1. Contract Requirements of CMS and TJC 2011 What hospitals need to know.

2. Speaker Sue Dill Calloway RN, Esq. CPHRM AD, BA, BSN, MSN, JD
President
5447 Fawnbrook Lane
Dublin, Ohio 43017

3. Joint Commission Contract Standard
The Joint Commission (TJC) has a contract standard
It is located in the leadership standard which was rewritten in 2009 and continues in 2011
Hospitals leadership must monitor patient care that is provided by contracted services
Standard LD and has10 elements of performance (EPs) and a rationale
Hospitals enter into a number of contracts from provider groups, diagnostic centers, vendors, employment agencies and other business partners

4. Contracts Hospitals need to have a system for management of contracts
It is necessary to manage contracts to save time and money, guard against liability exposure and reduce the likelihood of conflict and litigation
Does your hospital have a centralized contract development and review process?
Hospitals must also keep CMS and Joint Commission contract standards in mind in drafting contracts

6. LD Standard organized into 4 sections
There are 4 key sections which support effective performance
Leadership Structure
Leadership Relations
Hospital culture and system performance expectations
Operations
contract standard is located here, need to meet the patient needs

7. Operations IV of IV

8. Introduction Contracts
The same level of care must be provided to patients whether you provide the service directly or through contract services
The hospital leaders must over see the contracted services to make sure they are provided safety and efficiently
This standard outlines the requirements of leadership to manage and provide oversight of contracted services
There has been an increased focus on contracts during the survey by both CMS and TJC

9. Contracted Services
This standard apply to contracted agreement for providing care, treatment, and services to patients
Hospital hires pharmacy company to run the pharmacy and director of pharmacy is employee of contracted company
Hospital hires part time physical therapist who specialized in pediatrics and hand injures as contracted employee

10. Contracted Services Introduction
This standard does not apply to contracted services not directly related to patient care
Hospital signs contract with company to provide linen service or snow removal
Hospital contracts with company to put a new roof on the hospital
Contracts for consultation or referral are not subject to these requirements

11. Contracted Services or Agreements
However, regardless of whether or not a contract is subject to this standard, the actual performance of the standard is evaluated at other standards in the manual
Performance of the contract should reflect
Basic principles of risk reduction
Safety
Staff competence and
Performance improvement

12. Methods to Evaluate Contracted Services
The standard and EPs do not prescribe the methods for evaluating contracts
TJC allows the hospital leaders to select the best method to evaluate that quality and safety is provided through the contract
Hospitals may want to consider a number of sources of information that could be used to evaluate contracts

13. Contract Review Ideas Direct observe care provided Audit documentation
Audit the medical records
Review incident reports
Obtain input from staff and patients
Review of patient satisfaction surveys (patient experience)
Review the results of risk management activities

14. Contract Review Ideas
Review information to see if contractor is also accredited by TJC
See if certified or certification status
Has contracted employee been involved in any sentinel events
Review performance improvement data
Review indicators required in the contract
Review of periodic reports submitted by the individual

15. Credentialing and Privileging
In most cases, each LIP that provided services through a contract must be credentialed and privileged
This should be done by the hospital using their services
There are three exceptions to this rule
First, off-site services provided by a Joint Commission accredited contractor

16. Credentialing and Privileging (C&P)
Direct care through a telemedical link:
Standard MS describes several options for C&P LIPs who are responsible for the care, treatment, and services of the patient through a telemedical link
Interpretive services through a telemedical link:
EP 9 in this standard describes the circumstances under which a hospital can accept the C&P decisions of a TJC ambulatory care hospital for licensed independent practitioners providing interpretive services through a telemedical link (see CMS telemedicine standards discussed later)

17. Operations LD.04.03.09 Contract Definition
Definition of contractual agreement: An agreement with any organization, group, agency, or individual for services or personnel to be provided by, to, or on behalf of the organization.
Such agreements are defined in a contract or in some other form of written agreement;
Such as a letter of agreement, memorandum of understanding, contract, contracted services, contractual services, or written agreement.

