Provider Update
Volume 22, Issue 4
Winter Edition
Medicare Prescription Drug, Improvement and Modernization Act of 2003
Medicare Part D
Overview
The Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) made prescription drug coverage, also known as Medicare Part D, available to all Medicare beneficiaries. Prescription drug coverage will be available through private prescription drug plans (PDPs), which offer only prescription drug coverage, and Medicare Advantage Plans (MA PDs), which offer drug coverage integrated with the health coverage provided by the managed care plan.
Full Benefit Dual Eligible
Full benefit dual eligibles are individuals who are entitled to Medicare Part A and/or Part B as well as eligible for full Medicaid benefits. Effective January 1, 2006, full benefit dual eligible Medicaid recipients
will no longer receive their pharmacy benefits through the Louisiana Medicaid Pharmacy Program with the exception of some drugs excluded from the Part D benefit. Should a full benefit dual eligible Medicaid recipient elect not to be covered by a Part D plan, that recipient will not be allowed to receive prescription coverage from Medicaid.
Enrollment
Full benefit dual eligibles must enroll in Medicare Part D in order to continue receiving prescription drug coverage. No premiums or deductibles will be required from these beneficiaries for Medicare prescription drug coverage.
The Centers for Medicare and Medicaid Services (CMS) have auto-assigned on a random basis, full benefit dual eligibles into a PDP whose premium is at or below the low-income premium subsidy amount. Medicaid dual eligible recipients have been notified of their plan assignment. Full benefit dual eligible Medicaid recipients have an opportunity to change to a prescription drug plan that better fits their medication needs during open enrollment which began November 15, 2005. Full benefit dual eligibles must opt-out of their assigned plan by December 31, 2005, or they will be enrolled in their CMS assigned prescription drug plan.
Full benefit dual eligibles who are currently enrolled in a Medicare Advantage Plan will be auto-enrolled in the Part D benefit of that MA PD.
Full benefit dual eligibles are entitled to a special enrollment period and can therefore change at any time.
Lock-In Recipients
Beginning January 1, 2006, full benefit dual eligibles who are currently in the Lock-In program will no longer be restricted by the Lock-In program. These recipients will no longer be locked into one specific pharmacy and/or specific physician.
Medicare Part D Prescription Drug Coverage
Medicare Part D covered drugs include most prescription drugs, biological products, certain vaccines, insulin, and medical supplies associated with the injection of insulin (syringes, needles, alcohol swabs, and gauze). Some drugs will be excluded from Medicare Part D coverage as they are part of the Medicaid non-mandatory coverage provisions under Sections 1927 (d)(2) and (d)(3) of the Social Security Act or they are covered by Medicare Part A or B. The one exception is smoking cessation products, such as nicotine patches and gum, which will be covered by Medicare Part D. Reimbursement of prescription claims is determined by each individual prescription drug plan.
Medicaid Prescription Drug Coverage for Dual Eligibles
To the extent that the Louisiana Medicaid Program covers the following Medicare excluded drugs for Medicaid recipients who are not full benefit dual eligibles, Medicaid will be required to cover the excluded drugs for full benefit dual eligibles:
� Benzodiazepines
� Barbiturates
� Agents when used for anorexia, weight loss, weight gain (Xenical� only)
� Agents when used to promote fertility (Only when used for non-fertility treatment as described under
specific state criteria).
� Agents when used for cosmetic purposes or hair growth purposes (Accutane� only)
� Prescription vitamins and mineral products, except prenatal vitamins and fluoride (Limited drugs)
� Nonprescription drugs (Limited drugs)
All existing Louisiana Medicaid Pharmacy Program limits, co-payments and reimbursement policies apply to the Part D excluded prescriptions paid by Louisiana Medicaid.
Louisiana Medicaid will not cover PDP or MA PD non-preferred drugs, as there is a Medicare appeal process to obtain these medications.
Co-payments
Small co-payments of $1.00 to $5.00 for each Medicare Part D prescription will be required. However, co-payments do not apply to beneficiaries in nursing homes or in an intermediate care facility for the mentally retarded (ICF/MR).
The Medicaid co-payment schedule will apply for prescriptions for those Part D excluded drugs that are covered by Medicaid.
Medicare Part B Covered Drugs
Medicare Part B will continue to reimburse pharmacy providers for some prescription drugs. Medicaid will continue to pay deductibles and coinsurance amounts for these prescription services for dual eligible Medicaid recipients.
Medicare Part D will not cover those medications reimbursed by Medicare Part B. However, should Medicare Part B deny coverage because the drug does not meet the criteria for a Part B covered indication, the pharmacy provider should contact the Part D prescription plan.
Contacts
For the latest Medicare Part D information and educational resources, providers may log onto the CMS provider's page at
http://www.cms.hhs.gov/medlearn/drugcoverage.asp. Here, medical professionals can learn about and prepare for the new Medicare prescription drug coverage. It includes links to frequently asked questions as well as to regulations and guidance.
Programmatic and Licensing Changes Pursuant to
Governor's Health Care Reform Initiatives
In October 2004, Governor Blanco issued Executive Order KBB 2004-43 that described her views on long-term care and initiated a planning process to develop a comprehensive plan designed to reform Louisiana's health care delivery system and improve access to quality health care. During the past year, DHH has worked with national health care experts, legislative and other government leaders, health care providers, business leaders, consumers, and interested citizens to ensure the process of health care reform continues on a steady course. Listed below are important preliminary changes that have occurred subsequent to implementation of these reform initiatives. For more information on Louisiana's Health Care Reform Plan, go to:
http://www.dhh.lla.gov click on "reports" and scroll down to "Health Care Reform" topic.
Programmatic Changes
To improve coordination and access to services and consolidate administrative functions under the most appropriate program office,
effective immediately, the administrative and oversight functions listed below have been redesigned as follows:
� The Bureau of Community Supports and Services (BCSS) has been dissolved and program
responsibilities have been reassigned.
� Waiver issues pertaining to children and adults with developmental disabilities (e.g., New Opportunities
Waiver and Children's Choice Waiver populations) are now administered by the Office for Citizens with
Developmental Disabilities (OCDD) - Waiver Supports and Services (WSS), the program office within
the Department of Health and Hospitals (DHH) that provides supports and services to children and adults
with developmental disabilities.
� Waiver issues pertaining to the elderly and disabled adults (e.g., Elderly and Disabled Adult Waiver and
Adult Day Health Care Waiver populations) are now administered by the Division of Long Term
Supports and Services (DLTSS), a newly created division within the Department of Health and
Hospitals, Bureau of Health Services Financing.
� The Department of Health and Hospitals (DHH), Bureau of Health Services Financing (BHSF) is now
responsible for administrative oversight of Support Coordination for Early and Periodic Screening,
Diagnosis and Treatment (EPSDT), Nurse Family Partnership and Infants and Toddlers (Early Steps)
targeted populations. BHSF will be contacting you with further information regarding these changes.
� Support Coordination for the HIV targeted population is now administered by the Division of Long Term
Supports and Services (DLTSS).
� The Long Term-Personal Care Services program (LT-PCS) is now administered by the Division of Long
Term Supports and Services (DLTSS).
� The Nursing Facility Admissions Review process is now administered by the Division of Long Term
Supports and Services (DLTSS).
