Rare Disease Pharmacy Designation v. 1.0

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Rare Disease Pharmacy Designation v. 1.0

Definition Proposal – Public Comment

Definition Proposal – Public Comment

·       "Rare Disease (or Orphan Disease)": A disease affecting fewer than 200,000 people in the US.

·       "Ultra-Rare Disease": A disease affecting fewer than 50,000 people in the US.

·       "Rare Disease Pharmacy Practice": A specialty pharmacy that provides comprehensive medication management and coordinates care for patients who are taking an orphan drug for a rare or ultra-rare disease. Pharmacy staff are trained to provide services that are specific, targeted, and above and beyond what is provided by a traditional specialty pharmacy practice. The services provided recognize the unique needs of the Rare Disease patient.

Thank you for taking the time to provide feedback to URAC on proposed revised Rare Disease Pharmacy Designation standards. Everything we do – every standard we promote – seeks to improve the quality of healthcare delivered to patients.

Please provide any comments, input or feedback in the spaces provided. Comments submitted via letter may be uploaded on the General Comments page.

Elements of performance (EPs) where compliance will be scored are indicated by the assigned weight of [2], [4] or Mandatory [M]. The Designation standards comprise 2 Focus Areas.: Connected Patient Care (4 standards) and Rare Disease Patient Management & Outcomes (2 standards).

To assure that your comments are saved you must click on the “Submit” button found on the General Comments page.

Please comment below.
Focus Area: Connected Patient Care (RD-CPC)

RD-CPC 1: Transitions of Care
RD-CPC 1: Transitions of Care
The Rare Disease Pharmacy Practice supports patient access to medications during transitions of care.

RD-CPC 1-1: Transitions of Care
The pharmacy maintains processes to support patient access to medication [M]:
a.       When transitioning out of clinical trials
b.       During transitions between payers when there is limited access to the medication
c.       When transitioning from facility therapy administration to in-home therapy administration
d.       When transitioning to a new therapy that necessitates a change in pharmacy .

Interpretive Information:
- · Example of support may include connecting the patient to the HUB for their support with these items including coordinating with "Quick Start" and "Bridge" programs.
- · Support requires ability to connect patient to the right person if the pharmacy cannot resolve the matter themselves.
Thank you for taking the time to provide feedback to URAC on proposed revised Rare Disease Pharmacy Designation standards. Everything we do – every standard we promote – seeks to improve the quality of healthcare delivered to patients.

Please provide any comments, input or feedback in the spaces provided. Comments submitted via letter may be uploaded on the General Comments page.

Elements of performance (EPs) where compliance will be scored are indicated by the assigned weight of [2], [4] or Mandatory [M]. The Designation standards comprise 2 Focus Areas.: Connected Patient Care (4 standards) and Rare Disease Patient Management & Outcomes (2 standards).

To assure that your comments are saved you must click on the “Submit” button found on the General Comments page.

Please comment below.
Focus Area: Connected Patient Care (RD-CPC)

RD-CPC 2: Support and Outreach
RD-CPC 2: Support and Outreach
The Rare Disease Pharmacy Practice provides information regarding available support to patients and caregivers and participates in outreach programs.

RD-CPC 2-1: Patient and Caregiver Support
The pharmacy refers patients and/or caregivers to:
a.       Support groups specific their disease state and therapy [M]
b.       Appropriate rare disease and therapy registries [4]
c.       Appropriate clinical trials [2]
d.       Available support for caregivers [2]

RD-CPC 2-2: Pharmacy Community Outreach
The pharmacy:
a.       Participates in community outreach programs associated with disease states managed [L]
b.       Coordinates community outreach programs [L]

Interpretive Information:
- · Community can be local, regional, national, global, or virtual.
- · Leading Indicators are optional and have no impact on scoring of compliance with the requirement(s).
Thank you for taking the time to provide feedback to URAC on proposed revised Rare Disease Pharmacy Designation standards. Everything we do – every standard we promote – seeks to improve the quality of healthcare delivered to patients.

Please provide any comments, input or feedback in the spaces provided. Comments submitted via letter may be uploaded on the General Comments page.

Elements of performance (EPs) where compliance will be scored are indicated by the assigned weight of [2], [4] or Mandatory [M]. The Designation standards comprise 2 Focus Areas.: Connected Patient Care (4 standards) and Rare Disease Patient Management & Outcomes (2 standards).

To assure that your comments are saved you must click on the “Submit” button found on the General Comments page.

Please comment below.
Focus Area: Connected Patient Care (RD-CPC)

RD-CPC 3: Coordinating Patient Services
RD-CPC 3: Coordinating Patient Services
The Rare Disease Pharmacy Practices coordinates services to address barriers to access and alternative care needs.

RD-CPC 3-1: Coordinating Patient Services
The pharmacy maintains processes to:
a.       Manage financial assistance support and other services to address barriers to access [4]
b.       Coordinate alternative care for services not provided by the pharmacy [4]
c.       Understand the network of pharmacies for limited distribution medications dispensed and plan accordingly for access issues [4]

Interpretive Information:
- a) Barriers to care are more than just financial needs. May also include: geographic, social, logistical (e.g., transportation), cognitive, linguistic, etc.
- a) – b), This may include the pharmacy coordinating with HUB services. This is not limited to financial assistance, and would include Quick Start, Bridge, and other support programs.
- a) – b) This may include assisting the patient with personal transitions may include: loss of employment, additional health factors, divorce, etc.
Thank you for taking the time to provide feedback to URAC on proposed revised Rare Disease Pharmacy Designation standards. Everything we do – every standard we promote – seeks to improve the quality of healthcare delivered to patients.

