SECTION III: OTHER INFORMATION (Civil Monetary Penalty Adjustment)

FY 2017 HHS Agency Financial Report

Topics in this Section:  Other Financial Information | Reduce the Footprint | Summary of Financial Statement Audit and Management Assurances | Civil Monetary Penalty Adjustment for Inflation | Grants Oversight & New Efficiency Act Report | Payment Integrity Report (Section 1-10 | 11 | 12-13) | FY 2017 Top Management and Performance Challenges Identified by the Office of Inspector General

SUMMARY OF FINANCIAL STATEMENT AUDIT AND MANAGEMENT ASSURANCES

As described in the “Management’s Discussion and Analysis” section, management annually presents an assurance statement on the effectiveness of internal control.  The following two tables present summary information related to the material weakness identified during the audit, as well as conformance with FMFIA and compliance with FFMIA.

Table 1: Summary of Financial Statement Audit

Audit Opinion Unmodified for Four Financial Statements

Disclaimed Opinion on Statement of Social Insurance and Statement of Changes in Social Insurance Amounts
Restatement No
Material Weaknesses Beginning Balance New Resolved Consolidated Ending Balance
Financial Information Systems 1 1
Total Material Weaknesses 1 1

Definition of Terms – Tables 1 and 2

(Reference:  OMB Circular A-136, Financial Reporting Requirements, August 15, 2017, page 107)

Beginning Balance:  The beginning balance will agree with the ending balance of material weaknesses from the prior year.

New:  The total number of material weaknesses that have been identified during the current year.

Resolved:  The total number of material weaknesses that have dropped below the level of materiality in the current year.

Consolidated:  The combining of two or more findings.

Reassessed:  The removal of any finding not attributable to corrective actions (e.g., management has re-evaluated and determined a finding does not meet the criteria for materiality or is redefined as more correctly classified under another heading (e.g., Section 2 to a Section 4 and vice versa).

Ending Balance:  The agency’s year-end balance of material weaknesses.

 

Table 2: Summary of Management Assurances

Effectiveness of Internal Control over Financial Reporting (FMFIA #2)
Statement of Assurance Modified
 
Material Weaknesses Beginning Balance New Resolved Consolidated Reassessed Ending Balance
No Material Weaknesses Noted            
Total Material Weaknesses 0 - - - - 0
Effectiveness of Internal Control over Operations (FMFIA #2)
Statement of Assurance Modified
 
Material Weaknesses Beginning Balance New Resolved Consolidated Reassessed Ending Balance
Information System Controls and Security 1 - 1[1] - - 0
Error Rate Measurement 1 - - - - 1
Medicare Appeals Process 1 - - - - 1
Total Material Weaknesses 3 - 1 - - 2

[1] Beginning in FY 2015, HHS implemented a comprehensive strategy to strengthen the HHS Financial Systems Controls Environment and address the IT material weakness.  Since then, significant progress has been made in resolving audit findings, reducing risk across the operating environment, and maturing the security and controls posture of HHS’s financial systems.  As part of the strategy, HHS established a Management Assessment Framework that defines the conditions and criteria to evaluate the severity of control deficiencies found in Information System Controls and Security in HHS’s financial systems.  Evaluation criteria include four key components: (1) Leadership Commitment and Sustained Governance; (2) Reduced Risk through Corrective Actions; (3) Demonstrated Measurable Remediation Progress; and (4) Mature Controls Environment.  While control deficiencies still exist across several HHS FISCAM systems, our evaluation based on the HHS Management Assessment Framework demonstrates that these deficiencies, in aggregate, no longer rise to the level of a “material weakness” under OMB Circular A-123, as of September 30, 2017.

Compliance with Federal Financial Management System Requirements (FMFIA #4)

Statement of Assurance

Federal Systems comply to financial management system requirements

 
Non-Compliance Beginning Balance New Resolved Consolidated Reassessed Ending Balance
Information System Controls and Security 0 - - - - 0
Total Non-Compliance 0 - - - - 0
Compliance with Section 803(a) of the Federal Financial Management Improvement Act (FFMIA)
  Agency Auditor
1. Federal Financial Management System Requirements No lack of compliance noted Lack of compliance noted
2. Applicable Federal Accounting Standards No lack of compliance noted No lack of compliance noted
3. USSGL at Transaction Level No lack of compliance noted No lack of compliance noted

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CIVIL MONETARY PENALTY ADJUSTMENT FOR INFLATION

On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act) (Sec. 701 of Public Law 114-74), which further amended the Federal Civil Penalties Inflation Adjustment Act of 1990  (Public Law 104-410), to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect.  Agencies must report the most recent inflationary adjustments to civil monetary penalties in order to ensure penalty adjustments are both timely and accurate.

The 2015 Act applies to eight Operating Divisions (OpDivs) and Staff Divisions (StaffDivs): ACF, AHRQ, HRSA, FDA, CMS, Office for Civil Rights, Office of the General Counsel, and Office of Inspector General.  The table below illustrates HHS’s civil monetary penalties by OpDivs and StaffDivs.  Supporting details can be found in Federal Register 82, No. 22 (February 3, 2017): 9174-9189.