Licensing Changes
To reduce duplication/fragmentation of licensing functions and encourage a more efficient and timely licensing process, the licensing authority (including related survey and compliance activities) previously administered by the BCSS for all support coordination and adult day health care (ADHC) agencies has been transferred to the Bureau of Health Services Financing Health Standards Section (HSS). HSS is a regulatory agency within the DHH. The following licensing protocols are effective immediately:
� Support coordination and ADHC licenses up for annual renewal through September 30, 2005, have been
processed and issued under the previous BCSS guidelines.
� Support coordination and ADHC licenses up for renewal after September 30, 2005, (i.e., expiration dates
starting with October 1, 2005, and later) will be processed by HSS.
� Support coordination agencies and ADHC facilities pending final approval of an initial (new) licensing
application will be processed by HSS.
� HSS will be contacting support coordination agencies and ADHC facilities with further details regarding
these licensing procedures.
Your continued support and commitment to making a positive difference in the lives of individual recipients of home and community-based services is appreciated. If you have any questions concerning these changes, please contact the DLTSS by calling (225) 219-0200, OCDD-WSS by calling (225) 219-0200, or HSS by calling (225) 342-0415.
National Provider Identifier Update
The Centers for Medicare and Medicaid Services (CMS) began assigning numbers for the National Provider Identifier (NPI) on May 23, 2005. The NPI is a standard unique identifier for health care providers adopted by the Secretary of Health and Human Services under the Health Insurance Portability and Accountability Act (HIPAA) of 1996. The NPI is one of the steps that CMS is taking to improve electronic transactions for health care.
These electronic transactions include claims, eligibility inquiries and responses, claim status inquiries and responses, referrals and remittance advices. The NPI will replace health care provider identifiers numbers that are assigned today by different health care payers. The CMS announcement also provides contacts and resources should providers have questions about the NPI.
It can be viewed at: http://www.cms.hhs.gov/hipaa/hipaa2/npi_provider.asp on the CMS web site.
Update to the UB-92 Institutional Claim Form
The National Uniform Billing Committee (NUBC) is responsible for the development of a Standard Institutional Claim Billing form. NUBC is comprised of representatives from health care providers, payers, electronic standards development organizations, public health standards organizations, and others.
NUBC has completed a major upgrade of the institutional claim billing form, the "UB-04," which is scheduled to replace the UB-92 beginning with bills created on March 1, 2007. The UB-04 is scheduled to replace the UB-92 in accordance with the following transition:
� March 1, 2007 - Health plans, clearinghouses, and other information support vendors should be
ready to handle and accept the new UB-04 form and data set.
� March 1 to May 22, 2007 - Providers can use either the UB-04 or UB-92 forms/data set
specifications.
� May 23, 2007 - The UB-92 will be discontinued; only the UB-04 form and data set
specifications should be used. All rebilling of claims must use the UB-04 from this date forward,
even though earlier submissions may have been on the UB-92.
You may contact NUBC Secretary, Todd Omundson at: tomundson@aha.org., to obtain information regarding full color proofs of the form for testing purposes or a beta release of the corresponding data specifications manual.
Provider Memos Now Available On DHH Health Standards Web Site
Licensed and/or certified providers will now be able to view applicable memos on the Health Standards web site. Memos will be posted for a one year period. It is recommended that providers check the site periodically for updates that are pertinent to their programs. Instructions for accessing the information are as follows:
� Go to Health Standards Section's Internet Home Page located at
http://www.dhh.louisiana.gov/offices/?ID=112.
� Locate "Featured Services"
� Left click "Provider Memos"
� This will open the Publications page. Left click the arrow located on the right side of "Jump to
Section", select "Provider Memos".
� Provider Memos section will be displayed. Posted memos will be listed under the section header.
Partners for Healthy Babies
The Louisiana Office of Public Health provides a toll free helpline 1-800-251-BABY (2229) for pregnancy information and referrals. Trained educators help women find resources and social services in their area.
Guidelines to Request an Override of the Two Year Timely Filing Limits
Providers requesting an override of the timely filing limits for claims with dates of service over two years old must provide proof of timely filing and must assure that each claim meets at least one of the three conditions listed below:
� The recipient was certified for retroactive Medicaid benefits, and the claim was filed within 12 months
of the date retroactive eligibility was granted.
� The recipient won a Medicare or SSI appeal in which he or she was granted retroactive Medicaid
benefits.
� The failure of the claim to pay was the fault of the Louisiana Medicaid Program rather than the
provider's fault each time the claim was adjudicated.
All requests for two-year overrides must be mailed directly to:
Unisys Provider Relations
Correspondence Unit
P.O. Box 91024
Baton Rouge LA 70821
The provider must submit the claim with a cover letter describing the condition that has been met and must attach supporting documentation. Supporting documentation includes, but is not limited to, evidence of the allowable condition and proof of timely filing. A copy of a reject letter received from Unisys is not considered proof of timely filing.
Claims submitted without a cover letter, proof of timely filing, and/or supporting documentation of the allowable condition will be returned to the provider without consideration. Any request submitted directly to DHH staff will be routed to Unisys Provider Relations.
HIPAA Notification
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) requires that medical code sets be valid at the time the service is provided. This includes the Healthcare Common Procedure Coding System (HCPCS) and ICD-9-CM diagnosis codes. The Centers for Medicare & Medicaid Services (CMS) is no longer allowing providers 90 days to implement updated ICD-9-CM diagnosis codes and HCPCS codes. Providers should monitor the Louisiana Medicaid RA messages for program specific implementation dates on these requirements.
To view the HCPCS file, visit http://www.cms.hhs.gov/providers/pufdownload/anhcpcdl.asp. For the full list of the updated ICD-9-CM diagnosis codes, visit
http://www.cms.hhs.gov/medlearn/icd9code.asp.
Clarification of New Leave Day Policy
House Concurrent Resolution 277 of the 2004 Regular Session directed the Department of Health and Hospitals to exclude official state holidays from the annual 45-day leave limit for ICF/MR residents. In response to this directive, the Department of Health and Hospitals published a rule in the Louisiana Register (Vol. 31, Number 5, May 20, 2005). The effective date of this rule is May 20, 2005. These
holidays will always fall on a week day. Official state holidays should not be reported as leave days. The days preceding and following the official state holidays will not be excluded from the annual 45-day limit.
Approved official state holidays can be found on the Division of Administration's website
at: www.doa.louisiana.gov/employ_holiday.htm
Leave Day Policy in the Event of Evacuation of an ICF/MR
The April 20, 1998 Louisiana Register, (�10307 Payments, B.2) states when local conditions require evacuation of ICF/MR residents, the following payment procedures apply:
� When clients are evacuated for less than 24 hours, the monthly vendor payment is not interrupted;
� When staff is sent with clients to the evacuation site, the monthly vendor payment is not interrupted;
� When clients are evacuated to a family or friend's home at the ICF/MR's request, the ICF/MR shall
not submit a claim for a day of service or leave day, and the client's liability shall not be collected;
� When clients go home at the family's request or on their own initiative, a leave day will be charged;
� When clients are admitted to the hospital for the purpose of evacuation of the ICF/MR, Medicaid
payment shall not be made for hospital charges.