18. Operations Contracts LD.04.03.09
LD Standard: Care and treatment provided through contractual agreement are provided safely and effectively,
EP1. Clinical leaders and MS have an opportunity to provide advice about the sources of clinical services that are to be provided through contracts,

19. Operations Contracts LD.04.03.09
July 15, 2010 TJC manual was to be changed related to tele-intepretive reading and hospitals using TJC for deemed status-use of contract in lieu of credentialing and privileging is not acceptable (CMS requires full C&P at this time and different from TJC Standard)
TJC also issues MS on telemedicine
Next CMS proposed in May 26, 2010 Federal Register to revised CoP for CAH and PPS hospitals
After CMS proposes changes TJC delayed these changes until July 2011

21. CMS Proposes Changes
Stay tuned because CMS is now proposing less burdensome telemedicine credentialing rules
Would allow hospitals to rely on information provided from another location to base C&P decisions regarding physicians and practitioners who use telemedicine at their facility
CMS realizes that credentialing process is difficult for small hospitals that lack resources to conduct traditional credentialing for physicians that provide telemedicine services
Would need to amend MS by-laws

22. CMS Proposes Changes
The new rule would still allow hospitals to use a third party credentialing verification organization to compile and verify the credentials of practitioners applying for privileges
The hospital's governing body would still responsible for making all privileging decisions
Physician would still need to hold a license in the state where the hospital receiving the telemedicine service is located
Comment period ended July 26, 2010
Source: Federal Register May 26,

23. CMS Telemedicine Privileges Rules
Hospital A has large group of radiologist who want to provide teleradiology services to Hospital B, a small community hospital
Hospital A must and does participate in Medicare (can’t rely on information from non-hospital entities)
The practitioners has privileges at Hospital A and they give Hospital B a list of the practitioners privileges from Hospital A
Each practitioner must hold a state license in the state of the originating site (Hospital A) and licensed by or recognized by the state whose patients are receiving the service

24. CMS Telemedicine Privileges Rules
Hospital A reviews the practitioners performance and sends Hospital B the results to be used in the periodic performance review of the practitioners/radiologists
This information must include any adverse events that result from the telemedicine services
Hospital A is required to evaluate the quality and appropriateness of the diagnosis and treatment furnished by its own staff to a CAH hospital
Board is to ensure there is this agreement and that the agreement says distant hospital (A) is meeting these requirements

25. CMS Telemedicine Privileges Rules
Hospital A and B need an agreement between them and this must state that Hospital A (the distant hospital) has to conduct credentialing of telemedicine in accordance with CoPs
No distinction made between teleradiology and teleinterpretive service
Board (Hospital B) will grant privileges according to the MS recommendations which can rely on the information from Hospital A now (now an option or can continue traditional method)
CMS has regulations in both Board and MS sections

26. Contract Approval and Monitoring
EP2. The nature and scope of services provided through contracts are described in writing
EP3. Contracts are approved by designated leaders
EP4. Leaders monitor contracts by establishing expectations for the performance of the contracted services

27. Contracts with another organization
When the hospital contracts with another accredited organization for patient care,
To be provided off-site,
The hospital can verify that all LIPs who will be providing patient care and treatment, have appropriate privileges
By obtaining, for example, a copy of the list of privileges,
Specify in the contract that the contracted organization will ensure that all contracted services provided by LIP will be within the scope of their privileges,

28. Contract Expectations
EP5. Leaders monitor contracted services by communicating the expectations in writing to the provider of the contracted services
The expectation can be set forth in the contract
The facility can include a written description of the expectations as an addition
If use as an addition to the contract include language that it is incorporated by reference into the contract

29. Monitoring the Contract Expectations
EP6. Leaders monitor contracted services by evaluating the contracted services in relation to the expectations
Expectations for pharmacy services company that all policies and procedures will reflect the CMS CoP pharmacy requirements and the TJC MM standard requirements
Expectation that pharmacy director (a contracted employee) will manage pharmacy and medication management committee
Pharmacy company will carry agreed upon limits, licensed, privacy and confidentiality, follow all state and federal laws, attend meetings, etc.

