NOTICES
GOVERNOR'S OFFICE
Catalog of Nonregulatory Documents
[36 Pa.B. 4277]
[Saturday, August 5, 2006]Under Executive Order 1996-1, agencies under the jurisdiction of the Governor must catalog and publish non-regulatory documents such as policy statements, guidance manuals, decisions, rules and other written materials that provide compliance related information. The following compilation is the tenth list of the non-regulatory documents. This list is updated and published annually on the first Saturday in August.
This catalog is being provided to ensure that the public has complete access to the information necessary to understand and comply with state regulations. We have made every effort to ensure that the catalog includes all documents in effect as of August 5, 2006; however, due to the breadth and changing nature of these documents, we cannot guarantee absolute accuracy. Facilitating access to information is important to enhancing the partnership between the regulated community and the state.
Governor
ADMINISTRATION
Editor's Note: The Index of Issuances, Manual M210.3, issued by the Governor's Office of Administration, Directives Management System, includes Executive Orders, Management Directives and Manuals. New or revised documents to the Index are published monthly in the PA Bulletin and the entire index is revised yearly in the PA Code.
AGING
DECISIONS:
Office of Chief Counsel
Contact: Anna M. Borro, Assistant Counsel (717) 783-1609
* Reynolds vs. Department of Aging, 570 A.2d 1373 (Pa. Commw. 1990).
* Pennsylvania Department of Aging v. Lindbergh, 469 A.2d 1012 (Pa.1983).
* Suburban/Bustleton v. Department of Aging, 579 A.2d 426 (Pa. Commw. 1990).
* McGuire v. Department of Aging, 592 A.2d 830 (Pa. Commw. 1991).
* Dickey v. Department of Aging, 615 A.2d 990 (Pa. Commw. 1992).
* In the Interest of M.B., 686 A.2d 87 (Pa. Commw. 1996).
* Calabro v. Department of Aging, 689 A.2d 34 (Pa. Commw. 1997).
* Calabro v. Department of Aging, 698 A.2d 596 (Pa. 1997).
* Schaffren v. Philadelphia Corporation for Aging, 1997 U.S. Dist. Lexis 17493 (Middle Dist. Pa., 1997).
* Scanlon v. Department of Aging, 739 A.2d 635 (Pa. Commw. 1999).
* Nixon v. Com. of PA, 789 A.2d 376 (Pa. Commw. 2001).
* Peek v. Department of Aging, 873 A.2d (Pa. Commw. 2005).
* Silo v. Commonwealth, 886 A.2d 1193 (Pa. Commw. 2005)
* Commonwealth v. TAP Pharmaceutical Products, Inc., 885 A2d 1127 (Pa. Commw. 2005)
INTERNAL GUIDELINES:
PHARMACEUTICAL PROGRAM (PACE)
Contact: Gretchen Beard, Chief of Compliance Division (717) 787-7313
PACE PROVIDER BULLETINS: 2006
* June 16, 2006--MEDICARE DISCOUNT CARDS and OTHER COVERAGE CODES: The First Health Medicare Discount Card Program (MDP) ended on May 15, 2006. Claims filled on, or before, May 15th may still be submitted to First Health MDP; claims filled after May 15th are not eligible for reimbursement.
* June 9, 2006--Primary Plans With Prior Authorization: Increasing numbers of PACE and PACENET cardholders have Medicare Part D plans. As required by regulation, PACE and PACENET are billed as the secondary payer.
* May 26, 2006--PACE Cardholders enrolled in Medicare Part D Prescription Programs: IMPORTANT INFORMATION FOR PACE PROVIDERS
* May 25, 2006--Claims Review: Beginning Friday, May 26, 2006 PACE will begin reviewing adjudicated claims with an anticipated reimbursement exceeding $500.
* May 12, 2006--June 20, 2006 PACE Payer Specification Revision: Coding crosswalk grid
* May 12, 2006--June 20, 2006 PACE Payer Specification Revision: Please replace page 8 and 9 of your PACE NCPDP v5.1 PAYER SPECIFICATIONS with the accompanying revision.
* May 5, 2006--SECURITY BLUE AND FREEDOM BLUE PRESCRIPTION PLANS: PACE has been advised that effective January 1, 2006, cardholders having either Security Blue or Freedom Blue health plans as their primary payer AND who have any oral pharmaceutical prescribed that was previously billable to Medicare Part B MUST now use MEDMARK.
* April 28, 2006--MANUFACTURERS' REBATE NON-PARTICIPATION: NABI (North American Biological Inc) Labeler Code--59730
* April 21, 2006--OTHER COVERAGE CODES: Effective immediately, providers are advised that claims submitted to PACE/PACENET with Other Coverage Codes are subject to a desk level audit.
* April 21, 2006--Date the Prescription is Written Edit Questions: Effective February 28, 2006, the Date the Prescription is written is compared against the ''Date of Service'' on original and refilled prescriptions. Original or refill prescriptions whose date of service exceeds 6 months from the date the prescription was written deny with an NCPDP Error M4, PACE Error 724, ''Prescription Time Limit Exceeded.''
* April 14, 2006--MEDICARE PART D Logic Revisions: Effective Thursday, April 20, 2006, PACE is implementing 2 edits to assure the accuracy of data received from Providers submitting Part D claims to PACE as the secondary payer. Providers should be aware that these edits will also apply to all other Programs under the auspices of the Department of Aging.
* March 24, 2006--MANUFACTURERS' REBATE NON-PARTICIPATION: Bajamar Chemical Company Inc. Labeler Code 44184.
* March 10, 2006--BILLING MEDICARE PART D CLAIMS: Providers are to bill PACE for Medicare Part D plans following the same procedure used for the various Medicare Discount plans.