Scheduling Of Non Emergency Medical Transportation For Mental Health Rehabilitation Services
The Bureau has received numerous complaints regarding scheduling non emergency medical transportation (NEMT) for mental health rehabilitation (MHR) services. Recipients have stated that they are being told, in many cases, by both NEMT and MHR employees that they must misinform Medical Dispatch staff about the frequency of their treatment, (i.e., if they are only scheduled for 2 days/week, they are encouraged to tell Dispatch that they are going 3-5 days/week). Recipients are being told that if they do not lie about the frequency of treatment, the reimbursement to the NEMT provider is not sufficient and they will not be transported. This is inappropriate and fraudulent.
DHH will be investigating these cases with more frequency. Any provider determined to be participating in this fraudulent activity is subject to administrative sanctions, including termination from the Medicaid Program. They will also be referred to the Medicaid Fraud Investigation Unit of the State Attorney General's Office for criminal investigation.
Medicaid Electronic Clinical Drug Inquiry for MHR Psychiatrists
Effective January 2, 2006, all MHR psychiatrists will be required to use the Medicaid Electronic Clinical Drug Inquiry (e-CDI) application. The e-CDI application, which is updated nightly, allows the psychiatrist to review the recipient's Medicaid paid drug claims from the previous four months. The MHR provider is responsible for submitting a copy of the recipient's Clinical Drug Inquiry page with each prior authorization request submitted. The MHR psychiatrist must sign a printed copy of the e-CDI screen, indicating a review of the recipient's prescription utilization was completed. If the MHR provider fails to submit this information with the prior authorization request, the request will be denied.
In order to gain access into the Medicaid e-CDI application, the psychiatrist must establish an online account with LAMEDICAID.com. The following is needed to establish an online account: a valid 7-digit Provider ID number assigned by Louisiana Medicaid, an internet account with an internet service provider, a valid e-mail address, and a web browser that supports SSL with 128- bit encryption (example: Microsoft Internet Explorer v5 or v6).
THE FOLLOWING SERVICES ARE AVAILABLE TO CHILDREN AND YOUTH WITH DEVELOPMENTAL DISABILITIES. TO REQUEST THEM CALL THE OFFICE FOR
CITIZENS WITH DEVELOPMENTAL DISABILITIES (OCDD)/DISTRICT/AUTHORITY
IN YOUR AREA.
(See listing of numbers on attachment)
MR/DD MEDICAID WAIVER SERVICES
To sign up for "waiver programs" that offer Medicaid and additional services to eligible persons (including those whose income may be too high for other Medicaid), ask to be added to the Mentally Retarded/ Developmentally Disabled (MR/DD) Request for Services Registry (RFSR). The
New Opportunities Waiver (NOW) and the Children's Choice Waiver both provide services in the home, instead of in an institution, to persons who have mental retardation and/or other developmental disabilities. Both waivers cover Family Support, Center-Based Respite, Environmental Accessibility Modifications, and Specialized Medical Equipment and Supplies. In addition,
NOW covers services to help individuals live alone in the community or to assist with employment, and professional and nursing services beyond those that Medicaid usually covers. The
Children's Choice Waiver also includes Family Training. Children remain eligible for the Children's Choice Waiver until their nineteenth birthday, at which time they will be transferred to an appropriate Mentally Retarded/Developmentally Disabled (MR/DD) Waiver.
(If you are accessing services for someone 0-3 please contact EarlySteps at 1-866-327-5978.)
SUPPORT COORDINATION
A support coordinator works with you to develop a comprehensive list of all needed services (such as medical care, therapies, personal care services, equipment, social services, and educational services) then assists you in obtaining them.
If you are a Medicaid recipient and under the age of 21 and it is medically necessary, you may be eligible to receive support coordination services immediately.
THE FOLLOWING BENEFITS ARE AVAILABLE TO ALL MEDICAID ELIGIBLE CHILDREN AND YOUTH UNDER THE AGE OF 21 WHO HAVE A MEDICAL NEED. TO ACCESS THESE SERVICES CALL KIDMED (TOLL FREE) at 1-877-455-9955 or TTY 1-877-544-9544.
MENTAL HEALTH REHABILITATION SERVICES
Children and youth with mental illness may receive Mental Health Rehabilitation Services. These services include clinical and medication management; individual and parent/family intervention; supportive and group counseling; individual and group psychosocial skills training; behavior intervention plan development and service integration. All mental health rehabilitation services must be approved by mental health prior authorization unit.
PSYCHOLOGICAL AND BEHAVIORAL SERVICES
Children and youth who require psychological and/or behavioral services may receive these services from a licensed psychologist. These services include necessary assessments and evaluations, individual therapy, and family therapy.
EPSDT/KIDMED EXAMS AND CHECKUPS
Medicaid recipients under the age of 21 are eligible for checkups ("EPSDT screens"). These checkups include a health history; physical exam; immunizations; laboratory tests, including lead blood level assessment; vision and hearing checks; and dental services. They are available both on a regular basis, and whenever additional health treatment or services are needed. EPSDT screens may help to find problems, which need other health treatment or additional services.
Children under 21 are entitled to receive all medically necessary health care, diagnostic services, and treatment and other measures covered by Medicaid to correct or improve physical or mental conditions. This includes a wide range of services not covered by Medicaid for recipients over the age of 21.
PERSONAL CARE SERVICES
Personal Care Services (PCS) are provided by attendants when physical limitations due to illness or injury require assistance with eating, bathing, dressing, and personal hygiene. PCS does not include medical tasks such as medication administration, tracheostomy care, feeding tubes or catheters. The Medicaid
Home Health program or Extended Home Health program covers those medical services. PCS must be ordered by a physician. The PCS service provider must request approval for the service from Medicaid.
EXTENDED SKILLED NURSING SERVICES
Children and youth may be eligible to receive skilled nursing services in the home. These services are provided by a home health agency. A physician must order this service. Once ordered by a physician, the home health agency must request approval for the service from Medicaid.
PHYSICAL THERAPY, OCCUPATIONAL THERAPY, SPEECH THERAPY, AUDIOLOGY SERVICES, and PSYCHOLOGICAL EVALUATION AND TREATMENT
If a child or youth wants rehabilitation services such as physical, occupational, or speech therapy,
audiology services, or psychological evaluation and treatment; these services can be provided at school, in an early intervention center, in an outpatient facility, in a rehabilitation center, at home, or in a combination of settings, depending on the child's needs. For Medicaid to cover these services at school (ages 3 to 21), or early intervention centers and
EarlySteps (ages 0 to 3), they must be part of the Individualized Education Program (IEP) or Individualized Family Services Plan (IFSP). For Medicaid to cover the services through an outpatient facility, rehabilitation center, or home health, they must be ordered by a physician and be prior-authorized by Medicaid.
FOR INFORMATION ON RECEIVING THESE THERAPIES CONTACT YOUR SCHOOL OR EARLY INTERVENTION CENTER. EARLYSTEPS CAN BE CONTACTED (toll free) AT
1-866-327-5978. CALL KIDMED REFERRAL ASSISTANCE AT 1-877-455-9955 TO LOCATE OTHER THERAPY PROVIDERS.
MEDICAL EQUIPMENT AND SUPPLIES
Children and youth can obtain any medically necessary medical supplies, equipment and appliances needed to correct, or improve physical or mental conditions. Medical equipment and supplies must be ordered by a physician. Once ordered by a physician, the supplier of the equipment or supplies must request approval for them from Medicaid.