[1] Beginning in FY 2015, HHS implemented a comprehensive strategy to strengthen the HHS Financial Systems Controls Environment and address the IT material weakness.  Since then, significant progress has been made in resolving audit findings, reducing risk across the operating environment, and maturing the security and controls posture of HHS’s financial systems.  As part of the strategy, HHS established a Management Assessment Framework that defines the conditions and criteria to evaluate the severity of control deficiencies found in Information System Controls and Security in HHS’s financial systems.  Evaluation criteria include four key components: (1) Leadership Commitment and Sustained Governance; (2) Reduced Risk through Corrective Actions; (3) Demonstrated Measurable Remediation Progress; and (4) Mature Controls Environment.  While control deficiencies still exist across several HHS FISCAM systems, our evaluation based on the HHS Management Assessment Framework demonstrates that these deficiencies, in aggregate, no longer rise to the level of a “material weakness” under OMB Circular A-123, as of September 30, 2017.

 

Administration for Children and Families

Penalty Statutory Authority Date of Previous Adjustment Date of Current Adjustment Current Penalty Level ($ Amount)
Penalty for Misuse of Information in the National Directory of New Hires. 42 U.S.C. 653(l)(2) 2016 2017 $      1,474

 

Agency for Healthcare Research and Quality

Penalty Statutory Authority Date of Previous Adjustment Date of Current Adjustment Current Penalty Level ($ Amount)
Penalty for an establishment or person supplying information obtained in the course of activities for any purpose other than the purpose for which it was supplied. 42 U.S.C. 299c—(3)(d) 2016 2017 $      14,371

 

Health Resources and Services Administration

Penalty Statutory Authority Date of Previous Adjustment Date of Current Adjustment Current Penalty Level ($ Amount)
Penalty for each instance of overcharging a 340B covered entity. 42 U.S.C. 256b(d)(1)(B)(vi) 2016 2017 $      5,526

 

Office for Civil Rights

Penalty Statutory Authority Date of Previous Adjustment Date of Current Adjustment Current Penalty Level ($ Amount)
Penalty for violation of confidentiality provision of the Patient Safety and Quality Improvement Act. 42 U.S.C. 299b-22(f)(1) 2016 2017 $      12,135
Penalty for each pre-February 18, 2009 violation of the HIPAA administrative simplification provisions. 42 U.S.C. 1320(d)-5(a) 2016 2017 152
Calendar Year Cap 2016 2017 38,175
Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the covered entity or business associate did not know and by exercising reasonable diligence, would not have known that the covered entity or business associate violated such a provision.   2017  
Minimum 2016 2017 112
Maximum 2016 2017 55,910
Calendar Year Cap 2016 2017 1,677,299
Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to reasonable cause and not to willful neglect.   2017  
Minimum 2016 2017 1,118
Maximum 2016 2017 55,910
Calendar Year Cap 2016 2017 1,677,299
Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or, by exercising reasonable diligence, would have known that the violation occurred.   2017  
Minimum 2016 2017 11,182
Maximum 2016 2017 55,910
Calendar Year Cap 2016 2017 1,677,299
Penalty for each February 18, 2009 or later violation of a HIPAA administrative simplification provision in which it is established that the violation was due to willful neglect and was not corrected during the 30-day period beginning on the first date the covered entity or business associate knew, or by exercising reasonable diligence, would have known that the violation occurred.   2017  
Minimum 2016 2017 55,910
Maximum 2016 2017 1,677,299
Calendar Year Cap 2016 2017 1,677,299

 

Office of the General Counsel

Penalty Statutory Authority Date of Previous Adjustment Date of Current Adjustment Current Penalty Level ($ Amount)
Penalty for the first time an individual makes an expenditure prohibited by regulations regarding lobbying disclosure, absent aggravating circumstances. 31 U.S.C. 1352 2016 2017 $      19,246
Penalty for second and subsequent offenses by individuals who make an expenditure prohibited by regulations regarding lobbying disclosure.   2017  
Minimum 2016 2017 19,246
Maximum 2016 2017 192,459
Penalty for the first time an individual fails to file or amend a lobbying disclosure form, absent aggravating circumstances. 2016 2017 19,246
Penalty for second and subsequent offenses by individuals who fail to file or amend a lobbying disclosure form, absent aggravating circumstances.   2017  
Minimum 2016 2017 19,246
Maximum 2016 2017 192,459
Penalty for failure to provide certification regarding lobbying in the award documents for all sub-awards of all tiers.   2017  
Minimum 2016 2017 19,246
Maximum 2016 2017 192,459
Penalty for failure to provide statement regarding lobbying for loan guarantee and loan insurance transactions.   2017  
Minimum 2016 2017 19,246
Maximum 2016 2017 192,459
Penalty against any individual who - with knowledge or reason to know - makes, presents or submits a false, fictitious or fraudulent claim to the Department 31 U.S.C. 3801-3812 2016 2017 10,056
Penalty against any individual who - with knowledge or reason to know - makes, presents or submits a false, fictitious or fraudulent claim to the Department 2016 2017 10,056

