Part D / Prescription Drug Benefits – Center for Medicare Advocacy

Introduction to Medicare Part D

This section is an introduction to part d. For more detailed information on any of the topics in this section, click on the links within the topics. there, you will also find relevant legislative, statutory, and cfr citations.

Before 2006, Medicare paid for some drugs administered during a hospital stay (under Medicare Part A) or in a doctor’s office (under Medicare Part B). Medicare did not cover outpatient prescription drugs until January 1, 2006, when it implemented the Medicare Part D prescription drug benefit, authorized by Congress under the “Medicare Prescription Drug Improvement and Modernization Act.” of 2003”.[1] this law is generally known as “mma”.

Reading: Medicare prescription drug benefits for individuals who purchase the

the part d drug benefit (also known as “medicare rx”) helps medicare beneficiaries pay for outpatient prescription drugs purchased at retail, mail order, home infusion, and prescription pharmacies. long-term care.[2]

unlike parts a and b, which are administered by medicare itself, part d is “privatized”.[3] That is, Medicare contracts with private companies that are authorized to sell Part D insurance coverage. these companies are regulated and subsidized by medicare, under one-year contracts renewable annually.[4] To have Part D coverage, beneficiaries must purchase a policy (ie enroll in a plan) offered by one of these companies.

The costs associated with Medicare Part D include a monthly premium, an annual deductible (sometimes waived by plans), copays and coinsurance for specific drugs, a coverage gap called the “donut hole,” and catastrophic expenses. coverage once a limit amount has been reached.[5]

People with incomes up to 150 percent of the federal poverty level can get help with part d costs for premiums, deductibles, and copays through the part d low-income subsidy (known as “lis ” or “Extra Help”) , which is administered by the Social Security Administration.[6]

Within the parameters established by law, plans are free to establish their own forms.[7] There is an appeal process for members who need drugs that are not on their plan’s formulary.

Plans revise their formularies every year, adding new drugs, removing others, and generally charging higher copays and coinsurance for drugs. Beneficiaries should reevaluate their plan options each year to ensure that the chosen plan will continue to meet their financial and medical needs.

many part d plan sponsors offer multiple plans that can be seen as analogous to “good, better, better” business options. Buyers should weigh these options carefully, as it is sometimes the case that the “best” (and most expensive) plans offer little or no additional value for their higher prices.

Under the 2010 regulations, Medicare required plans to eliminate under-enrolled plans and consolidate duplicate plans.[8] this reduced the total number of plans available to beneficiaries, but there are still many plans to choose from and their differences are now more transparent to consumers.

part d coverage sources

Medicare does not administer Part D directly. contracts with private companies that are approved to sell part d insurance coverage.[9] there are two main sources of coverage of part d:

• pdps (prescription drug plans): These are independent companies that only sell prescription drug coverage. they do not offer hospital or medical coverage.[10]

pdp plan sponsors have a four-digit identifier beginning with the letter “s“. each of the different plan options offered by the sponsor has a unique three-digit suffix identifier.[11] For example, in 2015, United Healthcare sponsored the AARP Preferred Plan (S5820-002).

• ma-pds (medicare advantage prescription drug plans): These plans offer hospital, medical, and prescription drug coverage in a single policy.[12] Medicare Advantage Plans are sometimes called Medicare “Part C.” there are different types of ma-pds, for example, including hmos, ppos, pffs, and snps plans).[13] plans must identify their plan type in their plan names.[14] people who want to enroll in a medicare advantage plan must get their prescription drug coverage from the same plan, unless they are enrolled in a pffs that does not offer prescription drug coverage.[15]

ma-pd plan sponsors have a four-digit identifier beginning with the letter “h.“[16]the various plan options offered by the plan sponsor each have a unique three-digit suffix. For example, in 2015, Anthem sponsored the Mediblue HMO Standard Plan (H5854-008).

note: not all medicare advantage plans offer prescription drug coverage. some offer only hospital and medical coverage, with no prescription drug coverage. these are “ma” plans (as opposed to “ma-pd” plans). MA plans are only appropriate for people who have prescription drug coverage from some other source, such as the Veterans Administration (VA). members of these plans cannot enroll in a pdp for their prescription drug coverage.[23] In addition to pdps, ma-pds, and snps, there is another source of part d coverage.

Employer or Union-Sponsored Part D Retiree Plans: Employers and unions may offer Part D coverage to their Medicare-eligible employees and retirees through their own employer plans. P.S. These plans are only available to eligible employees and retirees and are not open to the public. these plans may have a four-digit identifier beginning with the letter “e” or a three-digit suffix “800 – serial” number. Employer-sponsored Part D plans must follow all of the same rules as commercial Part D plans. Likewise, members of these plans have the same rights as members of commercial plans.

drug subsidy for retirees

Employers and unions that offer their retirees prescription drug coverage that is actuarially equivalent to (as good as or better than) Part D may qualify for a federal retiree drug subsidy (RSD).[24] rds became available in 2006, with the advent of part d, to encourage employers and unions to continue offering high-quality prescription drug coverage to their medicare-eligible retirees. the 28% federal subsidy helps defray the employer/union cost of providing coverage. beneficiaries enrolled in an employer or union plan that receives an rds cannot enroll in part d.

eligibility for part d

Anyone with Medicare is eligible to join a Part D plan. to enroll in a pdp, a person must have part a or part b.[25] to enroll in a ma-pd, a person must have part a and part b.[26]

Members must live (have a permanent residence) in their plan’s service area.[27] for homeless people, permanent residence can be used: a post office box, the address of a shelter or clinic, or the address where the person receives mail, such as social security checks.[28]

PDPS are typically national plans, but MA-PDs have bounded regions, sometimes by state, sometimes by counties within states (42 U.S.C. § 1395w-111(a)). For this reason, MA-PDS may not be appropriate for those who travel extensively or maintain summer and winter residences in different parts of the country. Note: Some MA-PDs offer “passport” plans that allow members to obtain benefits outside of their regular service areas.

Persons residing outside of the United States* are not eligible to enroll, but may do so upon return to the country.[29] incarcerated individuals cannot enroll in part d, but can enroll upon release from prison.[30] Prior to 2021, people with End-Stage Renal Disease (ESRD) could not enroll in a MA-PD. (but you will not be disenrolled if you develop esrd while a member of the plan). Starting in 2021, people with ESRD can enroll in Medicare Advantage plans (including MA-PDS) during the annual open enrollment period.[31]

There are no other restrictions or eligibility requirements for part d.

• cms publication: medicare prescription drug benefit handbook: chapter 3: eligibility, enrollment, and disenrollment (revised 8/12/2020)

*the united states is defined as the fifty federated states, plus the district of columbia, american samoa, guam, the northern mariana islands, and puerto rico.

drugs covered by part d

Medicare law defines the drugs that are covered under Part D in relation to their coverage by the federal Medicare program and other parts of Medicare.[32] drugs that are required under medicaid may be covered under part d; drugs that are optional under medicaid are excluded under part d. In addition, the Part D drugs must be:

• approved by the food and drug administration (fda) for sale in the united states;
• available by prescription only;
• medically necessary and for a “medically accepted indication”.[33]

A drug that is for a “medically accepted indication” is one that is prescribed to treat an FDA-approved disease or condition (indication). A drug that is prescribed for a condition that is not approved by the FDA is considered prescribed “off-label.” off-label drugs may be covered only when supported as safe and effective in an officially recognized drug compendium or, in the case of cancer chemotherapeutic drugs, in peer-reviewed journals.[34]

(additional information: https://www.medicareadvocacy.org/cma-report-medicare-coverage-for-off-label-drug-use/)

• part d also covers biologic drugs, insulin and insulin syringes, and smoking cessation drugs.

Plans must provide coverage to Medicare-eligible individuals residing in long-term care facilities and must offer dosages and forms of drugs that are common in these settings. Medications used to treat opioid dependence may be covered when medically necessary. to treat opioid dependence, cms published a final rule in 2018 that establishes drug utilization through a limitation on the number of prescribers and pharmacies where such drugs are obtained.[35] lte-desi (less than effective drug efficacy study) drugs are not covered.[36]

Except for those covered by part b, most commercially available vaccines, including the shingles vaccine, have been covered by part d since 2008.[37] the amount paid for the vaccination includes a fee for administering the injection.

commercially available combination prescriptions that contain at least one part d drug component are considered part d drugs.[38] For extemporaneous compounds, only components that meet the condition of a Part D drug may be covered.[39]

Drug manufacturers must enter into an agreement with cms to offer a discount on brand name drugs purchased during the coverage gap. Drugs produced by manufacturers that do not sign such agreements will not be covered under Part D, even if they meet the definition of a Part D drug.[40]

forms

part d plans are not required to cover all part d drugs.[41] they will be able to establish their own formularies, which must include categories and classes of drugs that cover all disease states. the forms cannot be discriminatory, that is, designed to discourage the enrollment of certain beneficiaries. [42]A form is not considered discriminatory if:

• follows the US Pharmacopoeia model formulary;[43]
• includes at least two drugs in 148* drug categories;[44]
• covers all or “substantially all” drugs in the following protected classes of drugs: anti-cancer; antipsychotic; anticonvulsant, antidepressant, immunosuppressive, and antiretroviral medications.[45]

cms monitors the adequacy of the plan’s formularies, including drug tiering and application of utilization management restrictions relative to industry best practices.[46]

People are limited to the drugs on their plan’s formulary, but can request an exception to cover a drug that is not on the formulary. if a plan approves a non-formulary drug through the exception or appeal process, the plan may charge a higher price for the drug by placing it in a higher tier.[47] drugs that are not on the formulary also do not count toward the “actual payment” (“troop”) amount required to get out of the coverage gap, unless approved by exception or appeal. Barriers to obtaining non-formulary medications emphasize the importance of choosing a plan with a formulary compatible with the individual’s needs.

