Industry Payments to US Clinicians Excluded from Federal Health Care Programs, 2013 to 2024

INTRODUCTION

Federal law authorizes the exclusion of providers from federally funded health care programs (e.g., Medicare and Medicaid) for several reasons.¹ Mandatory exclusions include Medicare or Medicaid fraud, patient abuse or neglect, and crimes involving a controlled substance.¹ Permissive exclusions include license revocation, suspension, or surrender, obstruction of an investigation or audit, and default on a federal health education loan.¹ Exclusion represents a severe restriction and hiring or contracting with an excluded individual or entity can result in civil monetary penalties.²

The pharmaceutical and medical device industry routinely engages with clinicians for a variety of paid activities.³ The involvement of excluded clinicians poses a potential risk; however, the nature and extent of paid relationships with excluded clinicians is not known.

METHODS

We obtained the List of Excluded Individuals/Entities (LEIE) from the US Department of Health and Human Services (updated July 2025).⁴ Because the LEIE is only a record of currently active exclusions, we also obtained records of reinstatements since January 2023 (the earliest date available) to collect data on previous exclusions that ended. Next, we extracted physician, dentist, nurse practitioner, and physician assistant records with a valid National Provider Identifier (NPI) number. Next, we linked excluded clinicians with the 2013 to 2024 Centers for Medicare & Medicaid Services Open Payments⁵ database, by NPI. We filtered to obtain only payments received during the exclusion (i.e., accounting for reinstatements and waivers, if applicable). Finally, we calculated the total, median, and interquartile range of dollar values per clinician and per payment, by category of payment. The study was determined to be not human subjects research by the Oregon Health & Science University Institutional Review Board because it involved publicly available data.

RESULTS

Of 3,725 excluded clinicians identified, 16.2% (n=605) received one or more payments. These clinicians were mostly physicians (83.3%) or dentists (12.2%) and mostly male (79.3%; Table 1). Of 621 available exclusion reasons, conviction of program-related crimes (34.6%) was the most common. There were 7,061 payments totaling $2,286,339 (Table 2). By total amount, payments for royalty or licensing accounted for 52.8% of the total, followed by consulting fees (13.7%), food and beverage (9.1%), speaking fees (5.5%), and honoraria (4.6%). By clinician, 92.9% received a payment for food and beverage followed by 9.3% receiving a payment for educational activities.

Table 1.

Characteristics of Clinicians Receiving Industry Payments while Excluded from Federally Funded Health Care Programs in the US (n = 605)^a

Age, median (IQR)b	56.3 (49.1, 63.9)
Sex, n (%)
Male	480 (79.3)
Female	77 (12.7)
Not recorded	48 (7.9)
Clinician type, n (%)
Physician	504 (83.3)
Dentist	74 (12.2)
Nurse practitioner	15 (2.5)
Physician assistant	12 (2.0)
Physician specialty/subspecialty, n (%)c
General practice	122 (24.2)
Internal medicine	109 (21.6)
Family practice	82 (16.3)
Psychiatry	29 (5.8)
Medical subspecialty	27 (5.4)
Surgery	25 (5.0)
Pain management	23 (4.6)
Surgical subspecialty	18 (3.6)
Anesthesiology	17 (3.4)
Obstetrics and gynecology	17 (3.4)
Neurology	13 (2.6)
Pediatrics	8 (1.6)
Emergency medicine	6 (1.1)
Ophthalmology	4 (<1)
Dermatology	2 (<1)
Pathology	1 (<1)
Radiology	1 (<1)
Exclusion reason, n (%)d
Mandatory exclusions
Conviction of program-related crimes	215 (34.6)
Felony conviction relating to controlled substance	116 (18.7)
Felony conviction relating to health care fraud	56 (9.0)
Conviction relating to patient abuse or neglect	29 (4.7)
Permissive exclusions
License revocation, suspension, or surrender	152 (24.5)
Default on health education loan or scholarship obligations	21 (3.4)
Misdemeanor conviction relating to health care fraud or conviction relating to fraud in non-health care programs	6 (1.0)
Other permissive exclusion	26 (4.2)

^aPercentages may not sum to 100% due to rounding

^bRefers to the clinician’s age at the time of the first exclusion

^cSpecialty/subspecialty as listed in exclusion data. Percentages for each specialty/subspecialty refer to the percentage of physicians only

^dExclusion reason was available for 99.7% (n=621/623) of exclusions; clinicians with more than one exclusion reason are counted for each exclusion

Table 2.