Please provide any comments, input or feedback in the spaces provided. Comments submitted via letter may be uploaded on the General Comments page.

Elements of performance (EPs) where compliance will be scored are indicated by the assigned weight of [2], [4] or Mandatory [M]. The Designation standards comprise 2 Focus Areas.: Connected Patient Care (4 standards) and Rare Disease Patient Management & Outcomes (2 standards).

To assure that your comments are saved you must click on the “Submit” button found on the General Comments page.

Please comment below.
Focus Area: Connected Patient Care (RD-CPC)

RD-CPC 4: Staff Education
RD-CPC 4: Staff Education
The Rare Disease Pharmacy Practice employs staff who are specifically trained to manage patients within the disease states and products dispensed.

RD-COMP 4-1: Staff Education
The pharmacy:
a. Provides initial and ongoing staff education specific to each disease state and therapy managed, relevant to employee job functions. [M]

Interpretive Information:
- Patient facing staff may receive training different than those staff who deal with inventory.
Thank you for taking the time to provide feedback to URAC on proposed revised Rare Disease Pharmacy Designation standards. Everything we do – every standard we promote – seeks to improve the quality of healthcare delivered to patients.

Please provide any comments, input or feedback in the spaces provided. Comments submitted via letter may be uploaded on the General Comments page.

Elements of performance (EPs) where compliance will be scored are indicated by the assigned weight of [2], [4] or Mandatory [M]. The Designation standards comprise 2 Focus Areas.: Connected Patient Care (4 standards) and Rare Disease Patient Management & Outcomes (2 standards).

To assure that your comments are saved you must click on the “Submit” button found on the General Comments page.

Please comment below.
Focus Area: Rare Disease Patient Management & Outcomes (RD-PMO)

RD-PMO 1: Patient Assessments
RD-PMO 1: Patient Assessments
In addition to factors assessed during initial assessments and reassessments conducted within the specialty pharmacy practice, the Rare Disease Pharmacy Practice assesses additional factors and reports outcomes to patients and providers.

RD-PMO 1-1: Patient Assessment Requirements
During initial assessments and re-assessments, the pharmacy assesses:
a.       Patient reported outcomes [4]
b.       Patient experience [4]
c.       Severity of adverse drug events experienced by a patient [4]
d.       Patient barriers to access [4]

RD-PMO 1-2: Patient Assessment Technology
The pharmacy:
a.   Utilizes technology tools to track and trend individual patient's reported outcomes and experience [L]

RD-PMO 1-3: Individual Patient Reporting
The pharmacy:
a.       Reports trended patient assessment data to the individual patient or caregiver on a regular basis [4]
b.       Reports patient assessment data to providers on a regular basis [4]
c.       Shares patient assessment data with other pharmacies to enhance patient coordination and care [L]

Interpretive Information:
- · 1-1) All requirements for initial assessments and reassessments as defined in URAC's Specialty Pharmacy program remain. These requirements are in addition.
- · 1-1) Compliance is demonstrated through documentation of each factor in the patient assessment record. If an adverse drug event or barrier to access issue is identified, it is expected that the response and/or intervention to address is also documented in the record.
- · 1-1) d) Barriers to care are more than just financial needs. May also include: geographic, social, logistical (e.g., transportation), cognitive, linguistic, etc.
- · 1-2) a) Providing the patient with their specific data empowers them to participate more meaningfully in their care.
Thank you for taking the time to provide feedback to URAC on proposed revised Rare Disease Pharmacy Designation standards. Everything we do – every standard we promote – seeks to improve the quality of healthcare delivered to patients.

Please provide any comments, input or feedback in the spaces provided. Comments submitted via letter may be uploaded on the General Comments page.

Elements of performance (EPs) where compliance will be scored are indicated by the assigned weight of [2], [4] or Mandatory [M]. The Designation standards comprise 2 Focus Areas.: Connected Patient Care (4 standards) and Rare Disease Patient Management & Outcomes (2 standards).

To assure that your comments are saved you must click on the “Submit” button found on the General Comments page.

Please comment below.
Focus Area: Rare Disease Patient Management & Outcomes (RD-PMO)

RD -PMO 2: Patient Outcomes
RD -PMO 2: Patient Outcomes
The Rare Disease Pharmacy Practice tracks and analyzes specific patient outcomes, implements action plans when needed. The pharmacy aggregates and reports outcomes data when appropriate.

RD-PMO 2-1: Patient Outcomes
The pharmacy tracks and analyzes the following patient data implementing action plans as needed:
a. Time to therapy [4]
b. Barriers to access [4]
c. Patient Outcomes [4]
d. Patient Experience [4]

Note for public comment:
- Does "Time to Therapy" belong in the Rare Disease program?
- This is commonly tracked across SP's and is a current URAC measure that SP's report. Would "Converted to Therapy Rate" be more applicable? Is that specific to RD or also applicable to an SP?
RD-PMO 2-2: Outcomes Reporting
The pharmacy maintains processes to:
a. Report aggregate outcomes reporting data to payers and manufacturers as appropriate [4]
Thank you for taking the time to provide feedback to URAC on proposed revised Rare Disease Pharmacy Designation standards. Everything we do – every standard we promote – seeks to improve the quality of healthcare delivered to patients.

Please provide any comments, input or feedback in the spaces provided. Comments submitted via letter may be uploaded on the General Comments page.

Elements of performance (EPs) where compliance will be scored are indicated by the assigned weight of [2], [4] or Mandatory [M]. The Designation standards comprise 2 Focus Areas.: Connected Patient Care (4 standards) and Rare Disease Patient Management & Outcomes (2 standards).

To assure that your comments are saved you must click on the “Submit” button found on the General Comments page.

Please comment below.
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