* February 24, 2006--MEDICARE PART D PRESCRIPTIONS and PACE/PACENET: CMS has identified 62,000 PACE/PACENET Cardholders currently enrolled in a Medicare Part D Plan. The majority of these cardholders have been enrolled by Highmark.
* February 17, 2006--MEDICARE PART D PRESCRIPTIONS and OTHER COVERAGE CODES
* January 27, 2006--DATE PRESCRIPTION WRITTEN EDIT: A CD containing the revised PACE Provider Manual and revised NCPDP v5.1 Payer Specifications is currently being prepared for distribution. The revised specifications contain the following fields that will be edited effective February 28, 2006:
* January 20, 2006--Medicare Part D and PACE/PACENET: After January 1, 2006, PACE/PACENET Providers may be presented with both a PACE/PACENET card and a Medicare Part D prescription card.
* January 13, 2006--State Worker's Insurance Fund (SWIF) Program: This Bulletin is to clarify the recent PACE/PACENET/SWIF communication you may have received regarding the processing of pharmacy claims for workers' compensation injured workers.
PACE PROVIDER BULLETINS: 2005
* January 28, 2005--PACE & Generic Substitution: Senate Bill 1167 permits PACE to continue reimbursing for brand name products if the brand name drug is determined to be ''less expensive to the Program'' than the newly introduced A-Rated generically equivalent drug.
* January 28, 2005--MDP Transitional Assistance (T/A): The 2005 $600 T/A benefit for Medicare Discount Program (MDP) cardholders began January 1, 2005.
* January 28, 2005--Optometrist's Prescribing Privileges: Notifies of updated list of drugs established by the Department of Health on October 9, 1998, when The Department of Health promulgated the amending of § 6.1 of the regulations of the Department, 28 Pa. Code Chapter 6, to permit the prescribing of certain medications by optometrists certified to prescribe and administer pharmaceutical agents under § 4.1 of the Optometric Practice and Licensure Act.
* January 28, 2005--Optometrists Allowable Pharmaceutical Products: Updated list for PACE providers.
* February 11, 2005--Prospective Drug Utilization (ProDur) Additions: Effective Monday, February 14, 2005 this criteria will be applied to the following listed drugs
* February 18, 2005--Payer Specifications NCPDP 5.1 FUTURE EDITS: (PLEASE WATCH FOR REVISIONS) The fields listed below are contained in the current version of PACE/PACENET NCPDP v5.1 Payer Specifications dated June 1, 2004. Currently these data fields are not edited. Effective March 22, 2005, PACE will begin editing these fields. Providers are encouraged to contact their software vendors to ensure that valid data is being submitted to PACE in the data fields listed below:
* March 11, 2005--PACE Patient Location Definitions: (PLEASE WATCH FOR REVISIONS) At the request of PACE Providers, we are providing the following definitions to assist in the determining the number to be entered in NCPDP v5.1 field 307-C7, Patient Location.
* March 18, 2005--Non-Participating Manufacturer: Eli Lilly
* April 1, 2005 - REVISED PAYER SPECIFICATIONS NCPDP 5.1 FUTURE EDITS: The fields listed below are contained in the current version of PACE/PACENET NCPDP v5.1 Payer Specifications dated June 1, 2004.
* April 8, 2005--Bextra: Effective April 7, 2005: PACE no longer reimburses for Bextra. The FDA announced that effective April 7, 2005, Pfizer Inc. was voluntarily withdrawing Bextra at the request of the Food and Drug Administration.
* May 6, 2005--Payer Specifications NCPDP 5.1 Future Edits Reminder (Part 1 of 2): The fields listed below are contained in the current version of PACE/PACENET NCPDP v5.1 Payer Specifications dated June 1, 2004. PACE is monitoring these fields and is returning the paid claim with an E.O.B. (Explanation Of Benefits) message whenever Missing or Invalid Data has been entered. Claims containing incorrect or invalid data in these fields will continue to be paid and returned with these EOB's until September 27, 2005. Effective September 27, 2005, claims with missing or invalid data in these fields will deny.
* May 6, 2005--Payer Specifications NCPDP 5.1 Future Edits Reminder (Part 2 of 2): Explanatory Materials for Part 1
* May 13, 2005--Medicare Outpatient Drug Benefit Cardholder Information: The Department of Aging recognizes that many PACE cardholders are worried that this new Medicare benefit will diminish their current PACE coverage. This letter is intended to assure PACE cardholders that the new Medicare outpatient benefit will assist, not replace, PACE.
* June 3, 2005--Payer Specifications NCPDP 5.1 Future Edits REMINDER (Part 1 of 2): The fields listed below are contained in the current version of PACE/PACENET NCPDP v5.1 Payer Specifications dated June 1, 2004. PACE is monitoring these fields and is returning the paid claim with an E.O.B. (Explanation Of Benefits) message whenever Missing or Invalid Data has been entered. Claims containing incorrect or invalid data in these fields will continue to be paid and returned with these EOB's until September 27, 2005. Effective September 27, 2005, claims with missing or invalid data in these fields will deny.
* June 3, 2005--Payer Specifications NCPDP 5.1 Future Edits REMINDER (Part 2 of 2): Explanatory Materials for Part 1
* June 3, 2005--Eli Lilly & Company: Reconsideration of Rebate Participation.
PACE PROVIDER BULLETINS: 2004
* January 9, 2004--Federal Upper Limits (FUL) Pricing for A-Rated Multiple Source Products--Pending additional review, effective January 20th, 2004, the Department of Aging is temporarily suspending FUL reimbursement pricing on A-rated multiple source products.
* January 23, 2004--Provider Telephone Calls: Changes in PACE/PACENET Legislation have the potential for lessening the program's ability to address phone calls in a timely manner. The potential for thousands more to be enrolled in the program requires some interim information to be presented.
