by melanie poynter, assistant director susan moberly, rn, nci · 2019-10-07 · melanie poynter,...

Cabinet for Health and Family Services

Office of the Inspector General

Division of Health Care

Presents

OIG Hospital Survey and Process Review

By

Melanie Poynter, Assistant Director

Susan Moberly, RN, NCI

Goals of the training

Goal:

Provide information about the role of the OIG,

Division of Health Care.

Provide resources for hospitals concerning

state and federal regulations and processes.

Provide information on how a survey is

conducted.


Division of Health Care

Division of Health Care responsibilities:

Inspecting

Monitoring

Licensing and certifying

Investigating complaints

Facility plans review

Regulation development



Division of Health Care Responsibilities

The regional branches of the Division of Health

Care are responsible for conducting on-site

visits of all health care facilities in the state to

determine compliance with applicable

licensing regulations and Medicare/Medicaid

certification requirements.


OIG Branch County Coverage

Northern

Western Southern

Eastern

OIG/DHC Branch Offices

Western Branch

Kathy D. Perry, Regional Program Manager

Western State Hospital

P.O. Box 2200

2400 Russellville Road

Hopkinsville, KY 42241

Phone: 270-889-6052 Fax: 270-889-6089


Northern Branch

Northern Branch

Belinda Beard, Regional Program Manager

L & N Building, 10-W 908 W. Broadway

Louisville, KY 40203

Phone: 502-595-4958 Fax: 502-595-4540


Southern Branch

Southern Branch

Kim Brock, Regional Program Manager

116 Commerce Ave.

London, KY 40744

Phone: 606-330-2030 Fax: 606-330-2054


Eastern Branch

Eastern Branch

Gae Vanlandingham, Regional Program

Manager

1055 Wellington Way, Suite 125

Lexington, KY 40513

Phone: 859-246-2301 Fax: 859-246-2307


Why is OIG here?

• A long time ago, in a galaxy far, far, away…

• Hospitals obtained a Certificate of Need to

become a hospital.

• All Critical Access Hospitals were originally

licensed as an acute care hospital prior to

converting to a Critical Access Hospital.


Why is OIG here?

• KRS 216B.042 Licenses — Authority to

enter upon premises — Authority for

administrative regulations.

The cabinet may authorize its agents or

representatives to enter upon the premises of

any health care facility for the purpose of

inspection, and under the conditions set forth in

administrative regulations promulgated under

KRS Chapter 13A by the cabinet.


KRS 216B (cont’d)

Basically, KRS216B grants OIG the authority to

license, regulate and/or deny, modify or revoke

a license. It also grants OIG the authority to

enter the premises for the purposes of

inspection.


902 KAR 20:008

902 KAR 20:008 Licensing procedures and fee

schedule is the administrative regulation that

sets the fee schedule, the initial and renewal

application process, the procedures of

inspection and issuing statements of

deficiencies, the plan of correction process, the

waiver and variance process as well as

adverse action procedures.


902 KAR 20:008 (Cont’d)

In 2016, this regulation was amended to

include the provisional licensing process.

-Contains key definitions

-Grants OIG access to facilities and records

-Describes penalties may be imposed up to and

including modifying, suspending or revoking a

license for denying OIG access.


902 KAR 20:008 (cont’d)

• Describes the process and timeframes for

issuing statements of deficiencies and plans

of correction.

• Describes the process of Adverse Action of a

licensee.


OIG Role for Certification

• The Division of Health Care within the OIG is

also the state survey agency contracted by

the Centers for Medicare/Medicaid (AKA

CMS) to complete survey and certification

work under the 1864 agreement.

• When accessing medical records, not only

does OIG staff have authority to access

under KRS 216B, OIG/DHC is also exempt

from HIPPA as a federal oversight agency as

defined in §164.501(d) Cabinet for Health and Family Services

Types of Hospitals

• Several types of hospitals in KY and each

has a regulation describing the minimum

standards for operations and services as well

as a regulation for facility specifications.