TRANSPORTATION
Transportation to and from medical appointments, if needed, is provided by Medicaid. These medical appointments do not have to be with Medicaid providers for the transportation to be covered. Arrangements for non-emergency transportation must be made at least 48 hours in advance.
Children under age 21 are entitled to receive all medically necessary health care, diagnostic
services, treatment, and other measures that Medicaid can cover. This includes many services
that are not covered for adults.
IF YOU NEED A SERVICE THAT IS NOT LISTED ABOVE CALL THE REFERRAL
ASSISTANCE COORDINATOR AT KIDMED (TOLL FREE) 1-877-455- 9955 (OR TTY
1-877-544-9544). IF THEY CANNOT REFER YOU TO A PROVIDER OF THE SERVICE YOU NEED, CALL 1-888-758-2220 FOR ASSISTANCE.
Trade Area
The new trade area policy has been implemented effective for dates of service on or after July 1, 2005. All acute care out-of-state providers were notified of these impending changes in January 2005. Due to programming problems, implementation was delayed. The trade area now consists of only those counties located in Texas, Arkansas and Mississippi which border Louisiana. All acute care providers in these states which are not located in counties that border Louisiana are required to obtain prior authorization for any inpatient stay or outpatient service unless it is of an emergency nature.
Outpatient Operating Room Services
It has come to our attention that hospitals are billing outpatient surgeries utilizing revenue codes 360, 361 and 369. This is inappropriate billing. Effective for dates of service on or after August 5, 2005, outpatient claims billed using these revenue codes will deny with an error code 210 (provider not certified for procedure). Outpatient surgeries should be billed using the appropriate ambulatory surgery code.
Use of the GY Modifier For Medicare Non Covered Codes
There are some procedure codes which are covered by Medicaid that may or may not be covered by Medicare due to different criteria established for durable medical equipment, orthotics, and supplies. Therefore, effective immediately we will allow providers to submit requests for payment of the items listed below if the provider believes Medicaid's criteria have been met and knows Medicare's criteria have not been met. In these instances, providers are to use modifier GY with the procedure code when requesting authorization of payment from Unisys Prior Authorization Unit (PAU). Modifier GY is a modifier currently used under Medicare's billing guidelines to denote an item or service is excluded or does not meet the definition of any Medicare benefit.
Modifier GY may be used with procedure codes A4221, A4222, E0776, E0781, and E0791 to request authorization of payment for intravenous (IV) therapy pumps and supplies for a dually eligible person when these items are not covered by Medicare. Medicare only covers drugs used for antiviral therapies, some chemotherapy, and some inotropic therapies (i.e.; dobutamine).
Medicare does not cover elastic or compression stockings but will cover procedure codes L8110 and L8120 when these particular compression stockings are used under the surgical dressing benefit to secure a primary dressing over an open venous stasis ulcer requiring medically necessary debridement that has been treated by a physician or other healthcare professional. Providers may submit requests for payment of procedure codes L8110 and L8120 with the GY modifier when requesting stockings that are not covered under the Medicare criteria.
Providers of shoes, inserts, and shoe modifications should use modifier GY when requesting payment for orthopedic shoes that are not attached to braces or for shoes for diabetics that are not covered under Medicare's criteria for coverage of shoes for diabetics.
DME providers may use the GY modifier with procedure code E1399 when requesting miscellaneous equipment not covered by Medicare, such as shower chairs. Providers may not use E1399, with or without the GY modifier, when there is a more appropriate code.
Prior Authorization Unit (PAU) reviewers have been instructed to deny requests from a provider when the GY modifier or procedure code E1399 is used inappropriately. An example would be the use of IV and related supply codes with a GY modifier when used to request authorization of payment for IV pumps and/or related supplies that are covered by Medicare, such as antiviral therapies, some chemotherapy, and some inotropic therapies (i.e., dobutamine).
The system will not accept use of the GY modifier when used for items other than the ones discussed in this article.
It is the responsibility of the provider to know whether or not Medicare covers a particular item. Providers should not submit a request to PAU for recipients with Medicaid and Medicare coverage unless the provider has documentation that the item is not covered by Medicare. Misuse of the GY modifier to bypass the system edit for equipment and supplies covered by Medicare is considered abuse of the program. This abuse may result in sanctions including legal actions, recoupment of overpayments and possible exclusion from participation in the Medicaid Program.
For clarification regarding Medicare coverage of DME and supplies, providers should refer to the Medicare Region C DMEPOS Supplier Manual, Medicare newsletters and correspondence or should
contact a representative of Medicare or Palmetto GBA.
Durable Medical Equipment Supplies and Appliances
Providers of durable medical equipment and supplies have been advised that, due to mandates from the Centers for Medicare and Medicaid Services (CMS), reimbursement for durable medical equipment and supplies can no longer be authorized for recipients residing in nursing facilities and intermediate care facilities for the mentally retarded (ICF/MR). This change was effective July 1, 2005. CMS has given Louisiana Medicaid permission to honor authorizations given to providers prior to the implementation date. However, this authorization does not extend to reconsiderations for additional supplies or to request higher payment amounts. Please do not submit reconsiderations on any requests for recipients in a nursing facility or
ICF/MR.
Hurricanes Katrina and Rita Disasters
The impact of Hurricanes Katrina and Rita on the Louisiana Medicaid Program and the general healthcare community is significant. Recipients and providers have been displaced, many losing everything. We appreciate the healthcare providers from around the country who have come to the aid of our Louisiana citizens, and we are making every effort to assist both recipients and providers during this difficult time.
The following includes many of the steps taken toward providing this assistance and how to access this information through our web site:
� The home page of the Louisiana Medicaid web site, www.lamedicaid.com, displays hurricane related
information prominently at the top of the page.
� Providers not currently enrolled, but willing to provide services to Louisiana Medicaid recipients on an
emergency basis and be paid through the Louisiana Medicaid Program may obtain an enrollment packet through the web site link,
Emergency Provider Enrollment Packets.
� Emergency providers needing to access recipient eligibility are given quick reference information for using our automated eligibility verification systems - Click Recipient Eligibility - e-MEVS and REVS Quick Reference Charts. Emergency providers are also given temporary access codes to use these systems until they receive their assigned Louisiana Medicaid provider number. Once the provider number is received, it should be used to access these eligibility systems.
� The web site link, Hurricane Katrina Medicaid Provider and Recipient
Information, contains:
- Important phone numbers for both providers and recipients - Click: Important Phone Numbers.
- Emergency billing and policy information - Click Katrina Health for pharmacy information and
Emergency Billing and Policy and Procedures for Hurricane Evacuees for all other programs. To help
emergency providers service our recipients as easily as possible, some policies were waived during the
emergency period. Information concerning the reinstatement of these policies can be found here, also.
- Important provider notices distributed due to these disasters - Click on Hurricane Related
Provider
Notices and Hurricane Related RA Messages.
NOTE: If you are not enrolling as a Louisiana Medicaid provider to receive payment through the Louisiana Medicaid Program, it is not necessary to check eligibility through Louisiana Medicaid.
