• To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or
• To determine the optimal anatomic location for an invasive procedure; or
• To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.

Please note that the use of FDG-PET imaging for diagnosis of cervical cancer is non-covered and should be coded with G0235.

These decisions are final and effective for all claims date of service (DOS) November 10, 2009 or after.

PET facilities participating in the NOPR, should note that initial staging of cervical cancer cases that were previously covered only under NOPR no longer need to be put through the registry as these cases are now covered. Prior to November 10, 2009, PET performed for initial staging of cervical cancer could be done only under NOPR if: (1) prior CT or MRI was not performed, or (2) prior CT or MRI was performed but showed evidence of extrapelvic metastatic disease. We are in the process of making the necessary modifications to the NOPR case report forms to delete initial staging of cervical cancer (and diagnosis of cervical cancer as reasons for inclusion in the NOPR. You will be notified when the new forms must be put into use.

A summary of the decision can be found in the Society of Nuclear Medicine (SNM) decision summary posted online: http://interactive.snm.org/index.cfm?PageID=9266

Please see CMS link: https://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=232&

At this time, CMS is soliciting comments on the NOPR’s request. The public comment period will be open for 30 days, until December 9, 2009.

PET facilities participating in the NOPR are encouraged to provide comments (which can be entered directly on-line at the CMS web site). More importantly, we encourage PET facilities to ask that referring physicians who frequently use PET in their care of patients to submit comments to CMS indicating how PET has helped them in the care of their patients.

PET facilities that have acquired new scanners since completing their NOPR facility registration application (and have not updated this information in the database) are being asked to provide us with that information now. Please provide us with the manufacturer and model of your newly acquired PET or PET/CT scanner so that we may update the NOPR database. Also provide the date the new scanner went into service, and indicate whether it was a replacement for an older scanner or was an additional scanner at your facility. In addition, if the new scanner has been used for any cases enrolled in the registry, please provide the NOPR case numbers for which the new scanner information has been used.

Please submit the requested information by e-mail to the NOPR at pet_registry@phila.acr.org including the NOPR facility id number, the scanner manufacturer and model, the date put into service, whether it replaced an existing scanner or was an additional scanner, and list of cases enrolled using the new scanner. A list of scanners is attached to this notice.

All updates must be submitted to pet_registry@phila.acr.org by November 13, 2009.

Going forward, please remember to update your facility information whenever a new scanner is put into service and being used for the NOPR. Beginning in January 2010, participating sites will be required to update information about their scanners periodically. We will provide notice before this requirement becomes effective.

These transmittals further refine and clarify billing instructions to PET facilities and Medicare Administrator Contractors of the change in the effective date of the new coverage to April 3, 2009 and the implementation date to October 30, 2009. In addition, Business Requirements (BR 6632.6.1 and 6632.6.2) have been revised to clarify that they are subsets of BR 6632.6 and as such are specific to Coverage with Evidence Development (CED).

All other information remains unchanged.

A summary of the transmittal can be found in the Society of Nuclear Medicine (SNM) transmittal summary posted online: http://interactive.snm.org/index.cfm?PageID=9163

For additional information, please see the following:

Related Items

• CMS Published Transmittal 108 CR6632 Medicare Claims Processing Instruction for April 09 PET NCD
• CMS Published Transmittal 1833 CR 6632 Medicare National Coverage Determinations Manual Update for April 09 PET NCD
• CMS Re-issues Billing Instructions for April FDG-PET NCD Changes
• Billing for PET Studies in Medicare Patients, Pending Medicare Claims Guidance
• CMS Releases Final PET NCD
• Billing for PET Studies in Medicare Patients, Pending Medicare Claims Guidance

CMS Transmittal’s 1817 & 106, Change Request 6632, dated September 18, 2009

http://www.cms.hhs.gov/transmittals/downloads/R106NCD.pdf

As a reminder, Transmittal 1772, Change Request 6464, dated July 17, 2009, was rescinded and is replaced by CR6632. On September 18, 2009, CMS released to the Medicare Administrative Contractors (MACs) the long awaited and reissued Guidance and Billing Instructions for the April 2009 changes to the National Coverage Determination (NCD) on Positron Emission Tomography (FDG). Providers will have two new modifiers (in addition to the list of current modifiers) to consider when submitting claims with a date of service (DOS) April 6, 2009 for CPT codes 78608, 78811-78816 for oncologic procedures. Available on or after the implementation date of October 19, 2009, providers submitting claims with a DOS on or after April 6, 2009 for CPT codes 78608, 78811-78816 are now required to identify the procedure as either for initial treatment strategy or subsequent treatment strategy by appending the modifiers PI or PS, respectively.