• Acute Care hospital:

902 KAR 20:016-Operations and Services

902 KAR 20:009-Facility specifications


Types of Hospitals (cont’d)

• Psychiatric hospitals:

902 KAR 20:180 –Operations and Services

902 KAR 20:170-Facility Specifications

• Comprehensive Rehabilitation Hospitals:

902 KAR 20:240-Operations and Services

902 KAR 20:230-Facility specifications


Additional regulations

• Hospitals also comply with additional

regulations such as reporting information to the

Department for Public Health. For instance,

hospitals must comply with 902 KAR 20:205-

TB for Health Care workers, 902 KAR 2:020-

reportable disease and disease surveillance.

Hospitals also report information to DPH-

specifically to the Office of Vital Statistics on

Births, Deaths, and Fetal Deaths.


DPH contacts

• TB Branch-

Maria Lasley or Emily Anderson 502-564-4276

Surveillance Branch-Emily Anderson

Office of Vital Statistics Branch- 502-564-4212

Christina Stewart, Branch Manager, ext 3200 or

Jeff Sparks ext 3210.


OVS Reporting Requirements

Purposeful interruption of pregnancyAbortion

Fetal Death

“Live Birth” expulsion or extraction, breathes or shows any other evidence of life.Infant Death

Gestational weeks

20 weeks

Abortion Report Required

Stillbirth Certificate Required

Birth and Death Certificate

Required

Provisional Report of Death

Required

20 completed weeks or weighs 350 grams or more "Hospital Responsibility”. Death prior to the complete expulsion or extraction.

Fetal Death No Certificate RequiredLess than 20 weeks and or

weighs less than 350 grams.

KY-Child Application Required

KY-EDRS Application

RequiredProvisional Report of Death

Required

Provisional Report of Death Not

Required

ACCREDITATION ORGANIZATIONS (A0) AND

DEEMED STATUS

REGULATORY AUTHORITY: 42 CFR 488

Subpart A-General Provisions

488.1 Definitions

488.2 Statutory Basis

488.5 Application and Reapplication

488.8 Federal Review of AO’s

488.9 Validation Survey


DEEMED STATUS

What is “Deemed Status”?

Providers or suppliers accredited by a CMS

approved national accreditation organization

(AO) are deemed to meet CMS conditions of

participation in the Medicare program. These

providers or suppliers are referred to as

“deemed status” providers or suppliers.

23

Approval of Accreditation Organizations

• A national accreditation organization applying for approval of deeming authority must provide CMS with reasonable assurance that the accreditation organization requires the accredited provider to meet requirements that are at least as stringent as the Medicare conditions.

• The regulations require AOs to reapply for continued approval of deeming authority every 6 years, or sooner as CMS determines.

• The application and reapplication process involves on-site observations, crosswalk comparability review and a comprehensive evaluation of the AO’s policies and procedures, standards and survey process and electronic data management.


DEEMED STATUS

Deemed Status Providers/Suppliers

• Will lose “deemed status” when the State Agency cites a condition level deficiency during a complaint investigation and move under the jurisdiction of the SA until all condition level deficiencies are corrected.

• Sample Validation Surveys may also result in CMS removing deemed status.

Role of Accreditation

• Accreditation:

– Is voluntary

– Can substitute for on-going State Agency

review.

– Must be approved by CMS as meeting or

exceeding Medicare requirements.

Initial Certification Process

• Initial Certification of Hospital

Initial certification of a hospital can be attained two different ways:

1. Attain accreditation through a deeming organization. Joint Commission on Accreditation of Healthcare Organizations (JCAHO), The American Osteopathic Association (AOA), DNV GL-Healthcare (DNV), or American Association/Healthcare Facilities Accreditation Program (HFAP). The effective date of certification could not be earlier than the effective date of accreditation.