FindLADocs Physician Locator/Registry
Another useful tool recently developed by Louisiana Health Care Review, Inc. and MD Technologies is a web-based system for patients to connect with their physicians and physicians to register information on their current location, contact information, and their plans concerning their return to Louisiana to practice. The web site,
www.FindLADocs.com, officially opened on October 27, 2005 and is now available for use by patients and physicians.
Vaccines For Children (LOUISIANA PROVIDERS ONLY)
Because of the displacement of the primary New Orleans offices for Vaccines for Children (VFC) the Office of Public Health has established revised procedures for ordering VFC vaccines. All VFC vaccine orders should be faxed to Judi Greene at 318-676-7560. Do not send VFC requests or reports to the Regional Immunization Consultants.
For other VFC information Louisiana providers may contact Hilton Tacke at 337-658-5655.
We hope this information will be beneficial as you continue to provide assistance to our displaced
citizens.
Katrina Related Policy and Procedure Changes
Sterilization and Hysterectomy Procedures
Due to the displacement of Louisiana Medicaid recipients by Hurricane Katrina and the possible loss of medical records, the following waivers have been issued effective for dates of service August 25, 2005 through October 31, 2005.
Please note the dates of these waivers.
Sterilization Procedures
For out of state providers, the Louisiana Medicaid sterilization consent form will be waived if the recipient is an evacuee and the sterilization occurred with a delivery. If the provider is unable to obtain a Louisiana Medicaid consent form prior to surgery, the Medicaid consent form used by the state in which the procedure is performed will be accepted. The provider should attach a copy of the completed consent form and any supportive documentation obtained for the sterilization procedure to the hard copy claim. The thirty-day waiting period from recipient consent to date of sterilization is also waived for the situation outlined above.
For Louisiana Medicaid providers, the Louisiana consent form is to be used; however, the thirty-day waiting period from recipient consent to date of sterilization is waived.
A copy of the Louisiana Medicaid sterilization consent form can be obtained via telephone at (225) 342-1304 or fax (225) 376-4700. For standard billing or policy issues please refer to our website @
www.lamedicaid.com under "Training". Please direct any other billing or claims processing questions to the Unisys Provider Relations Telephone Inquiry Unit at (800) 473-2783 or (225) 924-5040.
Hysterectomy Procedures
For out of state providers, the Louisiana Medicaid hysterectomy consent form will be waived if the recipient is an evacuee. If the provider is unable to obtain a Louisiana Medicaid consent form prior to surgery, the consent form used by the state in which the procedure is performed will be accepted. The provider should attach a copy of the completed consent form and any supportive documentation obtained for the hysterectomy procedure to the hard copy claim.
For Louisiana Medicaid providers, the Louisiana consent form is to be used.
A copy of the Louisiana Medicaid hysterectomy consent form can be obtained via telephone at (225) 342-1304 or fax (225) 376-4700. For standard billing or policy issues please refer to our website @
www.lamedicaid.com under "Training". Please direct any other billing or claims processing questions to the Unisys Provider Relations Telephone Inquiry Unit at (800) 473-2783 or (225) 924-5040.
Expanded Coverage of Chemotherapy
Effective with date of services September 1, 2005 forward, Medicaid's Professional Services program has made most chemotherapy and supportive care drugs payable at the current Medicare rate to facilitate expanded access to chemotherapy services during the recovery from hurricane Katrina. These
medications are now reimbursable when provided in the office setting in addition to the previous places of services.
Substitute Physician Billing - Locum Tenens
Effective December 1, 2005, Louisiana Medicaid has revised the substitute physician billing policy as
described below. Medicaid will continue to allow both the reciprocal billing arrangement and the locum tenens arrangement. Claims submitted under these arrangements are subject to post-payment review.
Reciprocal Billing Arrangement
A reciprocal billing arrangement is when a regular physician or group has a substitute physician provide covered services to a Medicaid recipient on an occasional reciprocal basis. A physician can have
reciprocal arrangements with more than one physician. The arrangements need not be in writing.
The recipient's regular physician may submit the claim and receive payment for covered services which the regular physician arranges to be provided by a substitute physician on an occasional reciprocal basis if:
� The regular physician is unavailable to provide the services.
� The substitute physician does not provide the services to Medicaid recipients over a continuous period
of longer than 60 days*.
� The regular physician identifies the services as substitute physician services by entering the
HCPCS Q5
modifier after the procedure code on the claim form in item 24d. By entering the Q5 modifier, the
regular physician (or billing group) is certifying that the services billed are covered services furnished
by the substitute physician for which the regular physician is entitled to submit Medicaid claims.
� The regular physician keeps on file a record of each service provided by the substitute physician and
makes the record available to the Department or its representatives upon request. All Medicaid related
records must be maintained in a systematic and orderly manner and be retained for a period of five
years.
This situation does not apply to the substitution arrangements among physicians in the same medical group where claims are submitted in the name of the group. On claims submitted by the group, the group physician who actually performed the service must be identified.
[*A continuous period of covered services begins with the first day on which the substitute physician provides covered services to Medicaid recipients of the regular physician and ends with the last day on which the substitute physician provides these services to the recipients before the regular physician returns to work.
This period continues without interruption on days on which no covered services are provided on behalf of the regular physician. A new period of covered services can begin after the regular physician has returned to work. If the regular physician does not come back after the 60 days, the substitute physician must bill for the services under his/her own Medicaid number.]
Locum Tenens Arrangement
A locum tenens arrangement is when a substitute physician is retained to take over a regular physician's professional practice for reasons such as illness, pregnancy, vacation, or continuing medical education. The substitute physician generally has no practice of his/her own. The regular physician usually pays the substitute physician a fixed amount per diem, with the substitute physician being an independent contractor rather than an employee.
The regular physician can submit a claim and receive payment for covered services of a locum tenens physician who is not an employee of the regular physician if:
� The regular physician is unavailable to provide the services.
� The regular physician pays the locum tenens for his/her services on a per diem or similar fee-for-time basis.
� The substitute physician does not provide the services to Medicaid recipients over a continuous period of
longer than 60 days**.
� The regular physician identifies the services as substitute physician services by entering
HCPCS
modifier Q6 after the procedure code in item 24d of the claim form.
� The regular physician keeps on file a record of each service provided by the substitute physician and
makes the record available to the Department or its representatives upon request. All Medicaid related
records must be maintained in a systematic and orderly manner and be retained for a period of five years.
[**A continuous period of covered services begins with the first day on which the substitute physician provides covered services to Medicaid recipients of the regular physician and ends with the last day on which the substitute physician provides these services to the recipients before the regular physician returns to work. This period continues without interruption on days on which no covered services are provided on behalf of the regular physician. A new period of covered services can begin after the regular physician has returned to work. If the regular physician does not come back after the 60 days, a new 60-day period can begin with a different substitute physician.]
The "RA Message Corner" will serve as a reprint of the
messages that have been previously mailed out to providers.
A provider may not refuse health care to an individual covered by Medicaid because a Third Party has a legal obligation to pay for the services rendered. See 42 U.S.C. � 1396a (25) (D).
Hard Copy Mandate Removed for Anesthesia Codes
Effective March 1, 2005, the hard copy mandate for the following anesthesia codes has been removed for dates of service October 1, 2003 and forward.
| 00300 |
00402 |
00404 |
00406 |
00410 |
00620 |
00630 |
00790 |
00792 |
00794 |
00800 |
00810 |
| 00820 |
00840 |
00872 |
00873 |
00918 |
00920 |
00940 |
00942 |
|
|
|
|
Claims for the above procedure codes which were previously denied with error code 966 may be resubmitted electronically for processing.