CMS removed the previously identified ICD-9 range of codes allowing discretion at the local level with the Medicare Contractors. CMS did identify the combination of PI and ICD-9 code 185 as the newly non-covered use of PET for adenocarcinoma of prostate. Providers participating in the national oncologic PET registry (NOPR) for those procedures that continue to be covered only under coverage with evidence development (CED) continue to use the Q0 (zero) modifier and/or V70.7 in the second diagnosis position with condition code 30 in addition to using one of the two new modifiers below.

New Modifiers for PET Effective for Dates of Services (DOS) on or after April 6, 2009 Implemented on or after October 19, 2009

• PI – Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform the initial treatment strategy of tumors that are biopsy proven or strongly suspected of being cancerous based on other diagnostic testing. Short descriptor: PET tumor init tx strat
• PS – Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform the subsequent treatment strategy of cancerous tumors when the beneficiary's treating physician determines that the PET study is needed to inform subsequent anti-tumor strategy. Short descriptor: PET tumor subsq tx strategy

Since the Medicare Administrative Contractors have 30 days (no sooner than October 19) to implement these changes in their systems, that means PET facilities do too. Continue to submit your claims in accordance with past recommendations until your local contractor issues local instructions and implementation date.

A summary of the transmittal can be found in the Society of Nuclear Medicine (SNM) transmittal summary posted online: http://www.snm.org/index.cfm?PageID=9025&RPID=10

CMS states they will post a MLN Matters Educational article. Stay tuned for more details.

Related Items

• CMS Published Transmittal 106 CR6632 Medicare Claims Processing Instruction for April 09 PET NCD
• CMS Published Transmittal 1817 CR 6632 Medicare National Coverage Determinations Manual Update for April 09 PET NCD
• CMS Releases Final PET NCD
• Billing for PET Studies in Medicare Patients, Pending Medicare Claims Guidance

These transmittals serve as notification to PET facilities and Medicare Administrator Contractors of the new coverage policy for oncologic PET scans under which coverage has been expanded for the use of PET for initial treatment strategy evaluation (formerly diagnosis and initial staging) of patients with nearly all cancer types, and also will allow for use of PET in subsequent treatment strategy evaluations (formerly restaging, detection of suspected recurrence and treatment monitoring) for an expanded number of cancer types.

Also, included is the introduction of the following new modifiers: PI and PS to be used to inform for the initial or subsequent treatment strategy and KX to be used whenever a non-cancer ICD-9 code is submitted with a claim.

Since the Medicare Administrator Contractors have 30 days (no sooner than August 17) to implement these changes in their systems, that means PET facilities do too. Continue to submit your claims in accordance with past recommendations until your local contractor issues local instructions and implementation date.

We will provide additional information about the implementation of these new billing procedures as it becomes available.

A summary of the transmittal can be found in the Society of Nuclear Medicine (SNM) transmittal summary posted online: http://interactive.snm.org/index.cfm?PageID=8889

CMS transmittal link:

CMS Publishes April Final PET NCD For Solid Tumors and Myeloma and Additional Manual Updates CMS Publishes Medicare Claims Processing Instructions for PET NCD For Solid Tumors and Myeloma and Additional Manual Updates

http://interactive.snm.org/index.cfm?PageID=8734&RPID=1995

SPN and MPN PET Medicare Coverage Created: May 28, 2009

Question

We are confused about the Medicare PET coverage for lung masses, solitary pulmonary nodules and multiple pulmonary nodules. Can you please clarify? In the past we were billing with diagnosis codes 518.89 or 793.1 prior to biopsy when a biopsy was not available or medically feasible. Can you tell us which ICD 9 indications the Medicare contractors will accept as payable?

