CMS Pub. 100-10, ch. 4, § 4325

A. Purposes of the PRAF

The PRAF has been designed to achieve two objectives:

 Standardize the structure of the review process to obtain more consistent, reliable

review decisions; and

 Standardize data reporting to provide both you and CMS with more reliable data

for pattern analysis, feedback, and improving care.

To achieve these objectives, it is crucial that the format be an integral part of the review

of each case (i.e., each reviewer must assess the case according to the requirements of the

PRAF). Attempting to collect PRAF data from cases not reviewed according to the

PRAF structure does not fulfill the objectives of the PRAF.

The PRAF is a format, not a form. You may design a form other than the model PRAF.

However, collect and report all of the information found on the model PRAF. Collect the

information in such a way that the same linkages can be made as if you were using the

model PRAF (e.g., final determinations can be linked to specific quality screen criterion

failures, and category assignments can be linked to specific concerns) (see Exhibit 4-1).

B. Personnel Using the PRAF

All non-physician and physician reviewers must use the PRAF, as appropriate.

 The Non-physician Reviewer -- Non-physician reviewers will identify potential

concerns and initiate the PRAF by completing the:

• Patient identifying information section(s);

• Non-physician reviewer decision summary;

• Non-physician reviewer identification; and

• Case decision abstract and question/statement of concern. The non-physician reviewer may also write a case summary, depending on your

protocol.

NOTE: You may assign personnel other than non-physician reviewers to complete the

patient identifying information section(s).

 The First Level Physician Reviewer -- The first level physician reviewer

determines if a potential concern(s) exists. Whether a potential concern raised by

the non-physician reviewer is validated or invalidated, and/or if an additional

concern(s) is independently identified by the first level physician reviewer, he/she

must complete the:

• Physician reviewer preliminary decision summary;

• Physician reviewer identification; and

• Physician reviewer case decision abstract and rationale.

NOTE: The first level physician reviewer checks the "Immediate Attention" box, when

appropriate.

 The Second Level Physician Reviewer -- The second level physician reviewer

determines if a confirmed concern(s) exists. Whether a potential concern is

confirmed or not, he/she must complete the:

• Physician reviewer initial/final decision summary;

• Physician reviewer identification; and

• Physician reviewer case decision abstract and rationale.

NOTE: The second level physician reviewer checks the "Immediate Attention" box,

when appropriate.

 The Third Level Physician Reviewer (Reconsideration/Re-review) -- The third

level physician reviewer determines if an initial utilization denial, a confirmed

quality concern, or a QIO DRG validation should be upheld or reversed. Whether

a determination is reversed or not, he/she must complete the:

• Physician reviewer reconsideration/re-review decision summary;

• Physician reviewer identification; and

• Physician reviewer case decision abstract and rationale.

NOTE: The third level physician reviewer checks the "Immediate Attention" box, when

appropriate.

C. Elements of the Model PRAF

The PRAF is used to make review decisions for patients in any setting (e.g., inpatient

hospital, physician office).

 Patient Identifier Information -- The patient identifier information provides

administrative data for case identification. Enter patient identifier information at

the top of the Decision Summary, the Non-physician Reviewer - Case Decision

Abstract and Question/Statement of Concern, and the Physician Reviewer Case

Decision Abstract and Rationale at all levels of review.

 Non-physician Reviewer Decision Summary -- In the non-physician reviewer

decision summary, the non-physician reviewer identifies each concern by

sequential number, notes which quality screen criterion each concern failed as

appropriate, and assigns a suggested category to each concern. The non-physician

reviewer's ability to clearly identify, distinguish, and categorize potential concerns

is crucial to the development of further information on the PRAF. The non-physician reviewer enters his/her identification number and the date.

 Physician Reviewer Preliminary Decision Summary -- The first level physician

reviewer enters the category of each concern identified by the non-physician

reviewer in the sequential order assigned by the non-physician reviewer. If the

physician reviewer believes that the non-physician reviewer's concern is not valid,

he/she enters "0".

The first level physician reviewer may also add concerns he/she has identified

independent of the non-physician reviewer. These are to be assigned sequential concern

numbers and categorized by the physician reviewer.

The first level physician reviewer also enters the name(s) of the physician(s) who is to

receive a preliminary notice for each concern. The physician reviewer must identify

those physicians who should receive preliminary notices. Send preliminary notices only

to those physicians who can supply information necessary to address the concerns raised.

The first level physician reviewer enters his/her identification number and the date.

