitaxel

$146,571,165

$43,694,280

29.8%

28.1%

J9041 Velcade Bortezomib

$379,992,118

$104,493,105

27.5%

26.7%

J9351 Hycamtin Topotecan HCL

$474,014

$124,918

26.4%

23.4%

Q9961 Conray Iothalamate Meglumine

$19,263

$4,979

25.8%

18.0%

J0894 Dacogen Decitabine

$17,861,716

$4,383,499

24.5%

22.7%

J9044 Bortezomib Bortezomib

$4,614,083

$1,045,731

22.7%

21.8%

J9025 Azacitidine Azacitidine

$37,953,273

$8,464,431

22.3%

22.0%

J9017 Arsenic Trioxide Arsenic Trioxide

$1,734,221

$371,806

21.4%

18.3%

J0775 Xiaflex Collagenase Clostridium Hist.

$68,213,415

$14,289,396

20.9%

20.2%

J1448 Cosela Trilaciclib

$1,731,620

$361,554

20.9%

n/a6

Yes

J9065 Cladribine Cladribine

$448,801

$92,569

20.6%

18.1%

J9223 Zepzelca Lurbinectedin

$90,554,293

$18,650,080

20.6%

n/a6

Yes

J0565 Zinplava Bezlotoxumab

$3,902,449

$774,415

19.8%

19.6%

J9178 Ellence Epirubicin HCL

$9,923

$1,880

18.9%

12.2%

J9229 Besponsa Inotuzumab Ozogamicin

$17,827,073

$3,245,314

18.2%

12.1%

Q4121 Theraskin, per sq cm n/a9

$6,534,621

$1,153,492

17.7%

7.2%

Yes

J0223 Givlaari Givosiran Sodium

$10,700,177

$1,859,208

17.4%

20.8%

Q9966 Isovue-200 Iopamidol

$2,224,432

$375,791

16.9%

30.1%

Q4106 Dermagraft Cult Skin Subst,human-Bovine

$1,500,661

$251,210

16.7%

15.1%

J1640 Panhematin Hemin

$8,351,097

$1,311,570

15.7%

14.9%

J9153 Vyxeos Daunorubicin/Cytarabine Lipos

$5,519,948

$862,395

15.6%

14.6%

J2425 Kepivance Palifermin

$124,548

$19,075

15.3%

8.4%

Yes

Q4101 Apligraf Cult Skin Subst, human-Bovine

$2,167,077

$318,419

14.7%

12.1%

J9264 Abraxane Paclitaxel Protein-Bound

$347,082,269

$49,289,715

14.2%

14.5%

J0122 Xerava Eravacycline Di-Hydrochloride

$110,760

$15,667

14.1%

1.0%

Yes

J9027 Clofarabine Clofarabine

$62,487

$8,749

14.0%

1.3%

Yes

J2796 NPlate Romiplostim

$257,086,834

$35,660,702

13.9%

16.8%

J0515 Benztropine Mesylate Benztropine Mesylate

$16,479

$2,178

13.2%

8.2%

Yes

Q9956 OptIson Perflutren Protein-A Microsphr

$735,086

$96,158

13.1%

11.8%

J2562 Mozobil Plerixafor

$18,708,893

$2,437,455

13.0%

12.4%

J9179 Halaven Eribulin Mesylate

$43,558,916

$5,670,164

13.0%

12.6%

J9307 Folotyn Pralatrexate

$22,832,179

$2,903,611

12.7%

10.3%

J9037 Blenrep Belantamab

$32,989,426

$4,156,354

12.6%

n/a6

Yes

J9269 Elzonris Tagraxofusp-Erzs

$7,753,098

$952,097

12.3%

6.8%

Yes

J0485 Nulojix Belatacept

$76,726,554

$9,403,607

12.3%

11.4%

J9042 Adcetris Brentuximab Vedotin

$169,124,286

$20,461,098

12.1%

11.4%

J9319 Istodax Romidepsin

$6,512,543

$777,333

11.9%

n/a6

Yes

J9205 Onivyde Irinotecan Liposomal

$59,364,736

$7,027,567

11.8%

10.5%

J3396 Visudyne Verteporfin

$2,557,468

$302,023

11.8%

9.5%

Yes

Q9950 Lumason Sulfur Hexafluoride Microsphr

$512,606

$60,471

11.8%

13.0%

J9228 Yervoy Ipilimumab

$417,585,675

$48,488,372

11.6%

10.1%

J2997 Activase Alteplase

$66,073,440

$7,547,395

11.4%

11.3%

J3241 Tepezza Teprotumumab-Trbw

$306,354,597

$34,853,650

11.4%

10.0%

J3300 Triesence Triamcinolone Acetonide/PF

$8,955,625

$983,566

11.0%

11.4%

J3101 Tnkase Tenecteplase

$12,849,516

$1,374,852

10.7%

6.2%

J9315 Istodax Romidepsin