Answer

Deciding whether or not to do a PET scan and whether or not it is covered requires medical judgment, as well as compliance judgment. Where PET fits into the continuum in the evaluation of patients with lung nodules depends on many factors including the full clinical history, risk factors for lung cancer, history of prior cancers, the CT appearance of nodule(s), etc. Thus, the answer rests on the specific clinical question being posed by the referring MD. Moreover, the question should be well thought out before ordering an expensive diagnostic test.

To address the questions, we will give a few examples, but these are by no means all of the possibilities. Each of these examples is included under the current Medicare coverage for "initial treatment strategy".

As a general rule, it is usually preferable to get a tissue diagnosis before launching a complex imaging evaluation of a suspected cancer anywhere in the body. This is not always possible, however, and not always the best first step.

In the case of a single nodule or mass thought highly likely to be a primary lung cancer, PET is often ordered before biopsy, less as a test to diagnose cancer, but rather to stage the cancer. If PET demonstrates other lesions (e.g., supraclavicular or mediastinal nodes), it may be far easier to biopsy these than the index lesion in the lung.

In the case of an indeterminate solitary pulmonary nodule, PET is done for diagnosis (to determine whether the lesion is more likely benign or malignant). If PET is negative, the patient typically does not undergo biopsy. In other words, PET helps in this situation to avoid an invasive diagnostic procedure. The situation is similar with an indeterminate biopsy; if PET is negative; the patient is typically followed and avoids an even more invasive diagnostic procedure (resection by VATS or thoracotomy).

The situation with multiple pulmonary nodules also involves several scenarios.

If one or more of the nodules appear spiculated and the patient is a smoker, such that multifocal adenocarcinoma of the lung is the most likely diagnosis, we would view this as an instance of "Lung Cancer: Diagnosis", which is definitely a Medicare-covered indication. Depending on which ICD-9 codes your carrier accepts for a case like this as indicating medical necessity, you may need to be prepared to appeal for payment. Thus, extra care in documentation of medical necessity in the PET report is advised.

If the multiple nodules appear round and smooth and there is significant clinical concern for metastatic disease to the lungs from an unknown primary tumor, PET previously would have had to be performed under NOPR as "Diagnosis: Unknown Primary". This is now a Medicare-covered indication. The same proviso as above regarding ICD-9 codes to document medical necessity applies. We repeat extra care to document medical necessity in the PET report is advised.

Each Medicare Administrative Contractor (MAC) will be accessing and developing its own list of covered ICD-9 codes based on the April 3, 2009 National Coverage Determination (NCD) for PET. The current situation is in flux, because the CMS transmittal to the carriers pursuant to the recent NCD has not yet been issued, as of the date of this Q&A. The Medicare contractors will eventually be developing new lists of ICD-9 codes to support medical necessity. There will likely be much dialog between providers, medical specialties and contractors before the LCDs are finalized.

Please visit here (http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?from2=viewdecisionmemo.asp&id=218&) to see the final CMS PET NCD.

Disclaimer

The opinions referenced are those of the members of the SNM Coding and Reimbursement Committee and their consultants based on their coding experience. They are based on the commonly used codes in Nuclear Medicine, which are not all inclusive. Always check with your local insurance carriers as policies vary by region. The final decision for the coding of a procedure must be made by the physician considering regulations of insurance carriers and any local, state or federal laws that apply to the physicians practice. The SNM and its representatives disclaim any liability arising from the use of these opinions.

• All new patients will be registered in the new database (NOPR 2009).
• New facility registrations will only be accepted via the new database (NOPR 2009).
• Most of the data collection questions are the same or similar to the questions in the original registry, but there are some important differences, especially for PET studies being done for treatment monitoring. On Monday April 6th, facilities should download and review the new Operations Manual and new case report forms (CRFs), and the slightly revised Patient and Referring Physician Information Sheets (consent forms) that are available on the NOPR Web site. The new Pre-PET Form and Patient Information Sheet is available now at <http://nrdr.acr.org/PETRegistry/prePETwithConsent.pdf>
• The new registry will require the referring physician to sign both the Pre-PET and the Post-PET forms submitted for each patient attesting to the accuracy of the data on the forms.

