Comprar Cialis Tenerife : Generic And Brand Drugs

Transcripción

Comprar Cialis Tenerife : Generic And Brand Drugs
HCA
The Healthcare Company
DEPARTMENT:
Sunrise Hospital
PAGE: 1 of 6
APPROVED:
EFFECTIVE DATE:
POLICY DESCRIPTION:
Procedure for Identifying and Billing Clinical Trial
Patients
REPLACES POLICY DATED: New
RETIRED:
REFERENCE NUMBER:
SCOPE: Process for Identifying, Registering, Billing, Collecting and Posting Cash for Patients
involved in a Clinical Trial.
PURPOSE: To describe the steps necessary in identifying and registering a patient involved in a
clinical trial. To ensure the appropriate processes are followed as outlined in the clinical trial contract
for covered and non-covered services including the appropriate billing process to be compliant with
the federal guidelines.
POLICY:
PROCEDURE:
Responsible Party
Action
Ethics and Compliance
Research Gatekeeper
Each clinical trial contract, new and existing, will be placed on the
contract database and verified via the Clinical Trial Billing Checklist
for Medicare coverage eligibility. The contract database will be
available to facility personnel upon request.
Institutional Review Board
The Clinical Trial Billing Checklist (see attached) will be distributed
by the Institutional Review Board (IRB) with the IRB application
packet, and will be completed by the research physician/designee.
The IRB will collect the completed Clinical Trial Billing Checklist
and forward it to the designated hospital department.
Research Gatekeeper
The Research Gatekeeper will review the Clinical Trial Billing
Checklist. Any clinical trial receiving Medicare coverage of routine
costs must meet the following three requirements (See Clinical Trial
Billing Checklist):
1. The subject or purpose of the trial must be the evaluation of
an item or service that falls within a Medicare benefit
category (e.g., physicians’ service, durable medical
equipment, diagnostic test) and is not statutorily excluded
from coverage (e.g., cosmetic surgery, hearing aids).
2. The trial must not be designated exclusively to test toxicity or
disease pathophysiology. It must have therapeutic intent.
HCA
The Healthcare Company
DEPARTMENT:
Sunrise Hospital
PAGE: 2 of 6
APPROVED:
EFFECTIVE DATE:
POLICY DESCRIPTION:
Procedure for Identifying and Billing Clinical Trial
Patients
REPLACES POLICY DATED: New
RETIRED:
REFERENCE NUMBER:
3. Trials of therapeutic interventions must enroll patients with
diagnosed disease rather than healthy volunteers. Trials of
diagnostic interventions may enroll healthy patients in order
to have a proper control group.
Research Gatekeeper
The three requirements above are insufficient by themselves to
qualify a clinical trial for Medicare coverage of routine costs.
Clinical trials also should have the following desirable
characteristics; however, some trials as described below, are
presumed to meet these characteristics and are automatically qualified
to received Medicare coverage (See Clinical Trial Billing Checklist):
1. The principal purpose of the trial is to test whether the
intervention potentially improves the participants’ health
outcomes;
2. The trial is well-supported by available scientific and medical
information or it is intended to clarify or establish the health
outcomes of interventions already in common clinical use;
3. The trial does not unjustifiably duplicate exiting studies;
4. The trial design is appropriate to answer the research question
being asked in the trial;
5. The trial is sponsored by a credible organization or individual
capable of executing the proposed trial successfully;
6. The trial is in compliance with Federal regulations relating to
the protection of human subjects; and
7. All aspects of the trial are conducted according to the
appropriate standards of scientific integrity.
Research Gatekeeper
Effective September 19, 2000, clinical trials that are deemed to be
automatically qualified are (See Clinical Trial Billing Checklist):
1. Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA;
2. Trials supported by centers or cooperative groups that are
funded by the NIH, CDC, AHRQ, CMS, DOD and VA;
3. Trials conducted under an investigational new drug
application (IND) reviewed by the FDA; and
4. Drug trials that are exempt from having an IND under 21 CFR
HCA
The Healthcare Company
DEPARTMENT:
Sunrise Hospital
PAGE: 3 of 6
APPROVED:
EFFECTIVE DATE:
POLICY DESCRIPTION:
Procedure for Identifying and Billing Clinical Trial
Patients
REPLACES POLICY DATED: New
RETIRED:
REFERENCE NUMBER:
312.2(b)(1) will be deemed automatically qualified until the
qualifying criteria are developed and the certification process
is in place. At that tine the Principal Investigators of these
trials must certify that the trials meet the qualifying criteria in
order to maintain Medicare coverage of routine costs. This
certification process will only affect the future status of the
trial and will not be used to retroactively change the earlier
deemed status.
Research Physician/designee
Institutional Review Board
Each clinical trial will be documented on a Clinical Trial Billing
Notice (see attached) by the research physician/designee. The
Clinical Trial Billing Notice will be distributed with the IRB
application packet. This document will provide all the pertinent
information needed to track the details of the clinical trial.
Research Physician/designee
Research Physician/designee
The research physician/designee is responsible for completing the top
portion of the Clinical Trial Billing Notice upon receiving IRB
approval for the clinical trial. The form will be faxed to the Research
Gatekeeper for review and distribution to appropriate hospital