* February 6, 2004--Manufacturers' Rebate NONPARTICIPATION NOTICE FOR: MYLAN AND UDL Labs. Effective February 9, 2004.
* February 13, 2004--Clarifications: This memo provides examples of the possible situations involved with helping people understand the use of the PACENET $40 deductible.
* February 20, 2004--Manufacturers' Rebate REINSTATEMENT NOTICE FOR: MYLAN AND UDL Labs.
* February 27, 2004--Timoptic XE Days Supply Permissions: Merck was last manufacturer of 0.25% strength in 2ML size. Only 5ML size is available from Merck and Falcon. Days supply requirement is listed.
* March 12, 2004--Lorazepam/Clorazepate Assistance Program: On March 29, 2004, the Department of Aging will implement the Lorazepam/Clorazepate Assistance Program known as the PA (Pennsylvania) Patient Assistance Program. This new program reimburses for generic formulations of lorazepam and clorazepate.
* March 26, 2004--Renagel: Effective Monday, March 29, 2004 all claims for sevalamer hydrochloride (Renagel) will be denied at the point of sale.
* March 26, 2004--ProDUR Edit Revisions: Effective March 29, 2004, the following list shows the recommended initial maximum dose, maximum daily dose and duration criteria have been added to the Department of Aging's Prospective Drug Utilization Review Program for the following class of drugs.
* May 14, 2004--Non-Participating Drug Manufacturers: Manufacturer Rebate Program requires manufacturers' whose products are paid for by PACE, to pay a rebate to continue having PACE pay for their products. Attached is the latest information on nonparticipants.
PACE PROVIDER BULLETINS: 2003
* January 24, 2003--Pace Software Vendor List: Updates list of known software vendors that will be contacted regarding the requirements of the HIPAA initiative during the testing phase regarding NCPDP 5.1 and requests contact information from providers for vendors not included on the list.
* January 24, 2003--Requests to Void Prescriptions: The PACE Provider Manual, page IV.24 states that providers are responsible for voiding claims for prescriptions paid for by the Program but never received by the cardholder. This bulletin specifies costs and conditions involved with submitting voided claims.
* January 31, 2003--Important Cardholder Information Poster: Please post this provider bulletin. It summarizes general guidance for the cardholder regarding the major conditions under which PACE assistance can and cannot be used.
* February 14, 2003--Lumigan (bimatoprost): Describes dosing restrictions recommended by the manufacturer Allergan and describes subsequent PACE claim handling procedures regarding this medication.
* February 14, 2003--Avage and Botox Cosmetic: PACE legislation prohibits payment for ''drugs prescribed for wrinkle removal. . .''. This bulletin includes these medications in the category and removed them from PACE coverage.
* February 14, 2003--Medical Exception Processing for Lotronex, Forteo and Humira: Specific guidance for these medications.
* March 28, 2003--Early Refill Edit: Effective Monday, April 14, 2003, PACE cardholders must use 85% of their medication, based on the previous prescription's days supply, before the Program will consider the refill for reimbursement.
* April 4, 2003--HIPAA: This bulletin is in response to inquiries regarding the responsibility of the Department of Aging, PACE Program and its contractor, First Health in achieving HIPAA (Health Insurance Portability and Accountability Act of 1999) compliance.
* April 11, 2003--Cardholder Information for Early Refill Edit Poster: Illustrated poster describing that effective Wednesday, May 14, 2003, PACE cardholders must use 85% of their medication, based on the previous prescription's day's supply, before the Program will consider the refill for reimbursement.
* May 23, 2003--Provider Manual Insert: PACE legislation was amended in 1992 to require that cardholders be informed of the Usual and Customary price of the prescription they received under the PACE Program.
* June 6, 2003--Early Refill Edit: The Department of Aging is delaying the implementation of the revised early refill edit. As announced earlier, this revision will require that PACE cardholders must use 85% of their medication, based on the previous prescription's days supply, before the Program will consider the refill for reimbursement.
* August 1, 2003--Relocation: First Health Services announces its office relocation details. New address becomes effective August 11, 2003.
* August 8, 2003--Pro-DUR Edit Revisions: New drug classes to be added effective August 19, 2003.
* August 22, 2003--Important Telephone Numbers: Lists retained and changed general access telephone numbers, as well as, new address of First Health Services/PACE.
* November 28, 2003--Program Changes: Changes pursuant to House Bill 888 become effective January 1, 2004. This bulletin specifies the most notable changes applicable to providers.
* December 26, 2003--New Legislation Cardholder Impact: Further description of changes to PACE/PACENET detailing Income Limit Increases Co-pays, Generics, PACENET Claims Processing and Potential PACE/PACENET Applicants.
PACE PROVIDER BULLETINS: 2002
* January 18, 2002--Important Cardholder Information: It summarizes general guidance for the cardholder regarding the major conditions under which PACE assistance can and cannot be used.
* April 1, 2002--Nonparticipating Manufacturers: Manufacturers are required to extend a rebate to PACE for medications purchased through the program. This bulletin lists all labelers that choose not to participate in extending the required rebate to PACE.
* April 19, 2002--ProDUR Additions: Specifies several new additions to PACE Prospective Drug Utilization Review System. Included are: Prozac Weekly, Rivastigmine, Galantamine, Perindopril, Meloxicam, Doxycycline, Acetaminophen, Propoxyphene Napsylate and Propoxyphene HCL.
* May 3, 2002--PACE Moratorium Information: Provides for a readjustment of the COLA factor used by PACE to reprocess enrollments that were affected by a 2000 Social Security COLA adjustment in mid 2001.