2. A full Medicare survey (including LSC) is conducted by the State Agency. Effective date of certification is the earlier of the following:

a. The date on which the provider meets all Conditions of Participation (CoPs) and no standard level deficiencies issued or,

b. If the provider is found to meet all CoPs but has standard level deficiencies , the date an acceptable plan of correction (PoC) is received is the effective date for certification regardless of when the SA approves the PoC.

(see section 2008 CMS State Operations manual and 42 CFR 489.13)Cabinet for Health and Family Services

Additional Requirements for Initial

Certification

• Appropriately licensed by the state;

• Approval of the CMS-855 by the provider’s

fiscal intermediary for initial enrollment;

• Submission of additional certification forms to

Central Office.


Applicable Conditions of Participation (CoP)

• Acute Care Hospital– 42 CFR 482 Appendix A (A Tags)

• Acute Care Hospital with Swing Beds– 42 CFR 482 Appendix A (A Tags)

– 42 CFR 482.66 Appendix T

– 42 CFR 483 Selected sections as listed in Appendix T

• Critical Access Hospital (CAH) with or without Swing Beds, Psych Units, and/or Rehab Units

– 42 CFR 485 Appendix W

– 42 CFR 483 Selected sections as listed in Appendix W

• Psychiatric Hospital– 42 CFR 482 Appendix A (A Tags)

– 42 CFR 482.60, 61, 62 (2 Special Psychiatric Conditions) Appendix AA (B Tags)

*All appendices are subject to changes as specified in CMS Transmittals, Admin-Info Memos, and S&C (now known as QSO) documents. For example, S&C-04-48 updates Appendix W to include the CoPs for CAHs IPPS rehab and psych units


Applicable CoP (cont’d)

• Psych Unit– 42 CFR 482 Appendix A (A Tags)


• IPPS Psych Unit– 42 CFR 482 Appendix A (A Tags)


– 42 CFR 412.25 and 412.27 – These are the IPPS exclusion criteria (not CoPs) and are on Form CMS-437 Psychiatric Unit Criteria Work Sheet


Applicable CoP (Cont’d)

• Rehabilitation Hospital

– 42 CFR 482 Appendix A (A Tags)

• IPPS Rehabilitation Hospital

– 42 CFR 482 Appendix A (A Tags)

– 42 CFR 412.23 – This is the IPPS criterion (not

CoPs) and is on the Form CMS 437B

Rehabilitation Hospital Criteria Work Sheet


Applicable CoP (cont’d)

• Rehabilitation Unit

– 42 CFR 482 Appendix A

• IPPS Rehabilitation Unit

– 42 CFR 482 Appendix A

– 42 CFR 412.25, 412.29, and 412.30 – These are

the IPPS criteria (not CoPs) and are on Form

CMS-437A Rehabilitation Unit Criteria Work

Sheet


Accreditation

How do you become an accredited hospital and what does that mean?

A hospital completes an application, pays fees, and is subjected to a complete survey by the accrediting organization. The hospital must meet the requirements of the accrediting organization in order to be approved for accreditation. Upon approval by the accrediting organization, the hospital must maintain compliance with the accrediting organizations requirements and may be subjected to surveys on a regular basis.

How does a hospital become deemed for certification?

CMS & Accreditation for Deemed Status

CMS requires accreditation organizations to demonstrate that their requirements meet or exceed the Medicare conditions if they want to be recognized as a deeming authority . Section 1861(e) and 1865(a) of the Act allows hospitals accredited by an approved national accrediting body to be “deemed” to meet Medicare Conditions of Participation.

CMS has approved deeming authority for the following accrediting organizations:

Joint Commission on Accreditation of Healthcare Organizations (JCAHO)

American Osteopathic Association/Healthcare Facilities Accreditation Program (AOA/HFAP)

Center for Improvement for Healthcare Quality (CIHQ)

DNV GL-Healthcare (DNV GL)

***Deemed for certification means that a hospital meets the Federal CoPs***

***Please note hospitals must be accredited for their hospital type i.e. acute, critical access. A hospital who has recently changed from acute to critical access hospital must have the change in accreditation as well in order to be “deemed”.