Anesthesia For Vaginal Procedures
Effective July 1, 2004, forward, Louisiana Medicaid placed CPT code 00952 (anesthesia for vaginal procedures; hysteroscopy and /or hysterosalpingography) in pay status. The claims will pend to Medical Review and must be submitted hardcopy with the anesthesia record attached. If CPT code 00952 is billed for anesthesia administered during a hysterosalpingogram (HSG), the HSG must meet Medicaid requirements for anesthesia to be paid.
Clarification on Obstetric Anesthesia Billing
When billing CPT code 01967 (anesthesia; neuraxial labor analg vagin del) with add-on code +01968 (anesthesia; analg for cesarean delivery following neuraxial labor) or add on code +01969 (anesthesia; analg cesarean hysterectomy following neuraxial labor) both codes must be billed with the same date of service (the date of delivery) in order to process correctly. The two codes must be billed in conjunction to form one complete service.
Chiropractic Services Change
Procedure codes 97260 (manipulate one area by Physician) and 97261(manipulate by MD each add area) have been deleted in the 'Current Procedural Terminology' manual. Effective with dates of service September 1, 2005 forward, chiropractors should bill for services using the current appropriate CPT code 98940 (CMT; spinal, One to Two regions) or 98941 (CMT; spinal, Three to Four Regions) for the service provided. Louisiana Medicaid's non-enhanced fee for these codes is based on 80% of the 2005 Medicare allowance. HCPCS modifier 'AT' (Acute Treatment) may be appended. Medicaid coverage and criteria regarding these services has not changed. Claims using CPT codes 97260 and 97261 that deny effective 9-1-05 should be resubmitted using current codes.
Conscious Sedation
Effective with date of service August 1, 2005, Louisiana Medicaid has adopted the CPT guidelines which list procedures that include conscious sedation as an inherent part of providing the procedure. Claims paid inappropriately are subject to
recoupment.
Guidelines for Modifier 51 Usage
Effective with date of service December 1, 2005, Louisiana Medicaid will adopt CPT guidelines as these guidelines relate to modifier 51. Providers will no longer be required to append a 51 modifier to an add-on code or a modifier 51 exempt code. All surgical procedures that are not identified as modifier 51 exempt will be reimbursed based on multiple surgery policy.
If a 51 modifier is appended incorrectly, the claim line will deny. Fee schedule adjustments will be made to some procedure codes to accommodate these changes in reimbursement methodology.
Clarification of "Changes in Billing Procedures and Reimbursement for Certified Nurse Practitioners,
Clinical Nurse Specialists, and Certified Nurse Midwives"
It has come to the Department's attention that clarification is needed regarding the above referenced article published in the March/April issue of the Provider Update. The 'change' in billing for these practitioners effective July 1, 2005, is that there
will no longer be a 'list' of billable services. The services covered will be determined by individual licensure, scope of practice, and collaborative agreement (unless otherwise excluded by the Louisiana Medicaid Program).
The Louisiana Medicaid Program's long-standing policy of requiring Certified Nurse Practitioners (CNP's) and Clinical Nurse Specialists (CNS's) to obtain an individual provider number and to identify the services provided by these practitioners in block 24K (attending provider) on the CMS-1500 claim form has
NOT changed. Please see page 16 of the 2004 Professional Services Training Manual for further information. The list of codes payable to CNP's and CNS's is found in Appendix C of the same manual.
Supply of Radiopharmaceutical Diagnostic Imaging Agent Thallous Chloride TL 201/MCI
CPT procedure code 78990 has been placed in non-pay status effective June 1, 2005. HCPCS procedure code A9505 (Supply of Radiopharmaceutical Diagnostic Imaging Agent, Thallous Chloride TL 201/MCI) has been made payable effective January 1, 2005, at 80% of the Region 99 Medicare allowable. Claims for this imaging agent may now be submitted electronically as an invoice will no longer be required.
First Assistant in Surgery-Policy Change
Louisiana Medicaid will reimburse for only one first assistant in surgery. Ideally, the first assistant to the surgeon should be a qualified physician. However, in those situations when a physician does not serve as the first assistant; qualified, enrolled, advanced practice registered nurses (effective August 1, 2005) and physician assistants (effective July 1, 2005) may function in that role and submit claims for their services under their Medicaid provider number. The reimbursement of claims for more than one first assistant is subject to recoupment. Qualified certified nurse practitioners, clinical nurse specialists, and physician assistants who perform as the first assistant in surgery should use the HCPCS modifier 'AS' to identify these services.
Hospital Observation Care
Louisiana Medicaid considers "Initial Observation Care," CPT codes 99218-99220, a part of the evaluation and management services provided to patients that are designated as "observation status" in a hospital. The key components of the codes used to report physician encounter(s) are defined in CPT's "Evaluation and Management Services Guidelines." These guidelines indicate that professional services include those face-to-face and/or bedside services rendered by the physician and reported by the appropriate CPT code. In order to receive reimbursement for hospital observation care, the service provided by the physician must include face-to-face and/or bedside care.
CPT Code 58340
Effective with date of service January 1, 2005, forward, Louisiana Medicaid placed CPT code 58340 (Catheterization and introduction of saline or contrast for hysterosalpingography) in pay status.
Claims must be submitted hardcopy with attachments and will pend to Medical Review. Attachments must include the purpose for and radiological interpretation of the procedure. Reimbursement for this procedure is limited to the assessment of fallopian tube occlusion or ligation following a sterilization procedure. Louisiana Medicaid will not reimburse for the diagnosis and/or treatment of infertility.
CPT Code 58565
Effective January 1, 2005, forward, all hardcopy claims submitted for sterilization CPT code 58565 (Hysteroscopy, surgical; with fallopian tube cannulation to induce occlusion by placement of permanent implants) with correct consents will be payable. When the procedure is rendered in the office setting, the price of the device is covered in the physician's payment. When the procedure is rendered in an outpatient setting, the device is payable to the facility only.
New Sterilization Consent Form
A new sterilization consent form has been adopted by the Public Health Service. The new form conforms to standards of the Office of Management and Budget (OMB) concerning standards for maintaining, collecting, and presenting Federal data on race and ethnicity for all Federal reporting purposes.
Effective immediately form OMB No. 0937-0166 is acceptable for Louisiana Medicaid payment of sterilization. This sterilization consent form includes 3 pages which must be correctly completed and submitted in it's entirety in order for the sterilization procedure to be paid.
Louisiana Drug Utilization Review (LADUR) Education
A Review of Osteoporosis
By: Lezly A. Boudreaux, Pharm.D. Candidate and Shanna M. Thibodeaux,
Pharm.D., BC
Issues
� ...osteoporosis is "characterized by low bone mass and microarchitectural deterioration
of bone tissue leading to enhanced bone fragility and a consequent increase in fracture risk."
� Approximately 30% of all postmenopausal women and about
4 to 6% of all American men suffer from osteoporosis.