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Office of Inspector General

Penalty Statutory Authority Date of Previous Adjustment Date of Current Adjustment Current Penalty Level ($ Amount)
Penalty for each individual who violates safety and security procedures related to handling dangerous biological agents and toxins. 42 U.S.C. 262a(i)(1) 2016 2017 $      333,327
Penalty for any other person who violates safety and security procedures related to handling dangerous biological agents and toxins. 2016 2017 666,656
Penalty per violation for committing information blocking. 42 U.S.C. 300jj-51 2016 2017 1,016,360
Penalty for knowingly presenting or causing to be presented to an officer, employee, or agent of the United States a false claim. 42 U.S.C. 1320a-7a(a) 2016 2017 15,270
Penalty for knowingly presenting or causing to be presented a request for payment which violates the terms of an assignment, agreement, or PPS agreement. 2016 2017 15,270
Penalty for knowingly giving or causing to be presented to a participating provider or supplier false or misleading information that could reasonably be expected to influence a discharge decision. 2016 2017 22,906
Penalty for an excluded party retaining ownership or control interest in a participating entity. 2016 2017 15,270
Penalty for remuneration offered to induce program beneficiaries to use particular providers, practitioners, or suppliers. 2016 2017 15,270
Penalty for employing or contracting with an excluded individual. 2016 2017 14,959
Penalty for knowing and willful solicitation, receipt, offer, or payment of remuneration for referring an individual for a service or for purchasing, leasing, or ordering an item to be paid for by a Federal health care program. 2016 2017 74,792
Penalty for ordering or prescribing medical or other item or service during a period in which the person was excluded. 2016 2017 11,052
Penalty for knowingly making or causing to be made a false statement, omission or misrepresentation of a material fact in any application, bid, or contract to participate or enroll as a provider or supplier. 2016 2017 55,262
Penalty for knowing of an overpayment and failing to report and return. 2016 2017 11,052
Penalty for making or using a false record or statement that is material to a false or fraudulent claim 2016 2017 55,262
Penalty for failure to grant timely access to HHS OIG for audits, investigations, evaluations, and other statutory functions of HHS OIG. 2016 2017 16,579
Penalty for payments by a hospital or critical access hospital to induce a physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits. 42 U.S.C. 1320a-7a(b) 2016 2017 4,384
Penalty for physicians who knowingly receive payments from a hospital or critical access hospital to induce such physician to reduce or limit services to individuals under direct care of physician or who are entitled to certain medical assistance benefits. 2016 2017 4,384
Penalty for a physician who executes a document that falsely certifies home health needs for Medicare beneficiaries. 2016 2017 7,635
Penalty for failure to report any final adverse action taken against a health care provider, supplier, or practitioner. 42 U.S.C. 1320a-7e(b)(6)(A) 2016 2017 37,396
Penalty for the misuse of words, symbols, or emblems in communications in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS. 42 U.S.C. 1320b-10(b)(1) 2016 2017 10,055
Penalty for the misuse of words, symbols, or emblems in a broadcast or telecast in a manner in which a person could falsely construe that such item is approved, endorsed, or authorized by HHS. 42 U.S.C. 1320b-10(b)(2) 2016 2017 50,276
Penalty for certification of a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment. 42 U.S.C. 1395i-3(b)(3)(B)(ii)(1) 2016 2017 2,097
Penalty for causing another to certify or make a false statement in assessment of functional capacity of a Skilled Nursing Facility resident assessment. 42 U.S.C. 1395i-3(b)(3)(B)(ii)(2) 2016 2017 10,483
Penalty for any individual who notifies or causes to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted. 42 U.S.C. 1395i-3(g)(2)(A) 2016 2017 4,194
Penalty for a Medicare Advantage organization that substantially fails to provide medically necessary, required items and services. 42 U.S.C. 1395w-27(g)(2)(A) 2016 2017 38,175
Penalty for a Medicare Advantage organization that charges excessive premiums. 2016 2017 37,396
Penalty for a Medicare Advantage organization that improperly expels or refuses to reenroll a beneficiary. 2016 2017 37,396
Penalty for a Medicare Advantage organization that engages in practice that would reasonably be expected to have the effect of denying or discouraging enrollment. 2016 2017 149,585
Penalty per individual who does not enroll as a result of a Medicare Advantage organization’s practice that would reasonably be expected to have the effect of denying or discouraging enrollment. 2016 2017 22,438
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to Secretary. 2016 2017 149,585
Penalty for a Medicare Advantage organization misrepresenting or falsifying information to individual or other entity. 2016 2017 37,396
Penalty for Medicare Advantage organization interfering with provider’s advice to enrollee and non-MCO affiliated providers that balance bill enrollees. 2016 2017 37,396
Penalty for a Medicare Advantage organization that employs or contracts with excluded individual or entity. 2016 2017 37,396
Penalty for a Medicare Advantage organization enrolling an individual in without prior written consent. 2016 2017 37,396