30. Improving the Contracted Services
EP7. The leaders take steps to improve contracted services that do not meet expectations
Increased monitoring
Consultation or training to contractor
Terminate contract
Or apply defined penalties

31. Renegotiating or Terminating a Contract
EP8. When contracts are renegotiated or terminated, the continuity of patient care is maintained
Hospital terminates contracts of anesthesiologist
Need to ensure that new group coming in starts at the time the old contract is terminated so patients have access to needed anesthesia services

32. Operations LD Contracts
EP9. When using the services of LIP from a TJC accredited ambulatory care organization through a telemedical link for interpretive services,
The hospital accepts the C&P decisions of a TJC accredited ambulatory provider only after confirming that those decisions are made using the process described in the MS section
MS through MS , excluding MS , EP 2. (See also MS , EP 1)

33. Contract Lab Services
EP10. Reference and contract lab services meet the applicable federal regulations for clinical laboratories and maintain evidence of the same
CLIA or the Clinical Laboratory Improvement Act
42 CFR 493
Hospital contracts out all toxicology screens out of the ED for patients who over dosed

34. Examples of Compliance
Have a contract review policy,
Determine who has authority to sign contracts,
File contracts in one central location,
Have a contract management log,
Ensure that a list of all the contracts that affect patient care go the Med Executive Team,
Make sure you have a CLIA license,
Evaluate person providing contracted services in writing,

35. Examples of Compliance
Monitor patient satisfaction surveys for problems with contracted services (waited 6 weeks to get mammogram when patient had a suspicious lump),
Develop an evaluation tool to do this,
Contracts should include language about contractor expectations such as will comply with all TJC standards, federal and state and local regulations, etc.,
Consider having a contract committee,

36. Operations LD.04.02.02 Ethical PRs
LD.4.110: Ethical principles guide the hospital’s business practices.
EP1. The hospital establishes and uses mechanisms that allow staff, patients, and families to address ethical issues or issues prone to conflict.
EP2. The hospital follows ethical practices for marketing and billing.
EP3. Marketing materials accurately represent the hospital, and address the care and treatment that the hospital provides either directly or by contractual arrangement.

37. Operations LD.04.03.01 Needed Services
LD: The hospital provides services that meet patient population needs.
Leaders have to decide which services are essential to the population they serve,
Services can be provided directly or,
Can be provided through referral, consultation, contractual arrangements, or other agreements.

38. Operations Needed Services
EP1. The needs of the population served guide decisions about which services will be provided directly or through referral, consultation, contractual arrangements, or other agreements.
EP2. Essential services include at least the following: diagnostic radiology; dietetic, ED, nuclear medicine, nursing care; pathology and clinical laboratory; pharmaceutical; physical rehabilitation; respiratory care*; and social work.
* Not required for hospitals that provide only psychiatric and substance use services.

39. Examples of Compliance
Community health needs assessment can assist in determining what the needs of the population are (teen pregnancy program, outpatient Coumadin clinic, more OB beds, telemetry beds, inpatient behavioral health beds etc.),
Scope of Services document should reflect essential services that are required,
Include optional services that hospital has,
Hospital must decide if required services will be provided directly or under contract,

40. Contract TJC Has Asked About
How do you make a decision about where to purchase the drugs on your formulary?
How do you decide on what company to pick who makes the floor cleaner that is used in patient rooms?
What decision making process to select the company that supplies canned goods to the dietary department?
How did you choose the company to do pest control?