* Previously, plans were required to cover at least 2 drugs in 146 drug categories.[48] As of January 1, 2013, two new drug classes are covered under Part D.[49] these are the previously excluded classes of barbiturates and benzodiazepines. Please note that in 2013, barbiturates were only covered when used to treat cancer, epilepsy, or chronic mental illness. Beginning in 2014, barbiturates will be covered for all other medically appropriate diagnoses.

excluded drugs

certain drugs are optional under the medicaid program, and therefore are not covered (excluded) under part d. excluded drugs include:

• Over-the-counter medications (even if prescribed by a doctor);[50]
• drugs for weight loss or weight gain, even if used for non-cosmetic purposes, such as to treat morbid obesity.[51] note that medications to treat AIDS wasting and cachexia due to other diseases are not considered cosmetic and therefore are not excluded.[52]
• cough and cold preparations, when prescribed for symptomatic relief only, with no underlying medical indication;[53]
• fertility drugs;[54]
• Erectile dysfunction medications, unless medically necessary and FDA-approved to treat conditions other than sexual or erectile dysfunction;[55]
• cosmetic and hair growth drugs. note that medications to treat acne, psoriasis, rosacea, and vitiligo are not considered cosmetic;[56]
• medicines purchased in another country;[57]
• vitamins and minerals, except niacin products, vitamin d analogs (when used for a medically accepted indication), prenatal vitamins, and fluoride preparations;[58]
• drugs that may be covered under medicare part a or part b, even if coverage isn’t actually available (eg, because the person has a part a or b deductible, or doesn’t yet have part b ).[59] ]

Note the important distinction between excluded and non-formulary drugs. Non-formulary drugs are covered under Part D but are not on a particular plan’s formulary. For example, Plan A may only cover prescription forms of Prevacid and Nexium (or their generics) to treat acid reflux, while Plan B may only cover prescription forms of Protonix and Zantac (or their generics). ).

Excluded drugs are not covered under Part D, but may be offered as a supplemental benefit in some enhanced plans.[60] members cannot appeal the denial of excluded drugs and their cost will not be counted towards the troop. In addition, some states may continue to provide excluded drug coverage for their dual eligible and SPAP populations.

network and mail order pharmacies

Plan members must use pharmacies within the plan’s pharmacy network. (Exceptions may be made for emergencies). plans, in turn, must offer their members adequate access to retail, mail order, home infusion, and long-term care pharmacies.[61] [62]Plans are not required to contract with all long-term care pharmacies, but cms requires that they do so for its members who are in a nursing facility. Member costs may vary, depending on which network pharmacy they use. some network pharmacies have the status of “preferred” network pharmacies, where members can get better prices.[63] plans may encourage their members to use mail order for 90-day supplies, but must have at least one retail pharmacy where members can obtain a 90-day supply.[64] consumers should enter mail order with caution as mail order copays are not always less expensive. in fact, if the full cost of a drug is higher with mail order, the member will enter the coverage gap faster, even if the copays are the same as at retail. as noted below, to earn troop credit, members must use network pharmacies, which track member purchases.[65]

use management restrictions

part d plans may place restrictions on certain formulary drugs to control costs.[66] these cost reduction tools are collectively known as utilization management restrictions. they generally apply to drugs that are more expensive or have potential for abuse. pain relievers, for example, almost always have one or more of the following types of restrictions.

• Prior Authorization – The doctor must “justify” the prescription to the plan and explain why the drug is medically necessary as prescribed. If the plan continues to deny the drug, an appeal may be necessary.
• Quantity Limits: The plan may limit the dose allowed for a specific time period, for example, x milligrams over a 25-day period. such dose restrictions are often a problem for people with chronic illnesses who take high doses of pain relievers on a maintenance schedule. these cases often need to go on appeal.
• step therapy (sometimes called the “failure first” requirement, the requirement that a member try and fail other lower-cost drugs before the plan will approve the prescription). plans may require up to a 90-day trial of a different medication, which may be completely untenable for some patients.

Members and prospective members of a plan can review the plan’s utilization management restrictions on specific drugs in the plan’s formulary, on the website, or on the medicare plan finder at www.medicare.gov. these restrictions should be taken into account when choosing a plan.

In addition to utilization management restrictions, all plans also impose point-of-sale security editions. these may include, but are not limited to, overuse (early resupply), age/gender contraindications, drug interactions, therapeutic duplication, incorrect dosage or duration of therapy, etc.[67]

formulary changes

Plans generally change their formulary every year (so it’s important to review your plan choice annually). Plans can also change their formularies mid-year, but generally must get approval from CMS to do so.[68]

Unless the fda declares a drug to be unsafe, or the manufacturer removes a drug from the market, part d plans cannot remove drugs from their formularies, or make changes to drug cost-sharing status. a drug, from the start of the annual coordinated election period (aep) (October 15) through the first 60 days of the plan’s contract year (calendar).[69]

Plans can expand formularies by adding drugs, reducing cost-sharing, or eliminating utilization management tools, at any time of the year.[70]

after march 1, part d plans may modify their formularies as summarized below. cms approval and member notification are required for both types of form changes.

• maintenance changes – While cms appreciates the stability of plan forms, it generally gives positive consideration to maintenance changes, which are intended to improve the security of the benefit of part d and save taxpayers money. and protect the interests of beneficiaries throughout the plan year. maintenance changes include: removal (or change in tier placement) of a brand-name drug based on the addition of a new generic tier at a lower cost to members; removal (or change in tier placement) of a drug from the formulary in light of new clinical evidence; add new utilization management restrictions based on a new fda “black box” warning; withdrawal of a drug based on an fda recall notice; deletion of a non-part d drug listed in error on the formulary.[71] plans can notify members of maintenance changes at the same time they submit the changes to cms for approval.
• Non-maintenance changes : Form changes other than maintenance changes require prior approval from cms. these changes may include changing drug status from “preferred” to “non-preferred,” adding usage restrictions, or increasing cost-sharing (for reasons other than those noted for maintenance changes).[72] after providing justification and receiving approval from cms, the plan must provide members with 60 days advance written notice. additionally, members who are already taking the drug in question are exempt from the formulary change for the remainder of the calendar year.

generic substitution

Brand name drugs have patents that expire after several years. when these patents expire, other manufacturers are free to develop generic versions of these drugs. to keep medicare costs down, cms encourages part d plan members to take less expensive generic drugs. in fact, the pharmacy may substitute a generic drug for a brand-name drug at the point of sale because these formulary changes fall under the category of maintenance changes, which do not require prior notification to the beneficiary. There is no transition policy that guarantees a member the right to continue receiving the brand-name drug for the rest of the year when a generic becomes available.

Members should read their EOC (Evidence of Coverage) carefully to learn what they need to do to get brand-name drugs instead of generics. Usually, you need to file an exception request or appeal. to prevail in an exception or appeal, the doctor must document a history of adverse reactions or ineffectiveness of the generic.

transition policy

All part d sponsors are required to have a transition process in place to ensure that newly enrolled members and others described below have access to non-formulary drugs during their first 90 days in a plan. (For transition purposes, formulary drugs that are subject to prior authorization or step therapy are treated as non-formulary drugs.)[73]

the transition process applies to:

• new affiliates who register during the aep; (or, depending on the plan’s stated transition policy, current enrollees affected by a change in formulary from one contract year to the next)
• newly eligible Medicare enrollees who previously had other coverage;
• individuals who transition from one part d plan to another after the start of the contract year (such as through a special enrollment period);
• enrolled in long-term care facilities.[74]

The transition process requires Part D plans to allow a one-time, temporary supply of a non-formulary drug, during which time the member, their doctor, and the plan can agree on an appropriate switch to another drug, or start an exception request for drugs that are not on the formulary. the plan must provide written notice to all members receiving a transition supply within three business days of the temporary supply.[75]

For members living in the community, the temporary supply is a one-time supply of at least 30 days of medication (unless the script is written for fewer days). for members who live in long-term care facilities, the temporary supply must be for at least a 91-day supply and can be for at least a 98-day supply. the temporary supply must be consistent with the applicable spending increment and part d sponsors must allow multiple refills if necessary.[76]

the standard part d benefit

At a minimum, plan sponsors must offer a “standard benefit” package required by law. the standard benefit includes an annual deductible and a coverage gap, formerly known as the “donut hole”.[77] Sponsors may also offer plans that differ from the standard benefit but are actuarially equivalent. finally, they may also offer “enhanced” plans that provide additional benefits to the standard benefit.[78] Enhanced plans generally offer some coverage during the coverage gap.

