1. PHYSICIAN PRACTICE COMPLIANCE PROGRAMS
October 9, 2013
8:45 – 10:15 a.m.
Marcia Brauchler, MPH
CPC, CPC-H, CPC-I, CPHQ
Daryl Smith, FACMPE
All Rights Reserved.

2. What brought us here? Marcia Brauchler MPH, CPC-I, CPHQ
President, Physicians’ Ally, Inc.
The payer contract
Physician Practice must maintain compliance
HIPAA Training Assistance
Hundreds of practices are struggling with this still

3. Nobody wants to say it . . .

4. Daryl Smith, FACMPE What brought us here?
Surgical Division Administrator, Central Utah Clinic
Staff Training
Experience!

5. To Set the Stage…
Informal survey provided to small practices in the Denver area:

6. Does your practice have a Compliance Officer?

7. Does your Compliance Officer have a position description ?

8. My practice has written policies and procedures.

9. Everyone in the practice knows where the written compliance policies and procedures are located.

10. To the best of my knowledge, “compliance” was last addressed in my practice in this year:

11. $1,215 37.5% of respondents said “0” or “no budget.”
For my practice, “compliance” efforts should be allotted an annual budget of:
37.5% of respondents said “0” or “no budget.”
For the practices that gave a dollar amount, the annual average was:
$1,215

12. Disclaimer:
This is not legal advice and represents only recommendations and observations in general compliance issues.
We recommend you use this information to better examine your practices and to open a dialogue with your legal counsel.

13. Objectives: 1: Describe the importance of a compliance program
2: Explain the basics of creating and maintaining a compliance program
3: Review specific elements of a physician practice compliance plan

14. Objective:
Describe the importance of a compliance program

15. What is Compliance? Practical definition:
We should all follow the rules & regulations
But how? 15

16. What is Compliance? … to conform, submit or adapt (as to a regulation)
Compliance happens in every organization, as employers strive to comply with employment and labor law guidelines for safe workplaces and a responsible organization, including:
… to conform, submit or adapt (as to a regulation)

17. What is Health Care Compliance?
Health care industry has to comply with the federal government’s expectations for participating in and receiving payment from its Medicaid and Medicare health insurance programs

18. About the Office of Inspector General (OIG)
Daniel R. Levinson
As mandated by Inspector General Act (Public Law ), the mission of the OIG is to protect the integrity of Department of Health and Human Services (HHS) programs and the health and welfare of program beneficiaries
OIG also plans, conducts and participates in a variety of interagency cooperative projects and undertakings relating to fraud and abuse with the Department of Justice (DOJ), the Centers for Medicare & Medicaid Services (CMS) and other governmental agencies 18

19. Why YOU should care about Compliance?
Tangible benefits
Abide by applicable laws and regulations
Reduce exposure to civil damages, criminal sanctions, and administrative remedies, such as program exclusion
Demonstrate commitment to good corporate conduct
May reduce or mitigate risks to your practice

20. Why care about Compliance?
Tangible benefits of complying
Identify & prevent criminal and unethical conduct
Procedures for prompt, thorough investigations of alleged misconduct
Initiate immediate and appropriate corrective action 20

21. Why care about Compliance?
Tangible benefits of complying
Centralized source of information on health care regulations
Methodology encouraging employees to report problems
Improve quality of patient care 21

22. Why care about Compliance?
Intangible benefits of complying
Good investment in your practice
Peace of mind that rules are being followed 22

23. Why care about Compliance?
Intangible benefits of complying
Decrease the risk of whistleblowers
Clear and consistent message to employees
An improved practice culture! 23

24. A Basic Compliance Program
Good business for any workplace
Should include prevention and detection of criminal conduct and
Enforcement of the rules 24

25. This all started with… HIPAA of 1996*
Doubled Office of Inspector (OIG) auditors and investigators
Expanded Federal Bureau of Investigation’s (FBI) ability to investigate health care fraud
Created Medicare Integrity Program (MIP)
Federal government may enter into contracts with private entities to review and audit activities where Medicare provides coverage
Established reward program to encourage Medicare beneficiaries to report questionable behavior
* HIPAA = Health Insurance Portability and Accountability Act

26. OIG Model Compliance Plan(s)
“Voluntary” Guidance(s) for creating a Compliance Programs for:
Individual and small group physician practices p
Third party medical billing companies
Hospitals
Nursing homes
Etc.

