Specialized Medications and Other FAQs
If you are a UCHealth patient with complex or specialized medication prescriptions and management, there is additional information you need to know.
What do I need to know about Medicare and my prescription?
Medicare Prescription Drug Coverage and Your Rights
Your Medicare rights.
You have the right to request a coverage determination from your Medicare drug plan if you disagree with information (such as charges) provided by the pharmacy. You also have the right to request a special type of coverage determination called an “exception” if you believe:
- you need a drug that is not on your drug plan’s list of covered drugs. The list of covered drugs is called a “formulary;”
- a coverage rule (such as prior authorization or a quantity limit) should not apply to you for medical reasons; or
- you need to take a non-preferred drug and you want the plan to cover the drug at a preferred drug price.
What you need to do.
You or the provider who prescribed the medication can contact your Medicare drug plan to ask for a coverage determination by calling the plan’s toll-free phone number on the back of your plan membership card, or by going to your plan’s website. You or the provider who prescribed the medication can request an expedited (24 hour) decision, if your health could be seriously harmed by waiting up to 72 hours for a decision. Be ready to tell your Medicare drug plan:
- The name of the prescription drug that was not filled. Include the dose and strength, if known.
- The name of the pharmacy that attempted to fill your prescription.
- The date you attempted to fill your prescription.
If you ask for an exception, the provider who prescribed the medication will need to provide your drug plan with a statement explaining why you need the off-formulary or non-preferred drug or why a coverage rule should not apply to you.
Your Medicare drug plan will provide you with a written decision. If coverage is not approved, the plan’s notice will explain why coverage was denied and how to request an appeal if you disagree with the plan’s decision.
Refer to your plan materials or call 1-800-Medicare for more information.
PRA Disclosure Statement According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this collection is 0938-0975. The time required to complete this information collection is estimated to average 1 minute per response, including the time to review instructions, search existing data resources, and gather the data needed, and complete and review the information collection. If you have any comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Baltimore, Maryland 21244-1850.
CMS does not discriminate in its programs and activities: To request this form in an accessible format (e.g., Braille, Large Print, Audio CD) contact your Medicare Drug Plan. If you need assistance contacting your plan, call: 1-800-MEDICARE.
Form CMS -10147 OMB Approval No. 0938-0975
What are the Medicare DMEPOS Supplier Standards?
Medicare DMEPOS Supplier Standards – 10/1/2014
Note: This is an abbreviated version of the supplier standards every Medicare DMEPOS supplier must meet in order to obtain and retain their billing privileges. These standards, in their entirety, are listed in 42 C.F.R. 424.57(c).
- A supplier must be in compliance with all applicable Federal and State licensure and regulatory
- A supplier must provide complete and accurate information on the DMEPOS supplier application. Any changes to this information must be reported to the National Supplier Clearinghouse within 30 days.
- A supplier must have an authorized individual (whose signature is binding) sign the enrollment application for billing privileges.
- A supplier must fill orders from its own inventory, or contract with other companies for the purchase of items necessary to fill orders. A supplier may not contract with any entity that is currently excluded from the Medicare program, any State health care programs, or any other Federal procurement or non-procurement
- A supplier must advise beneficiaries that they may rent or purchase inexpensive or routinely purchased durable medical equipment, and of the purchase option for capped rental equipment.
- A supplier must notify beneficiaries of warranty coverage and honor all warranties under applicable State law, and repair or replace free of charge Medicare covered items that are under
- A supplier must maintain a physical facility on an appropriate site and must maintain a visible sign with posted hours of operation. The location must be accessible to the public and staffed during posted hours of business. The location must be at least 200 square feet and contain space for storing records.
- A supplier must permit CMS or its agents to conduct on-site inspections to ascertain the supplier’s compliance with these standards.
- A supplier must maintain a primary business telephone listed under the name of the business in a local directory or a toll free number available through directory assistance. The exclusive use of a beeper, answering machine, answering service or cell phone during posted business hours is
- A supplier must have comprehensive liability insurance in the amount of at least $300,000 that covers both the supplier’s place of business and all customers and employees of the supplier. If the supplier manufactures its own items, this insurance must also cover product liability and completed operations.
- A supplier is prohibited from direct solicitation to Medicare beneficiaries. For complete details on this prohibition see 42 CFR§ 424.57 (c) (11).
- A supplier is responsible for delivery of and must instruct beneficiaries on the use of Medicare covered items and maintain proof of delivery and beneficiary instruction.
- A supplier must answer questions and respond to complaints of beneficiaries and maintain documentation of such
- A supplier must maintain and replace at no charge or repair cost either directly, or through a service contract with another company, any Medicare-covered items it has rented to beneficiaries.