The standard benefit is defined in terms of the cost-sharing financial structure, not the drugs that must be covered by the plan.[79]

• In 2021, the standard benefit requires an initial annual deductible of $445, an increase of $10 starting in 2021 (the maximum allowed by law). [80] this is called the deductible phase, or stage 1.
• after meeting the deductible, the beneficiary pays 25% of the cost of a prescription drug covered by part d up to the initial coverage limit of $4,130 ($1,032.50).[81] this is called the initial coverage period or stage 2.
• Before 2019, once the plan and the beneficiary paid the initial coverage limit together, the beneficiary had a gap in coverage known as the “donut hole” or Stage 3, during which the beneficiary had to pay a percentage of the total cost of your drugs.[82] the health care and education reconciliation act of 2010 (hcera) mandated a phase-out of the donut hole until 2020 and the bipartisan budget act of 2018 (bba) accelerated this closure by one year, to 2019, for prescription drugs brand and non-generic.[83] As of 2021, the donut hole has been formally “closed”, but there is still a coverage phase often referred to as the “donut hole”. In this coverage phase, standard drug plan beneficiaries who have met their deductible pay 25% coinsurance for brand-name and generic prescription drugs until they reach the catastrophic tier.
• The beneficiary enters the catastrophic coverage period, or Stage 4, when the beneficiary’s (troop) actual out-of-pocket expenses for the year, including deductible, initial coinsurance, and coverage gap, reach $6,550.[ 84] At this time, the beneficiary pays $3.70 for a generic or preferred drug and $9.20 for other drugs, or 5% coinsurance, whichever is greater. Beneficiaries who meet the $6,550 out-of-pocket threshold remain in Stage 4 for the remainder of the calendar year. the process starts again next year.
• In 2021, on brand-name drugs, the member receives a 70% manufacturer discount and a 5% “subsidy” from the plan.[85] therefore, the member cost will be 25%. the 70% manufacturer discount counts for the troop, as the beneficiary remains responsible for the full cost of the drug, while the 5% medicare subsidy does not count for the troop.[86] on generic drugs, the member receives a 75% subsidy from medicare.[87] the 75% medicare subsidy does not count for the troop as the beneficiary is only responsible for 25% of the drug cost, not 100%.[88]

Medicare does not set premium amounts for plans. Instead, the premiums are established through an annual public bidding process and are evaluated by CMS. premiums vary from plan to plan and region to region. Medicare sets the maximum deductible amount, initial coverage limit, troop threshold, and catastrophic coverage levels each year. The table below shows the standard benefit for this year (and the next, when available).

2020-2021 part d standard benefit[89]

alternatives to the standard benefit

Most plans do not follow the standard defined benefit (DS) model. Medicare law allows plans to offer actuarially equivalent or even better plans. although structured differently, these alternative plans cannot impose a higher deductible ($445 in 2021) or require a higher out-of-pocket limit ($6,550 in 2021).[90] The value of benefits in an actuarially equivalent plan must be at least as valuable as the standard benefit. actuarially equivalent (ae) plans may modify the deductible and have a different cost share than the standard benefit.[91] insurers can reduce the maximum deductible of $445 and impose cost-sharing requirements higher than 25%. Almost all plans use a tiered cost-sharing structure in which beneficiaries have a lower copay for generic drugs and a higher copay for more expensive brand-name drugs.

income-related monthly adjustment amount (irmaa) – part d

Higher-income Medicare Part D beneficiaries pay higher Medicare Part D premiums based on their income, similar to the higher Part B premiums already paid by this group.[92] the premium adjustment is called the income-related monthly adjustment amount (irmaa).[93] the irmaa is not based on the beneficiary’s specific plan premium, but rather is a fixed amount per income level that is based on the beneficiary’s national base premium (the beneficiary’s national base premium is recalculated annually; for 2021 it is $33 .06). [94] in effect, the irmaa is a second premium paid to social security, in addition to the monthly part d premium already paid to the plan.[95]

irmaa is withheld from a person’s monthly social security payment, even if the beneficiary makes premium payments directly to the plan.[96] if the beneficiary is not receiving social security, or if the social security payment is insufficient to cover the irmaa, medicare or the railroad retirement board will bill the beneficiary for the irmaa.[97]

income-related adjustments – 2021[98]

drug tiers

Instead of the fixed 25% copay during the initial coverage period in standard benefit plans, alternative and enhanced plans may employ a tiered cost-sharing system.[99] In a tiered model, various drugs are assigned to different drug tiers and will cost more or less than other drugs depending on where they are in the tier. Tiered cost-sharing can take the form of copays (a flat dollar amount) or coinsurance (a percentage of the costs).

When part d started in 2006, the drug tiers were pretty straightforward. that is: generic drugs were the least expensive in level 1; “preferred” brand name drugs were more expensive in tier 2; Non-Preferred Brand Drugs were still more expensive in Tier 3, and Specialty Drugs were in Tier 4. For example, the cost share might appear as follows:

Since 2006, however, plans have taken advantage of their ability to define their own levels. some plans have four levels, while others now have five or even six. the placement of drugs within the tiers also varies between plans. for example, the same generic may be a tier 1 drug in one plan, a tier 2 drug in another plan, and a tier 3 drug in yet another plan. Adding to the confusion, some plans make tier distinctions between “value” and “regular” generics, and may classify (and price accordingly) “value,” “preferred,” and “non-preferred” generic and brand drugs “.

this lack of standardization between tiered plans means it’s virtually impossible to compare plans and part d cost shares without using cms’s online plan lookup tool. Although the Plan Finder is relatively easy to use, Medicare beneficiaries who are not confident in their computer skills should seek help from family, friends, their local pharmacy, or the health insurance assistance program (barco) agency. of the state in your area to help you compare plans on the plan finder. .

the donut hole

The coverage gap is a gap in coverage common to standard, alternative, and enhanced plans.[100] Unless your plan offers any coverage during the donut hole, beneficiaries will pay 100% for drugs during the donut hole (subject to a discount starting in 2011, see below).[101] will continue to pay out of pocket until your total expenses (copayments, deductibles, and costs in the coverage gap) reach the out-of-pocket threshold ($6,350 in 2020; $6,350 in 2021).[102]

While some plans offer drug coverage during the donut hole, that coverage is generally limited to generics. Few plans cover brand name drugs during this period. also, copays for covered drugs during the coverage gap may be higher than in the initial coverage period.[103]

“troop”

Once beneficiaries reach their out-of-pocket limit (their “actual out-of-pocket” costs (troops)), they leave the coverage gap and move into catastrophic coverage.[104]

the only expenses that count for the troop are formulary drugs purchased by the member, the member’s family, charity, a spap or adap, the indian health service, part d lis (“extra help”) and, for brand-name drugs, the manufacturer’s discount.[105]

premium payments, non-formulary drugs (unless approved by exception or appeal), drugs purchased outside of the us. uu. and medications paid for by other insurance do not count for the troop.[106]

The member’s part d plan tracks troop expenses so it can determine when the member qualifies for catastrophic coverage. therefore, to get credit for their drug costs during the coverage gap, members must use the plan’s network pharmacies and show the pharmacy their plan membership card.[107]

eobs

Plans must send their members an explanation of benefits (eob) for each month the member uses plan services.[108] The EOB is a summary of the services and items a beneficiary has received and states how much the provider billed, the approved amount the plan will pay, and how much the beneficiary owes the provider. The EOB also tells the member which coverage stage the member is in and how much more the member must spend to move to the next coverage stage.[109]

For some people, drug costs during the coverage gap represent an extreme financial hardship. in some cases, a single medication can cost hundreds, even thousands of dollars. paying for such an expensive drug during the coverage gap will help the member qualify for catastrophic coverage. however, raising this amount of money all at once, even for a critical drug, may be impossible for some people. This common scenario means that some people simply don’t take their medications during the coverage gap.

There are programs to help people with the costs of Part D, including some that provide coverage during the donut hole. one of them is part d of the low income subsidy (lis).[110] Medicare Savings Programs (MSPs) or State Pharmaceutical Assistance Programs (SPAPs) may also provide assistance and typically have more generous income and asset limits than listed. Other sources of help include pharmacy discount cards, drug manufacturer patient assistance programs (PAPs), and insurance company discount programs. For a complete list of many drug assistance programs, see our article “finding help getting prescription drugs.”

donut hole discount

The donut hole was phased out between 2010 and 2020. In the first phase, eligible individuals who hit the donut hole in 2010 received a one-time $250 rebate check.[111].