* May 24, 2002--TracleerTM: Specifies the addition of Actelion Pharmaceutical's TracleerTM (bosentan) product to the PACE drug file. Describes the only approved diagnosis and explains the mandatory medical exception processing claims for TracleerTM must undergo.
* August 23, 2002--PACE Moratorium Information: A supplemental PACE moratorium reprocessing project announcement. All affected cardholders and providers are being notified. A toll-free phone number is provided for additional information.
* September 6, 2002--RemodulinTM: A treatment for pulmonary arterial hypertension (PAH), RemodulinTM (treprostinil) injection has been added to PACE program coverage but only for this diagnosis. Claims for this medication must go through the medical exception process to be considered for payment.
* November 8, 2002--HIPAA Compliance: Lists software vendors that will be contacted regarding the requirements of the HIPAA initiative and requests contact information from providers for vendors not included on the list.
* December 27, 2002--Mandatory Substitution of Prilosec: Identifies manufacturers that will be a source for the generic version of Prilosec, omeprazole.
PACE PROVIDER BULLETINS: 2001
* January 26, 2001--Prescription Records: Notified Providers that the Department of Aging will accept the ''daily hardcopy record'' identified in Section 22.62, (c)(3) of Chapter 22, Pharmaceutical Assistance Contract for the Elderly, as being a certification statement which will contain verbiage clearly identifying the prescriptions and stating that the pharmacist, identified by his or her signature, attests to the identified prescriptions' validity, accuracy and completeness. Reminder that Section 22.62 (c) and (d) state that ''hardcopy prescriptions'' and ''other records necessary to disclose the full nature and extent of prescription drugs ... dispensed by a provider shall be retained for 4 years . . .''.
* February 23, 2001--Sarafem: Effective February 26, 2001, the PACE Program will deny all claims for Sarafem. This action is being taken based on the manufacturer's package insert which states, ''Sarafem is indicated for treatment of premenstrual dysphoric disorder (PMDD).''
* March 9, 2001--Immuno suppressants: Notified Providers that effective April 1, 2001, Medicare has eliminated the time limitation for Medicare recipients receiving immunosuppressant drug benefits. This change re-establishes coverage for disabled Medicare recipients as well as Medicare recipients over age 65 who had previously exceeded the Medicare time limit for immunosuppressant drug coverage. Effective April 1, 2001, all medical exceptions for immuno suppressants will calculate the PACE reimbursement based on the percentage NOT reimbursable by Medicare, which is currently 20%.
* March 16, 2001--Mandatory Substitution Coumadin: Notified Providers that effective April 16, 2001, the PACE Program will mandate substitution for all new claims for Coumadin.
* March 16, 2001--Ketoprofen Reminder: Notified Providers that as stated on page V.20 of your PACE Provider Manual, section m, ''Ketoprofen being compounded for off-label use to treat arthritis will be disallowed when identified in utilization review reports.''
* March 23, 2001--PACE--CRDP Cardholders Reminder: Notified Providers that PACE is payor of last resort.
* March 30, 2001--Renagel: Notified Providers that effective Monday, April 9, 2001, PACE will deny all claims for Renagel. No additional medical exceptions will be approved prior to the receipt of supporting diagnostic and treatment information.
* April 20, 2001--Nonparticipating Manufacturers: Notified Providers of manufacturers not participating in the PACE Program.
* April 20, 2001--Mandatory Substitution for Coumadin Clarification: Notified Providers that Cardholders whose prescription history contains Coumadin usage and therefore received a Medical Exception should submit the Coumadin claim to PACE with a DAW code of ''1.'' PACE will not disallow Coumadin claims on future audits in those instances in which a medical exception was granted to continue Coumadin therapy even in the absence of Brand Medically Necessary documentation. Cardholders with no history of Coumadin usage are subject to the Program's mandatory substitution regulations unless a Medical Exception is authorized.
* May 11, 2001--Imitrex: Notified Providers that effective May 14, 2001, PACE Will Deny Claims for all forms of sumatriptan (Imitrex). No medical exceptions will be approved prior to the receipt of a cardiovascular evaluation stating the patient is free of cardiovascular disease.
* May 25, 2001--TOBI(: Notified Providers that effective June 4, 2001, PACE will deny claims for TOBI(. Only approved FDA indication is for the ''management of cystic fibrosis patients with Pseudomonas aeruginosa.'' Off label indications will be denied. Medical Exceptions granted only upon confirmation from prescriber of a diagnosis of cystic fibrosis.
* June 26, 2001--PACENET Expansion: Notified Providers that effective July 1, 2001, PACENET eligibility income limits have been increased. No change in PACE income limits.
* June 26, 2001--PACENET Expansion: Pharmacy poster with details of program changes.
* June 26, 2001--Legislative Changes: PACE Moratorium: Notified Providers that PACE cardholders whose eligibility was terminated in 2001 solely because of a Social Security cost-of-living-adjustment would be reinstated automatically in PACE. An automated process to be established to address PACENET claims for cardholders reinstated into PACE.
* July 6, 2001--GLEEVECTM: Notified Providers that Novartis Pharmaceutical's anti-cancer drug added to PACE drug file. Approved only for treatment of chronic myelogenous leukemia (CML) and not currently covered by Medicare. Provider should understand that PACE will ensure that drug is approved FDA indication and is prescribed in the approved dosage before authorizing payment.
* July 13, 2001--Cardholders with July 15, 2001 Ending Eligibility Dates: Notified providers of an extension of eligibility to August 21, 2001.
* July 20, 2001--Renagel: Notified Providers that effective immediately, only Medical Exception documentation received from prescriber verifying calcium phosphate products of 70 or greater will be considered for the granting of medical exceptions.
* August 10, 2001--Baycol: Notifies Providers that effective August 9, 2001, PACE no longer reimburses for Baycol because of a voluntary manufacturer withdrawal of the product.