 Physician Reviewer Initial/Final Decision Summary -- The second level physician

reviewer enters the category of each concern he/she reviews in sequential order

(The category assignment may change after the opportunity for discussion). If the

concern is not confirmed, the physician reviewer enters "0".

The second level physician reviewer enters the source(s) of any confirmed quality

concerns in sequential order. The sources to be assigned are found on the source legend.

For DRG or utilization concerns, the source is "0".

The second level physician reviewer also sequentially enters the name(s) of any

physician(s) determined to be the source, or one of the sources, of a confirmed quality

concern.

The second level physician reviewer enters his/her identification number and the date.

 Physician Reviewer Reconsideration/Re-review Decision Summary -- The third

level physician reviewer enters the category of each concern he/she reviews in

sequential order (The category assignment may change after the

reconsideration/re-review). If the concern is not reconfirmed, the physician

reviewer enters "0".

The third level physician reviewer enters the source(s) of any reconfirmed quality

concerns in sequential order. The sources to be assigned are found on the source legend.

The third level physician reviewer also sequentially enters the name(s) of any

physician(s) believed to be the source, or one of the sources, of a confirmed quality

concern.

The third level physician reviewer enters his/her identification number and the date.

 Office Use Only -- Use this section to identify physicians who are to receive

notices by Unique Physician Identification Number (UPIN) and to track the case

as it moves through the physician review process.

 Immediate Attention -- A physician reviewer at any level of review may check the

Immediate Attention box when he/she believes that you should pay special

attention to the case under review (e.g., the physician reviewer believes that

additional investigation should be undertaken).

When the box is checked, the physician reviewer must justify the need for special

attention in the physician reviewer Case Decision Abstract and Rationale section of the

PRAF. Determine the appropriate way to process PRAFs marked for special attention

(e.g., immediate review by the medical director).

 Non-physician Reviewer Case Decision Abstract and Question/Statement of

Concern -- For each potential concern he/she has identified, the non-physician

reviewer must define the concern clearly and concisely and provide clinical data

from the medical record to support the identified potential concern. You may also

require a non-physician reviewer case summary in this section.

The non-physician reviewer may sign this section (optional), but must enter his/her

identification number and the date.

 Physician Reviewer Case Decision Abstract and Rationale -- Note whether the

case decision abstract and rationale is for the preliminary, initial/final, or

reconsideration/re-review determination.

First level physician reviewers are to address all potential concerns raised by the non-physician reviewer, as well as any independently identified concerns. Second level

physician reviewers are to address all concerns for which the opportunity for discussion

is provided. Third level physician reviewers are to address all concerns for which the

reconsideration or re-review is requested. At each level, the physician reviewer must

justify his/her decision clearly and concisely and provide clinical data from the medical

record to support the decision. You may also require a physician reviewer case summary

in this section. Second and third level physician reviewers are to include alternative

courses of action that would have precluded the confirmed (or reconfirmed) concern.

Physician reviewers are to consider concerns from a systems perspective. It is seldom

that a concern is the result of a single individual's action. For example, if the physician

ordered an incorrect dose of medication and the medication was administered, the

reviewing physician should consider the elements (e.g., nursing department, pharmacy)

and the processes (e.g., poor communications) that failed to prevent the occurrence.

The physician reviewer may sign this section (optional), but must enter his/her

identification number and the date.

 Categories for Classifying Concerns -- Categories are grouped as Utilization

Categories (applicable to review of NODMARs), Prohibited Action Categories,

Quality Categories, and DRG categories (Only the Quality Categories are used for

managed care review except for review of NODMARs). Place each potential and

confirmed concern in these categories. In general, assign one category to each

concern. If a concern seems to fall into several categories, rethink the concern

because it may be that several separate concerns are being combined. There may

be several concerns within one clinical episode.

NOTE: There are a few DRG validation categories that are to be reported as such even

though the case may not have been referred for physician review (e.g., D.14, D.15).

4400 - Introduction - (Rev. 2, 07-11-03)

You are authorized to conduct Fee-For-Service (FFS) review under §1154 of the Social

Security Act (the Act) and 42 CFR, Part 476, Subpart C. You are also authorized to

conduct Medicare + Choice Organization (M+CO) review under §§1154(a)(4) and

1852(e)(3) of the Act and 42 CFR 476.70 and 476.72.