In subsequent years, gradually increasing discounts were applied to brand-name and generic drugs. the percentage of beneficiaries paid while in the coverage gap/donut hole from 2011 to 2020 decreased until they paid a flat 25% coinsurance on all drugs.[112]

Drug discounts during the coverage gap per year, 2011-2019[113]

discounts will be granted directly at the pharmacy; members won’t have to fill out any forms or do anything to get the discount. members will have to pay a small dispensing fee (cost for the pharmacy to fill the medication), which will not be deducted

the full amount (negotiated price) of the brand name drugs (not the discounted amount paid by the member) will count towards the troop.[114] This means members won’t need to spend as much to get out of the donut hole. for generic drugs, only the actual amount paid for the drug will be applied to the troop.[115]

People on the Part D Low Income Subsidy (LIS) are not eligible for the $250 reimbursement or discounts because they already have very low cost-sharing during the coverage gap.[116] but people enrolled in a spap (state pharmaceutical assistance program) are eligible for reimbursement and discount.[117]

The discount is only available if the drug manufacturer has signed an agreement to participate in the discount program. drugs sold by manufacturers who do not sign an agreement will not be covered by part d and cannot be requested by exception.[118]

The discount is only available if Medicare Part D is the primary payer. If there is secondary insurance (such as SPAP), it will pay after the Part D discount has been applied. if the plan already offers coverage during the coverage gap, the discount will be applied to the drug price the member would pay under the plan’s coverage gap.[119]

if the prescription crosses the part d coverage stages, that is, a “cross claim”, the discount will only be applied to the portion of the drug that is in the coverage gap.[120]

crossed claims

Whether in a standard, alternative, or enhanced plan, with each formulary prescription drug purchase during the plan year (calendar year), plan members go through all four stages of part d coverage: deductible period, the initial coverage period, the coverage gap/donut hole, and the catastrophic coverage period. Beneficiaries experience different cost shares as they progress through these stages. a “cross claim” occurs when a prescription drug crosses multiple benefit stages.[121] For example, the member may have $400 left in the initial coverage period but needs a brand-name drug that costs $500. her claim therefore “straddles” the initial coverage period and the coverage gap. the plan will “prorate” the claim accordingly. in the example above, the first $400 is subject to a 25% copay (assuming the member is on a standard plan) and the member pays 47.5% of the $100 balance.

Calculating what the beneficiary owes is complicated and even more so when the plan has tiered copays instead of the standard benefit. For a more detailed discussion of shared claims, see Part Covered, Part Not: “Shared Claims” in Medicare Part D.

inscription in part d

For most people, enrollment in Part D is voluntary. most people need to select and enroll in a plan to be covered. there are several enrollment periods in part d.

• Initial Enrollment Period (iep) – Individuals may enroll during the 7-month period surrounding their 65th birthday. For example: the three months prior, the month of and three months after your birth month. (note: this iep is the same as for part b.).[122] People who become eligible for Medicare because of a disability have an IEP that begins the month they are notified of Medicare entitlement and continues for three months afterward. a second 7-month iep is available for people who already have medicare due to a disability and turn 65.
• coordinated annual election period (aep) [also called annual election period]: During the aep, people can add, change, or drop their medicare advantage or part d coverage for the next year. [123] the aep extends from October 15 to December 7 of each year, for coverage from the following January 1[124]. (before 2011, the aep was from November 15 to December 31). members are “locked in” to their chosen plan for the remainder of the calendar year and cannot change plans unless they qualify for a special enrollment period).[125]
• initial coverage election period (icep): During the icep, people can join or change their ma-pd.[126] The ICEP is the same as one’s IEP if you enroll in Part B when you turn 65. When a beneficiary joins later, their IEP is the three months before their Part B coverage takes effect. Members are “locked in” to their chosen plan for the remainder of the calendar year unless they opt out of the Medicare Advantage (MAPD) ​​Disenrollment Period or qualify for a Special Enrollment Period (September).
• medicare advantage disenrollment period (madp): during the madp, which ran from January 1 to February 14 of each year, people enrolled in a medicare advantage plan (ma-only or ma-pd) you could disenroll from medicare advantage, rejoin original medicare, and enroll in a pdp for drug coverage.[127] (Individuals cannot simply change their PDP or join a different MA plan during this period.) If the MADP election is held in January, the new coverage will be effective February 1. if the election is made in February, the new coverage will begin March 1.
• Please note that the madp was new in 2011 and replaced the old open enrollment period (oep), which ran from January 1 to March 15 and allowed people in medicare advantage plans switch to another medicare advantage. plan or return to original medicare, as long as they do not add or drop prescription drug coverage during this period.[128] Pursuant to federal legislation enacted in December 2016, the MADP ended in 2018 and the OEP that was previously in effect was reinstated as of 2019.[129]
• General Enrollment Period (Application for Part D) – Individuals who enroll in Medicare Part B (whether or not they have Part A) during the Medicare General Enrollment Period. for part b (January 1 to March 31) , you can sign up for part d between April 1 and June 30, with coverage beginning July 1.[130]

involuntary cancellation

Members can be involuntarily disenrolled from a plan if the plan ends, or the member loses eligibility for part d, moves out of the plan’s service area, engages in behavior that makes it difficult for the plan to provide services, or does not pay premiums on time.[131] note that the plan cannot terminate a member for nonpayment of premiums if the premiums are withheld from social security.[132] Plans must also provide a two-month grace period before terminating a member for non-payment. the notice period begins when the plan notifies the member that payment is due.

Exceptions to Voluntary Enrollment

Enrolling in Part D is generally voluntary, however, some people must enroll and others must not enroll.

• People who have Medicare and receive assistance under certain federal programs (Medicaid, Medicare Savings Programs, SSI, or the Part D Low Income Subsidy) must enroll.[133] If they don’t self-enroll, Medicare will automatically enroll them in a plan. People enrolled in their state’s State Pharmaceutical Assistance Program (SPAP) must also enroll.
• People who have “creditable” prescription drug coverage (coverage that is as good as or better than part d) are not required to enroll and are often better off in their private plans than part d. [134] should not consider enrolling in part d without consulting with the benefits administrator of their current plan.

Non-eligibles who don’t have creditable coverage and who don’t sign up for part d when they’re first eligible to do so, may have a late enrollment penalty and may have to wait up to 12 months to sign up in a plan.[135]

creditable coverage

Creditable coverage is prescription drug coverage that is actuarially as good as or better than Part D coverage.[136] All insurers must notify their Medicare-eligible members of their plan’s creditable coverage status each year.[137] this notice must be in writing and must be received before September 30.

Examples of creditable coverage include TriCare (coverage for the military and their families), Veterans Benefits (VA), and the Federal Employees Health Benefits Program (FEHBP). [138] many medigap policies that offer prescription drug coverage are not creditable. people with medigap policies should check with their plans.[139]

People with creditable coverage are not required to enroll in part d and may not want to do so.[140] This is because they may lose hospital and medical coverage if they enroll in Part D. should check with their plan’s benefits administrator before deciding to enroll in part d.

People who involuntarily lose creditable coverage are entitled to a special enrollment period. they have 63 days to enroll in a part d plan. failure to pay the premium is not considered an involuntary loss.[141]

note: people who do not receive a notice of creditable coverage, or who receive an incorrect notice, may qualify for a sep that allows them to enroll in part d outside of the aep. Complaints related to underreporting or improper reporting should be reported to 1-800-medicare.

the late enrollment penalty (lep)

Unless you’re exempt, there’s a penalty for not signing up for Part D when you’re first eligible to do so.[142] Those exempt from the sanction include individuals who:

• had creditable coverage, or
• qualify for the list, or
• are eligible for a special enrollment period because they were affected by hurricanes katrina, wilma or rita

The penalty is 1% of the national base monthly premium ($33.06 in 2021 and $32.74 in 2020) for each full month the individual could have been but was not enrolled.[143] the base calculation changes each year, based on the average national base premium amount. the lep cannot be dated back to June 2006.

cms calculates the amount of the penalty, which is collected by the part d plan. the penalty is a “lifetime” penalty and is added to the person’s monthly premium. note, however, that if a sanction is imposed before the person is 65, the slate will be “wiped off” when they turn 65.[144]

There is a process for requesting reconsideration if it appears that a late enrollment penalty was imposed in error. [145] Medicare contracts with an independent review entity (maximus) to conduct these reconsiderations, and the decision is final. the penalty must be paid during the time the penalty is being reconsidered, which can take many months. if reconsideration is granted, the beneficiary will be reimbursed for the erroneously assessed penalty charges.

Special Enrollment Periods[146]

the special affiliation periods allow people to sign up, drop out or change plans outside the aep, icep and madp. the most commonly available are listed here. all seps require cms approval, some on a case by case basis.

how to enroll, pay premiums and other enrollment misc

cms (medicare) plays a central role in part d enrollment and actual enrollment in a plan is not complete without approval from cms. enrollment can be done by calling the plan directly, by calling 1-800-medicare, by contacting the area remittance agency, or by using the online plan search tool at www.medicare.gov.[147]

Premiums can be paid directly to the plan, deducted from social security, or deducted from a bank account (eft).[148] Members who want to change their payment method during the year should contact their plan to make the change, but the synonym on this exchange is “patience.” Some changes, like going from social security withholding to “direct pay” status, can take up to three months. any changes not processed within three months should be reported to 1-800-medicare.