Value Received Per Clinician and Per Payment Among Clinicians Receiving Industry Payments While Excluded from Federally Funded Health Care Programs in the US (n = 605)^a

	Payments, total amount $ (%)	Clinicians, n (%) b	Value per clinician, median (IQR) $	Payments, n (%)	Value per payment, median (IQR) $
All	$2,286,339 (100)	605 (100)	$107 (30, 316)	7061 (100)	$19 (14, 35)
Charitable contribution	$541 (<1)	5 (<1)	$90 (90, 90)	6 (<1)	$90 (90, 90)
Consulting fee	$313,601 (13.7)	17 (2.8)	$750 (300, 13543)	84 (1.2)	$1,235 (755, 1766)
Current or prospective ownership or investment interest	$21,623 (<1)	2 (<1)	$10,812 (11, 21612)	2 (<1)	$10,812 (11, 21612)
Debt forgiveness	$128,438 (5.6)	5 (<1)	$987 (492, 12866)	6 (<1)	$2,220 (492, 9413)
Education	$22,921 (1.0)	56 (9.3)	$62 (33, 250)	305 (4.3)	$59 (12, 75)
Entertainment	$594 (<1)	4 (<1)	$36 (25, 271)	6 (<1)	$20 (15, 26)
Food and beverage	$208,468 (9.1)	562 (92.9)	$92 (27, 230)	6,270 (88.8)	$18 (13, 25)
Gift	$43,151 (1.9)	26 (4.3)	$202 (95, 1021)	68 (1.0)	$103 (26, 247)
Honoraria	$104,979 (4.6)	7 (1.2)	$1,500 (129, 5000)	32 (<1)	$4,750 (604, 4750)
Long term medical supply or device loan	$997 (<1)	1 (<1)	$997 (997, 997)	10 (<1)	$100 (100, 100)
Research	$64,085 (2.8)	4 (<1)	$7,903 (1169, 30874)	17 (<1)	$553 (65, 1071)
Royalty or license	$1,206,411 (52.8)	6 (1.0)	$22,763 (2351, 322492)	58 (<1)	$875 (122, 8320)
Speaking fees	$125,804 (5.5)	15 (2.5)	$140 (54, 3750)	86 (1.2)	$46 (35, 3500)
Travel and lodging	$44,725 (2.0)	24 (4.0)	$825 (405, 1336)	111 (1.6)	$320 (136, 512)

^aPercentages may not sum to 100% due to rounding

^bClinicians receiving a payment in more than one category are counted in each category

DISCUSSION

The pharmaceutical and medical device industry should reconsider paid relationships with excluded clinicians. Although the number of excluded clinicians receiving payments is relatively small, and not all exclusions are of equal significance, many exclusions represent severe cases that stemmed from patient harm. Broadly, treatment by clinicians excluded for fraud and abuse, compared with other clinicians, is associated with higher rates of emergency hospitalization and mortality.⁶ Therefore, in many cases, excluded clinicians may not represent reliable sources of medical information based on sound clinical skill and judgment. Specifically, involvement of excluded clinicians in research is concerning due to the potential risk to research integrity.

Healthcare organizations routinely screen employees and contractors for exclusion and pharmaceutical and medical device companies should follow similar procedures. While it may not be feasible to screen all clinicians receiving a meal, for example, or there may be contractually protected payments (e.g., royalty and licensing), companies could screen clinicians prior to and during engagement for other substantive activities such as research, consulting, and speaking.

This study has several limitations and is likely to represent an undercount of excluded clinicians. First, clinicians that are reinstated are removed from the exclusions list and therefore do not appear in our data. While we obtained reinstatements since January 2023, prior data were not available. Second, we only extracted exclusion records containing a valid NPI. Clinicians excluded prior to adoption of NPI as the national standard (May 2007) rarely had an NPI. Third, we were unable to identify advanced practice registered nurses other than nurse practitioners from the exclusions list. Finally, payments to nurse practitioners and physician assistants were only added in 2021.

In conclusion, industry payments to excluded clinicians raise significant concerns due to the severe nature of many of the reasons for exclusion. Where elective, paid relationships with excluded clinicians should be reexamined. Drug and medical device manufacturers can also consider proactively screening clinicians for exclusion prior to establishing a financial relationship.

Data Availability

Data are available upon reasonable request to the corresponding author.