Penalty for a Medicare Advantage organization transferring an enrollee to another plan without consent or solely for the purpose of earning a commission. 2016 2017 37,396
Penalty for a Medicare Advantage organization failing to comply with marketing restrictions or applicable implementing regulations or guidance. 2016 2017 37,396
Penalty for a Medicare Advantage organization employing or contracting with an individual or entity who violates    1395w-27(g)(1)(A)-(J). 2016 2017 37,396
Penalty for a prescription drug card sponsor that falsifies or misrepresents marketing materials, overcharges program enrollees, or misuse transitional assistance funds. 42 U.S.C. 1395w-141(i)(3) 2016 2017 13,066
Penalty for improper billing by Hospitals, Critical Access Hospitals, or Skilled Nursing Facilities. 42 U.S.C. 1395cc(g) 2016 2017 5,082
Penalty for a hospital or responsible physician dumping patients needing emergency medical care, if the hospital has 100 beds or more. 42 U.S.C. 1395dd(d)(1) 2016 2017 104,826
Penalty for a hospital or responsible physician dumping patients needing emergency care, if the hospital has less than 100 beds. 2016 2017 52,414
Penalty for a HMO or competitive plan is such plan substantially fails to provide medically necessary, required items or services 42 U.S.C. 1395mm(i)(6)(B)(i) 2016 2017 52,414
Penalty for HMOs/competitive medical plans that charge premiums in excess of permitted amounts 2016 2017 52,414
Penalty for a HMO or competitive medical plan that expels or refuses to reenroll an individual per prescribed conditions 2016 2017 52,414
Penalty for a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in future. 2016 2017 209,653
Penalty per individual not enrolled in a plan as a result of a HMO or competitive medical plan that implements practices to discourage enrollment of individuals needing services in the future. 2016 2017 30,166
Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to the Secretary. 2016 2017 209,653
Penalty for a HMO or competitive medical plan that misrepresents or falsifies information to an individual or any other entity. 2016 2017 52,414
Penalty for failure by HMO or competitive medical plan to assure prompt payment of Medicare risk sharing contracts or incentive plan provisions. 2016 2017 52,414
Penalty for HMO that employs or contracts with excluded individual or entity. 2016 2017 48,114
Penalty for submitting or causing to be submitted claims in violation of the Stark Law’s restrictions on physician self-referrals. 42 U.S.C. 1395nn(g)(3) 2016 2017 24,253
Penalty for circumventing Stark Law’s restrictions on physician self-referrals. 42 U.S.C. 1395nn(g)(4) 2016 2017 161,692
Penalty for a material misrepresentation regarding Medigap compliance policies. 42 U.S.C. 1395ss(d)(1) 2016 2017 10,055
Penalty for selling Medigap policy under false pretense. 42 U.S.C. 1395ss(d)(2) 2016 2017 10,055
Penalty for an issuer that sells health insurance policy that duplicates benefits. 42 U.S.C. 1395ss(d)(3)(A)(ii) 2016 2017 45,268
Penalty for someone other than issuer that sells health insurance that duplicates benefits. 2016 2017 27,160
Penalty for using mail to sell a non-approved Medigap insurance policy. 42 U.S.C. 1395ss(d)(4)(A) 2016 2017 10,055
Penalty for a Medicaid MCO that substantially fails to provide medically necessary, required items or services. 42 U.S.C. 1396b(m)(5)(B)(i) 2016 2017 50,276
Penalty for a Medicaid MCO that charges excessive premiums. 42 U.S.C. 1396b(m)(5)(B)(i) 2016 2017 50,276
Penalty for a Medicaid MCO that improperly expels or refuses to reenroll a beneficiary. 2016 2017 201,106
Penalty per individual who does not enroll as a result of a Medicaid MCO’s practice that would reasonably be expected to have the effect of denying or discouraging enrollment. 2016 2017 30,166
Penalty for a Medicaid MCO misrepresenting or falsifying information to the Secretary. 2016 2017 201,106
Penalty for a Medicaid MCO misrepresenting or falsifying information to an individual or another entity. 2016 2017 50,276
Penalty for a Medicaid MCO that fails to comply with contract requirements with respect to physician incentive plans. 2016 2017 45,268
Penalty for willfully and knowingly certifying a material and false statement in a Skilled Nursing Facility resident assessment. 42 U.S.C. 1396r(b)(3)(B)(ii)(I) 2016 2017 2,097
Penalty for willfully and knowingly causing another individual to certify a material and false statement in a Skilled Nursing Facility resident assessment. 42 U.S.C. 1396r(b)(3)(B)(ii)(II) 2016 2017 10,483
Penalty for notifying or causing to be notified a Skilled Nursing Facility of the time or date on which a survey is to be conducted. 42 U.S.C. 1396r(g)(2)(A)(i) 2016 2017 4,194
Penalty for the knowing provision of false information or refusing to provide information about charges or prices of a covered outpatient drug. 42 U.S.C. 1396r-8(b)(3)(B) 2016 2017 181,071
Penalty per day for failure to timely provide information by drug manufacturer with rebate agreement. 42 U.S.C. 1396r-8(b)(3)(C)(i) 2016 2017 18,107
Penalty for knowing provision of false information by drug manufacturer with rebate agreement. 42 U.S.C. 1396r-8(b)(3)(C)(ii) 2016 2017 181,071
Penalty for notifying home and community-based providers or settings of survey. 42 U.S.C. 1396t(i)(3)(A) 2016 2017 3,621
Penalty for failing to report a medical malpractice claim to National Practitioner Data Bank. 42 U.S.C. 11131(c) 2016 2017 21,916
Penalty for breaching confidentiality of information reported to National Practitioner Data Bank. 42 U.S.C. 11137(b)(2) 2016 2017 21,916