Individuals cannot be in more than one Part D plan at a time. in fact, enrollment in one plan automatically cancels enrollment in the previous plan. for this reason, beneficiaries who wish to change plans need only enroll in the desired plan. Medicare will disenroll you from your old plan.

Please note that people who wish to stay with their existing plan from one year to the next do not need to do anything. your enrollment will automatically “roll over” to the next year.

evidence of coverage (eocs)

Shortly after enrolling in a plan, new members should receive a membership card and a contract called an evidence of coverage (eoc).[149] The EOC explains member benefits under the plan, how to access member services, such as mail order (if offered), and how to access the plan’s grievance and appeal processes.

Along with the eoc, the member should receive at least an abridged copy of the plan’s formulary and information on how to obtain or access the full formulary.[150] The formulary will show not only which drugs are covered by the plan, but also what restrictions may apply to some of those drugs (such as prior authorization, quantity limits, and step therapy).

Returning members (those who stay in the plan for one more year) should also receive an eoc and a copy of the plan’s formulary by September 30 of each year.[151]

Note: Complaints that a plan has not honored its contract as described in the eoc should be reported to 1-800-medicare.

annual notice of change (anocs)

all plans must send their existing members an annual notice of change (anoc) by September 30 of each year.[152] ACNO tells members how their plan will change next year, including any formulary changes that may be made.

October 15 marks the start of the Annual Election Period (AEP) when people can enroll or change their Part D plans. People should read the anoc carefully to decide if they should stay on their existing plan or find another one during the aep.

Individuals should not assume that their existing plan will meet their needs or continue to be a suitable option for years to come. This is because plans change their costs and coverage every year. It’s not unexpected that costs will go up, but people may not realize that plans can also remove drugs from their formularies, change the price of certain drugs, or impose utilization management restrictions (such as prior authorization, quantity and step therapy) on your medications in the next year.

the anoc is so important that a plan’s failure to send the anoc on time is cause for a special enrollment period (sep) which will allow the member to switch plans outside of normal enrollment periods. Complaints that a plan has not submitted the anoc by the above date should be reported to Medicare.

medicare savings programs

Medicare Savings Programs help low-income people pay Medicare Part A and/or Part B copays and deductibles.[153] There are four Medicare Savings Programs, all of which are administered by state Medicare agencies and are jointly funded by the states and federal governments. participants in these programs are sometimes referred to as “partial dual eligibles.” People who qualify for a Medicare Savings Program automatically qualify for the Part D Low Income Subsidy (LIS), which is also known as “Extra Help.”[154] LIS helps qualified individuals to pay their share of costs, including monthly premiums, copays, and coinsurance. The list also covers people during the deductible period and the coverage gap called the “donut hole.”

the list of the four medicare savings programs are:

• qmb (qualified medicare beneficiary): Eligible individuals have a single monthly income limit of $1,094, a married couple monthly income limit of $1,472, a $7,970 individual or $11,960 couple resource limit.[155] qmb helps pay for part a premiums, part b premiums, deductibles, coinsurance, and copays. For prescription drugs covered by Medicare Part D, pharmacists may charge up to a limited amount (no more than $4.00 in 2021).
• slmb (specified low-income medicare beneficiary): Eligible individuals have a single monthly income limit of $1,308, a married couple monthly limit of $1,762, a single resource limit of $7,970 and a resource for married couples limit of $$11,960.[156] This state program helps pay for the Medicare Part B premium, which increases a beneficiary’s spendable income each month.
• qi (qualifying individual): Eligible individuals have a single monthly income limit of $1,469, a married couple monthly income limit of $1,980, an individual resource limit of $7,970 and a resource limit for married couples of $11,960.[157] Like SLMB, Qi helps pay for the monthly Part B premium.
• qdwi (qualified working disabled individuals): This program helps pay Medicare’s portion of a premium for disabled people who have lost their share of benefits because they returned to work.[158] Eligible individuals may have countable income up to 200% for FPL and countable assets not to exceed $4,000 for an individual and $6,000 for a couple. must be eligible to purchase part a and may not be covered by medicaid.

Note: The calculation of applied income and assets follows the SSI rules, but some states liberalize these rules for their residents. for example, some states have increased or eliminated the asset test and significantly increased unearned income disregards as a means of effectively increasing program income limits. Interested individuals should contact their state Medicaid agency for more information and applications.

the low income subsidy

The Low Income Subsidy (“LIS”), also known as “Extra Help,” is administered by the Social Security Administration (SSA) and helps qualified individuals pay for Part D expenses, including monthly premiums, copays, and coinsurance.[159] The list also covers people during the deductible period and the coverage gap called the “donut hole.”

eligible considered and not considered

Some people automatically qualify for the LIS and do not have to apply for the program, regardless of their income or asset levels. this “considerate” group includes:

• full dual eligibles (people with medicare and full medicaid)

• partial duals (people in a medicare savings program: qmb, slmb and qi)

• ssi recipients who have medicare but not medicaid.[160]

Other individuals (the “helpless) may qualify if their income and assets are within the LIS program limits. The calculation of income and assets follows the ssi rules.

full and partial subsidies

there are “total subsidies” and “partial subsidies.”

• a full subsidy means that the monthly part d premium is paid in full if the person enrolls in a “benchmark” plan.[161] a benchmark plan is a pdp that offers basic (rather than enhanced) coverage and has a premium below the regional benchmark monthly threshold (scroll to page 2 for link).

• A partial subsidy means that the individual’s premium obligation will be calculated on a sliding scale. individuals will pay a $92 deductible, 15% coinsurance instead of the full $25, and a copay of no more than $3.70/preferred or generic brand or $9.20/non-preferred brand for all drugs after reaching the out-of-pocket limit .[162]

• Both full and partial subsidies offer cost-sharing assistance for the part d deductible, low copays for drugs, coverage during the coverage gap, and reduced copays for drugs during the catastrophic coverage period.

• All lis beneficiaries who wish to enroll in an enhanced plan (instead of a benchmark plan) can do so, as long as they pay the excess premium out of pocket.

lis eligibility and cost sharing (2021), 48 states + d.c.[163]

Once granted, the list continues for one year.[164]

ssa redetermines eligibility for the lis each year.[165] a portion of the universe of disregarded individuals is selected for redetermination each August. people considered eligible for the lis between January 1 and June 30 are eligible for the rest of the year[166]. individuals deemed eligible between July 1 and December 31 are deemed eligible for the remainder of the year and the entire following calendar year. eligibility notices (if the subsidy is reduced or terminated) go out in the fall.[167] no notice is sent to those who remain eligible at the same subsidy level for the following year.

double eligible and others eligible for lis

Until 2006, when part d began, full benefit duals in most states received prescription drug coverage through their state’s medicaid programs.[168] since the advent of part d, prescription drug coverage for full dual benefits is now provided by private medicare part d plans.[169]

automatic entry of doubles

To make sure that dual plans don’t “slip under the radar,” those who can’t enroll in a part d plan on their own are self-enrolled by medicare.[170] to ensure that full dual benefits can pay for part d costs, beneficiaries are randomly assigned to part d plans with premiums at or below the average premium for their region and all individuals are temporarily covered by the program Limited Income Newly Eligible (Net) Transition Plan, providing immediate prescription drug coverage for those who qualify for the list but are not enrolled in a Part D plan, until CMS enrolls them in a Part D plan.[171 ]

Prescription drug plans that offer basic coverage and have a monthly premium set below each state’s regional benchmark thresholds are known as “benchmark” plans.[172] Full benefit duals (and everyone else eligible for LIS) are encouraged to enroll in benchmark plans, but can enroll in non-benchmark plans if they pay the premium above the benchmark threshold. Benchmark plans often have less robust formularies than non-benchmark plans, and it may be worth it for the beneficiary to pay the excess premium out of pocket to get the drugs they need. Dual eligibles (and all other LIS eligibles) have a rolling gap that allows them to enroll in more compatible plans at any time. Enrollment in the new plan is effective the first day of the month following the month of enrollment.