- A supplier must accept returns of substandard (less than full quality for the particular item) or unsuitable items (inappropriate for the beneficiary at the time it was fitted and rented or sold) from
- A supplier must disclose these standards to each beneficiary it supplies a Medicare-covered
- A supplier must disclose any person having ownership, financial, or control interest in the
- A supplier must not convey or reassign a supplier number; i.e., the supplier may not sell or allow another entity to use its Medicare billing
- A supplier must have a complaint resolution protocol established to address beneficiary complaints that relate to these standards. A record of these complaints must be maintained at the physical facility.
- Complaint records must include: the name, address, telephone number and health insurance claim number of the beneficiary, a summary of the complaint, and any actions taken to resolve
- A supplier must agree to furnish CMS any information required by the Medicare statute and
- All suppliers must be accredited by a CMS-approved accreditation organization in order to receive and retain a supplier billing number. The accreditation must indicate the specific products and services, for which the supplier is accredited in order for the supplier to receive payment for those specific products and services (except for certain exempt pharmaceuticals).
- All suppliers must notify their accreditation organization when a new DMEPOS location is opened.
- All supplier locations, whether owned or subcontracted, must meet the DMEPOS quality standards and be separately accredited in order to bill
- All suppliers must disclose upon enrollment all products and services, including the addition of new product lines for which they are seeking accreditation.
- A supplier must meet the surety bond requirements specified in 42 CFR § 424.57 (d).
- A supplier must obtain oxygen from a state-licensed oxygen
- A supplier must maintain ordering and referring documentation consistent with provisions found in 42 CFR §516(f).
- A supplier is prohibited from sharing a practice location with other Medicare providers and
- A supplier must remain open to the public for a minimum of 30 hours per week except physicians (as defined in section 1848(j) (3) of the Act) or physical and occupational therapists or a DMEPOS supplier working with custom made orthotics and prosthetics.
DMEPOS suppliers have the option to disclose the following statement to satisfy the requirement outlined in Supplier Standard 16 in lieu of providing a copy of the standards to the beneficiary.
The products and/or services provided to you by (UCHealth Specialty Pharmacy Program) are subject to the supplier standards contained in the Federal regulations shown at 42 Code of Federal Regulations Section 424.57(c). These standards concern business professional and operational matters (e.g., honoring warranties and hours of operation). The full text of these standards can be obtained at http://ecfr.gov . Upon request we will furnish you a written copy of the standards.
Other Pharmacy FAQs
What is a compounding pharmacy?
A compounding pharmacy is a type of pharmacy that specializes in compounding services, which is the creation of a pharmaceutical preparation (a drug) by a licensed pharmacist to meet a patient’s unique needs when a commercially available drug does not meet those needs. In a compounding pharmacy, pharmacists spend most or all of their time compounding special preparations for patients, which include both sterile and nonsterile dosage forms.
Where do I dispose of unused prescriptions and sharps (needles, syringes and other sharp objects)?
Select UCHealth pharmacy locations offer on-site disposal, those include:
- UCHealth Pharmacy – Harmony Campus
- UCHealth Pharmacy – Greeley Hospital
- UCHealth Pharmacy – Anschutz Outpatient Pavilion
Proper Disposal of Unused Medicines
For instructions on how to dispose of unused medicines, check with your local waste collection service. You can also check the following websites for more information:
- https://www.fda.gov/consumers/consumer-updates
- https://www.fda.gov/drugs/ensuring-safe-use-medicine/safe-disposal-medicines
- https://www.colorado.gov/pacific/cdphe/colorado-medication-take-back-program
Proper Disposal of Sharps
Place all sharps into a sharps container. If you are prescribed any medicines to be injected, the pharmacy will give you a container, if needed. Contact local waste pickup services for their policy on sharps container pickup. You can also check the following websites for more information:
- https://www.fda.gov/medical-devices/safely-using-sharps-needles-and-syringes-home-work-and-travel/sharps-disposal-containers
- https://www.fda.gov/medical-devices/safely-using-sharps-needles-and-syringes-home-work-and-travel/best-way-get-rid-used-needles-and-other-sharps
- https://safeneedledisposal.org/
How do I get my prescription in case of an emergency?
Emergency and Disaster Preparedness Plan
In case of emergencies, including natural disasters, UCHealth’s main goal is to continue to meet your prescription care needs. When there is a threat of disaster or an emergency in the local area that may impact delivery of your medicine, UCHealth Pharmacy will contact you as soon as possible to arrange delivery. However, if there is a threat of disaster or inclement weather in the area where you live (and that is not near Aurora, CO), it is your responsibility to contact the pharmacy as soon as you have knowledge of the impending emergency. UCHealth will take make reasonable efforts to meet your pharmacy needs in the event of an emergency, the more notice you can provide to us, the more chance we have to provide you with your needed medication.
