Common use of Beneficiary Protections Clause in Contracts

Beneficiary Protections. The New Section 1860D-1 would establish guaranteed issue and community-rating requirements. The provision would specify that individuals electing qualified prescription drug coverage under a PDP plan or MA Rx or EFFS Rx plan could not be denied enrollment based on health status or other factors. MA provisions relating to priority 1) access to specific covered drugs, including access through pharmacy networks; 2) how any formulary used by the sponsor functioned; 3) copayment and deductible requirements (including any applicable tiered copayment requirements); and 4) grievance and appeals procedures. In addition, beneficiaries would have the right to obtain more detailed plan information. Plans would be required to have a mechanism for providing specific information to enrollees on request. The sponsor would be required to make available, through an Internet web site and, on request, in writing, information on specific changes in the formulary. Plans would be required to furnish to enrollees, at least monthly, a detailed explanation of benefits when drug benefits were provided, including information on benefits compared to the initial coverage limit and the applicable out-of-pocket threshold. PDP sponsors and entities offering an MA Rx or EFFS Rx plan would be required to permit the participation of any pharmacy that met the plan’s terms and conditions. A PDP and an MA Rx or EFFS Rx plan could reduce copayments for its enrolled beneficiaries below the otherwise applicable level for drugs dispensed through in-network pharmacies; in no case could the reduction result in an increase in subsidy payments made by the Administrator to the plan. PDP sponsors and entities offering an MA Rx or EFFS Rx plan would be required to secure participation in its network of a sufficient number of pharmacies that dispense drugs directly to patients (other than by mail order) to assure convenient access. The Administrator would establish convenient access rules that were no less favorable to enrollees than rules for convenient access established by the Secretary of Defense on June 1, 2003, for purposes of the TRICARE Retail Pharmacy program. The rules would include adequate emergency assess for enrolled beneficiaries. Sponsors would permit enrollees to receive benefits through a community pharmacy, rather than through mail-order, with any differential in cost paid by enrollees. Pharmacies could not be required to accept insurance risk as a condition of participation. PDP sponsors and entities offering an MA Rx or EFFS Rx plan would be required to issue (and reissue as appropriate) a card or other technology that could be used by an enrolled beneficiary to assure access to negotiated prices for drugs when coverage was not otherwise provided under the plan. The Administrator would provide for the development of uniform standards relating to a standardized format for the card or other technology. These standards would be compatible with the administrative simplification requirements of Title XI of the Social Security Act. The provision would specify that if a PDP sponsor or an MA or EFFS entity used a formulary, it would have to meet certain requirements. It would be required to establish a pharmaceutical and therapeutic committee to develop and review the formulary. The committee would include at least one physician and one pharmacist, independent and free of conflict with respect to the committee, both with expertise in the care of elderly or disabled persons. The majority of members would be physicians or pharmacists. The committee would be required, when developing and reviewing the formulary, to base clinical decisions on the strength of scientific evidence and standards of practice. This would include assessing peer-reviewed medical literature, such as randomized clinical trials, pharmacoeconomic studies, outcomes research data, and such other information the committee determined appropriate. The committee would also take into account whether including a particular covered drug had therapeutic advantages in terms of safety and efficacy. The formulary would have to include drugs within each therapeutic category and class of covered outpatient drugs, although not necessarily all drugs within such categories or classes. When establishing such classes, the committee would take into account the standards published in the United States Pharmacopeia Drug Information. It would be required to make available to plan enrollees, through the Internet or otherwise, the bases for the exclusion of coverage of any drug on the formulary. The committee would be required to establish policies and procedures to educate and inform health care providers and enrollees concerning the formulary. Any removal of a drug from the formulary, and any change in the preferred or tier cost-sharing status of a drug, could not occur until appropriate notice had been provided to beneficiaries and physicians. The plan would provide for periodic evaluation and analysis of treatment protocols and procedures. Further, the PDP sponsor or entity offering a MA Rx or EFFS Rx plan would be required to have, as part of its appeals process, a process for appeals of coverage denials based on application of the formulary. The PDP sponsor would be required to have (directly, or indirectly through arrangements) an effective cost and drug utilization management program; quality assurance measures including a medication therapy management program; and a program to control waste, fraud, and abuse. Utilization management programs would be required to include medically appropriate incentives to use generic drugs and therapeutic interchange where appropriate. Medication therapy management programs would be designed to assure, for beneficiaries at risk for potential medication problems such as beneficiaries with complex or chronic diseases (such as diabetes, asthma, hypertension, and congestive heart failure) or multiple prescriptions, that drugs under the plan were appropriately used to optimize therapeutic outcomes through improved medication use and to reduce the risk of adverse events, including adverse drug interactions. The program would be developed in cooperation with licensed pharmacists and physicians. The PDP sponsor would be required, when establishing fees for pharmacists and other providers, to take into account the resources and time associated with the medication therapy management program. The sponsor or entity would disclose the amount of such fees to the Administrator upon request; the fees would be confidential. Each PDP sponsor and entity offering a MA Rx or EFFS Rx plan would ensure that each pharmacy or other dispenser informed enrolled beneficiaries at the time of purchase, of any price differential between their prescribed drug and the price of the lowest cost generic drug covered under the plan that was therapeutically equivalent and bioequivalent. Each PDP sponsor would be required to have meaningful procedures for the hearing and resolving of any grievances between the organization (including any entity or individual through which the organization provided covered benefits) and enrollees. Enrollees would be afforded access to expedited determinations and reconsiderations, in the same manner afforded under MA. A beneficiary in a plan that provided for tiered cost-sharing could request coverage of a non- preferred drug on the same conditions applicable to preferred drugs, if the prescribing physician determined that the preferred drug for the treatment of the same condition was not as effective for the enrollee or had adverse effects for the enrollee. In general, PDP plan sponsors would be required to meet the requirements for independent review and appeals of coverage denials and tiered cost-sharing in the same manner that such requirements applied to MA organizations. An individual enrolled in a PDP plan could appeal to obtain coverage for a drug not on the formulary if the prescribing physician determined that the formulary drug for treatment of the same condition was not as effective for the individual or had adverse effects for the individual. The PDP sponsor would be required to meet requirements related to confidentiality and accuracy of enrollee records in the same manner that such requirements applied to MA organizations.