$23,128,462

$2,403,694

10.4%

10.3%

J9352 Yondelis Trabectedin

$9,222,158

$933,528

10.1%

11.0%

 

Table 2 – Part B Drugs with Discarded Units Nearing 10% Threshold (>8%)10

HCPCS

Brand Name

Generic Name

2021 Total Allowed Amount

2021 Total Allowed Amount for Units Discarded

2021 Discarded Units as % of Total Allowed Amount

2020 CMS Discarded Units as % of Total Allowed Amount

J0594 Busulfan Busulfan

$65,247

$6,506

10.0%

6.6%

J9203 Mylotarg Gemtuzumab Ozogamicin

$2,970,017

$294,047

9.9%

5.5%

J9263 Oxaliplatin Oxaliplatin

$3,995,999

$387,153

9.7%

9.4%

J0641 Fusilev Levoleucovorin Calcium

$454,127

$41,406

9.1%

9.0%

J9355 Herceptin Trastuzumab

$232,099,376

$20,425,837

8.8%

8.6%

J0585 Botox Onabotulinumtoxina

$369,462,938

$32,181,718

8.7%

8.3%

J9400 Zaltrap Ziv-Aflibercept

$1,593,900

$137,978

8.7%

9.8%

J2786 Cinqair Reslizumab

$11,899,277

$981,743

8.3%

8.5%

J0222 Onpattro Patisiran Sodium,lipid Complex

$83,468,489

$6,869,746

8.2%

8.4%

J9309 Polivy Polatuzumab Vedotin-Piiq

$43,939,303

$3,570,913

8.1%

15.8%

 

 

Future Research

ADVI is following CMS guidance on implementation of the Part B drug discarded units policy. With our access to near real-time Medicare claims data, we are able to analyze specific drugs dosing patterns in both the outpatient hospital and physician office setting to better understand the discarded unit’s issue. We can aggregate results at the patient, physician, group practice, or hospital outpatient provider level and have claims from CY2017 through June of 2022.

If you are interested in additional analysis related to Part B drug discarded units, please contact Caitlin Sheetz (Caitlin.sheetz@advi.com), Pete Kardel (Peter.kardel@advi.com), or your ADVI account manager.

 

2 SSA §1847A(h)(7)

3 CY 2023 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies: https://public-inspection.federalregister.gov/2022-14562.pdf

4 Not all 39 drugs would meet the proposed definition of refundable single-dose container or single-use package drug.

5 ADVI used the Research Identifiable Files (RIFs) from January through December 2021. These are not 100% final actions claims and due to varying run out times, results may be slightly different than future published dashboards.

6 These drugs are: Q4195 (Puraply, per square centimeter), J9309 (Polivy [Polatuzumab Vedotin-Piiq]), and J0291 (Zemdri [Plazomicin Sulfate). J9309 has a 2021 discarded units of over 8.1% and appears in Table 2 as a drug nearing the discarded unit threshold.

7 Table 1 presents claims billed with the JW HCPCS modifier and does not account for any of the discarded unit policy exceptions under P.L. 117-58. Reach out to ADVI for more information about whether specific products would be affected by the discarded unit rebate policy.

8 Drug not sold in 2020.

9 Q4121 – Brand/generic name not applicable. Name reflects the HCPCS short descriptor.

10 Table 2 presents claims billed with the JW HCPCS modifier and does not account for any of the discarded unit policy exceptions under P.L. 117-58. Reach out to ADVI for more information about whether specific products would be affected by the discarded unit rebate policy.

$251,210