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Food and Drug Administration

Penalty Statutory Authority Date of Previous Adjustment Date of Current Adjustment Current Penalty Level ($ Amount)
Penalty for violations related to drug samples resulting in a conviction of any representative of manufacturer or distributor in any 10-year period. 21 U.S.C. 333(b)(2)(A) 2016 2017 $      100,554
Penalty for violation related to drug samples resulting in a conviction of any representative of manufacturer or distributor after the second conviction in any 10-yr period. 21 U.S.C. 333(b)(2)(B) 2016 2017 2,011,061
Penalty for failure to make a report required by 21 U.S.C. 353(d)(3)(E) relating to drug samples. 21 U.S.C 333(b)(3) 2016 2017 201,106
Penalty for any person who violates a requirement related to devices for each such violation. 21 U.S.C 333(f)(1)(A) 2016 2017 27,160
Penalty for aggregate of all violations related to devices in a single proceeding. 2016 2017 1,810,706
Penalty for any individual who introduces or delivers for introduction into interstate commerce food that is adulterated per 21 U.S.C. 342(a)(2)(B) or any individual who does not comply with a recall order under 21 U.S.C. 350l. 21 U.S.C 333(f)(2)(A) 2016 2017 76,352
Penalty in the case of any other person other than an individual) for such introduction or delivery of adulterated food. 2016 2017 381,758
Penalty for aggregate of all such violations related to adulterated food adjudicated in a single proceeding. 2016 2017 763,515
Penalty for all violations adjudicated in a single proceeding for any person who fails to submit certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification. 21 U.S.C 333(f)(3)(A) 2016 2017 11,569
Penalty for all violations adjudicated in a single proceeding for any person who violates 21 U.S.C. 331(jj)(1) by failing to submit the certification required by 42 U.S.C. 282(j)(5)(B) or knowingly submitting a false certification; by failing to submit clinical trial information under 42 U.S.C 282(j); or by submitting clinical trial information under 42 U.S.C. 282(j) that is false or misleading in any particular under 42 U.S.C. 282(j)(5)(D). 21 U.S.C 333(f)(3)(B) 2016 2017 11,569
Penalty for any responsible person that violates a requirement of 21 U.S.C. 355(o) (post-marketing studies, clinical trials, labeling), 21 U.S.C. 355(p) (risk evaluation and mitigation (REMS)), or 21 U.S.C. 355-1 (REMS). 21 U.S.C 333(f)(4)(A)(i) 2016 2017 289,239
Penalty for aggregate of all such above violations in a single proceeding. 2016 2017 1,156,953
Penalty for REMS violation that continues after written notice to the responsible person for the first 30–day period (or any portion thereof) the responsible person continues to be in violation. 21 U.S.C 333(f)(4)(A)(ii) 2016 2017 289,239
Penalty for REMS violation that continues after written notice to responsible person doubles for every 30–day period thereafter the violation continues, but may not exceed penalty amount for any 30–day period. 2016 2017 1,156,953
Penalty for aggregate of all such above violations adjudicated in a single proceeding. 2016 2017 11,569,531
Penalty for any person who violates a requirement which relates to tobacco products for each such violation 21 U.S.C 333(f)(9)(A) 2016 2017 16,773
Penalty for aggregate of all such violations of tobacco product requirement adjudicated in a single proceeding. 2016 2017 1,118,199
Penalty per violation related to violations of tobacco requirements. 21 U.S.C 333(f)(9)(B)(i)(I) 2016 2017 279,550
Penalty for aggregate of all such violations of tobacco product requirements adjudicated in a single proceeding. 2016 2017 1,118,199
Penalty in the case of a violation of tobacco product requirements that continues after written notice to such person, for the first 30–day period (or any portion thereof) the person continues to be in violation. 21 U.S.C 333(f)(9)(B)(i)(II) 2016 2017 279,550
Penalty for violation of tobacco product requirements that continues after written notice to such person shall double for every 30–day period thereafter the violation continues, but may not exceed penalty amount for any 30–day period. 2016 2017 1,118,199
Penalty for aggregate of all such violations related to tobacco product requirements adjudicated in a single proceeding. 2016 2017 11,181,993
Penalty for any person who either does not conduct post-market surveillance and studies to determine impact of a modified risk tobacco product for which the HHS Secretary has provided them an order to sell, or who does not submit a protocol to the HHS Secretary after being notified of a requirement to conduct post-market surveillance of such tobacco products. 21 U.S.C 333(f)(9)(B)(ii)(I) 2016 2017 279,550
Penalty for aggregate of for all such above violations adjudicated in a single proceeding. 2016 2017 1,118,199
Penalty for violation of modified risk tobacco product post-market surveillance that continues after written notice to such person for the first 30–day period (or any portion thereof) that the person continues to be in violation. 21 U.S.C 333(f)(9)(B)(ii)(II) 2016 2017 279,550
Penalty for post-notice violation of modified risk tobacco product post-market surveillance shall double for every 30–day period thereafter that the tobacco product requirement violation continues for any 30–day period, but may not exceed penalty amount for any 30–day period. 2016 2017 1,118,199
Penalty for aggregate above tobacco product requirement violations adjudicated in a single proceeding. 2016 2017 11,181,993
Penalty for any person who disseminates or causes another party to disseminate a direct-to-consumer advertisement that is false or misleading for the first such violation in any 3–year period. 21 U.S.C 333(g)(1) 2016 2017 289,239
Penalty for each subsequent above violation in any 3–year period. 2016 2017 578,477
Penalty to be applied for violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) (e.g., violations of regulations in 21 CFR Part 1140) with respect to a retailer with an approved training program in the case of a second regulation violation within a 12–month period. 21 U.S.C 333 note 2016 2017 279
Penalty in the case of a third tobacco product regulation violation within a 24–month period. 2016 2017 559
Penalty in the case of a fourth tobacco product regulation violation within a 24–month period. 2016 2017 2,236
Penalty in the case of a fifth tobacco product regulation violation within a 36–month period. 2016 2017 5,591
Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48–month period as determined on a case-by-case basis. 21 U.S.C 333 note 2016 2017 11,182
Penalty to be applied for violations of restrictions on the sale or distribution of tobacco products promulgated under 21 U.S.C. 387f(d) (e.g., violations of regulations in 21 CFR Part 1140) with respect to a retailer that does not have an approved training program in the case of the first regulation violation. 2016 2017 279
Penalty in the case of a second tobacco product regulation violation within a 12-month period. 2016 2017 559
Penalty in the case of a third tobacco product regulation violation within a 24–month period. 2016 2017 1,118
Penalty in the case of a fourth tobacco product regulation violation within a 24–month period. 2016 2017 2,236
Penalty in the case of a fifth tobacco product regulation violation within a 36–month period. 2016 2017 5,591
Penalty in the case of a sixth or subsequent tobacco product regulation violation within a 48–month period as determined on a case-by-case basis. 2016 2017 11,182
Penalty for each violation for any individual who made a false statement or misrepresentation of a material fact, bribed, destroyed, altered, removed, or secreted, or procured the destruction, alteration, removal, or secretion of, any material document, failed to disclose a material fact, obstructed an investigation, employed a consultant who was debarred, debarred individual provided  consultant services. 21 U.S.C 335b(a) 2016 2017 426,180
Penalty in the case of any other person (other than an individual) per above violation. 2016 2017 1,704,720
Penalty for any person who violates any such requirements for electronic products, with each unlawful act or omission constituting a separate violation. 21 U.S.C 360pp(b)(1) 2016 2017 2,795
Penalty imposed for any related series of violations of requirements relating to electronic products. 2016 2017 952,838
Penalty per day for violation of order of recall of biological product presenting imminent or substantial hazard. 42 U.S.C. 262(d) 2016 2017 219,156
Penalty for failure to obtain a mammography certificate as required. 42 U.S.C.263b(h)(3) 2016 2017 17,047
Penalty per occurrence for any vaccine manufacturer that intentionally destroys, alters, falsifies, or conceals any record or report required. 42 U.S.C. 300aa-28(b)(1) 2016 2017 219,156