***If a hospital is accredited by another accrediting organization that is not approved by CMS as having deemed authority, it would NOT be deemed for certification.


Accreditation (cont’d)

• State Licensure and Accreditation (Deemed Status)

Effective July 15, 2002, KRS 216B.185 was established.

KRS 216B.185 (1)(a)(b) states:

The Office of the Inspector General shall accept accreditation by the Joint Commission on Accreditation of Healthcare Organizations or another nationally recognized accrediting organization with comparable standards and survey processes, that has been approved by the United States Centers on Medicare and Medicaid Services, as evidence that a hospital demonstrates compliance with all licensure requirements under this chapter. An annual on-site licensing inspection of a hospital shall not be conducted if the Office of the Inspector General receives from the hospital:

(a) A copy of the accreditation report within thirty (30) days of the initial

accreditation and all subsequent reports; or

(b) Documentation from a hospital that holds full accreditation from an approved accrediting organization on or before July 15, 2002.


Accreditation (cont’d)

• State Licensure and Accreditation (Deemed Status) (cont’d)

Therefore a hospital that is deemed for certification is also deemed for licensure and a routine relicensure survey would never be conducted unless deemed status is removed.

However, licensure complaint investigations shall be conducted as necessary. Licensure validation surveys shall also be conducted as defined in 906 KAR 1:140.

Annual relicensure surveys shall be conducted on non-deemed hospitals.



END of MP’s portion

Enforcement Process/Adverse Actions

Remember earlier when we discussed Deemed

Status? It will come into play when complaints

are investigated and at any time Condition

Level deficiencies are cited.


NUMBERS

– 88% of hospitals nationally have deemed

status. State Agencies (SAs) may only perform

CMS validation surveys at CMS Regional Office

(RO) direction

– Representative sample – small number

– Substantial allegation – complaint

• >80% of all SA Federal hospital surveys are

complaint surveys >3,300 surveys nationally


CAH’s

• Very different situation from hospitals:

• 32% of CAHs have deemed status

• Federal surveys roughly divided equally

between standard and complaint surveys

• Nationally < 3% of CAHs have a complaint

survey each year

• CAHs have different CoPs

• But the general principles of complaint

investigations apply as well to CAHs


Complaint numbers

• Nationally about 25% of all hospitals have a

Federal complaint survey each year

• In Kentucky, the average amount of

complaints received on all hospital types that

require an onsite investigation= @ 150-200

per year.


Hospital Complaints

Since most of Kentucky’s hospitals have

deemed status, the majority of surveys are

initiated based on complaint allegations.

OIG/DHC also receives complaints that do not

require an on-site investigation and refers those

complainants to the applicable accrediting

organization.


Hospital Complaints (Cont’d)

• Although OIG has the authority to investigate

complaint allegations under state licensing

regulations on all hospitals, prior to

investigation for complaints on deemed

hospitals, the state agency (OIG) obtains a

2802 from CMS.

• OIG surveyors then initiate the investigation

in the form of a survey.


Investigating Complaint in

Deemed/Non-Deemed Facilities

Complaint Investigation Findings/Scenarios:

1. Standard level deficiencies or no deficiencies

are cited during complaint investigation

2. Condition-level deficiency non-IJ cited during

complaint investigation

3. Condition-level deficiency IJ cited during

complaint investigation 44

Certification re-survey or Complaint survey findings in


1. Standard level deficiencies or no deficiencies

are cited from survey or complaint

investigation

• Deemed: Facility is in substantial

compliance. SA sends SOD but does not

request POC. (An exception can be made for

LSC.)

• Non-Deemed: SA sends SOD and requests

POC for standard level deficiencies.

45



2. Condition-level deficiency non-IJ cited

during complaint investigation

Deemed Facilities:

• 90 day termination does not begin at this

time

• SA sends courtesy notice to the hospital;

RO sends SOD; can request a POC; advises

facility that SA may conduct full certification

survey--deemed status is removed.