An elderly woman slowly walks past you in a store. She is slumped forward in posture with a "hunch-back" appearance. You wonder what has crippled her. In her old age, this woman has developed weak, porous bones prone to breakage if she happens to fall. If the bones are weak enough, fracture can occur even during bending or lifting or with no action at all. Her "slumped" appearance is due to small vertebral fractures that have caused compression of her spine. She may have lost several inches in height in the last three to four decades of her life. She may experience chronic pain and is likely limited in activity. This elderly woman is the picture of osteoporosis.
Epidemiology
Eight million American women and 2 million American men have osteoporosis. An estimated 34 million more Americans (women and men) have osteopenia (low bone mass) placing them at risk for osteoporotic fractures. Non-hispanic white women and Asian women make up the largest populations to suffer from osteoporosis at 20%, with Mexican-American women at 10% and Non-Hispanic black women at 5%. Approximately 30% of all postmenopausal women and about 4 to 6% of all American men suffer from osteoporosis.
Defining the Disease
According to the World Health Organization (WHO), osteoporosis is "characterized by low bone mass and microarchitectural deterioration of bone tissue leading to enhanced bone fragility and a consequent increase in fracture risk." The word osteoporosis means "porous bones" that become weak and brittle.
The Natural Process of Bone
Bone is made up of collagen, protein, and cells such as osteoclasts, osteoblasts, and osteocytes. These cells work to constantly break down and rebuild bone, a natural lifetime process of bone remodeling or turnover. Osteoclasts reabsorb the bone (resorption) and osteoblasts reform bone, while osteocytes summon osteoclast precursors to initiate resorption. There are two types of bone, trabecular and cortical. Trabecular bone makes up one-fifth of the human skeleton and is a meshwork of horizontal and vertical struts. It is more metabolically active than cortical bone because of trabecular bone's close proximity to cells in the marrow cavity that affect bone turnover. Approximately 28% of trabecular bone is remodeled annually. On the other hand, cortical bone is formed in layers, and only 4% of this type is remodeled each year. Bones most prone to breakage due to osteoporotic processes are the hip (neck of femur), forearm, and vertebrae. Osteoporosis often goes unnoticed until bone breakage actually occurs.
Diagnosis
Bone Mineral Density (BMD) is measured to determine bone mass status and reflects the balance between resorption by osteoclasts and formation by osteoblasts. The WHO classifies bone mass using T-scores. A T-score is the number of standard deviations away from mean BMD population parameters of young, healthy adults of the same gender and race of the patient being tested. A T-score of > -1.0 is considered normal bone mass, while a score between -1.0 and -2.5 is referred to as osteopenia. A T-score of < -2.5 is classified as osteoporosis.
The "Gold Standard" in aiding in the diagnosis of osteoporosis is Dual Energy X-ray Absorptiometry (DEXA). The DEXA system uses low beam x-rays to measure BMD. Two energy peaks are relied upon, one being absorbed by soft tissue and the other by bone. BMD is obtained by subtracting the soft tissue amount from the total. The central DEXA unit, used mainly in hospitals, provides direct measurements of BMD of the hip, vertebrae, and forearm. It is considered quite accurate, reflecting true BMD, and quite precise, having the ability to measure differences in bone mineral density over time. This precision allows the DEXA method to be useful in monitoring treatment. Limitations of central DEXA include possible error from compression fractures of the spine and osteoarthritis, and thus should not be used in patients with previous spinal deformity or surgery. The peripheral DEXA exam is a simpler, less sensitive exam. A finger, hand, forearm or foot is placed in a small device, and a BMD reading is obtained in minutes. Because the measurement is not a direct one of the hip or spine, it is considered a less accurate exam and is often used in community mobile health vans because of its portability and decreased cost.
Who should be tested?
The National Osteoporosis Foundation recommends BMD testing in the following:
� Postmenopausal women > 65 years old
� Postmenopausal women ages 50-65 years old with additional risk factors (See Table 1) and/or the following:
-Clinical fracture present
-Radiographic abnormality suggesting bone loss
-Results of test may influence clinical decisions regarding therapy
-On hormone replacement therapy for prevention of osteoporosis (to determine efficacy)
� Chronic corticosteroid users - The American College of Rheumatology "recommends hip BMD measurements for
all patients on or beginning glucocorticoid therapy and spine BMD measurements for patients age 60 and older."
� Men with any of the following criteria:
-Presence of multiple risk factors for osteoporosis (Table 2)
-Evidence of low-trauma fracture
-Evidence of a prevalent vertebral deformity
-Documented osteopenia via standard x-ray
-Conditions known to increase the risk for bone loss and fracture, such as hypogonadism and
glucocorticoid use.
Source: AJHP 2004;61(17):1802.
Classifications
Major classifications of osteoporosis are postmenopausal, age-related, and secondary osteoporosis. Secondary osteoporosis is further broken down into drug-induced and disease-induced.
Postmenopausal Osteoporosis
Peak BMD is achieved during young adulthood, between the ages of 25 and 35. At this point in life, resorption by osteoclasts and formation by osteoblasts are equal. Estrogen and other hormones regulate bone remodeling, so at menopause, BMD loss accelerates as estrogen production declines. Ten to twenty-five percent of bone is lost in the first decade after menopause. This loss slows to 8-12% per decade after the first 7-10 years of menopause. As estrogen is lost, osteoclasts are up-regulated and bone resorption exceeds its formation having greater impact on trabecular bone structure. Also contributing are osteocytes that normally trigger increased BMD with increased weight-bearing, but during menopause this response is dulled.
Interestingly, some estrogen is still synthesized in adipose tissue after menopause. Women with the highest estrogen concentrations are found to have the lowest risk of fracture; therefore, heavier women with increased amounts of adipose tissue tend to be less prone to developing a break.
Age-related Osteoporosis
Age-related osteoporosis results from bone loss occurring after peak bone mass is attained. It affects both trabecular and cortical bone, so occurrences of hip, forearm, and vertebral fractures are increased with this type of disease.
Bone resorption increases with age. As previously mentioned, women experience 8-12% loss of bone each decade after the first ten years of menopause. In men, 3-4% of bone is lost each decade after peak BMD is attained. Osteocytes that normally respond to strain and aid in bone repair are being killed off at higher rates and are hindering these former normal responses. Years of remodeling now cause deterioration and porosity.
Aging predisposes us to increased risk of falling due to comorbid conditions, cognitive impairment, medications, or deconditioning. Increased hip fracture risk with age may be due to more falls, as well as lower bone density. Nutritional intake also becomes a concern. We may be receiving insufficient amounts of calcium and vitamin D in our diets. Vitamin D production is triggered in the body during sun exposure, and elderly individuals may be less active and spend less time outdoors soaking in those helpful vitamin D-stimulating sun-rays.
Secondary Osteoporosis
Drug-induced osteoporosis is the most common secondary cause of the disease. Glucocorticoids put patients at the highest risk of developing osteoporosis from a
medicinal agent. Other drugs that may induce osteoporosis are thyroid-replacement agents when used in excess, some antiepileptic agents, and long-term use of heparin.
Excessive thyroid replacement can be managed by monitoring thyroid-stimulating hormone levels. Antiepileptics affect vitamin D metabolism which in turn affects calcium absorption. Antiepileptic-induced osteoporosis is more often seen in patients taking multiple antiepileptic medications, those that are institutionalized, and those that have several comorbidities. Long-term heparin use in excess of 15,000 to 30,000 units daily for more than 3-6 months can cause bone loss and vertebral fractures. On the other hand, low-molecular weight heparins, such as enoxaparin are associated with less risk of bone loss.