* August 24, 2001--PACE Moratorium Agreements: Notifies Providers of agreement mailings and of process involved in the provider refunding the cardholder and PACE reimbursing the provider due to the Moratorium.
* September 21, 2001--Broncholidlator Drugs: Notifies Providers that effective October 1, 2001, the restriction of denying at point-of-sale the reimbursement of these agents has been removed. Medicare remains primary payor. PACE continues to reimburse at 20%, the part not covered by Medicare.
* September 28, 2001--Miscellaneous Agents, Maximum Dosing Edit: Notifies providers that effective October 8, 2001, PACE will review several new agents. Patients whose prescribing regimen exceeds PACE maximum daily dose will have their prescriber contacted to obtain documentation to support dosing therapy.
* November 30, 2001--National Drug Code (NDC) Accuracy: Reminds Providers of their responsibilities in accurately reporting NDCs. Discusses prohibited acts. Providers with error rates greater than 50% may be subject to recovery audit and termination.
* December 14, 2001--Other Prescription Coverage Edit: Specifies proper use of ''Other Coverage Code'' field and identifies NCPDP claim denial responses in the event of improper submission.
PACE Provider Bulletins: 2000
* February 4, 2000--Medical Exception Authorization. Notified Providers that requests for Medical Exceptions for medications routinely prepared during non-processing hours will not be considered. Requests for Emergency Medical Exceptions for medications dispensed under exceptional circumstances during nonprocessing hours may be reviewed.
* February 4, 2000--Other Prescription Coverage. Notified Providers that effective February 14, 2000, PACE will edit claims for PACE cardholders identified by the following insurance carriers: Healthguard; Highmark; Qualmed; Health America; and KHP Central/Senior Blue. Claims submitted to PACE for cardholders identified by these companies will deny if the provider submits the claim with an incorrect Other Coverage value of ''0''--''Not Specified'' or ''1''--''No Other Coverage Identified.''
* February 11, 2000--Alupent Billing. Notified Providers that to assist providers in maintaining billing consistency, PACE is changing its reimbursement calculation for Alupent 14 gm-10ml, NDC 00597007017 from price per ml to price per gram, effective with dates of service of February 19, 2000 and thereafter. Providers submitting a claim for 1 inhaler of Alupent 14 gm-10 ml, NDC 00597007017 should submit a quantity of 14 in the metric decimal quantity field.
* February 11, 2000--Medicare Billable Pharmaceuticals Additions. Notified Providers effective February 14, 2000, PACE will reject the following medications at the point-of-service: Synvisc; Hyalgan; Polygam; Imovax; Leukine; and Aredia because PACE has been advised that, with the proper diagnosis, physicians may submit these claims to Medicare.
* March 3, 2000--Duplicate Therapy Edit. Notified Providers that effective March 13, 2000 and thereafter, PACE is implementing a Duplicate Therapy Edit for benzodiazepines and miscellaneous sedative hypnotics.
* March 24, 2000--Nonparticipating Manufacturers. Notified Providers of manufacturers not participating in the PACE Program.
* March 24, 2000--Propulsid Boxed Warning Revision. Notified Providers that Janssen Pharmaceutica has notified physicians of important changes to its Boxed Warnings, Drug Interactions and Dosage and Administration sections. Highlights of the changes included: 1) A 12-lead ECG should be obtained before Propulsid is administered; 2) Propulsid should not be initiated if the QTs value exceeds 450 milliseconds; and 3) Propulsid is contraindicated in patients with electrolyte disorders (hypokalemia, hypocalcemia and hypomagnesemia). Serum electrolytes should be assessed in diuretic-treated patients before initiating Propulsid and periodically thereafter.
* March 24, 2000--Dentist Prescribers. Notified Providers that effective April 3, 2000, and thereafter, claims containing a dentist's license number in the prescriber license number field and submitted for pharmaceuticals other than antibiotics, analgesics, nonsteroidals or fluoride preparations will reject with NCPDP Error 88, accompanied by the DUR response ''CH.''
* March 24, 2000--Duplicate Therapy Edit. Notified Providers effective April 17, 2000 and thereafter, PACE is augmenting its Duplicate Therapy Edit for Benzodiazepines and Miscellaneous Sedative Hypnotics with the inclusion of Ambien and Sonata.
* March 31, 2000--Oral Antidiabetic Agents. Notified Providers effective June 5, 2000 and thereafter PACE will review claims submitted for oral antidiabetic agents for maximum daily dose.
* March 31, 2000--Antirheumatic Drug Therapy. Notified Providers that effective June 5, 2000 and thereafter, PACE will review claims submitted for the antirheumatic drug etanercept (Enbrel).
* March 31, 2000--COX-2 Inhibitors. Notified Providers that effective June 5, 2000 and thereafter, PACE will review claims submitted for the COX-2 inhibitors (Celebrex) and rofecoxib (Vioxx) for maximum daily dose.
* March 31, 2000--Antiplatelet Agent PLETAL. Notified Providers effective June 5, 2000 and thereafter, PACE will review claims submitted for the antiplatelet agent cilostazol (Pletal) for maximum daily dose of 200 mg.
* March 31, 2000--Skeletal Muscle Relaxants. Notified Providers effective June 5, 2000 and thereafter, PACE will review claims submitted for skeletal muscle relaxants for both maximum daily dose and duration of therapy.
* March 31, 2000--Rezulin. Notified Providers that effective March 22, 2000 PACE no longer reimburses for Rezulin. This action is in response to the Warner Lambert Company's voluntary withdrawal of Rezulin from the marketplace on Tuesday, March 21, 2000.