There may be times where we cannot meet your needs. In that case, you need to use the resources of your local rescue or medical facility. Please read the guide below to help you in the case of an emergency or disaster:
- The pharmacy will call you 3 to 5 days before any predicted inclement weather emergency, such as a severe snowstorm.
- If you are not in the Adams County area and are aware you will have inclement weather, you are responsible for calling the pharmacy 3 to 5 days before the event.
- If possible, the pharmacy will send your medicine by next day delivery prior to any inclement weather emergencies.
- If the pharmacy cannot get your medicine to you before an inclement weather emergency, the pharmacy will attempt to transfer your prescription to a local specialty pharmacy near you.
- If a local disaster occurs, and the pharmacy cannot reach you or you cannot reach the pharmacy, please listen to your local news, and rescue centers for advice on getting medicine. Visit your local hospital right away if you might miss a dose.
- UCHealth pharmacy recommends all patients leave a secondary emergency number so that we can contact you in case of an emergency or disaster.
If you have a personal emergency (not weather related) and you need your medicine, please contact the pharmacy.
What are my rights and responsibilities as a UCHealth Pharmacy patient?
UCHealth Specialty Pharmacy Program recognizes that patients have inherent rights. Patients who feel their rights have not been respected, or who have questions or concerns, should talk to the pharmacist on duty.
Patients and their families also have responsibilities while under the care of The following patient rights and responsibilities shall be provided to, and expected from, patients or their legally authorized individuals.
As our patient, you have the right to:
- Have your property and person treated with respect, consideration, and recognition of patient dignity, personal values, beliefs, philosophy and individuality.
- Express spiritual beliefs and cultural practices as long as they do not harm or interfere with your medical treatment, or that of another patient or staff member.
- Effective communication, regardless of language or other
- Be involved in the development and periodic revision of your plan of care and to understand what is expected of
- Refuse care or treatment as permitted by law and to be informed of the medical consequences of your
- Be interviewed, examined, and treated in a safe setting that provides personal
- Be free from mistreatment, neglect, or verbal, mental, sexual, and physical abuse, including injuries of unknown source, and misappropriation of permitted patient property.
- Understand the philosophy of the University of Colorado Hospital Specialty Pharmacy Patient Management Program (PMP), including the disciplines that furnish care and the frequency of visits, as well as any modifications to the plan of care.
- Receive information about the scope of services that UCHealth provided and specific limitations on those services.
- A clear, concise explanation of your condition, proposed care/service being provided and your financial responsibility.
- Information about the outcomes of care, including unanticipated outcomes.
- Know who is responsible for your care (physicians and others) and your role, including any relationships you may have to other health care providers or educational institutions and be able to identify them through proper identification.
- The right to speak with the staff member’s supervisor, if requested.
- Be informed of rules and regulations that apply to your
- View your medical record within the guidelines established by
- Access protective services, information and
- Know in advance of any experimental, research or educational activities involved in your treatment. A patient can refuse to participate in any such
- Be fully informed of your rights and responsibilities in a simple and easy to understand manner
- Have an authorized representative exercise the patient’s rights if patient is unable to participate in care or treatment
- Have grievances/complaints regarding treatment or care that is (or fails to be) furnished, or lack of respect of property investigated.
- To express concerns, grievances/complaints, or recommend modifications to our Pharmacy in regard to services or care, lack of respect of property or recommended changes in policy, personnel, or care/service without fear of discrimination, reprisal, restraint, interference, or coercion.
The patient/caregiver may contact the University of Colorado Hospital Patient Representative department to file a complaint or grievance. Patient representatives may be reached at 720-848-5277 from 8 a.m. to 4:30 p.m., Monday through Friday. On holidays, weekends or after hours, you may call the hospital operator at 720-848-0000 and ask for the hospital manager. Patient representatives may also be contacted via writing at:
- electronically at: https://www.urac.org/file-a-grievance
The patient/caregiver may contact the Accreditation Commission for Health Care (ACHC) to file a complaint or grievance electronically at:
Patients/caregivers are entitled to information about the hospital’s mechanism for the initiation, review, and resolution of patient/caregiver complaints or grievances and should be informed of their right to file a grievance by calling the Hospital’s Patient Representative who will implement the UCHealth Patient Grievance Procedure policy. The complaint resolution process starts with interviews by the patient representatives. The appropriate hospital teams will review, investigate and attempt to resolve each patient’s grievance within 7 to 15 days of the submittal of the grievance and provide a written response to the patient.
