As most jurisdictions across the U.S. are now subject to some kind of “stay at home” order due to COVID-19, people need have access to their medications during an extended period at home. In most of those jurisdictions, pharmacies are considered “essential” businesses and remain open, though individuals are encouraged to limit their trips outside the home. Still, the CDC has encouraged “those at higher risk, particularly older adults and those who have severe underlying health conditions” to make sure to “have access to several weeks of medications and supplies in case you need to stay home.” And as individuals across the U.S. are asked to stay home for an extended period as COVID-19 spreads, everyone who needs continued access to prescription medications must take steps to ensure they will have access to their medications during the pandemic.
Unfortunately, we currently do not know how long people may have to stay home and avoid going out during an outbreak. But government orders and recommendations that people stay home as much as possible and avoid contact with other people are at odds with health program rules that require people to make frequent trips to the pharmacy by limiting the access to prescriptions by mail, or placing caps on the quantity of prescription drugs a person may obtain at one time, or the number of times they may refill a prescription. Insurance companies, state Medicaid programs, and other payors need to relax these rules now to ensure that people are able to have the drugs they need without exposing themselves to COVID-19. The sections below describe the rules that currently limit home-delivery or mail-order pharmacy and quantities and refills for prescription drugs, as well as strategies to help people obtain additional quantities of medications or refill a prescription in the wake of the COVID-19 emergency.
Rules that Apply Regardless of Program
Some drugs are subject to rules that apply to all drugs dispensed regardless of whether or how the drug is covered. For example, certain prescription drugs that are classified as controlled substances may have dispensing limits imposed on them by federal law or by the Drug Enforcement Administration (DEA). Delivery, quantity and refill limits are also often imposed at the state level for certain controlled substances written in the state. In response to COVID-19, states may waive some of federal rules to ensure access to medications to treat opioid use disorders. Indiana, for example, announced that it will permit opioid treatment programs to distribute naloxone to some participants through a lockbox, to minimize the need for human contact in order to receive necessary medication assisted treatment.
In addition, a few states impose quantity limits on all prescriptions filled in the state. Many of these states, for example Ohio, are taking action to relax or suspend those rules to allow people to obtain the medications they need to have on hand during a COVID-19 outbreak.
The CARES Act requires Medicare Part D and Medicare Advantage plans to provide up to a 90-day supply of covered prescription drugs to those who request it. In addition, on March 10 CMS issued COVID-19 guidance to Medicare Part D plans that required them to reimburse enrollees for prescriptions obtained from out-of-network pharmacies if their access to network pharmacies is disrupted, though the cost may be more than the cost of obtaining drugs from a network pharmacy. For enrollees who are discouraged or prohibited from visiting a retail pharmacy, Part D plans may voluntarily relax any policies that discourage alternative delivery methods, such as mail order or home delivery. Under existing regulations affirmed in CMS’s recent guidance, Part D plans must offer any permissive benefits implemented during the COVID-19 emergency uniformly provided to all similarly situated enrollees.
Currently, state Medicaid programs have a fair amount of discretion to limit access to covered drugs, including determining whether covered drugs may be provided to beneficiaries by a home-delivery or mail-order service, and the quantity of drugs available and number of refills permitted. Thus, state Medicaid programs can generally relax or adjust those limits without any action from CMS, though in some cases where limits are specified in a state’s Medicaid state plan, an amendment from CMS may be necessary. Many states, like North Carolina and California, are taking action to make it easier for their Medicaid beneficiaries to obtain additional refills or exceed quantity limits to ensure they have the drugs they need during a COVID-19 outbreak.
Private Insurance Coverage Including Marketplace Plans
Most small group and individual plans, including those sold in the health insurance marketplaces, are required to cover prescription drugs as an essential health benefit. Large group plans are not required to cover prescription drugs, though most do. In general, dispensing requirements and refill and quantity limits for private plans are regulated at the state level. Some states, like Connecticut, are working with the plans in their state to eliminate or relax quantity and refill limits during the COVID-19 pandemic. New Hampshire is temporarily allowing out-of-state pharmacies to operate as mail-order pharmacies in the state to increase access to prescription drugs.
Many large employers “self-fund” health coverage for their employees. Such self-funded plans are generally not subject to state insurance laws and are only subject to the federal Employee Retirement and Income Security Act (ERISA). ERISA does not require self-funded plans to cover prescription drugs, though most do, and permits plans significant discretion in terms of quantity and refill limits on covered drugs. Thus, each self-funded plan will make its own decisions about allowing exceptions to its quantity and refill limits.
Advocates should work with state regulators, including insurance commissioners and state Medicaid directors, to obtain emergency relief from rules that limit access to needed prescription drugs during the pandemic. However, advocates should also be aware of potential unintended consequences. Allowing people to stockpile large quantities of prescriptions could lead to shortages of some medications. In addition, the broader impact of COVID-19 on the international supply chain and pharmaceutical manufacturing remains unknown.
Stay safe, stay well, stay informed.