* April 7, 2000--Propulsid Reimbursement. Notified Providers effective April 10, 2000 PACE will deny all claims received for cisapride (Propulsid). Physicians desiring their patients to continue taking cisapride (Propulsid) have been advised they may request a Medical Exception. These exception requests will be considered only until the product is withdrawn from the market by Janssen Pharmaceutica effective July 14, 2000.
* April 7, 2000--Dispensing Date. Reminded Providers that claims are to be submitted to PACE on the date they are dispensed. Advised PACE Providers enrolled as Nursing Home Providers as well as those providers servicing nursing homes that effective with dates of service of June 1, 2000 and thereafter, claims submitted with incorrect dates of service will have those claims disallowed.
* May 12, 2000--Mandatory Substitution Dilantin. Notified Providers effective May 22, 2000, PACE is mandating substitution for Dilantin.
* May 12, 2000--Generic Refills. Reminder to Providers that Section 22.55(e) of Title 28 (Health and Safety) of the Pennsylvania Code states: ''Prescription refills, where permitted by the practitioner, shall be completed using the identical product (same distributor and manufacturer) as dispensed on the original, unless the person presenting the prescription and the practitioner authorize, in advance, a different manufacturer's generic equivalent product. Advance authorization is not required in an emergency, but the physician shall be notified by the pharmacist as soon as possible thereafter.''
* May 19, 2000--LOTROXEX. Notified Providers that in the package insert that accompanies Lotronex, Glaxo Wellcome Inc. states that ''Lotronex has NOT been shown to work in men with IBS.'' (Irritable Bowel Syndrome). Effective June 12, 2000, all claims for Lotronex will be denied with NCPDP Code 70, PACE Code 055 ''Drug not covered.'' At a future date this edit will be converted to a DUR drug--gender denial. In the interim, providers should contact Provider Services to receive a Medical Exception for female cardholders.
* May 19, 2000--Zyvox. Notified Providers effective June 5, 2000, PACE will deny all claims for Zyvox. Medical Exceptions for the antibiotic linezoid (Zyvox) will only be considered upon receipt of the appropriate documentation from the cardholder's physician. Providers should note that no evidence supports Zyvox for use in the management of antibiotic associated colitis (AAC). No medical exceptions will be approved prior to the receipt of supporting diagnostic and treatment information.
* May 26, 2000--Dispensing Date Update. Notified Providers enrolled as Nursing Home Providers and those who service nursing homes affected by the PACE Provider Bulletin of April 7, 2000, that the implementation date cited in this notification has been delayed thirty days until July 1, 2000.
* June 9, 2000--Provider Update: Generic substitution for Dilantin: Notified Providers as stated in the Provider Bulletin of May 12, 2000, PACE notified the physicians of all PACE cardholders currently receiving Dilantin of the impending mandatory substitution and provided a Medical Exception Form if the prescriber did not wish the cardholder to receive the generic.
* July 14, 2000--PACENET Deductible Reminder: Notified Providers that any providers refusing to submit PACENET deductible claims through the on-line claims adjudication system at the time of presentation or prior to dispensing the prescription are in violation of their PACE/PACENET Provider Agreement. Failure to abide by the terms and conditions of the Provider Agreement could result in provider termination and/or suspension of payments by the Department of Aging until such noncompliance is corrected.
* August 4, 2000--Dispensing Date & Nursing Home Providers: Notified Providers our Bulletin of April 7, 2000, instructed that all claims for cardholders residing in nursing homes are to be submitted to PACE on the date that they are dispensed. Subsequently, the Department has reviewed issues raised by nursing home providers and providers who service nursing homes regarding this requirement. Although the Department recognizes that it cannot dictate a nursing home's medication dispensing policy, the Program does encourage the submission of claims for those chronic maintenance drugs to be on a monthly basis. The authorizations apply ONLY to those cardholders residing in nursing homes who are subject to the nursing home's controlled environment and internal drug utilization review policy.
* August 18, 2000--Vaniqa: Notified Providers that PACE will NOT reimburse for Bristol- Myers Squibb and Gillette's Vaniqa (eflornithine HCL) cream recently approved by the FDA for the treatment of unwanted facial hair in women.
* September 15, 2000--Other Prescription Coverage: Notified Providers that effective October 16, 2000, PACE will edit claims for PACE cardholders with dual coverage. Providers enrolled in other third party point-of-sale prescription plans must have the ability to ''dual bill.'' PACE is to be billed after the claim is adjudicated by the primary insurer but prior to dispensing.
* November 10, 2000--Reminder of Other Prescription Coverage: Notified Providers that PACE denies claims for cardholders identified as having other insurance if the provider submits the claim with an incorrect ''other coverage'' value.
* December 1, 2000--Manufacturers' Rebate: Notified Providers that Act 128-1992 amending the Lottery Fund Preservation Act, in part, requires all pharmaceutical manufacturers to have in effect a rebate agreement with the PACE Program if they wish to have their products covered. Sidmak Laboratories, Labeler Code 50111 is being added to PACE's non-participating list. Sidmak's products are no longer reimbursable effective December 18, 2000.
* December 15, 2000--Sidmak Laboratories Reinstatement: Notified Providers that the Department of Aging advises that Sidmak Laboratories, Labeler Code 50111 will continue to participate in the Manufacturers' Rebate Program. Providers should disregard the previous December 18, 2000 termination announcement.
PACE Provider Bulletins: 1999
* 2/19/99: Kytril and Zofran: Reminder to providers that PACE will reimburse only on the 20% not reimbursed by DMER
* 2/19/99: Optometrists's Prescribing Privileges: Provides PACE Providers with a list of medications permitted by Department of Health regulation to be prescribed by optometrists. Warns providers to not dispense and bill the Program for pharmaceuticals that are prohibited by regulation from being prescribed by optometrists.