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Centers for Medicare & Medicaid Services

Penalty Statutory Authority Date of Previous Adjustment Date of Current Adjustment Current Penalty Level ($ Amount)
Penalty for a clinical laboratory’s failure to meet participation and certification requirements and poses immediate jeopardy. 42 U.S.C. 263a(h)(2)(B) &  42 U.S.C. 1395w-2(b)(2)(A)(ii)   2017  
Minimum 2016 2017 $      6,134
Maximum 2016 2017 20,111
Penalty for a clinical laboratory’s failure to meet participation and certification requirements and the failure does not pose immediate jeopardy.   2017  
Minimum 2016 2017 101
Maximum 2016 2017 6,033
Failure to provide the Summary of Benefits and Coverage (SBC) 42 U.S.C. 300gg-15(f) 2016 2017 1,105
Penalty for violations of regulations related to the medical loss ratio reporting and rebating. 42 U.S.C. 300gg-18 2016 2017 111
Penalty for manufacturer or group purchasing organization failing to report information required under 42 USC 1320a-7h(a), relating to physician ownership or investment interests 42 U.S.C. 1320a-7h(b)(1)   2017  
Minimum 2016 2017 1,105
Maximum 2016 2017 11,052
Calendar Year Cap 2016 2017 165,786
Penalty for manufacturer or group purchasing organization knowingly failing to report information required under 42 USC 1320a-7h(a) , relating to physician ownership or investment interests 42 U.S.C. 1320a-7h(b)(2)   2017  
Minimum 2016 2017 11,052
Maximum 2016 2017 110,524
Calendar Year Cap 2016 2017 1,105,241
Penalty for an administrator of a facility that fails to comply with notice requirements for the closure of a facility. 42 U.S.C. 1320a-7j(h)(3)(A) 2016 2017 110,524
Minimum penalty for the first offense of an administrator who fails to provide notice of facility closure. 2016 2017 553
Minimum penalty for the second offense of an administrator who fails to provide notice of facility closure. 2016 2017 1,658
Minimum penalty for the third and subsequent offenses of an administrator who fails to provide notice of facility closure. 2016 2017 3,315
Penalty for an entity knowingly making a false statement or representation of material fact in the determination of the amount of benefits or payments related to old-age, survivors, and disability insurance benefits, special benefits for certain World War II veterans, or supplemental security income for the aged, blind, and disabled. 42 U.S.C. 1320a-8(a)(1) 2016 2017 8,084
Penalty for the violation of 42 USC 1320a-8a(1) if the violator is a person who receives a fee or other income for services performed in connection with determination of the benefit amount or the person is a physician or other health care provider who submits evidence in connection with such a determination. 2016 2017 7,623
Penalty for a representative payee (under 42 USC 405(j), 1007, or 1383(a)(2)) converting any part of a received payment from the benefit programs described in the previous civil monetary penalty to a use other than for the benefit of the beneficiary. 42 U.S.C. 1320a-8(a)(3) 2016 2017 6,331
Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility. 42 U.S.C. 1320b-25(c)(1)(A) 2016 2017 221,048
Penalty for failure of covered individuals to report to the Secretary and 1 or more law enforcement officials any reasonable suspicion of a crime against a resident, or individual receiving care, from a long-term care facility if such failure exacerbates the harm to the victim of the crime or results in the harm to another individual. 42 U.S.C. 1320b-25(c)(2)(A) 2016 2017 331,572
Penalty for a long-term care facility that retaliates against any employee because of lawful acts done by the employee, or files a complaint or report with the State professional disciplinary agency against an employee or nurse for lawful acts done by the employee or nurse. 42 U.S.C. 1320b-25(d)(2) 2016 2017 221,048
Penalty for any person who knowingly and willfully fails to furnish a beneficiary with an itemized statement of items or services within 30 days of the beneficiary’s request. 42 U.S.C. 1395b-7(b)(2)(B) 2016 2017 149
Penalty per day for a Skilled Nursing Facility that has a Category 2 violation of certification requirements. 42 U.S.C. 1395i-3(h)(2)(B)(ii)(I)   2017  
Minimum 2016 2017 105
Maximum 2016 2017 6,289
Penalty per instance of Category 2 noncompliance by a Skilled Nursing Facility. 42 U.S.C. 1395i-3(h)(2)(B)(ii)(I)   2017  
Minimum 2016 2017 2,097
Maximum 2016 2017 20,965
Penalty per day for a Skilled Nursing Facility that has a Category 3 violation of certification requirements.   2017  
Minimum 2016 2017 6,394
Maximum 2016 2017 20,965
Penalty per instance of Category 3 noncompliance by a Skilled Nursing Facility.   2017  
Minimum 2016 2017 2,097
Maximum 2016 2017 20,965
Penalty per day and per instance for a Skilled Nursing Facility that has Category 3 noncompliance with Immediate Jeopardy   2017  
Per Day (Minimum) 2016 2017 6,394
Per Day (Maximum) 2016 2017 20,965
Per Instance (Minimum) 2016 2017 2,097
Per Instance (Maximum) 2016 2017 20,965
Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements.  These amounts represent the upper range per day.   2017  