For FFS cases, you are to review services provided by PPS providers located in your

State or review area or by non-PPS providers in a waived/excluded area. For M+C cases,

you are to review services provided by M+COs in the State covered by the organization's

contract (except for beneficiary's immediate review request of the Notice of Discharge

and Medicare Appeals Rights (NODMAR), see chapter 7). Where the M+COs

immediate service area crosses State lines, your review responsibility extends across

State lines also (i.e., review remains the responsibility of the QIO in the State in which

the M+CO has its contract).

4405 - Review of Medicare Services - (Rev. 2, 07-11-03)

The objectives of case review are dependent on whether you are conducting FFS or

M+CO review. Review FFS and M+C services paid under Medicare when all of the

following conditions are met:

A. Types of Services

The services were covered by Medicare, regardless of whether they were covered for this

particular beneficiary or whether Medicare payment was made (see 42 CFR 424.5(a)(1)).

For example, review the Medicare-covered services provided in a Medicare-certified

SNF or SNF distinct part of a hospital even if the beneficiary's SNF days may have been

exhausted at the time. Consult the intermediary if you have questions as to whether the

services are covered by Medicare.

B. Sources of Services

The services were furnished by a provider, non-participating hospital, or supplier that

was, at the time it furnished the services, qualified to have payment made to it (see 42

CFR 424.5(a)(2)).

C. Recipient of Services

The recipient of the service(s) in question must be a Medicare beneficiary (see 42 CFR

424.5(a)(3)). If it is not apparent that the case involves a Medicare beneficiary, check the

Beneficiary Eligibility Status Tapes (BEST) through the RO, the Social Security Office,

or the intermediary/carrier to determine Medicare status.

4410 - Review Settings - (Rev. 2, 07-11-03)

Conduct a utilization, quality review and/or beneficiary complaint review applicable to

the review setting.

 Utilization Review -- A review focused on determining the medical necessity and

reasonableness of the items/services furnished or to be furnished to a patient and

the appropriateness of the care settings (see §1862(a) of the Act and 42 CFR

476.71(a)(1) and (a)(3)). As a result of your review, you may make an initial

denial determination with respect to the above issues (see 42 CFR 476.83). This

review does not apply to M+CO settings.

 Quality Review -- A review focused on determining whether the quality of the

services meets professionally recognized standards of care (see 42 CFR

476.71(a)(2)). For M+CO settings, the review includes whether appropriate

health care services have not been provided or have been provided in

inappropriate settings (see 42 CFR 476.72(a)(1)). Perform FFS (may include

utilization and/or quality) and M+C (includes quality only) review of services

furnished in health care settings specified below:

• Ambulatory Surgery Performed in Ambulatory Surgical Centers (ASCs)

and Hospital Outpatient Areas (HOPAs) -- ASCs are distinct entities that

operate exclusively for the purpose of providing surgical services to

patients not requiring hospitalization. ASCs must meet the Conditions for

Coverage specified in 42 CFR Part 416, Subpart C. HOPAs must meet the

Conditions of Participation (CoP) specified in 42 CFR, Part 482 (Conduct

beneficiary complaint review only for both ASC and HOPAs).

• Comprehensive Outpatient Rehabilitation Facilities (CORFs) -- CORFs

provide diagnostic, therapeutic, and restorative services to outpatients for

the rehabilitation of injured, disabled, or sick persons. CORFs must meet

the CoP specified in 42 CFR, Part 485, Subpart B (Conduct beneficiary

complaint review only).

• Home Health Agencies (HHAs) -- HHAs are public or private agencies

that specialize in giving skilled nursing services and other therapeutic

services, such as physical therapy, in the home. HHAs must meet the CoP

specified in 42 CFR, Part 484 (Conduct beneficiary complaint review).

• Hospices -- Hospices are public agencies or private organizations that are

primarily engaged in providing care to terminally ill individuals. Hospices

must meet the CoP specified in 42 CFR, Part 418 (Conduct beneficiary

complaint review only).

• Hospitals -- Hospitals (including emergency services/departments) are

acute care, general hospitals, and acute long-term care hospitals that are

subject to the provisions of the Prospective Payment System (PPS) or cost

reimbursement. Inpatient hospitals must meet the CoP specified in 42

CFR, Part 482 (For PPS Hospitals and non-PPS hospitals in Maryland,

conduct utilization and, when applicable, conduct quality review and

beneficiary complaint review) (For psychiatric hospitals or rehabilitation

hospitals, conduct beneficiary's request for immediate review of a

HINN/NODMAR).