* 2/19/99: Optometrist's License Numbers: Notifies providers that Optometrists certified to prescribe and administer pharmaceutical agents for therapeutic purposes under section 4.1 of the Optometric Practice and Licensure Act are being issued a license with a suffix of ''T.''
* 3/5/99: PACENET Deductible: Reminder to PACE Providers that the $500 PACENET deductible is accumulated based on each individual cardholder's enrollment year; not the calendar year.
* 4/9/99: Notified PACE Providers that effective May 14, 1999, PACE will mandate substitution on the following medications: Lasix, Depakene, Mysoline, Quinaglute Dura-tabs, Mexitil, Tegretol and all sustained-release Theophylline preparations.
* 4/9/99: Betoptic Solution: Notified PACE Providers that Alcon Laboratories had informed PACE that it had discontinued production of Betoptic solution in the 2.5 and 5 ml sizes.
* 4/30/99: Propulsid Drug to Drug Interactions: Notifies providers that effective May 10, 1999, PACE will review history across all providers and reject all prescriptions in the drug classes which are contraindicated for patients using Propulsid.
* 5/7/99: Drug Utilization Review Program: Notified Providers that effective May 15, 1999, several new and revised maximum daily dose criteria, duration criteria and duplicate criteria will be added to the PACE ProDUR Program.
* 7/2/99:Trovan(Trovafloxacin/Alatrofloxacin Mesylate): Notified Providers that effective July 6, 1999, PACE will deny all claims for Trovan. In accordance with FDA recommendations, PACE will reimburse for Trovan only through the Medical Exception Process.
* 7/2/99: Medicare Reimbursable Chemotherapeutics: Notified Providers that effective July 12, 1999, the following pharmaceuticals will be included with those products being reimbursed by the PACE/PACENET Program at 20%: Oaklide and Neumega
* July 16, 1999--HISMANAL. Notified Providers that effective July 26, 1999, PACE will no longer reimburse for HISMANAL. This action is in response to Janssen Pharmaceutica informing the U.S. Food and Drug Administration that it has voluntarily decided to discontinue the manufacturing and distribution of HISMANAL 10 mg tablets.
* July 16, 1999--Cellcept and Prograf. Notified Providers that effective July 26, 1999, PACE claims for Cellcept and Prograf may be submitted to the Program using the PACE On-Line Claims Adjudication System (POCAS) Medical Exception process.
* July 16, 1999--Drug Utilization Review Program Anti-obesity Agents. Notified Providers that effective July 26, 1999, maximum dose and initial duration of therapy criteria will be added to the PACE ProDUR Program specifically for the anti-obesity class of medication.
* September 3, 1999--NEORAL and SANDIMMUNE. Notified Providers that effective September 13, 1999, PACE claims for Neoral and Sandimmune will be adjudicated by the Program using the PACE On-Line Claims Adjudication System (POCAS) Medical Exception process.
* October 20, 1999--Other Prescription Coverage. Notified Providers effective November 1, 1999, PACE cardholders identified by Highmark as possessing Security Blue prescription coverage, will have their claims denied by PACE IF the provider submits the claim with an incorrect Other Coverage value of: ''0''--''Not Specified'' or ''1''--''No Other Coverage Identified.''
* October 29, 1999--Multiple Point of Service Billing. Notified Providers whose software does not permit dual or multiple point-of-sale submissions may not bill cardholders for medications submitted to PACE after dispensing and experiencing a subsequent denial.
* November 5, 1999--RAXAR. Notified Providers that Glaxo Wellcome has announced the voluntary withdrawal of RAXAR tablets from the market. Any claims submitted for RAXAR on or after November 3, 1999 will deny.
* November 19, 1999--PACENET Cardholders and Other Prescription Coverage. Reminded Providers that claims submitted to PACE during the PACENET cardholder's deductible period are to contain the dollar amount paid by the PACENET cardholder for the prescription. The out of pocket expense, borne by the cardholder, is the amount the Program accumulates toward the cardholder's $500 deductible.
* December 3, 1999--Medicare Reimbursable Agents. Notified Providers that effective December 13, 1999, PACE will deny claims submitted for all Medicare Reimbursable Agents. Providers attempting to bill for these products may contact Provider Services for a Medical Exception.
PACE Provider Bulletins: 1998
* 2/13/98: PACENET Deductible: Reminder to Providers that the PACENET $500 deductible is accumulated based on each individual's enrollment year, not the calendar year.
* 2/13/98: PACE Required Documentation for ''Brand Medically Necessary'' (DAW Code 1) Prescriptions: Reminder to Providers who are being reimbursed for a Brand Name product having an A-rated generic because the Program has granted a cardholder medical exception or because the Program has elected not to require substitution must, by PACE regulation, have at the time of dispensing, a prescription on which the prescriber has handwritten ''Brand Medically Necessary'' or ''Brand Necessary.''
* 2/13/98: Clozapine (Clozaril): Notified Providers that Clozaril is subject to the PACE Program's mandatory substitution requirement. Generic clozapine is available from Zenith Goldline Pharmaceuticals.
* 2/13/98: Use of NDC Codes and Calculation of Reimbursement: Reminder to PACE Providers that all claims submitted to the Program for reimbursement must accurately report the labeler code and product code of the drug dispensed. Reimbursement paid by the PACE Program will be based upon the package size as reported by the Provider.
* 2/20/98: Other Prescription Coverage: Notified Providers that EOB Message ''041--Billable to Other Payor'' will soon be rejected with an Error Code 041.
* 2/27/98: Bromfenac Sodium Capsules (DURACT): Reminder to Providers that DURACT is only intended for the short term (10 days or less) management of acute pain and is not indicated for long term use. Notified Providers effective March 2, 1998 PACE will reject all claims for DURACT at the point of sale. A one-time medical exception will be considered, upon request from the Provider, for a maximum 10-day supply at a maximum dose that does not exceed 150 mg per day. Written correspondence from the cardholder's physician will be necessary for reimbursement beyond ten days.