• Data for patients previously entered into the NOPR will continue to be stored and accessed through the 2006 Version.
• Patients currently registered in NOPR who had their PET performed on or before April 3, 2009 will remain in the current registry database (NOPR 2006) and their data will continue to be entered in that database. This will allow for data collection on open cases and report generation on all cases with scan completion dates prior to April 3, 2009.
• For patients registered in the current database (NOPR 2006) who did not have PET performed on or before April 3, 2009, the case registration should be cancelled and the patient should be re-registered in the new database (NOPR 2009). To be clear, the PET facility is responsible for canceling and re-registering these patients. Credits that are applied to accounts in NOPR 2006 after April 3, 2009 will be transferred to the facility’s account in NOPR 2009.

• All facility information and escrow balances will be transferred from the original database (NOPR 2006) to the new database (NOPR 2009). Facility staff who have been entering patients on the existing database will be able to enter new patients on the new database immediately.

1. after completion of treatment for the purpose of detecting residual disease; or
2. for detecting suspected recurrence or metastasis; or
3. to determine the extent of a known recurrence:
4. if it could potentially replace one or more conventional imaging studies when it is expected that conventional study information is insufficient for the clinical management of the patient.
5. Restaging applies to testing after a course of treatment is completed, and is covered subject to the conditions above.

Comment: As noted above, PET is not covered as a screening test (i.e., testing patients without specific signs and symptoms of disease) and thus is not covered for surveillance of patients treated for cancer in whom there is no clinical reason to suspect recurrent disease.

Comment: As an example, PET performed under NOPR may be covered for monitoring after 2 or 3 of a planned 6 cycles of chemotherapy in a patient considered not to be responding as expected.

• Keep the current site operational until midnight (ET) on the publication date for sites to register and enter pre-PET data for cases that were scanned earlier on that day.
• Send out a broadcast announcement to all NOPR users outlining the changes in NOPR and in Medicare coverage for PET.
• At midnight ET, close the current NOPR web site for new entries and temporarily close it for data collection.
• Within 12 to 72 hours, depending upon when the NCD is published, open a new site (NOPR 2009) for entry of cases eligible under the new criteria, and re-open the old site (NOPR 2006) for data entry on cases still in progress under the old program. Note that the planned successor CED program (NOPR 2009) will require the use of revised pre- and post-PET forms to be completed by the referring physician and slightly revised Patient and Referring Physician Information Sheets (consent forms).

• For the next few days, wait until a patient appears for his/her scan to register the patient in the current NOPR system. [ Whether a patient will need to be registered and have data collected in the NOPR 2006 system or the NOPR 2009 system depends on the date of service (i.e., the date of the PET scan). In other words, if a patient is registered in NOPR 2006, but not scanned until after NOPR 2009 is operational, the old registration would need to be cancelled and the patient would need to be re-registered in the new system.]
• If a patient must be scanned while NOPR is closed for patient entry, complete the paper version of the case registration form and the new Pre-PET Form and fax them to NOPR Headquarters.
• As soon as the registry reopens, download the new versions of the case report forms, Patient Information Sheet, Referring Physician Information Sheet, and Operations Manual from the Web site.
• Begin using the new forms for cases entered into NOPR 2009 and continue using the old forms for cases previously entered into NOPR 2006 (for which all data collection has not yet been completed).

The Medicare Monthly Review MMR 2008-2, page 71-73 states; NOTE: If a Category A or B investigational device is used on the clinical trial, providers should continue to include the Investigational Device Exemption (IDE) in item 23 of the CMS 1500 claim form or the electronic equivalent. Also, your Medicare contractor will validate the IDE# number when it appears on the claim with the Q0 modifier and if the IDE# does not meet validation criteria, the claim will be returned as unprocessable.

Date: Sunday November 25
Session Time: 10:45 - 12:15 PM;
Room: E353C

1. body PET or PET/CT only (examination billed with one CPT code in the range from 78811 through 78816);
2. dedicated brain PET only (examination billed with CPT code 78608); or
3. body PET or PET/CT AND dedicated brain PET (examination billed with one CPT code in the range from 78811 through 78816 AND with CPT code 78608).