Grievances may be complicated and may require an extensive review. If the grievance is not resolved, or if the review is not complete within 7 days, the hospital’s written response should address that the hospital is still working to resolve the complaint and state that the hospital will follow up with another written response within a stated number of days.
- Receive information about the PMP, including any changes or termination to services within the PMP.
- Receive information regarding the status of prior authorizations or refill renewal requests processed by the Medication Access and Renewal Center (MARC) in conjunction with the University of Colorado Hospital Specialty Pharmacy.
- Receive information regarding the status of a prescription and co-pay details by asking a MARC representative.
- Refuse enrollment or opt out from the PMP at any time.
- Have personal health information shared with the University of Colorado Hospital Specialty Pharmacy under the parameters of state and federal law.
- Reviewed and understand the UCHealth Specialty Pharmacy’s policies and procedures regarding the disclosure of clinical records.
- Information regarding their medication plan benefits including:
- Whether dispensing pharmacies are in or out of network per their health plan. Participation in the PMP is not dependent on payer plan, and the program does not exclude services based on any particular payer plan.
- Out-of-pocket costs depending on patient health plan (including co-pays).
- Where and how to obtain claims-related information.
- Be informed of client/patient rights under state law to formulate an Advanced Directive, if applicable.
- Confidentiality and privacy of all information contained in the client/patient record and of Protected Health Information (PHI).
- Choose a healthcare provider, including an attending physician, if applicable.
- Speak to a health care professional.
- Receive appropriate care without discrimination in accordance with physician’s orders, if applicable.
- Be informed of any financial benefits when referred to an organization.
- Access his/her clinical records upon reasonable notice and within a reasonable period of time The MARC assists attempts by the patient to gain access to his/her own medical records and provides copies upon written authorization from the patient and payment of reasonable fees within current state law requirements. A patient/caregiver has the right to inspect the records without charge.
As a patient, you have the responsibility to:
- Provide, to the best of your knowledge, accurate and complete information about contact information, present complaints, past illnesses, hospitalizations, medications, and other matters relating to their health.
- Report unexpected changes in your condition to the responsible practitioner. A patient/caregiver is responsible for making it known whether you clearly comprehend a contemplated course of action and what is expected.
- Understand your actions if they refuse treatment or do not follow the practitioner’s instructions.
- Follow instructions for treatment and maintenance of equipment provided as well as rules about patient
- Actively participate in the assessment and management of their specialty medications. You work with your provider to develop a disease management plan that includes: asking about what to expect regarding their specialty medication management, helping the MARC PMP team assess medication therapies, and identifying any concerns regarding specialty medications.
- Complete and submit any forms that are necessary per participation in the PMP to the extent as required by law.
- Keep appointments and notifying the responsible provider when you are unable to do so for any reason.
- Understand your insurance coverage and requirements such as preauthorization, deductibles, and co-payments.
- Notify the treating provider of participation in the services provided by the organization.
- Notify the organization of any concerns about the care or services provided.
Statement of Patient Rights and Responsibilities
The statement of patient rights and responsibilities is provided to all patients’ as part of the PMP. The statement of patient rights and responsibilities is available in at least two languages, English and Spanish. The University of Colorado Hospital Specialty Pharmacy makes reasonable efforts to provide the information to patients who need additional assistance because of language barriers or other challenges.
What is UCHealth’s privacy policy?
Please visit this page to view and learn more about UCHealth’s Privacy Policy.
Who should I contact if I have other questions or concerns about specialty medications?
Patients and caregivers have the right to voice complaints or recommendations on services to the specialty pharmacy. Patients and caregivers can do so by phone, fax, in writing, or by email.
The organizations below are available to contact anytime you feel your complaint was not resolved by the pharmacy:
- The patient or caregiver may contact the University of Colorado Hospital Patient Representative department to file a complaint or grievance. Patient representatives may be reached at 720.848.5277 from 8 am to 4:30 pm, Monday through Friday. On holidays, weekends or after hours, you may call the hospital operator at 720.848.0000 and ask for the hospital manager. Patient representatives may also be contacted via writing at:
University of Colorado Hospital
UCHealth – Patient Representatives
12605 East 16th Avenue
1st Floor
Mail Stop, C300
Aurora, Colorado 80045 - Colorado State Board of Pharmacy
Website: https://dpo.colorado.gov/FileComplaint
General Phone Number: 303.894.7800 - URAC Complaint Info
Website: https://www.urac.org/file-a-grievance
Email Address: [email protected]
General Phone Number: (202) 216.-9010 - ACHC Complaint Info
Website: https://www.achc.org/contact/
For more information, you may contact ACHC toll-free at (855) 937.2242 or 919.785.1214 and request the Complaints Department.