41. TJC FAQ on Contracted Services
TJC has a section on standards FAQ1
Scroll down to leadership section and one FAQ on contracted services
New and posted April 8, 2010
Does the contract standards apply if the organization you are contracting with is also TJC accredited?
What are hospital responsibilities related to services by our contracted organizations?
Does surveyor manually verify with HR files for contracted services
1www.jointcommission.org/AccreditationPrograms/Hospitals/Standards/09_FAQs/default.htm

42. FAQ Leadership Contract Services

46. CMS Contract Regulations

47. The Conditions of Participation
Regulations first published in 1966
Many revisions since with final interpretive guidelines were issued June 5, 2009
First it is published in the Federal Register first-42 CFR Part 4821
CMS then publishes Interpretive Guidelines2
Some have survey procedures
Hospitals should check this website once a month for changes
1www.gpoaccess.gov/fr/index.html 2www.cms.hhs.gov/SurveyCertificationGenInfo/PMSR/list.asp

49. CMS Hospital CoPs
Interpretative guidelines under state operations manual1
Appendix A, Tag A-0001 to A-1163 and 370 pages long
Interpretative guidelines updated
Manuals found at2
Manuals are now being updated more frequently
Still need to check survey and certification website monthly
1www.cms.hhs.gov
2http://

51. Entrance Activities of Surveyor
Provide information to surveyor
Infection control plan
List of employees
Medical staff bylaws, rules and regulations
List of contracted services (page 12)
Surveyor to clarify any contracted patient care services or activities (page 11)
Provide any contracted patient care services such as dietary, treatment or diagnostic services (page 15)

52. Document Review Session
During document review session provide the following documents
“Contracts, if applicable, to determine if patient care, governing body, QAPI, and other CoP requirements are included”
Page 20

53. Contract Section Starts at Tag 83

54. Contracted Services 83
Board is responsible for services provided in hospital
Whether provided by hospital employees or under contract
Board must make sure the contractors furnish services that meet the hospital CoPs and standards for contracted services
This includes ones for shared services and joint ventures
Different from the TJC standards that only affect patient care contracts

55. Contracted Services 83
Board must take action under hospital’s QAPI program to assess services provided both by employees and under direct contract
Board must take action to identify quality problems and ensure monitoring and correction of any problems
Board must make sure corrections sustained
TJC has more detailed contract management standards in LD chapter, revised and and continued into 2011 as previously discussed

56. Contracted Services A-0084
Board must ensure services performed under contract are performed in a safe and efficient manner
Indirect arrangements may take into consideration services provided through formal contracts, joint ventures, informal agreements, shared services, or lease arrangements
Patient care services provided under contract are subject to the same QAPI evaluations as services provided directly by the hospital

57. List of Contracted Services A-0085
Review QAPI plan to ensure that every contracted service is evaluated
Hospital must maintain a list of all contracted services (85)
Contractor services must be in compliance with CoPs
Consider adding a section to all contracts to address CoP requirements that contractors agree to follow all hospital CoPs and TJC requirements

65. TJC Contract Services Tracer
Tracers are a great way to prepare staff
Be sure to should know scope and nature of contract services
Surveyor will interview leaders on their oversight for contracted services
LD has the ten elements of performance which hospitals should make sure they are in compliance with (already discussed)
Surveyor to include patient that received care from contracted providers in individual tracer selection

66. Contract Services Tracer
Know how you monitor contracted services and contracted individuals
Be sure to know the PI you are doing on contracted services and individuals
Surveyor may review contracts
Consider having all contracts in one place and have log of all contracts
Make sure you have place on review form to cover any specific performance based expectations, goals, or benchmarks contained in the contract

67. Contract Services Tracer
Leaders need to monitor contract services and evaluate these contracts
Surveyor will interview leaders on their oversight process for contracted services
Surveyor is to interview staff about the scope and nature of services they provide and how there were oriented to the organization processes
Surveyor may review some contracts

