Common use of Beneficiary Protections Clause in Contracts

Beneficiary Protections. Eligible entities offering Medicare Prescription Drug Plans would be required to disclose plan information comparable to that required for MedicareAdvantage plans. Entities would have to disclose information on access, operation of any formulary, beneficiary cost-sharing, and grievance and appeals procedures. Further, upon request of an individual, they would be required to disclose general information on coverage, utilization, and grievance procedures. An eligible entity would be required to have a mechanism for providing specific information to enrollees, upon request, including information on coverage of specific drugs and changes in its formulary. Entities would be required to provide easily understandable explanation of benefits and a notice of benefits in relation to the initial coverage limit and the annual out-of-pocket limit. The MedicareAdvantage requirements relating to approval of marketing materials would apply to information provided by entities on drug plans. The bill would include several provisions designed to assure beneficiary access to drugs. Eligible entities would be required to have in place procedures to ensure that beneficiaries were not charged more than the negotiated price of a covered drug. The procedures would include the issuance of a card or other technology that could be used by a beneficiary to assure access to negotiated prices for which coverage was not otherwise provided under the plan. Entities would be required to secure the participation in the network of a sufficient number of pharmacies that dispensed drugs directly to patients (other than by mail order) to ensure convenient access for beneficiaries. The Administrator would be required to establish standards to ensure convenient access, including emergency access. The standards would take into account reasonable distances to pharmacy services in both urban and rural areas and to pharmacy services and access to pharmacy services of the Indian health service and Indian tribes and tribal organizations. An entity would be required to establish a point-of-service method of operation under which the plan would provide access to any or all pharmacies not participating in the network and could charge beneficiaries, through adjustments in cost sharing, the additional costs associated with this option. This additional cost sharing would not count toward the program’s cost-sharing requirements or benefit limits. Entities would be required to permit enrollees receiving benefits (which may include a 90-day supply of drugs or biologicals) through a community pharmacy, rather than through mail order and may permit a differential amount to be paid by enrollees. New Section 1860D-6 would permit entities to use a variety of cost control mechanisms including formularies, tiered copayments, selective contracting with drug providers, and mail order pharmacies. Under New Section 1860D-5, plans electing to use a formulary would be required to establish a pharmacy and therapeutic committee to develop and review the formulary. The pharmacy and therapeutics committee would include at least one academic expert, at least one practicing physician, and at least one practicing pharmacist, all of whom must have expertise in the care of elderly or disabled persons. The committee would base clinical decisions on the strength of scientific evidence and standards of practice. The committee would establish policies and procedures to educate and inform health care providers concerning the formulary. Drugs could not be removed from the formulary until after appropriate notice had been provided to beneficiaries, physicians, and pharmacists. An enrollee would have the right to appeal to obtain coverage for a drug not on the formulary if the prescribing physician determined that the formulary drug was not as effective for treatment of the same condition for the individual or had adverse effects for the individual. If a plan offered tiered cost-sharing for covered drugs, an enrollee would have the right to request that a nonpreferred drug be treated on terms applicable for a preferred drug if the prescribing physician determined that the preferred drug was not as effective for treatment of the same condition for the individual or had adverse effects for the individual. The formulary would be required to include drugs within all therapeutic categories and classes of covered drugs (although not necessarily for all drugs within such categories and classes). For purposes of defining therapeutic categories and classes, the Administrator would be required to use the following compendia: American Hospital Formulary Service Drug Information, United States Pharmacopeia-Drug Information, the DRUGEX Information System, and American Medical Association Drug Evaluations. Eligible entities would be required to have a cost-effective drug utilization management program (including incentives to reduce costs when appropriate). They would be required to have a program to control fraud, abuse, and waste. Further, they would be required to have quality assurance measures, including a medication therapy management program, to reduce medical errors and adverse drug interactions. The medication therapy management program would be designed to assure that drugs for beneficiaries with chronic diseases (such as diabetes, asthma, hypertension, hyperlipidemia, and congestive heart failure) or multiple prescriptions were appropriately used to optimize therapeutic outcomes and reduce the risk of adverse events including adverse drug interactions. The program could include enhanced beneficiary understanding of appropriate use through education, counseling and other appropriate means; increased adherence with prescription regimens through refill reminders, special packaging and other appropriate means; and detection of patterns of overuse and underuse of drugs. The program would be developed in cooperation with pharmacists and physicians. Associated costs would be taken into account by the entity when establishing fees for pharmacists and others providing services under the medication therapy management program. Pharmacies or other dispensers would be required to assure that beneficiaries were informed at the time of purchase of any difference between the price of the prescribed drug and the lowest cost generic drug that is therapeutically equivalent and bioequivalent and that is available at the pharmacy or other dispenser. Entities would also be required to have meaningful procedures for hearing and resolving grievances, comparable to those established for MedicareAdvantage plans. In addition, eligible entities would be required to meet MedicareAdvantage requirements relating to coverage determinations. Entities would be required to safeguard the privacy of individually identifiable beneficiary information, maintain such records in an accurate and timely manner, ensure timely access by beneficiaries, and otherwise comply with laws relating to patient privacy. Eligible entities would be required to conduct consumer satisfaction surveys with respect to the plan and entity. The Administrator would establish uniform requirements for such survey.