departments. The research physician/designee is responsible for
completing the bottom portion of the Clinical Trial Billing Notice
with each inpatient/outpatient encounter that occurs for each research
participant. The form will be faxed to the Research Gatekeeper for
review and distribution to appropriate hospital departments.
Research Gatekeeper
IT&S Meditech Application
Analyst
Upon receipt of the Clinical Trial Billing Notice, the Research
Gatekeeper will contact the IT&S Meditech Application Analyst to
establish a client/industrial account for the clinical trial.
Research Physician/designee
Ethics and Compliance
Research Gatekeeper
The research physician/designee will be responsible for providing
contract amendments updates to the facility Ethics and Compliance
office. The Research Gatekeeper is responsible to notify the
appropriate hospital departments of relevant contractual changes
affecting patient registration or billing.
Scheduling
The hospital department schedules procedure/test according to
normal protocols; a prompt will be in the scheduling module to
Research Gatekeeper
HCA
The Healthcare Company
DEPARTMENT:
Sunrise Hospital
PAGE: 4 of 6
APPROVED:
EFFECTIVE DATE:
POLICY DESCRIPTION:
Procedure for Identifying and Billing Clinical Trial
Patients
REPLACES POLICY DATED: New
RETIRED:
REFERENCE NUMBER:
identify patient as a research participant.
Scheduling
Research Physician/designee
Registration
Scheduling and/or research physician/designee will notify the PAD
and/or PAM of the scheduled patient.
If PAD and/or PAM have been previously notified of scheduled
research patient, registration notifies staff and insurance/pre
registration staff, if applicable, of scheduled patient and verifies they
have received the Clinical Trial Billing Notice indicating which
services will be billed to the clinical trial sponsor, and therefore not
requiring pre-authorization by the insurance.
The registration is completed using the “Clinical Trial” provider as
the guarantor. I-Plan 698-10 “Misc-Research Patients” is assigned to
the account possibly along with the patient’s health insurance I-Plan,
if the patient is receiving both research and non research related
services. This information should be provided on the Clinical Trial
Billing Notice.
If registration has no information on the patient and patient presents
for an outpatient procedure, the Registrar will ask patient if they are
involved in a clinical trial through a prompt in Meditech.
Registrar will place a condition code “30” in Meditech to indicate the
patient is involved in a clinical trial. This condition code will inform
the PAS billing staff this patient’s claim needs to be evaluated for the
appropriate billing process as patient is involved in a clinical trial.
Account should be placed on “hold” to ensure it is reviewed for
appropriate charge splitting prior to final bill.
Nursing
Patient will be asked through prompts in Meditech during the
Nursing History to ensure all information is obtained regarding
clinical trial participation.
HIM
Clinical Areas
A positive response to the Meditech research prompts will generate
reports that will be sent to the appropriate clinical areas (pharmacy,
OR, Cath Lab) and to Health Information Management. HIM is
HCA
The Healthcare Company
DEPARTMENT:
Sunrise Hospital
PAGE: 5 of 6
APPROVED:
EFFECTIVE DATE:
POLICY DESCRIPTION:
Procedure for Identifying and Billing Clinical Trial
Patients
REPLACES POLICY DATED: New
RETIRED:
REFERENCE NUMBER:
responsible for retaining research participant records for a period of
30 years.
Revenue Integrity
Facility Revenue Integrity department will review and split the
charges per the clinical trial contract. Charges will be split according
to the contract for compliant billing. Various billing scenarios could
occur depending on the contract and services provided.
1. If all charges are related to the clinical trial, then all charges
can be billed on a UB04 following the process outlined in the
clinical trial contract.
2. If only specific charges can be billed to the clinical trial then
all charges related to patient’s routine health care will be
billed to patient’s health plan and billed on a UB92 form. All
charges related to the clinical trial will be billed on an
client/industrial account as indicated in the contract.
Revenue Integrity
Revenue Integrity will transfer the charges from the patient account to
the “client/industrial account” and release the claim from hold once
completed.
The breakdown of charge information will be placed in Artiva and
serve as an audit trail.
PAS Billing
An edit will be established in the SSI Billing System to prevent the
claim from automatically processing. The edit will be written by
reading the condition code 30 and will require each claim to be
manually reviewed to ensure compliant billing.
Billing will review notes in Artiva to ensure compliant billing per the
hospitals Revenue Integrity department documentation.
PAS Collections
For accounts billed to the patient’s health plan the account will be
followed-up through the normal Collections process.
Client/Industrial Account
For accounts billed to the client/industrial account the account will be
HCA
The Healthcare Company
DEPARTMENT:
Sunrise Hospital
PAGE: 6 of 6
APPROVED:
EFFECTIVE DATE:
Billing and Follow-Up
POLICY DESCRIPTION:
Procedure for Identifying and Billing Clinical Trial
Patients
REPLACES POLICY DATED: New
RETIRED:
REFERENCE NUMBER:
followed-up through the normal Collections process.
REFERENCE:
SSI Billing Vendor Processing Manual
Patient Accounting User’s Guide/Folio Views
CPT/HCPCS and ICD9 Manuals
UB92 Editor Manual

Documentos relacionados