• The individuals responsible for data entry at some PET facilities are answering this question on the Pre-PET Form incorrectly. We believe this is the most likely explanation in most of these cases. Accordingly, we request that staff at each PET facility review the procedures they are using to determine what specific PET procedures have actually been performed and will be billed to Medicare. In addition, we will be adding some further instructions about this on the PET Completion Form.
• The dedicated brain PET studies were reported separately from the body PET studies, but only the body PET reports were uploaded to the NOPR database. We think this is unlikely based on the reports reviewed. However, we are requesting that PET facilities upload both brain and body reports when both have been performed. We will add a reminder to this effect on the Web screen for PET Report Submission Form.
• The studies have been coded and billed incorrectly, e.g. the study was billed with CPT codes 78815 and 78608 when only billing for 78815 was justified based on the request from the referring physician and/or the technical details of the study performed and interpreted. If this is the case, it could present a compliance problem for the PET facility. Accordingly, we encourage staff at participating PET facilities to review their billing processes and the criteria they use to determine when to bill for dedicated brain PET. We further suggest that PET facilities forward a copy of this notice to individuals responsible for billing and compliance (and to the corresponding individuals in the physician practice, if professional-component billing is performed separately).

• your facility name;
• your facility number; and
• he case ID number(s) needing to be corrected.

a. Cancer Type (ICD-9 Code) - check the one cancer that most closely relates to the specific reason for the PET study indicated in response to Question 1. (Check only one)

Note: The three-digit ICD-9 codes included on this form are for purposes of identifying the cancer type in the NOPR database, but the one selected is not necessarily the one that should be used for claim submission.

Acceptable responses are 159, 165, 173, 181, 184, 192, 194, 195, and 235-238

• New Question 3 added:
  • 3. Region(s) Scanned (you must check only one)
    • Body Only (CPT 78811-78816)
    • Brain Only (CPT 78608)
    • Both Body AND Brain (CPT 78811-78816 AND 78608)
• Original Question 3 renumbered as Question 4 and original Question 4 renumbered as Question 5.

• Diagnosis: To determine if a suspicious lesion is cancer
• Diagnosis/Unknown Primary Tumor: To detect a primary tumor site in a patient with a confirmed or strongly suspected metastatic lesion
• Diagnosis/Paraneoplastic: To detect a primary tumor site in a patient with a presumed paraneoplastic syndrome
• Initial Staging of histologically confirmed, newly diagnosed cancer
• Monitoring Treatment Response during treatment
• Restaging after completion of therapy
• Suspected Recurrence of a previously treated cancer

• The PET Completion and the PET Report Submission Forms have been changed. The question asking the name of the interpreting radiologist has been moved from the PET Completion Form to the PET Report Submission Form. This change is intended to prevent delays in the submission of the PET Completion Form when the name of the interpreting radiologist is not known until the PET report is completed.
• As a further aid to the timely submission of time-critical data, due dates for future form submissions have been added to several of the e-mail reminders.
  • Pre-PET Form Submission Confirmation - the due date for the PET Completion Form has been added to this e-mail.
  • PET Form Reminder - the due date for the PET Completion Form has been added to this e-mail.
  • Post PET Form Reminder - the due date for the Post-PET Form has been added to this e-mail.

• A note concerning potential limitations of FDG-PET for cancers and indications covered by NOPR has been added:
  • IMPORTANT NOTE: The scientific evidence concerning the clinical utility of FDG-PET is generally less robust for cancers and indications that are currently covered by Medicare only in the NOPR than for cancers and indications that are currently covered without clinical data submission to the NOPR. For this reason, Medicare has conditioned coverage of FDG-PET under the NOPR on the collection of clinical data. These data will be used to help determine the clinical utility of FDG-PET for conditionally covered cancers and indications. The billing physician remains responsible for documenting medical necessity, which is required for the coding and billing of both covered and NOPR-eligible PET studies. Eligibility for the NOPR does not constitute a clinical management recommendation for the use of PET for the conditionally covered cancers and indications, by either the Medicare program or NOPR investigators. Referring and interpreting physicians are thus advised to refer to the published literature to better understand the potential limitations of FDG-PET for NOPR-eligible uses.
• The entry for Male Breast Cancer has been changed to reflect its eligibility for inclusion into the NOPR, which is identical to that for Female Breast Cancer.
• The following footnote was added for Diagnosis of both Female and Male Breast Cancer:
  • PET is non-covered for "Diagnosis" of breast cancer to evaluate a suspicious breast mass. However, a patient with suspected breast cancer is eligible for entry in NOPR for the indications (1) "Diagnosis: Unknown Primary Site" in a patient with axillary nodal metastasis but no evident primary breast cancer by conventional evaluation and (2) "Diagnosis: Paraneoplastic Syndrome".
• A footnote was added for Anal Cancer eligibility:
  • Some Medicare carriers include anal cancer in their coverage of "colorectal cancer"; for PET facilities served by those carriers, PET for anal cancer diagnosis, initial staging, or restaging/suspected recurrence would be a covered indication.
• A General Note was added:
  • GENERAL NOTE: PET imaging of the brain with CPT code 78608 for diagnosis, initial staging, treatment monitoring, or restaging/suspected recurrence of any type of cancer is covered only under NOPR.