46

Non-Deemed Hsp:COP out (non-IJ)

• SA sends SOD and requests POC and initiates 90

day termination process. SA can conduct 1 revisit

by 45th day. If compliance is not achieved by 45th

day, SA sends courtesy notice and notifies RO by

55th day.

• RO takes over enforcement after 55th day and will

direct SA if 2nd revisit is required. Termination by

90th day if compliance is not achieved

(CMS State operations Manual, 3012, Chapter 5)47




complaint investigation

Deemed and Non-Deemed Facilities:

• RO takes over enforcement whenever an IJ is

cited.

• SA sends courtesy notice to the hospital by

2nd working day; RO sends SOD and starts

23 day termination.

(CMS State operations Manual, 3010, Chapter 5)

48


complaint investigation (cont’d)

Deemed and Non-Deemed Facilities:

• If acceptable POC is received, SA will

conduct revisit to determine if IJ is removed.

• Deemed Facilities: Full cert survey may also

be required if directed by CMS.

Also, if the COP will remains out of compliance

on the revisit, the CMS RO may convert to 90

day termination.49



Recertification Surveys

2. Condition-level deficiency non-IJ cited

during recertification survey

• If COP is out during recert survey, the 90 day

termination process begins.

• SA sends SOD/requests POC and places

facility on 90 day termination track.

• SA will conduct 1 revisit by 45th day if

acceptable POC is received. If compliance is

not achieved by 45th day, SA sends courtesy

SOD and refers to RO by 55th day.50

Recertification Surveys

2. Condition-level deficiency non-IJ cited during

recertification survey of a Non-Deemed hsp.

• RO sends SOD and requests POC.

• SA will be requested to conduct 2nd revisit if

acceptable POC is received.

• If compliance is not achieved by 90th day,

facility is terminated from the Medicare

program.

51

EMTALA

Medicare participating hospitals must meet the

Emergency Medical Treatment and Labor Act

(EMTALA) requirements codified at §1866

§1867 of the Social Security Act and

accompanying regulations in 42 CFR §489.24

and 42 CFR 489.20 (l), (m), (q), and (r).

52

EMTALA

EMTALA requires hospitals with emergency

departments to:

• Provide medical screening exams to any

individual who comes to the ED and requests

an examination or treatment; and

• Provide necessary stabilizing treatment or

appropriate transfer for those with emergency

medical conditions.

• EMTALA requirements also include the

recipient hospital responsibilities.53

EMTALA

• OIG receives an average of 10-15 EMTALA

allegations for investigation each year.

• EMTALA violations also have civil monetary

penalties assessed by CMS. They can be

assessed to hospitals as well as individual

physicians.

• Once the SA completes investigation, the

findings are transmitted to the RO.


EMTALA

• If the RO determines no violation, the RO

notifies the facility via letter.

• If the RO determines a violation, the RO will

notify facility when they are placed on a 23 or

90 day termination—beginning with the date

of the notice. RO will request a POC from the

hospital.

• RO will request SA to do revisit to determine

compliance prior to the termination date.

55

Most Common Deficiencies

• KY’s most commonly cited Condition-Level

deficiencies:

• Nursing Services

• Patient Rights

• Governing Body

• QAPI (Quality Assessment & Performance

Improvement

• Emergency Services

• Surgical ServicesCabinet for Health and Family Services

Immediate Jeopardy


• In March 2019, CMS updated Appendix Q of

the State Operations Manual in a QSO

Memorandum to State Survey Agencies

(QSO-19-09-ALL)

• Identified a Core Appendix Q for all provider

types with Subparts for specific provider

types such as nursing homes and

laboratories.

Immediate Jeopardy


• The memo also clarified the Key Components

of Immediate Jeopardy

• Introduced the IJ template that surveyors

utilize to determine IJ as well as

communicate each component to convey

information to the surveyed entity.