27. I am aware of the OIG Individual and Small Group Voluntary Compliance Plan from 2000.

28. “Mandatory” Compliance Programs Coming “Soon”…
2 PPACA provisions mandate compliance programs for Medicare and Medicaid providers
§ 6401 applies to ALL Medicare and Medicaid providers
§ 6402 applies to Medicare skilled nursing facilities & Medicaid nursing facilities ONLY
Patient Protection and Affordable Care Act (PPACA) 28

29. I am aware that the Patient Protection and Affordable Care Act will require all Medicare and Medicaid providers to have mandatory compliance plans in the future.

30. CMS Comment to Providers:
Implementing a Compliance program is “not just a paper exercise”
Must be able to demonstrate that they have a “systemic process for proactively and promptly fixing noncompliance issues”
Must be effective

31. Objective:
Explain the basics of creating and maintaining a compliance program

32. Start with a Snapshot
OIG suggests at inception of a Compliance Program, a review “snapshot” of operations be done to judge later progress in reducing or eliminating potential areas of vulnerability

33. Baseline Audit “How To”
OIG Work Plan issues
Any previous audit findings
Existing policies
Are they appropriate? Followed? Missing?
Analysis of current education & training
Attestation & attendance forms?
Government regulations
Updates?
Professional association insights into current issues/trends
Professional liability carrier newsletter of potential risk areas
Interview staff
Write-up & let them review
Minutes of Board or Compliance Committee

34. Does your practice have a Code of Conduct?

35. What a Code of Conduct Does
Creates communication channels
Sets up ethical guidelines for how you go about your day-to-day activities
Helps to create an enjoyable work environment

36. HANDOUT: SAMPLE CODE OF CONDUCT

37. The 7 Elements
The OIG believes any Compliance Plan has 7 basic elements…
Written Policies and Procedures
Designating a compliance officer or contact
Conduct appropriate training and education
Effective lines of communication
Internal Monitoring
Enforcement of Standards
Prompt Response
And an informal 8th…
8. Ensure it is effective – Periodically reassess

38. Compliance Plan - Element #1
Written Policies & Procedures
Up-to-date
User friendly
Reflect what is actually going on in the practice!
Employee Handbook

39. Compliance Plan - Element #2
Designate a compliance officer or contact
Give them reporting authority to go ‘to the top’ when necessary

40. Compliance Plan - Element #3
Conduct appropriate training and education
Make training part of the job
Test employee knowledge
Ensure compliance officer job education and training too!

41. Compliance Plan - Element #4
Effective lines of communication
Solicit feedback
Maintain visibility with staff members

42. Compliance Plan - Element #5
Internal Monitoring
Create an audit plan to audit:
Coding
Contracts
Care

43. Compliance Plan - Element #6
Enforcement of Standards
Enforce disciplinary standards through well-publicized guidelines (i.e. your Sanctions Policy!)
Act promptly when issue arise
Take corrective action
Document it all!

44. Compliance Plan - Element #7
Respond promptly to identified risks or compliance issues
Conduct an investigation
Create a Corrective Action Plan
Train staff (if necessary)
Tell the government (if determined necessary)
Modify your program (if necessary)

45. Make it “effective” (#8)
Once the Plan is established, develop a process to evaluate it and measure its effectiveness

46. Evaluating Effectiveness Ideas
Possible Metrics of an effective Compliance Program:
Staff knowledge
Pre & post tests
Quizzes
Skits/role play
Educational sessions
# hrs. logged on compliance
# policies & procedures reviewed
# charts audited

47. Evaluating Effectiveness Ideas
Possible Metrics of an effective Compliance Program:
% of denials in claims
# mtgs with compliance on agenda (Staff, RN, BoD, Compliance Cmte, finance, billing)
# of CPCs on staff/MDs
# of CHCs on staff/MDs
# of networking contacts for compliance related questions/issues in contacts database

48. Objective:
Review specific elements of a physician practice compliance plan

49. “I didn’t know”
Is no longer an excuse . . .