• Case Registration Form - Scan Date - You will once again be able to enter the correct date if the scan date is the date of case entry.
• Pre-PET Form - the ICD-9 code must be entered for all patients' whose cancer type (question 2a and 2c) is entered as "Other, or not listed." This was explained in greater detail in the NOPR Update of September 1, 2006 and the reminder sent on September 5, 2006.
• PET Report Submission Form - The entry of text of less than 500 characters in the text box for the PET report will cause a pop-up window to appear asking for confirmation that the complete PET report has been entered.

• Revised to emphasize that the PET Completion Form must be entered in the database within 14 days of case registration. Revised sections include: Schema, Section 7.0, and Appendix I.

• A section, "Covered Indications for PET Scans and Limitations/Requirements for Usage," has been added to the instructions for question 1, "Specific Reason for PET Study."
• Question 2a and 2c revised to collect the ICD-9 code for all cancer types or metastatic disease sites entered as "Other or not listed."

1. Berner U, Menzel C, Rinne D, et al. Paraneoplastic syndromes: detection of malignant tumors using [(18)F]FDG-PET. Q J Nucl Med 2003; 47:85-9.
2. Rees JH, Hain SF, Johnson MR, et al. The role of [18F]fluoro-2-deoxyglucose-PET scanning in the diagnosis of paraneoplastic neurological disorders. Brain 2001; 124: 2223-31.
3. Younes-Mhennia S, Janier MF, Cinotti L, et al. FDG-PET improves tumour detection in patients with paraneoplastic neurological syndromes. Brain 2004; 127:2331-8.

• Patient Information Sheet - updated to include contact information for questions concerning research subjects' rights and research-related injury. An updated version of the Spanish translation will be posted when available.
• Physician Information Sheet - updated to include:
  • Notification that records will be stored "permanently".
  • Notification of right to withdraw from, or not participate in, the study with no loss of benefits.
  • Contact information for questions concerning research subjects' rights and research-related injury.
• Case Registration Form
  • Clarification of question 1, "Ethnicity." Added: [Note: "Hispanic" is defined as a person of Cuban, Mexican, Puerto Rican, South or Central American, or other Spanish culture or origin, regardless of race.]
  • Referring physician e-mail address will no longer be collected.
• Pre-PET Form
  • Revised to reflect the new delivery procedures described above.
  • Question 1, Specific Reason for PET Study. Answer for "Diagnosis/Unknown Primary Tumor" amended to read: "To detect a primary tumor site in a patient with a confirmed or strongly suspected metastatic lesion (answer 2c)"
  • Question 2.c - Amended to read: "Unknown primary: site of pathologically proven or strongly suspected metastatic disease (196-199)"
  These changes will allow for inclusion of patients where pathologic confirmation of metastatic disease is not possible or not in the patient's best interest. The most common example of this situation would be a patient presenting with multiple brain lesions seen on MRI that are most consistent with metastases, and without an apparent primary cancer after a conventional diagnostic assessment. In this situation, PET is typically ordered not only to find the occult primary tumor, but also to find a more accessible site for biopsy.
• Post-PET Forms - revised to reflect the new delivery procedures described above.
• HIPAA Compliance and IRB Approval for the NOPR (Appendix IV)
  • Revised to reflect the new Pre- and Post-PET Form delivery procedures
  • Added ACR IRB "Statement Regarding Use of Individual Protected Health Information in NOPR"
• Operations Manual - updated to incorporate all changes listed above. Revised sections include: Schema, Section 5.0 Registry Workflow, Appendix I, Appendix II, and Appendix IV.