The Basics

The standard imposes two requirements on the policies and procedures governing the functions of the P&T committee:

• a clearly defined policy regarding consumer use of and access to drugs before their inclusion in the formulary
• other formulary management activities, such as prior authorizations, step therapies, quantity limits generic substitutions, drug utilization, and other functions that address issues of consumer access to drugs.

Management Tips

Not only does this standard explicitly mention "protocols and procedures," but it also imposes a requirement that components of those policies addressing the requirements of the standard be "clearly defined."  In a reference to the issues raised in the standard will be insufficient.

URAC Accreditation Tips

Both elements of this standard are mandatory.

You'll need to submit the applicable policies and procedures for the desktop review, and have available the committee minutes for the on-site review.

The Basics

This standard requires the P&T committee to adopt and follow a policy and procedure requiring that it consider new drugs for inclusion in the formulary.  The policy and procedure should include a specific timeframe after the drug's release into the market that it will take up the possibility of including it.

Management Tips

This is another standard explicitly mentioning policies and procedures, not just compliant performance.  Be sure that the time frame you set is reasonable.  URAC suggests three to five months after the drug hits the market.  because URAC is measuring the time from introduction into the market to the time of committee consideration, it is probably a best practice to include in the discussion in the committee the date of introduction of a truck to the market.

URAC Accreditation Tips

The standard is weighted 2.

The documentation required for the desktop review phase is simply the applicable policy and procedure.

The on-site reviewer will specifically asked to be shown portions of the committee minutes in which new drugs were considered.  He/she is also likely to include this in the interview of the P&T committee member.  it therefore would be a good idea to refresh the committee member's memory as to the most recent time a new drug was considered.

The Basics

This standard requires that your organization's policies and procedures regarding formulary envy P&T committee specifically address how it interfaces with both the drug utilization management and quality management programs.

Management Tips

A mere reference to quality of health care for utilization management is likely to be insufficient in the eyes of URAC.  Rather, your policy and procedure should address, overtly, the mechanisms by which the three programs (DrUM, QM, and PTFD) interact.  Such mechanisms could include a requirement of inter-program communications and/or a review of the formulary program by the quality management committee.

URAC Accreditation Tips

The single element of the standard has a weight of 2.

The applicable policy and procedures the sole documentation required for initial submission for this standard.

The on-site reviewer will examine quality management committee minutes for evidence of inter-program interaction.  He/she also may look for other documented indicators of inter-program interaction (e.g., reports).

The Basics

The standard sets forth the fundamental activities of the P&T committee:

• the appraisal, evaluation, and selection of drugs for the formulary
• the evaluation and review of policies and procedures designed to educate prescribers about drugs, their use, and the decisions of the committee regarding formulary
• the evaluation, analysis, and review of protocols and procedures regarding the use of and access to drugs that are not on the formulary.

Management Tips

Make sure that the policies and procedures setting forth the committee's responsibilities include its oversight of the formulary system, interventions, therapeutic interchange programs, the education of prescribers, pharmacists, and consumers, and quality improvement.

URAC Accreditation Tips

The three elements of the standard are each weighted 2.

Documentation at the desktop review level is simply the applicable policies and procedures and/or the committee charter.

In addition to reviewing committee minutes during on-site review, the URAC reviewer will review communications materials designed to meet the intent of the standard as well as interview a member of the committee.  It will be particularly important to make sure the committee member to be selected for this interview is fully trained on URAC standards about which he/she is likely to be asked during this interview.

The Basics

The standard requires that the P&T committee meet no less frequently than quarterly.  It also requires the documentation in writing of the decision-making process around inclusion and exclusion of drugs from the formulary.

Management Tips

The intent of this standard must be met by one or both of the organization's policies and procedures and P&T committee charter.  In addition, it is imperative that the committee's minutes are meticulously kept and well-organized.

URAC Accreditation Tips

This standard has a weight of 2.

The applicable policies and procedures/committee charter are the only documentation required at the desktop preview stage.

The on-site review activity for the standard is limited to a review of committee minutes to assure that they are sufficiently detailed in describing the formulary decision-making process.

The Basics

The standard on policies and procedures of the P&T committee imposes two requirements on the organization's policies and procedures regarding formulary management:

• representatives of pharmaceutical companies may neither be members nor attend committee meetings;
• all committee members must adhere to the organization's policy on disclosure and participation in formulary discussions as it relates to conflict of interest.