50. OIG – Billing risk areas for small practice (and 3rd party billing)
Examples of necessary general coding & billing policies:
Unbundling
Upcoding the level of service provided
Inappropriate balance billing
Etc.

51. OIG – 2013 Work Plan Issues: Noncompliance with assignment rules . . .
Incident To services by non-physicians
Place of Service coding errors
Modifiers during global surgery period, etc.

52. COMPLIANCE HEAT MAP RISK ASSESSMENT Stark Anti-Kickback HIPAA ADA FCA5
Stark
Anti-Kickback
HIPAA
ADA 4
FCA
Medical Records
RISK 3
DEA
OSHA HR
Overpayment 2
Anti-Trust 1 1 2 3 4 5
PROBABILITY

53. A NOTE ABOUT SLIDE FORMAT
1st Bullet = What is the regulation?
2nd Bullet = Why should your practice care?
3rd Bullet = Where do you get help to comply?

54. HIPAA
What? HIPAA is the Federal Standards for Privacy of Individually Identifiable Health Information and/or the Security Standards for the Protection of Electronic Protected Health Information (45 Code of Federal Regulations [CFR] Parts and 164.
Why?
Enforcement is increased due to ARRA. Maximum fine increased to $1.5 million per incident.
Where?

55. Medical Records - Documentation
What?
The way to defend yourself
Why?
Proving compliance with laws
Where?

56. Correct Coding What? Why? Where?
Medicare National Correct Coding Initiative (NCCI) edits apply now under ACA [Section 1902(a)(42)(B)(i) to Medicaid agencies
Why?
Recovery Audit Contractor (RAC) Program
Allows government to contract with 3rd parties to audit billing and coding practices
October 1, 2014—Transition from ICD-9 codes (13,000) to ICD-10 codes (65,000)
Where?

57. False Claims Act www.OIG.hhs.gov
What? Prohibits the submission of false or fraudulent claims to the federal government 31 U.S.C. §§
Why?
Federal government’s #1 tool for fighting fraud and abuse. The OIG has returned over $30 billion to the federal government.
Expected recoveries from 2012 alone = $6.9 billion
Penalty is $5k-$10k & 3x damages to the federal program
Where?

58. Overpayment Refunds What? Section 6402(a) of PPACA
Requires providers to report and return an overpayment to the appropriate Medicaid state agency or Medicare contractor within 60 days of identification
Why?
False Claims Act liability
Where?
(Proposed Rule)

59. HR: Non-Discrimination
What?
Civil Rights Act of 1964 (Title VII)
U.S. Equal Employment Opportunity Commission (EEOC) promotes equal opportunity in employment
Required to investigate all employment discrimination charges
Why?
EEOC may file claims in federal court
Substantial civil damages
Loss of reputation
Where?

60. HR: Sexual Harassment What? Why? Where?
Sexual harassment is a form of sex discrimination that violates Title VII of the Civil Rights Act of 1964
Why?
Penalties (via litigation)
Lost wages
Compensatory damages
Punitive damages
Where?
Title VII of the Civil Rights Act of 1964 :
Guidelines:

61. HR: Family Medical Leave Act (FMLA)
What? Family Medical Leave Act of 1993
Applies to employers with 50 or more employees
Provides entitlement of up to 12 weeks of job-protected leave during any 12-month period for birth of a child, care of an immediate family member, employee’s own serious health condition, or an immediate family member is on active military duty.
Why?
Enforced by the Department of Labor, Wage and Hour Division
Court actions to compel compliance
Civil actions filed by employees
Where?
FMLA:
DOL Poster:

62. HR: Fair Labor Standards Act (FLSA)
What?
Fair Labor Standards Act of 1938, as amended 29 U.S.C. 201
Basic minimum wage and overtime pay
Why?
Enforced by Department of Labor, Wage and Hour Division
Civil suits for back wages, liquidated damages, and expenses
Civil money penalties (up to $100,000 each violation for some child labor violations)
Criminal penalties including fines and imprisonment
Protection of employees filing complaints
Where?