Newly awarded Duals are created when Medicaid recipients become eligible for Medicare. To ensure newly granted dual eligibles have Part D coverage, states send electronic data files twice a month to CMS.[173] These files identify people who will be eligible for Medicare within 3 months by virtue of turning age 65 or 24 months of disability. cms then enrolls these individuals in the temporary net plan, pending their final prospective random assignment to a benchmark plan (in approximately two months).[174] coverage under part d is retroactive to the effective date of entitlement to medicare. the process of enrolling full dual eligibles in a part d plan is called automatic enrollment.[175]

Newly vested duals are also created if a Medicare beneficiary becomes eligible for Medicaid. in these cases, the person may already have a part d plan, which must update the individual’s status as lis-eligible by submitting best available evidence (bae).[176]

enrollment made easy

See also : Life Insurance Conversion: How Term to Permanent Conversion Works | Thrivent

other lis eligibles include people in a medicare savings program, or ssi (with medicare but not medicaid), or “non-exempt” eligibles who qualify because they meet lis income and asset requirements.[177] lis eligibles who don’t choose a part d plan on their own are also enrolled in a medicare plan. unlike full duals who are enrolled in a temporary (net) plan and then randomly assigned to referral plans), other LIS-eligibles enroll directly in a referral plan through the random assignment process.[178] this is called facilitated enrollment.[179]

registration at the point of sale (pos)

These eligible individuals should be automatically enrolled or facilitated to enroll in a Part D plan if they do not select a plan on their own. these processes generally work very well. however, if a lis-eligible individual shows up at the pharmacy without a part d plan, there is the net-managed point-of-sale (pos) process.[180]

If the pharmacy is reasonably certain that the individual qualifies for the list and has no other prescription drug coverage, the pharmacy may immediately fill the prescription(s) and bill the claim net. The pharmacy may confirm LIS eligibility through an online inquiry or may accept other reasonable documentation, such as (but not limited to) a copy of a current Medicaid award letter with effective dates and a Medicare or SSA notice. granting extra help.[ 181] medicaid card, a letter of award of lis. individuals and advocates can call net if they have questions about a person’s eligibility for lis.

net (newly eligible transition program for low income individuals)

net is a cms part d program, administered by human, which began on January 1, 2010. linet manages the enrollment process at the point of sale for eligible lis who are not enrolled in a plan of the part d.[182] net also acts as a temporary plan for newly enrolled full dual eligibles, offering rebates to people who have retroactive medicare prescription drug coverage. net has an open formulary, no utilization management restrictions on any drugs, and no pharmacy network restrictions.[183]

spa programs

State pharmacy assistance programs are state-funded prescription drug assistance programs for dual eligibles and other low-income residents.[184] program rules, income and asset limits, and program benefits vary by state. federal law allows spaps to “wrap” part d coverage by filling gaps in the part d program. SPAPS can provide assistance with copays, coverage during the Part D donut hole, and coverage for non-formulary and/or excluded drugs. payments made by a spap for formulary drugs purchased while the beneficiary is in the donut hole count toward the troop.[185]

part d appeals and complaints

Coverage Determinations and Exceptions

All Part D plans must have an appeals process whereby members can challenge a denial of drug coverage.[186] The appeals process for Part D is based on and similar to (but not identical to) the appeals process for Part C.

Denials of drug coverage by a pdp or ma-pd are called “coverage determinations.” for example, the plan may issue a coverage determination if the drug is not considered medically necessary or the drug was obtained at an out-of-network pharmacy.[187] a coverage determination (an oral or written denial from the plan) is required in order to initiate an appeal.[188] A supporting statement from a physician is not required for this type of appeal, but it may be helpful to file one. if the coverage request is denied, the member may proceed to additional levels of appeal, including redetermination by the plan, reconsideration by an independent review entity (maximus), administrative law judge (alj) review , the medicare appeals council (mac), or federal district court.[189]

One type of coverage determination is called an “exception request”.[190] An exception request is a coverage determination that requires a supporting medical statement to proceed with the appeal. There are two types of exceptions that can be requested:

Formulary Exceptions – This type of exception is requested because the member:

• need a drug that is not on the plan’s formulary,
• requests to waive a utilization management requirement (eg, step therapy, prior authorization, quantity limit) for a formulary drug).[191]

Members cannot request an exception to get an excluded drug. Excluded drugs include (but are not limited to) drugs for erectile dysfunction, drugs for weight loss or gain, and drugs for the symptomatic relief of cough.

tier exceptions – This type of exception is requested because the member needs a non-preferred drug at the lower cost-sharing terms applicable to drugs in a preferred tier.[192] Members cannot request a generic tier price for a drug if the plan maintains a separate tier 1 for generics. In addition, members cannot request a tier exception for unique and high-cost genomic and biotech products if the plan maintains a separate tier (tier 4 or 5) for these drugs. These two warnings essentially mean that the member can only request to receive a drug in Tier 3 (Non-Preferred) and Tier 2 (Preferred) prices. Also note that if a member receives a favorable formulary exception decision, she cannot request a tiering exception for the same drug.

If a formulary or tier exception is denied, the member may proceed to additional levels of appeal, including redetermination by the plan, reconsideration by an independent review entity (maximum), judge review of administrative law (alj), the medicare appeals council (mac), or federal district court.[193]

what to do when a drug is denied at the pharmacy

There are two things a member must do when a drug is denied at the pharmacy.

• The member must first contact their prescriber. If the drug has been denied because it is not on the formulary, the prescriber may believe that a switch to a formulary alternative would be equally effective and unlikely to cause negative side effects. in this case, it is not necessary to proceed with an exception request. If an exception request is necessary, for example, because there is no viable alternative on the formulary, or because the member needs a dose that exceeds the plan’s quantity limit, the prescriber will need to submit a statement of support to the plan.
• Second, the member must contact the plan to obtain a written denial or coverage determination to seek an exception or further levels of appeal. Please note that a statement from a pharmacy that the drug will not be covered does not constitute a coverage determination. the decision must come from the plan itself. all network pharmacies must post or provide information to members on how to contact your plan to request a coverage determination or request an exception.[194]

the medical statement

Without the support of the prescriber (doctor or other provider), the exception will not go forward. The importance of the supporting medical statement cannot be overstated. without it, the member may not progress according to the prescribing physician’s treatment plan and goals. The statement does not need to be lengthy, but it must be specific as to why the prescribed drug is medically necessary in the prescribed dosage. diagnosis must be provided. any adverse reaction to the plan’s preferred drug or dosage level must be documented to date and specific effects. if the drug is denied due to a step therapy requirement, the statement must indicate which formulary alternatives the member tried and failed, including the dates and length of treatment and the reason the drug failed. At the initial exception request and redetermination levels, the physician’s statement may be oral or written, but the latter is preferred (and is required in later stages of the appeal process). The plan is not required to reverse a decision based simply on the provider’s letter of support; however, the strength of that support will increase the likelihood of a favorable decision. Providers may include case notes, charts, lab reports, etc. to strengthen their support.

Deadlines for exception requests and authorized representatives

The member (or their representative, or the prescriber) has 60 days from the date of the plan’s denial notice to request an exception. the plan has 72 hours (three calendar days) to issue a “standard” decision, or 24 hours if an expedited (“fast”) decision is requested.[195] The plan must issue an expedited decision (within 24 hours or less, based on medical necessity) if the plan determines, or the prescribing physician’s statement indicates, that a standard decision would seriously jeopardize the life or health of the patient or his or her ability to regain maximum function.[196] the plan is not required to issue an expedited decision if the member has already obtained the drug. The plan’s decision time begins when it receives the documentation from the prescriber.

The member or their prescriber (usually a doctor) can request an exception. (At higher levels of appeal, the member’s physician may not file an appeal without being a designated representative.) A duly appointed guardian or other person named in a health care power of attorney may also apply on behalf of the member. or the member may designate any person of their choice to act as representative. It is usually better and simpler to use CMS Form 1696 to appoint a representative. the form can be downloaded from the cms website.

how to file an exception request

The plan’s initial notice of denial (coverage determination) or redetermination decision will provide clear instructions on when, where, and how to file the next level of appeal. the plan’s website and 1-800 customer service should also provide this information clearly. the appeal can be sent by mail or by fax (the latter is preferred in situations that require an expedited decision). no specific form is required to complete an exception request or redetermination request. a detailed cover letter, accompanied by relevant medical documentation and a signed Appointment of Representative form is sufficient.[197] An attorney is not required to file an exception request, but may be required at higher levels of appeal.

if an exception is granted

If an exception is granted, coverage is granted from the first date of request for the approved drug. if the member has already paid for the drug, the plan must reimburse the member in a timely manner. the exception continues for the remainder of the plan year (although the plan may extend the approval beyond this period). for example, some drugs may be approved “for life,” depending on the member’s diagnosis and condition. The plan may establish a specific tier in which it will place all drugs approved by exception or appeal. a non-formulary drug approved by exception will be considered a formulary drug for troop purposes.

other levels of attractiveness

If the exception is denied, the member may proceed to additional levels of appeal, which are briefly summarized below.[198]