Immediate Jeopardy- Definition


IJ Components


IJ Template

• Survey teams must use the Immediate

Jeopardy (IJ) Template to document evidence

of each component of IJ; and if IJ is confirmed,

the IJ Template will be used to convey

information to the entity. Any information

presented on this template is subject to change

and does not reflect an official finding against a

Medicare provider or supplier. Form CMS-

2567 is the only form that contains official

survey findings.


IJ Template


Definitions

• Likely/Likelihood means the nature and/or

extent of the identified noncompliance creates

a reasonable expectation that an adverse

outcome resulting in serious injury, harm,

impairment, or death will occur if not corrected


Definitions (Cont’d)

• Noncompliance means failure to meet one

or more federal health, safety, and/or quality

regulations.

• Recipient at Risk is a recipient who, as a

result of noncompliance, and in consideration

of the recipient’s physical, mental,

psychosocial or health needs, and/or

vulnerabilities, is likely to experience a serious

adverse outcome. Cabinet for Health and Family Services


• Serious injury, serious harm, serious

impairment or death are adverse outcomes

which result in, or are likely to result in:

• death; or

• a significant decline in physical, mental, or

psychosocial functioning, (that is not solely

due to the normal progression of a disease or

aging process); or



• loss of limb, or disfigurement; or

• avoidable pain that is excruciating, and more

than transient; or other serious harm that

creates life-threatening

complications/conditions.


IJ (Cont’d)

• *NOTE: IJ does not require serious injury,

harm, impairment or death to occur. It is

sufficient that non-compliance makes

serious injury, harm, impairment or death

likely to occur to one or more recipients.

• Disclaimer: The findings on the IJ Template

are preliminary and do not represent an official

finding against a Medicare provider or supplier.

Form CMS-2567 is the only form that contains

official survey findings. Cabinet for Health and Family Services

Key Takeaways

• Timeframes are accelerated when

Immediate Jeopardy is present.

• Each situation is unique.

• CMS interpretive guidelines are helpful but

are not regulation.


RESOURCES

• OIG Division of Health Care webpage:

https://chfs.ky.gov/agencies/os/oig/dhc/Pages/d

efault.aspx

• CMS State Operations Manual link:

https://www.cms.gov/Regulations-and-

Guidance/Guidance/Manuals/Internet-Only-

Manuals-IOMs-Items/CMS1201984.html


https://chfs.ky.gov/agencies/os/oig/dhc/Pages/default.aspx

https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS1201984.html

Resources

• OIG Directories & links to common hospital state

regulations:

https://chfs.ky.gov/agencies/os/oig/dhc/Pages/hcf.asp

x

• CMS Appendix A-Federal CoP’s including CMS

interpretive guidelines:


Guidance/Guidance/Manuals/downloads/som107ap

_a_hospitals.pdf


https://chfs.ky.gov/agencies/os/oig/dhc/Pages/hcf.aspx

Resources

• CMS SOM Appendix V-EMTALA including

CMS interpretive guidelines:


Guidance/Guidance/Manuals/downloads/som1

07ap_v_emerg.pdf

• CMS SOM Appendix W-Federal CoP’s

including CMS interpretive guidelines:



07ap_w_cah.pdf Cabinet for Health and Family Services

Resources

• CMS SOM Appendix AA-Psychiatric Hospital

CoP’s including CMS interpretive guidelines:



07ap_aa_psyc_hospitals.pdf

• CMS SOM Appendix Q-Guidelines for

Determining Immediate Jeopardy:



07ap_q_immedjeopardy.pdfCabinet for Health and Family Services

Resources

QSOG Policy memo’s to States and Regions:

https://www.cms.gov/Medicare/Provider-

Enrollment-and-

Certification/SurveyCertificationGenInfo/Policy-

and-Memos-to-States-and-Regions.html


Conclusion

by melanie poynter, assistant director susan moberly, rn, nci · 2019-10-07 · melanie poynter,...

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