• Inpatient Hospital Units -- These units are distinct-part, separately

certified PPS-excluded units within PPS hospitals (e.g., psychiatric and

rehabilitation). PPS-excluded hospital units must meet the CoP specified

in 42 CFR, Part 482 (Conduct beneficiary complaint review only).

• Providers of Outpatient Physical Therapy and Speech/Language Pathology

Services -- These providers must meet the CoP specified in 42 CFR, Part

485, Subpart H (Conduct beneficiary complaint review only).

• Critical Access Hospitals (CAHs) -- CAHs offer emergency care and

short-term inpatient care. CAHs must meet the CoP specified in 42 CFR,

Part 485, Subpart F (Conduct beneficiary complaint review and

beneficiary's request for immediate review of a HINN/NODMAR).

• Skilled Nursing Facilities (SNFs) -- SNFs are specially qualified facilities

that have the staff and equipment to provide nursing care or rehabilitation

services and other health-related services. SNFs must meet the CoP

specified in 42 CFR 483, Subpart B (Conduct beneficiary complaint only).

• SNF Swing Beds -- These are inpatient hospitals that have beds certified

as swing beds or CAHs that provide post-hospital SNF care. Inpatient

hospital swing beds must meet the CoP specified in 42 CFR 482.66. CAH

swing beds must meet the CoP specified in 42 CFR 485.645 (Conduct

beneficiary complaint review only).

• Specialty Hospitals -- Examples of specialty hospitals are psychiatric and

rehabilitation hospitals. Specialty hospitals must meet the CoP specified

in 42 CFR, Part 482 (Conduct beneficiary complaint review and

beneficiary's request for immediate review of a HINN/NODMAR).

• Community Mental Health Centers -- CMHCs deliver partial

hospitalization services (specialized outpatient mental health services) to

Medicare beneficiaries. CMHCs must meet the requirement for coverage

specified in 42 CFR 410.110 (Conduct beneficiary complaint review

only).

4500 - Introduction - (Rev. 2, 07-11-03)

Other Fee-For-Service (FFS) and Medicare+Choice Organization (M+CO) review

procedures include:

 Using screening criteria;

 Requesting medical records/reviewing documentation;

 Affording practitioners and providers an opportunity to discuss potential initial

denials, DRG assignment changes, and potential quality of care concerns;

 Adhering to timing of review requirements;

 Monitoring practitioners’/providers’ improvement plans;

 Profiling case review results, and developing and implementing projects to

address hospital admission and coding patterns;

 Monitoring hospital's physician acknowledgment statements; and

 Conducting internal quality control activities (see chapter 13).

4510 - Using Screening Criteria - (Rev. 2, 07-11-03)

See §1154(a)(6) of the Act.

You are to establish written criteria or obtain national criteria for non-physician reviewer

use when screening FFS and M+CO cases for referral for physician review (see 42 CFR

476.100). Criteria must be based on typical patterns of practice in your area for each

review setting. For M+CO review, use FFS criteria plus additional criteria unique to

M+COs. Criteria must be reassessed regularly and updated as necessary to reflect current

standards of practice. CMS does not require that you use a specific criteria set so long as

the criteria you select meets the above requirements.

Consult with physicians/practitioners actively engaged in practice in the State when

establishing or updating criteria. Also request comments from physician organizations

(e.g., State medical societies, the osteopathic society, and specialty societies), the State

Hospital Association, and the Medicare carrier(s) in the State. Attempt to develop

mutually satisfactory timeframes for comment periods. Involve Health Care Practitioners

Other Than Physicians (HCPOTPs) in the development of criteria used in the review of

services delivered by HCPOTPs (see 42 CFR 476.102(a)).

Notify provider, physician, and M+COs within the State of newly established or revised

criteria at least 30 calendar days prior to implementation. New QIO contractors must

notify provider, physician, and M+COs of their medical criteria within 30 calendar days

of their contract effective date. Provide copies of criteria to

providers/practitioners/M+COs, upon request. Provide copies of criteria to carriers upon

mutual agreement. Do not send copies of your criteria to CMS for approval, but you

must have copies available for CMS' review upon request.

NOTE: If the screening criteria you use are copyrighted, provide the

provider/practitioner with the information on how and where a copy of the screening

criteria may be obtained, and any associated costs.

Specify in your Memorandum of Agreement (MOA) with providers, M+COs, and payers

how they will provide input in the development/amendment process and how you will

notify them when you are establishing the criteria you will use (see chapter 3).