The first requirement is absolute, prohibiting drug company representatives attendance at any meeting.

Management Tips

This is another one of those standards that specifically mentions "policies", making it even more essential than usual that the organization's policies and procedures capture the essence of the standard, not just its behavior.

URAC Accreditation Tips

Both elements of the standard are mandatory.

Documentation for the desktop review phase is merely the organization's applicable policies and procedures.

The on-site reviewer will be looking at P&T committee meeting minutes for evidence that conflict of interest has been the subject of a committee discussion.  In addition, the reviewer will be examining all committee members' executed conflict of interest statements.

The Basics

This standard simply requires that your organization require the members of the P&T Committee to sign a conflict of interest statement each year revealing their economic interests or relationships that could influence committee decisions.  

Management Tips

Again, it is not sufficient to produce conflict of interest statements from the members of the committee.  Not only must you assure that the statements are dated less than a year before the date of the on-site review, but also you must have a policy and procedure that requires the annual signing by your committees members of a conflict of interest statement.

URAC Accreditation Tips

This is a mandatory standard.

For the desktop review, you may submit either the policies and procedures or committee charter, or both.  In addition, you should submit a template of a conflict of interest statement.

During the on-site review, you will need to provide copies of conflict of interest statements from every member of your committee.  We recommend that you simply provide a binder that has all such statements gathered together.  In addition, the reviewer will examine committee minutes to make sure that there is nobody on the committee for whom you do not have a current conflict of interest statement.

The Basics

This standard describes minimum requirements for the P&T Committee members.  The members must represent diverse clinical specialties that correspond to plan beneficiary needs as well as appropriate specialists.  Most members of the committee should be physicians and/or practicing pharmacists.  At least one practicing physician and one practicing pharmacist must be an expert in the care of the elderly.  At least one practicing pharmacist and one practicing physician should be free of conflict of interest regarding both health plan and pharmaceutical manufacturers.

Management Tips

It will not be sufficient if you are actual membership of the committee complies with the standard.  In addition, your policy and procedure or committee charter must require membership that meets the dictates of this standard.  Make sure that your policy and procedure or committee charter also addresses the issue of replacing members.

Because this standard emanates from federal regulations, URAC may also want to see evidence that your compliance program addresses this issues.

URAC Accreditation Tips

All five elements of this standard are weighted 3.

Documentation for the desktop review should include applicable policies and procedures and/or committee charters.

The on-site review will involve examination of committee minutes, the resumes of members of the committee, as well as an interview of a committee member (by telephone, if needed) and a ranking compliance officer.

The Basics

The standard imposes a requirement on your organization that it informs prescribers, patients, and payers about the various factors that go into formulary decisions.  The organization also must provide information about how to obtain non-formulary drugs and information about drug compliance.  The standard also requires that the organization's consumer education program explains how the organization makes its decision about inclusion in and exclusion from the formulary, as well as what is expected of the consumer.  Finally, consumers and providers must be able to readily access copy of the formulary.

Management Tips

In all such consumer and provider notification standards, URAC requires multiple methods of delivering information, as much as not everybody has access to the Internet.  Therefore, mere access to a formulary web page will not meet the intent of the standard.

URAC Accreditation Tips

One of the elements of the standard is weighted 3, while the others weigh 4 each.

The submission requirement for the desktop review is the applicable policy and procedure as well as a comprehensive communication plan.

The on-site review will involve an examination of the formulary, probably on the website.  The reviewer also is likely to request a sample of notifications to prescribers, pharmacies, and consumers of any recent changes in the formulary.  It is therefore best practice to have recent notifications of changes on hand during the on-site review.

The Basics

Under this standard, the P&T committee may consider economic factors, but only after it has considered a drug's safety, efficacy, and therapeutic need.  In addition, if the FDA has approved a new drug therapy shown to be beneficial in peer-reviewed studies, and there is no equivalent drug therapy, the committee should not exclude that therapy.

Management Tips

Your organization's policy and procedure on this topic must be clear that economic considerations are secondary to a drug's clinical factors.  You will need to make sure that the policy complies with any applicable regulatory considerations.

URAC Accreditation Tips

The first element of the standard is mandatory; the second is weighted 4.

For the desktop review, submit the applicable policies and procedures that address economic formulary considerations.  URAC also recommends that you submit any documents from the regulatory compliance program that address mandatory generics.

The on-site review will focus on committee minutes in an interview of formulary staff members to assess their understanding of the requirements of the standard.