Glucocorticoids decrease muscle strength and bone formation and increase bone resorption. Calcium absorption is decreased and renal excretion is increased, leading to a secondary hypoparathyroidism. Steroids are also able to reduce the differentiation, replication, and life span of the osteoblasts that build bone.
Chronic glucocorticoid use is defined as using the equivalent of 7.5mg of prednisone daily for at least 3 months. Fracture incidence with chronic use of steroids is 30-50%. Bone loss is continuous throughout chronic steroid use but is greatest during the first 6 to 12 months and affects trabecular bone more than cortical bone.
Hypogonadism is the most common secondary cause of osteoporosis in men. With hypogonadism comes a decreased testosterone level, increased sex-hormone binding globulin, endocrine dysfunction, and androgen ablation.
Non-pharmacologic prevention
There exist measures to aid in the prevention of osteoporosis. These factors should be enforced throughout life, even at our peak, and include:
1. Engaging in aerobic exercise and weight training
2. Avoidance of tobacco use - Tobacco interferes with calcium absorption and is associated with lower
estrogen levels, early onset of menopause, and an increased need for hormone replacement therapy after
menopause.
3. Reduced alcohol consumption - Excessive alcohol intake and prolonged consumption inhibit bone remodeling, but moderate alcohol consumption has been shown to increase BMD. Also, fall risk is increased with excessive
alcohol consumption.
4. Sufficient intake of dietary or supplemental calcium and vitamin D - Experts recommend daily calcium intakes of 1000-1500mg daily for adult men and women. Vitamin D aids in calcium absorption. One source of vitamin D is sun exposure. Often, 10 to 15 minutes of sun exposure several times each week are enough to help the body produce sufficient vitamin D. For those unable to attain sufficient outdoor exposure, the National Academy of Sciences recommends 400 to 800 IU daily supplemental intake of Vitamin D.
Pharmacologic Treatment and Prevention
Bisphosphonates
Alendronate (Fosamax�) and risedronate (Actonel�) are indicated for both the prevention and treatment of postmenopausal and glucocorticoid-induced osteoporosis. Alendronate is also approved for treatment of male osteoporosis. Bisphosphonates inhibit bone resorption via actions on osteoclasts or their precursors. Adverse effects associated with these agents are gastrointestinal, esophageal irritation and ulceration, and abdominal pain. Alendronate reduces the incidence of spine, hip, and nonspine fractures by up to 50%. Risedronate reduces the incidence of spine fractures by 40% and hip and nonspine fractures by 30%.
Bisphosphonates must be taken with 6-8 ounces of plain water at least 30 minutes before the first food, beverage, or medication of the day so not to inhibit absorption. Patients also must be able to stand or sit upright for at least 30 minutes and until after the first food of the day to reduce irritation to the stomach and esophagus. While taking bisphosphonates, calcium and vitamin D should be supplemented.
Once weekly administration of alendronate and risedronate has shown efficacy and safety similar to once daily administration in the prevention and treatment of postmenopausal osteoporosis. (See Table 3 for dosing.)
Ibandronate (Boniva�) is approved for the prevention and treatment of osteoporosis in postmenopausal women. It is dosed as a 2.5mg oral tablet taken once daily or a 150mg oral tablet taken once monthly on the same day of each month. In clinical trials, vertebral fractures have been reduced up to 50%. Adverse effects include upper respiratory tract infection, dyspepsia, bronchitis, back pain, and arthralgia.
Selective Estrogen Receptor Modulator (SERM)
Raloxifene (Evista�)
Raloxifene is a benzothiophene SERM developed to avoid the uterotrophic effects of other SERMs, such as tamoxifen (Nolvadex�). In a three year study, raloxifene has reduced the risk of vertebral fractures by 30-50%. It is indicated for the prevention and treatment of osteoporosis in postmenopausal women. Raloxifene works like estrogen to prevent bone loss and improve lipid profiles. Adverse effects associated with raloxifene use include thromboembolism and hot flashes. (See Table 3 for dosing.)
Parathyroid hormone (PTH) analog
Teriparatide (Forteo�)
Teriparatide is the one of the newest types of agents added to the list of osteoporosis treatments. It is a human recombinant parathyroid hormone used for treatment of postmenopausal women with osteoporosis who are at high risk for fracture. It can also be used to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. Through stimulation of osteoblasts and increased absorption and reabsorption of calcium, teriparatide has the ability to increase bone mineral density, bone mass, and strength. In studies, this PTH analog has reduced risk of spine fractures up to 65% and nonspine fractures by 54% at an average of 18 months.
Teriparatide is supplied as a 250mcg/mL (3mL) injection. The prefilled syringe delivers 20mcg/dose given once daily. Orthostasis may occur during initial administration, so the patient should sit down during this time. Other adverse effects associated with teriparatide use include arthralgia, leg cramps, and dizziness. Teriparatide also carries a "black box warning". It is not to be used in those at increased risk of osteosarcoma. Patients at high risk for osteosarcoma include those with Paget's disease, prior radiation therapy, unexplained elevations in alkaline phosphatase, and patients with open epiphyses.
Calcitonin
Salmon Calcitonin (Calcimar�, Miacalcin�, Miacalcin�NS)
Calcitonin is recommended for use in women at least five years menopausal. It has reduced spine fractures by 21%.9 Its mechanism of action is to directly inhibit osteoclastic bone resorption. Adverse effects associated with calcitonin use are flushing, nausea, diarrhea, anorexia, and rhinitis.
Calcitonin is available as an intramuscular or subcutaneous injection of 200 IU/mL dosed at 100 units daily. This agent is also available as a nasal spray. This formulation is dosed as 200 IU (1 spray) intranasally daily, alternating nostrils daily.
Estrogens
Estrogens should only be used prophylactically in high risk women because of the increased risk of adverse effects such as breast cancer, heart attack, stroke, and thromboembolism discovered during the Women's Health Initiative Trial. Because of the potential harm in using these agents, estrogens should be initiated at the lowest available dose.
Summary
Osteoporosis is a debilitating disease of low bone mass and high fracture risk occurring when bone resorption exceeds its formation. The populations most afflicted with osteoporosis are older white or Asian women normally occurring after a menopausal-induced estrogen deficiency. When found in men, osteoporosis is usually due to decreased testosterone levels. Other causes are simply age-related or drug- or disease-induced. Chronic use of steroids poses the greatest medicinal risk of developing osteoporosis. Tobacco use, regular alcohol consumption, inactivity, and insufficient calcium and vitamin D intake all contribute to possible development of osteoporosis. Due to the often undetected progression of the disease, women greater than 50 years of age need to consider their risk factors and ask their doctor if BMD testing is appropriate for them. Those at high risk for development should consider pharmacologic means of prevention such as a bisphosphonate, raloxifene, or estrogen replacement in low doses. If treatment is needed, a bisphosphonate, raloxifene, teriparatide or salmon calcitonin may be of benefit in reducing fracture risk. We may not be able to completely avoid osteoporosis, but our best defense is to educate ourselves. Early detection leads to early intervention and greater opportunity to slow the progression of bone loss.
References Available Upon Request