Minimum 2016 2017 6,394
Maximum 2016 2017 20,965
Penalty per day of a Skilled Nursing Facility that fails to meet certification requirements.  These amounts represent the lower range per day.   2017  
Minimum 2016 2017 105
Maximum 2016 2017 6,289
Penalty per instance of a Skilled Nursing Facility that fails to meet certification requirements.   2017  
Minimum 2016 2017 2,097
Maximum 2016 2017 20,965
Penalty for knowingly, willfully, and repeatedly billing for a clinical diagnostic laboratory test other than on an assignment-related basis.  (Penalties are assessed in the same manner as 42 USC 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395l(h)(5)(D) 2016 2017 15,270
Penalty for knowingly and willfully presenting or causing to be presented a bill or request for payment for an intraocular lens inserted during or after cataract surgery for which the Medicare payment rate includes the cost of acquiring the class of lens involved. 42 U.S.C. 1395l(i)(6) 2016 2017 4,022
Penalty for knowingly and willfully failing to provide information about a referring physician when seeking payment on an unassigned basis. 42 U.S.C. 1395l(q)(2)(B)(i) 2016 2017 3,849
Penalty for any durable medical equipment supplier that knowingly and willfully charges for a covered service that is furnished on a rental basis after the rental payments may no longer be made.  (Penalties are assessed in the same manner as 42 USC 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395m(a)(11)(A) 2016 2017 15,270
Penalty for any nonparticipating durable medical equipment supplier that knowingly and willfully fails to make a refund to Medicare beneficiaries for a covered service for which payment is precluded due to an unsolicited telephone contact from the supplier.  (Penalties are assessed in the same manner as 42 USC 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395m(a)(18)(B) 2016 2017 15,270
Penalty for any nonparticipating physician or supplier that knowingly and willfully charges a Medicare beneficiary more than the limiting charge for radiologist services.  (Penalties are assessed in the same manner as 42 USC 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395m(b)(5)(C) 2016 2017 15,270
Penalty for any supplier of prosthetic devices, orthotics, and prosthetics that knowing and willfully charges for a covered prosthetic device, orthotic, or prosthetic that is furnished on a rental basis after the rental payment may no longer be made.  (Penalties are assessed in the same manner as 42 USC 1395m(a)(11)(A), that is in the same manner as 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395m(h)(3) 2016 2017 15,270
Penalty for any supplier of durable medical equipment including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully distributes a certificate of medical necessity in violation of Section 1834(j)(2)(A)(i) of the Act or fails to provide the information required under Section 1834(j)(2)(A)(ii) of the Act. 42 U.S.C. 1395m(j)(2)(A)(iii) 2016 2017 1,617
Penalty for any supplier of durable medical equipment,  including a supplier of prosthetic devices, prosthetics, orthotics, or supplies that knowingly and willfully fails to make refunds in a timely manner to Medicare beneficiaries for series billed other than on as assignment-related basis under certain conditions.  (Penalties are assessed in the same manner as 42 USC 1395m(j)(4) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395m(j)(4) 2016 2017 15,270
Penalty for any person or entity who knowingly and willfully bills or collects for any outpatient therapy services or comprehensive outpatient rehabilitation services on other than an assignment-related basis.  (Penalties are assessed in the same manner as 42 USC 1395m(k)(6) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395m(k)(6) 2016 2017 15,270
Penalty for any supplier of ambulance services who knowingly and willfully fills or collects for any services on other than an assignment-related basis.  (Penalties are assessed in the same manner as 42 USC 1395u(b)(18)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395m(l)(6) 2016 2017 15,270
Penalty for any practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services by the practitioners on other than an assignment-related basis.  (Penalties are assessed in the same manner as 42 USC 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395u(b)(18)(B) 2016 2017 15,270
Penalty for any physician who charges more than 125% for a non-participating referral.  (Penalties are assessed in the same manner as 42 USC 1320a-7a(a)). 42 U.S.C. 1395u(j)(2)(B) 2016 2017 15,270
Penalty for any physician who knowingly and willfully presents or causes to be presented a claim for bill for an assistant at a cataract surgery performed on or after March 1, 1987, for which payment may not be made because of section 1862(a)(15).  (Penalties are assessed in the same manner as 42 USC 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395u(k) 2016 2017 15,270