63. HR: Americans with Disabilities Act (ADA)
What?
ADA Employment (Title I) [42 U.S.C. § ]
Employers with 15 or more employees must provide qualified individuals with disabilities an equal opportunity to the full range of employment-related opportunities available to others.
Prohibits discrimination in recruitment, hiring, promotions, training, pay, social activities and other employment privileges.
Why?
Enforcement through Department of Justice
Where?
Current text of ADA Law -
Guide to Disability Rights Laws -
ADA Q&A -

64. OSHA Medical Practice What? Occupational Safety and Health Act of 1970
Safe and healthful workplace
Primary OSHA standards affecting physician practices:
Bloodborne Pathogens
Hazardous Chemicals
Exit routes
Electrical
Reporting occupational injuries and illness (state-law)
OSHA Poster
Ionizing Radiation (only if you have it)
Why?
Enforced by OSHA
Penalties of up to $63,000 per instance for willful violations
Where?

65. Anti-Kickback Statute
What?
Anti-Kickback Statute [42 U.S.C. § 1320a-7b(b)]
Prohibits knowing & willful payment of remuneration to induce or reward patient referrals
Don’t confuse with STARK rules
Why?
Enforced by the Office of the Inspector General (OIG)
Civil penalties: <$50,000 per and administrative sanctions (i.e. exclusion)
Criminal penalties—fines up to $25K each occurrence/prison sentence up to 5 years
Where?

66. STARK
What?
Physician Self-Referral Law [42 U.S.C. § 1395nn]
Prohibits physicians from referring patients to a health facility in which the physician has a financial interest
OIG 3 Questions
Why?
Enforced by OIG. Penalties include:
Refunds, FCA liability, program exclusion
CMP up to $15K per service; $100K per arrangement
Civil assessments up to 3x the claim
Where?

67. Self-Disclosure Protocol
NEW!
What?
Section 6409(a) of PPACA
Why?
A tool for your Compliance Program
Where?

68. Americans with Disabilities Act (ADA)
What? ADA Employment (Title I) [42 U.S.C. § 12186(b)]
Public accommodations (Title III)
Prohibits discrimination, exclusion, segregation and unequal treatment
Architectural standards
Reasonable modifications to policies, practices, and procedures
Example: Service animals
Effective communication with people with hearing, vision, or speech disabilities
Example: Interpreters for hearing impaired
Why?
Enforcement through Department of Justice
Where?

69. DEA What? Title 21 CFR, Part 1300-1399
Drug Enforcement Administration (DEA)
Provider must apply for DEA certificate to handle controlled substances
Why?
DEA Audits. Loss of DEA Certificate prevents prescribing appropriate medications.
Where?

70. FDA
What?
Approved drugs are found in the Food & Drug Administration (FDA) Orange Book
Off-Label use
Physician must be well informed
Use “firm scientific rationale” and “medical evidence”
Maintain records of use and effects
Order only FDA-approved drugs
Why?
Can lead to a violation of the FCA, and a RAC audit.
Where?

71. Electronic Claims What?
Administrative Simplification Compliance Act (ASCA) requires electronic filing of Medicare claims
As of January 2014, all Medicare claims must be filed electronically
Each provider must complete an Electronic Data Interchange (EDI) enrollment form
Why? Medicare will only pay on claims submitted electronically on claims after 1/1/2014.
Where?

72. Use of Non-Physician Providers
What? Medicare billing options:
NPPs own provider #
NPP can use physician provider # in certain circumstances (“incident to”)
Inpatient = Shared visit
Why?
False Claims Act liability. Higher reimbursement rate.
In 2012 and 2013 OIG Work Plans.
Where?