• Redetermination – This is a secondary review of the decision by the plan itself, using a different set of reviewers. the member, prescriber, or authorized representative may submit the request. the request may be oral or written, although the latter is preferred.[199] medical support is required. the request must be submitted within 60 days of the plan’s denial notice. this is a paper review, no hearing is held. no specific forms are required. an attorney is not required. a standard decision must be issued within 7 days, an expedited decision within 72 hours. the time begins when the plan receives the medical documentation.
• reconsideration: the case is reviewed by an independent review entity (ire).[200] maximus is the contractor of anger. If the plan is not timely in its redetermination decision, it must refer the case to Maximus for review. otherwise, the member, prescriber, or authorized representative must request reconsideration. the request must be made in writing within 60 days of the redetermination decision, but this time frame may be extended for good cause. again, this is just a paper review. the appellant may submit more medical information than was previously submitted to the plan. An attorney is not required, but may be better able to represent the appellant. instructions on how to request reconsideration are in the plan’s redetermination decision. maximus must request and record the opinions of the prescriber. a standard decision must be issued within 7 days, an expedited decision within 72 hours. the time starts when maximus receives the information from the supplier.
• alj review: The case is reviewed by an administrative law judge. appellants are generally required to use an attorney at this level and beyond, but it is not required. the amount in dispute (projected one-year cost of the denied drug) must be at least $180 in 2021.[201] The Office of Medicare Appeals and Hearings (OMHA) provides forms and information about the AJ process on its website. the request must be in writing and must be filed within 60 days of the reconsideration decision. the member may submit additional supporting medical information. hearings are usually held by video or teleconference. a standard decision is issued in 90 days, but there is also a 10-day provision for expedited decisions.[202]
• mac review: This is a paper review of the case by the medicare appeals board.[203] filing information is located on the omha website. the member must be represented by an attorney at this level. the mac can refuse to review the case and allow the alj decision to stand. or you can, at the request of the ire (if the ire does not agree with the alj’s decision), take the case on your own initiative. the mac review request must be filed within 60 days of the alj decision. a member may submit additional supporting information. a standard decision is 90 days, but there is also a 10-day provision for expedited decisions.[204]
• federal court: the fifth and final level of appeal. the amount in dispute must be at least $1,760 in 2021.[205] The appeal must be filed within 60 days of the MAC decision. an attorney is required at this level.

complaints

A grievance is a complaint about some aspect of the plan’s service, other than an actual denial of a medication.[206] for example, mail order delays, poor customer service, enrollment problems, pharmacy overcharges, etc. some complaints may have both appeal and grievance aspects. For example, a person may file an appeal because a drug was denied, and then file a complaint because the plan failed to issue a timely coverage determination. it is up to the plan to determine if a complaint is an appeal or a grievance.

A complaint must be filed within 60 days of the event that is the source of the complaint.[207] The complaint may be oral or in writing. the plan must issue a decision in writing if requested. Generally, the plan must respond to the complaint within 30 days. however, if a complaint is filed because the plan did not expedite a coverage determination or sent an extemporaneous redetermination decision to the ire, and the member still does not have the drug, the plan must respond within 24 hours of receipt of the complaint. [208]

Unlike an appeal, there are no further levels of appeal if the member is not satisfied with the plan’s decision on a grievance.[209] however, a plan’s failure to respond to a complaint must be reported to Medicare through 1-800-medicare or the complaint tracking feature on www.medicare.gov.

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• Marking Part D Legislation Today: Improving Beneficiary Appeals July 25, 2019
• center for medicare advocacy sends comments to houseways & media and energy & trade committees on part d bill June 13, 2019
• center feedback on part d improvements June 13, 2019
• center for medicare advocacy submits comments to draft 2020 cms solicitation letter for medicare advantage and part d march 7, 2019
• state of the union: want more affordable prescription drugs? start with medicare. February 7, 2019
• Center Submits Comments on Proposed Medicare Prescription Drug Rule on January 31, 2019
• Congressional hearings explore rising prescription drug costs January 31, 2019
• Don’t Be Fooled By Distraction: The President’s Prescription Drug Proposal Is Too Much Hype And Too Little Oct 30, 2018
• Special Report: Recent Changes in Law, Regulations, and Guidance Related to Medicare Advantage and the Prescription Drug Benefit Program September 17, 2018
• dual eligibility and access to part d drugs: very good news from the oig on july 26, 2018
• The Right Way to Lower Your Medicare Prescription Drug Costs June 7, 2018
• Center for Medicare Advocacy and Florida Health Justice Project Sue to Get “Off-Label” Part D Prescription Drug Coverage for Beneficiary April 19, 2018
• Medicare Advocacy Center and Florida Health Justice Project Sue to Get “Off-Label” Part D Prescription Drug Coverage for Beneficiary April 16, 2018
• center for medicare advocacy submits comments to draft 2019 cms solicitation letter for medicare advantage and part d march 8, 2018
• Bill to Control Medicare Prescription Drug Costs Introduced March 8, 2018
• center urges cms to preserve and strengthen consumer protections in medicare advantage and part d april 26, 2017
• center comments on medicare advantage and part d “transformation ideas” April 25, 2017
• Preview: 2017 Part D Standard Benefit & other threshold amounts September 20, 2016
• Longtime Center Concerns Gain Attention Aug 31, 2016
• off-label prescription drug refusals and medicare part d June 29, 2016
• federal court issues favorable decision on off-label part d drug coverage on May 18, 2016
• attention patients and prescribers of medicines part d March 2, 2016
• eliminate barriers to obtaining medications covered by medicare January 20, 2016
• office of inspector general authorizes hospitals to discount or waive certain drug charges for patients classified as “outpatients” December 10, 2015
• assistance paying for prescription drugs November 30, 2015
• Department of Health and Human Services Forum on Drug Pricing and Innovation Nov 24, 2015
• Kaiser Family Foundation Releases Reports On Ma And Part D In 2016 Oct 15, 2015
• cms 2016 final cover letter for medicare parts c and d published on April 9, 2015
• Center for Medicare Advocacy Submits Comments on Draft 2016 Call Letter for Medicare Parts C and D on March 12, 2015
• 2016 medicare advantage (part c) and part d final rule issued on February 19, 2015
• update on ma and part d plans Oct 23, 2014
• 2015 medicare cost share October 9, 2014
• update on palliative care and access to medicines: cms replacement guide 24 july 2014
• center joins 26 other organizations in calling for hospice cessation and part d guidance on June 12, 2014
• submitting part d claims for prescription drugs administered in the hospital during a stay in observation status on May 1, 2014
• hospice and access to medications – new cms guidance april 10, 2014
• 2014 income and resource information for low-income medicare programs February 6, 2014
• Medicare Prescription Drug Reimbursement Discussion Nov 21, 2013
• Medicare Annual Coordinated Election Period Begins! October 17, 2013
• Debunking Medicare Myths: Drug Reimbursements for Dual Eligibility May 8, 2013
• Reminder: Medicare Advantage (MADP) Disenrollment Period Ends February 14 February 7, 2013
• Deficit Reduction and Medicare: Save Money Without Hurting Beneficiaries Nov 15, 2012
• choose a plan during the annual enrollment period? choose carefully on October 18, 2012
• Impact of the Budget Control and Sequestration Law on AIDS Drug Assistance Programs September 24, 2012
• Increased Funding for AIDS Drug Assistance Program Responds to Need for Additional HIV/AIDS Services August 23, 2012
• Affordable Care Act in Action: People with Medicare continue to see savings May 3, 2012
• new medicare part d pharmacy notice rule in effect; keep an eye out for the final model notice on January 5, 2012
• 2012 Medicare Premiums, Deductibles and Copays October 27, 2011
• medicare advantage and part d changes and enrollment updates October 6, 2011
• Annual enrollment begins October 15 and ends December 7 for medicare part c & part d plans september 22, 2011
• new rules for medicare advantage and part d plans June 2, 2011
• cms sends reminders to lis-eligible medicare beneficiaries May 26, 2011
• help someone keep part d extra help March 17, 2011
• extension of time to enroll in a prescription drug plan for medicare beneficiaries who lost coverage on February 10, 2011
• 2011 Poverty Levels Affect Eligibility for Many Federal Programs January 27, 2011
• 45 day disenrollment period for medicare advantage members January 6, 2011
• center for medicare advocacy applauds hhs for making it easier for medicare beneficiaries to choose a drug plan in 2011 october 7, 2010
• the court emphatically denies the right of beneficiaries to sue a part d plan when the plan delays enrollment september 30, 2010
• cma report: medicare coverage for off-label drug use September 16, 2010
• Healthcare Reform in Action: Donut Gap Reimbursement Checks Start Arriving June 10, 2010 June 10, 2010
• li net: more help for dual eligibles December 24, 2009
• part covered, part not: “cross-claims” in medicare part d july 24, 2008
• adapted to offer free hepatitis c medication March 15, 2005
• ms drug, tysabri, discontinued March 1, 2005

for older articles, check out our article archive.

references

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“facilitated registration notice”. medicare centers & Medicaid Services, https://www.medicare.gov/forms-help-resources/mail-you-get-about-medicare/facilitated-enrollment-notice.

“are you eligible for the $250 part d refund? cms publishes questions and answers”. California Health Advocates, May 24, 2010, https://cahealthadvocates.org/part-d-250-rebate-questions/.

Frequently asked questions and answers for pharmacy providers. (human). https://apps.humana.com/marketing/documents.asp?file=2584998.

“general program information”. medicare centers & Medicaid Services, May 8, 2020, https://www.rds.cms.hhs.gov/?q=common-questions/general-program-information#cq1001.

health reform and medicare: the $250 donut hole reimbursement. (Medicare Rights Center, June 11, 2010). https://www.medicarerights.org/pdf/health-reform-$250-doughnut-hole-rebate.pdf.