Penalty for any nonparticipating physician who does not accept payment on an assignment-related basis and who knowingly and willfully fails to refund on a timely basis any amounts collected for services that are not reasonable or medically necessary or are of poor quality under 1842(l)(1)(A).  (Penalties are assessed in the same manner as 42 USC 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395u(l)(3) 2016 2017 15,270
Penalty for any nonparticipating physician charging more than $500 who does not accept payment for an elective surgical procedure on an assignment related basis and who knowingly and willfully fails to disclose the required information regarding charges and coinsurance amounts and fails to refund on a timely basis any amount collected for the procedure in excess of the charges recognized and approved by the Medicare program.  (Penalties are assessed in the same manner as 42 USC 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395u(m)(3) 2016 2017 15,270
Penalty for any physician who knowingly, willfully, and repeatedly bills one or more beneficiaries for purchased diagnostic tests any amount other than the payment amount specified by the Act.  (Penalties are assessed in the same manner as 42 USC 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395u(n)(3) 2016 2017 15,270
Penalty for any practitioner specified in Section 1842(b)(18)(C) of the Act or other person that knowingly and willfully bills or collects for any services pertaining to drugs or biologics by the practitioners on other than an assignment-related basis.  (Penalties are assessed in the same manner as 42 USC 1395u(b)(18)(B) and 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395u(o)(3)(B) 2016 2017 15,270
Penalty for any physician or practitioner who knowingly and willfully fails promptly to provide the appropriate diagnosis codes upon CMS or Medicare administrative contractor request for payment or bill not submitted on an assignment-related basis. 42 U.S.C. 1395u(p)(3)(A) 2016 2017 4,022
Penalty for a pharmaceutical manufacturer’s misrepresentation of average sales price of a drug, or biologic. 42 U.S.C. 1395w-3a(d)(4)(A) 2016 2017 13,066
Penalty for any nonparticipating physician, supplier, or other person that furnishes physician services not on an assignment-related basis who either knowingly and willfully bills or collects in excess of the statutorily-defined limiting charge or fails to make a timely refund or adjustment.  (Penalties are assessed in the same manner as 42 USC 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395w-4(g)(1)(B) 2016 2017 15,270
Penalty for any person that knowingly and willfully bills for statutorily defined State-plan approved physicians’ services on any other basis than an assignment-related basis for a Medicare/Medicaid dual eligible beneficiary.  (Penalties are assessed in the same manner as 42 USC 1395u(j)(2)(B), which is assessed according to 1320a-7a(a)). 42 U.S.C. 1395w-4(g)(3)(B) 2016 2017 15,270
Penalty for each termination determination the Secretary makes that is the result of actions by a Medicare Advantage organization or Part D sponsor that has adversely affected an individual covered under the organization’s contract. 42 U.S.C. 1395w-27(g)(3)(A); 42 U.S.C. 1857(g)(3) 2016 2017 37,396
Penalty for each week beginning after the initiation of civil money penalty procedures by the Secretary because a Medicare Advantage organization or Part D sponsor has failed to carry out a contract, or has carried out a contract inconsistently with regulations. 42 U.S.C. 1395w-27(g)(3)(B);42 U.S.C. 1857(g)(3) 2016 2017 14,959
Penalty for a Medicare Advantage organization’s or Part D sponsor's early termination of its contract. 42 U.S.C. 1395w-27(g)(3)(D); 42 U.S.C. 1857(g)(3) 2016 2017 138,925
Penalty for an employer or other entity to offer any financial or other incentive for an individual entitled to benefits not to enroll under a group health plan or large group health plan which would be a primary plan. 42 U.S.C. 1395y(b)(3)(C) 2016 2017 9,054
Penalty for any non-governmental employer that, before October 1, 1998, willfully or repeatedly failed to provide timely and accurate information requested relating to an employee’s group health insurance coverage. 42 U.S.C. 1395y(b)(5)(C)(ii) 2016 2017 1,474
Penalty for any entity that knowingly, willfully, and repeatedly fails to complete a claim form relating to the availability of other health benefits in accordance with statute or provides inaccurate information relating to such on the claim form. 42 U.S.C. 1395y(b)(6)(B) 2016 2017 3,234
Penalty for any entity serving as insurer, third party administrator, or fiduciary for a group health plan that fails to provide information that identifies situations where the group health plan is or was a primary plan to Medicare to the HHS Secretary. 42 U.S.C. 1395y(b)(7)(B)(i) 2016 2017 1,157
Penalty for any non-group health plan that fails to identify claimants who are Medicare beneficiaries and provide information to the HHS Secretary to coordinate benefits and pursue any applicable recovery claim. 42 U.S.C. 1395y(b)(8)(E) 2016 2017 1,157

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