73. Medicare Incentive Programs
What?
Programs such as Meaningful Use, PQRS, eRx, ACOs, and others that offer additional bonus payments and/or penalties for meeting specific criteria. Must be able to document that criteria are actually met.
Why?
Receive incentives
Avoid penalties
Avoid implication of False Claims or Fraud/Abuse
Where?
Meaningful Use -
PQRS and others -

74. Patient Check-In What? Why? Where? Collecting Co-pays and Deductibles;
Advance Beneficiary Notice (ABN)
Financial Hardships; Professional Courtesies
Why?
False Claims Act & Anti-Kickback Statute. Penalties include jail time.
Where?
Not collecting co-pays, deductibles on a regular basis could constitute fraud.
Professional Courtesy:
Advanced Beneficiary Notice:

75. Antitrust Laws What? Why? Where?
Sherman Act (1890) outlaws or restricts business practices that are monopolistic or restrain interstate commerce
Clayton Act (1914) prohibits pricing discrimination among customers and prohibits business combinations the effect of which “substantially lessens competition”
Why?
Enforced Federal Trade Commission (FTC) and Department of Justice (DOJ)
Injunction, civil penalties, or consumer redress
Where?

76. Sunshine Act What? Why? Where? NEW!
Physician Payment Sunshine Act Final Rule - ACA Section 1128G
Anything over $10 or $100/yr per manufacturer or Group Purchasing Organization (GPO) must be reported by them.
Why?
Possible reputation and whistleblower risk to physicians and practices
No legal ramifications for providers yet
Where?

77. Dismissing a Patient What? Why? Where?
State law and risk management area.
Legal and ethical compliance issues.
Why?
You must be careful when terminating patient relationships so that you do not discriminate or terminate in such a way as to violate your legal and ethical obligations to the patient.
Where?
Check with state medical board to ensure compliance with state-specific rules
Malpractice carrier.

78. Informed Consents What? Basic principle of law and ethics
Center for Medicare & Medicaid Services (CMS) Conditions of Participation
Why?
Discussion and disclosure (Malpractice risk)
Where?
State law
Malpractice carrier

79. Medicare Provider Exclusion Law
What?
Sections 1128 & 1156 of the Social Security Act
Office of Inspector General (OIG) maintains a list that identifies individuals found guilty of fraudulent billing, misrepresentation of credentials, etc.
Why?
Office of the Inspector General - can’t bill Medicare or Medicaid
Private insurers are running the lists of providers as well
Practice policy should be to not employ or contract with individuals on the list
Where?
for List of Excluded Individuals/Entities (LEIE)

80. In-Office Labs What? Why? Where?
Clinical Laboratory Improvements Amendments (CLIA) 42 CFR Part 493
Certification required to receive federal funds for services
Why?
False Claims Act implication. (enforced by the OIG)
Criminal penalties and Civil Monetary Penalties. Program exclusion.
Where?

81. On-Call/Emergency Treatment
What?
Emergency Medical Treatment and Labor Act (EMTALA) 42 USC Sec. 1395dd
Impacts hospitals w/ ED (mostly) and on-call physicians
On-call lists must be current and signed
Physician must arrive within a reasonable amount of time (30-60 min)
Why?
Average of 400 investigations/year
CMP up to $50k per penalty
Termination from CMS (exclusion)
Where?

82. Collections for Bad Debt
What?
Fair and Accurate Credit Transactions Act (FACTA)
Fair Debt Collection Act (FDCR)
Collections of bad debt pose unique problems for health care providers and entities
Why?
Enforced by the Federal Trade Commission (FTC)
Where?

83. Objectives: 1: Describe the importance of a Compliance program
2: Explain the basics of creating and maintaining a compliance program
3: Review specific elements of a physician practice compliance plan

84. Questions? Daryl Smith Marcia Brauchler Central Utah Clinic
Marcia Brauchler
Physicians’ Ally, Inc.