* 2/27/98: Mibefradil Dihydrochloride (POSICOR): Notified Providers of advisory issued by Roche Laboratories Inc. of reported cases of interaction of POSICOR with certain HMG-CoA Reductase Inhibitors. PACE claims for POSICOR identified as being coadministered with either lovastatin or simvastatin will reject with the NCPDP Error ''88, DUR Reject''; PACE Error Code ''706,'' accompanied with the Conflict Code ''DD,'' the free text message of ''DRUG-DRUG,'' and the NDC of the drug in conflict.
* 4/10/98: PACE Cardholders Enrolled in Medicare HMO's: Reminder to Providers that PACE Cardholders enrolled in Medicare certified HMO's are entitled to the same prescription medications under the Medicare certified HMO as those covered under Medicare Part ''B.'' This entitlement is not affected by a cardholder's decision not to subscribe to supplemental HMO offered prescription coverage.
* 4/17/98: Drug Utilization Review Program: Notified Providers effective April 22, 1998, several new maximum daily dose criteria, duration criteria and duplicate therapy criteria will be added to the PACE ProDUR Program. The criteria is as follows: Mibefradil HCl (POSICOR) 100 mg maximum dose/duplicate therapy edit; Carvedilol (Coreg) 100 mg maximum dose/duplicate therapy edit; Losartan (Cozaar) 100 mg maximumdose/duplicate therapy edit with the ACE Inhibitors; Quetiapine (Seroquel) 400 mg maximum dose; Hydrocodone and Ibuprofen (Vicoprofen) 37.5 mg maximum dose/duration edit: 10 days out of every 30.
* 4/25/98: Mandatory Substitution Diltiazem Extended Release Capsules: Notified Providers effective April 29, 1998, the PACE Program will begin mandating substitution of Dilacor XR and Cardizem SR. This is a result of information received from the FDA granting therapeutic equivalence to capsules manufactured by Mylan Pharmaceuticals, Watson Labs, Andrx and Teva Pharmaceuticals.
* 5/8/98: Early Refill Edit: Notified Providers effective May 19, 1998, the additional classes will be added to the early refill edit: Intranasal Steroids; Topical Corticosteroids--Single Entity; Anti-diabetic Agents--Insulins; Bronchodilators; Conjugated Estrogens; Estrogens--Transdermal Patches; and Opiates. Reimbursement will not be made until 75% of the medication has been used.
* 5/22/98: Drug Utilization Review Program: Notified Providers effective May 26, 1998 several new criteria will be added to the PACE ProDUR Program and applied to all claims submitted on or after this date for the medication Viagra. The criteria added are: maximum daily dose of 50 mg. Claims submitted for greater than 50 mg daily will require a diagnosis and approval through the PACE medical exception process. Duration of therapy will be thirty tablets per month. PACE will only reimburse claims submitted for male cardholders. Claims submitted for female cardholders will be reversed.
* 6/1/98: Drug Utilization Review Program: Notified Providers that Pfizer, Inc. has recently reiterated that patients taking nitrates in any form, including nitroglycerin and long-acting nitrates commonly used for chest pain, should not take Viagra. PACE will reject prescriptions for Viagra and Nitroglycerin at the point-of-sale in order to comply with this guideline for appropriate use.
* 6/12/98: RECALL: Notified Providers that a Voluntary Class I recall has been initiated by Meridian Medical Technologies, manufacturer of both Epipen and Epipen Jr. Auto-Injectors. All PACE cardholders for whom reimbursement was made during this period have been instructed to return their product to their pharmacy for a lot number review.
* 6/12/98: RECALL: POSICOR--Notified Providers that Roche Laboratories Inc. is withdrawing POSICOR from the market effective June 8, 1998. The PACE Program will deny reimbursement for claims submitted with dates of service of June 9, 1998 or thereafter will be denied.
* 6/19/98: Cholinesterase Inhibitors: Notified Providers that effective June 22, 1998, several new maximum initial dose and maximum daily dose criteria will be added to the PACE ProDUR Program. The criteria added are for Tacrine (Cognex), initial maximum dose 40 mg/6 weeks; 80 mg/6 weeks; 120 mg/6 weeks and a maximum dose of 160 mg; and Donepezil (Aricept), initial maximum dose 5 mg and a maximum dose of 10 mg.
* 6/26/98: DURACT: Notified Providers that effective June 22, 1998, Wyeth-Ayerst Laboratories is withdrawing Duract capsules from the market. Accordingly, any Duractclaim submitted to PACE after June 22, 1998 is being denied.
* 6/26/98: Early Refill Edit Applied to Ophthalmics: Notified Providers that effective July 6, 1998, PACE is applying the early refill edit criteria to ophthalmic preparations requiring that at least 75% of the medication, based on the day's supply submitted on the previous claim, has been used before PACE will consider reimbursement for a prescription refill.
* 12/11/98: Meridia Drug to Drug Interactions: Notified Providers that in order to comply with the manufacturers' warnings that Meridia should not be used concomitantly with MAOI's (at least a two week interval after stopping an MAOI before commencing with Meridia), PACE will review history across providers and reject all prescriptions for Nardil, Eldepryl and Parnate at the point of sale.
* 12/31/98: Drug Utilization Review Program: Notified Providers that effective January 4, 1999, revised criteria will be added to the PACE ProDUR Program and applied to all claims submitted on or after this date for the medication Viagra. The criteria is as follows: Maximum Daily Dose--50 mg; Duration of Therapy decreased from thirty to eight tablets per month.
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