68. Summary Review the contract process and P&P
Update the written contract policy as needed
Verify that all the contracts in the organization to make sure meets CMS CoP and TJC requirements
Make sure contract services have language about performance expectations
Have a contract log that lists all contracts with expiration dates
Managers should know if can sign a contract and threshold amount

69. Summary
Some contracts should be reviewed by senior management in consult with legal counsel or risk management
Some contracts (depending on the amount set out or purpose) may need to be approved by the Board
A checklist may helpful in reviewing whether the contractor is meeting expectations
Remember to have a place on form to document specific performance criteria set out in contract
Communicate in writing any concerns the hospital has with the contractor

70. Summary Document the contract review process to show over sight
The policy is specific about how leadership monitors the care provided through contracted services
File contracts in one central location
Have a contract management log
Consider having contracts in one central location
Have someone in charge of contracts
Ensure that a list of all the contracts that affect patient care go the Med Executive Committee (MEC)

71. Summary
Make sure all contractors are properly licensed, credentialed and privileged
Including that all services be within the scope of practices
A requirement in the contract that all services will be provided in a safe and effective manner
A requirement that all local, state, federal laws and accreditation (such as TJC) and CMS regulations are met
A requirement to comply with all applicable hospital policies and procedures

72. Summary
Some hospitals require monthly or quarterly reports regarding services provided
A requirement to fully cooperate upon termination of the agreement in order to effectuate a smooth transition
The right of the hospital to terminate the agreement without cause and without liability upon the provision of reasonable notice,
At a minimum, the right to immediately terminate the agreement in the event that the contractor’s actions adversely impact patient care and safety

73. The End Questions? Sue Dill Calloway RN, Esq. CPHRM
AD, BA, BSN, MSN, JD
President
5447 Fawnbrook Lane
Dublin, Ohio 43017

74. MS Telemedicine TJC
MS : For originating sites only: Licensed independent practitioners who are responsible for the care, treatment, and services of the patient via telemedicine link are subject to the credentialing and privileging processes of the originating site.
Rationale: the originating site retains responsibility for overseeing the safety and quality of services offered to its patients
Physicians who provide readings of x-rays, tracings, or specimens (interpretive services) through a telemedicine link are C&P under LD

75. MS.13.01.01 Telemedicine TJC Called C&P by proxy
Original site (where patient is located) is allowed to accept the C&P of the distant site (where the radiologist or practitioner is located)
Must follow all state and federal laws such as make sure practitioner is licensed in that state
Will reduce the C&P burden for original site or the small and rural or CAH hospitals
Recognized the distant site (big Hospital) has more relevant information to base its C&P decisions

76. MS Telemedicine TJC
Recognized that the small hospitals or originating site may have little experience in privileging these specialties
Also see EC and .03 to make sure there is appropriate use of telemedicine equipment and that the equipment is maintained
Telemedicine is defined as the use of medical information exchanged from one site to another via electronic communications for the health and education of the patient or health care provider and for the purpose of improving patient care, treatment, and services. Source: American Telemedicine Association.

77. MS.13.01.01 Telemedicine TJC EP1 DS
EP1: All LIPs who are responsible for the patient’s care via a telemedicine link are C&P to do so at the originating site, according to standards MS through MS
Note: If the distant site is a Medicare-participating hospital, the originating site's medical staff may use a copy of the distant site's credentialing packet for privileging purposes (deemed status-most hospitals)
This packet includes a list of all privileges granted to the licensed independent practitioner by the distant site and an attestation signed by the distant site indicating that the packet is complete, accurate, and up-to-date

78. MS.13.01.01 Telemedicine TJC EP1 DS
For hospitals that do not use TJC for deemed status
All LIPs who are responsible for the patient’s care via a telemedicine link are C&P to do so at the originating site, according to standards though one of the following:
Fully C&P practitioner according to Standards MS through MS
See MS for rest for hospitals that do not use TJC for deemed status (such as VA hospitals or Shriners)