“Medicare Part D Prescription Drug Plans: The Market in 2013 and Key Trends, 2006-2013”. kaiser family foundation, December 11, 2013, https://www.kff.org/medicare/issue-brief/medicare-part-d-prescription-drug-plans-the-marketplace-in-2013-and- key-trends -2006-2013/.

how medicare prescription drug coverage works with a medicare advantage plan or a medicare cost plan. (Centers for Medicare and Medicaid Services, May 2018). https://www.medicare.gov/pubs/pdf/11135-prescription-drug-coverage-with-ma-mcp.pdf.

“irmaa initial determination”. medicare centers & Medicaid Services, https://www.medicare.gov/forms-help-resources/mail-you-get-about-medicare/initial-irmaa-determination.

Instructions for completing the 2020 contract year prescription drug plan offer pricing tool. (Centers for Medicare & Medicaid Services, April 5, 2019). https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents/2012215122-op-cy2020_part_d_bpt_instructions_04_05_2019.pdf.

kirchhoff, suzanne m. medicare coverage of end-stage renal disease (esrd). (Congressional Research Service, August 16, 2018). https://fas.org/sgp/crs/misc/r45290.pdf.

———. medicare part d prescription drug benefit. (Congressional Research Service, Dec. 18, 2020). https://fas.org/sgp/crs/misc/r40611.pdf.

“15 years of access to health care: a retrospective look”. patient access network foundation, July 22, 2019, https://www.panfoundation.org/15-years-of-healthcare-access/.

“appeals of penalties for late enrollment (lep)”. medicare centers & Medicaid Services, May 20, 2021, https://www.cms.gov/medicare/appeals-and-grievances/medprescriptdrugapplgriev/late-enrollment-penalty-lep-appeals.

“medicare advantage disenrollment period (madp)”. ehealthinsurance services, inc., Jan 25, 2021, https://www.ehealthmedicare.com/medicare-enrollment-articles/medicare-advantage-disenrollment-period-madp/.

“explanation of the medicare advantage (madp) disenrollment period”. Agent Pipeline, Inc., https://www.agentpipeline.com/2011/01/medicare-advantage-disenrollment-period-madp-explained/.

“medicare benefit eligibility for people with esrd”. medicare interactive, https://www.medicareinteractive.org/get-answers/medicare-health-coverage-options/medicare-and-end-stage-renal-disease-esrd/medicare-advantage-eligibility-for-people-with -esrd.

medicare marketing and communication guides (mcmg). (Centers for Medicare & Medicaid Services, September 15, 2018). https://www.cms.gov/medicare/health-plans/managedcaremarketing/downloads/cy2019-medicare-communications-and-marketing-guidelines_updated-090518.pdf.

“medicare enrollment periods”. medicarefaq.com, July 2, 2021, https://www.medicarefaq.com/original-medicare/medicare-enrollment-periods/.

“net medicare limited income program”. medicare centers & Medicaid Services, December 17, 2018, https://www.cms.gov/medicare/eligibility-and-enrollment/lowincsubmedicareprescov/medicarelimitedincomenet.

“medicare low income subsidy: get extra help paying for part d”. National Council on Aging, Inc., November 10, 2020, https://www.ncoa.org/article/medicare-low-income-subsidy-get-extra-help-paying-for-part-d.

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“medicare part d cost sharing chart”. National Council on Aging, Inc., August 28, 2020, https://www.ncoa.org/article/medicare-part-d-cost-sharing-chart.

“the medicare part d coverage gap discount (2011 to 2020)”. q1group llc, https://q1medicare.com/partd-medicarepartd_donuthole_discount.php.

“medicare part d plans and the coverage gap for 2021”. insurance connection usa, October 11, 2020, https://insuranceconnectionusa.com/medicare-part-d-plans-and-the-coverage-gap-for-2021/.

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medicare part d immunizations. (Centers for Medicare and Medicaid Services, December 2020). https://www.cms.gov/outreach-and-education/medicare-learning-network-mln/mlnproducts/downloads/vaccines-part-d-factsheet-icn908764textonly.pdf.

“medicare program; application of certain appeals provisions to the Medicare prescription drug appeals process.” medicare centers & Medicaid Services, December 9, 2009, https://www.federalregister.gov/documents/2009/12/09/e9-28710/medicare-program-application-of-certain-appeals-provisions-to-the- medicare- prescription drug appeals.

“medicare savings program”. medicare centers & Medicaid Services, https://www.medicare.gov/medicare-savings-programs.

medicare transition policy and procedures. https://beonbrand.getbynder.com/m/31a9f3367dd2a8a9/original/part-d-transition-policy.pdf.

“net medicare limited income program”. Humana, https://www.humana.com/provider/pharmacy-resources/medicare-limited-income-net-program.

“monthly premium for drug plans”. medicare centers & Medicaid Services, https://www.medicare.gov/drug-coverage-part-d/costs-for-medicare-drug-coverage/monthly-premium-for-drug-plans.

“an overview of the medicare part d prescription drug benefit.” kaiser family foundation, October 14, 2020, https://www.kff.org/medicare/fact-sheet/an-overview-of-the-medicare-part-d-prescription-drug-benefit/#: ~:text =enroll%20in%20medicare%20part%20d,a%20plan%20in%20your%20own.

“part d costs for those with higher incomes”. medicare interactive, https://www.medicareinteractive.org/get-answers/medicare-prescription-drug-coverage-part-d/medicare-part-d-costs/part-d-costs-for-those-with-higher -income.

“the donut hole from part d”. medicare interactive, https://www.medicareinteractive.org/get-answers/medicare-prescription-drug-coverage-part-d/medicare-part-d-costs/the-part-d-donut-hole.

“part d information for manufacturers of pharmaceutical products”. medicare centers & medicaid services, June 28, 2021, https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovgenin/pharma.

“part d late enrollment penalties”. medicare interactive, https://www.medicareinteractive.org/get-answers/medicare-prescription-drug-coverage-part-d/medicare-part-d-enrollment/part-d-late-enrollment-penalties.

“part d low income subsidy/extra help coverage and eligibility chart”. National Council on Aging, Inc., Jan 26, 2021, https://www.ncoa.org/article/part-d-low-income-subsidy-extra-help-eligibility-and-coverage-chart.

parts c & d member complaints, organization/coverage determinations, and appeals guidance. (Centers for Medicare and Medicaid Services, 2020). https://www.cms.gov/medicare/appeals-and-grievances/mmcag/downloads/parts-c-and-d-enrollee-grievances-organization-coverage-determinations-and-appeals-guidance.pdf.

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“part d coverage phases”. medicare interactive, https://www.medicareinteractive.org/get-answers/medicare-prescription-drug-coverage-part-d/medicare-part-d-costs/phases-of-part-d-coverage.

“private fee-for-service plans (pffs)”. medicare centers & Medicaid Services, https://www.medicare.gov/sign-up-change-plans/types-of-medicare-health-plans/private-fee-for-service-pffs-plans.

“disabled people and skilled workers program (qdwi)”. benefits.gov, https://www.benefits.gov/benefit/6180.

“reconsiderations by the independent review entity”. medicare centers & Medicaid Services, May 20, 2021, https://www.cms.gov/medicare/appeals-and-grievances/medprescriptdrugapplgriev/reconsiderations.

“redetermination by the part d plan sponsor”. medicare centers & medicaid services, February 11, 2020, https://www.cms.gov/medicare/appeals-and-grievances/medprescriptdrugapplgriev/redetermination.

“review by a federal district court”. medicare centers & medicaid services, Feb. 3, 2021, https://www.cms.gov/medicare/appeals-and-grievances/medprescriptdrugapplgriev/federalcourtreview.

“medicare appeals council review”. medicare centers & medicaid services, Jan. 8, 2020, https://www.cms.gov/medicare/appeals-and-grievances/medprescriptdrugapplgriev/medicareappealscouncil.

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“state mma file of beneficiaries with dual eligibility”. medicare centers & Medicaid Services, December 22, 2020, https://www.cms.gov/medicare-medicaid-coordination/medicare-and-medicaid-coordination/medicare-medicaid-coordination-office/datastatisticalresources/statemmafile.

stein, judith a., alfred j. chiplin and kata m. kertesz. medicare handbook, 2021 edition. wolters kluwer, 2020.

“what are mapd plans in medicare?” healthline media, April 22, 2021, https://www.healthline.com/health/medicare/mapd-medicare.

tudor, cynthia g. Transition to Part D coverage for benzodiazepines and barbiturates beginning in 2013. (Centers for Medicare and Medicaid Services, Oct 12, 2012). https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovcontra/downloads/benzoandbarbituratesin2013.pdf.

“what are drug utilization management restrictions?” q1group llc, https://q1medicare.com/q1group/medicareadvantagepartdqa/faq.php?faq=what-are-drug-utilization-management-restrictions-&faq_id=668&category_id=.

“what are medicare part d ‘cross claims’?” q1group llc, https://q1medicare.com/q1group/medicareadvantagepartdqa/faq.php?faq=what-are-medicare-part-d-straddle-claims-&faq_id=368&category_id=.

“what exactly is troop or total out of pocket expenses?” q1group llc, https://q1medicare.com/q1group/medicareadvantagepartdqa/faq.php?faq=what-exactly-is-troop-or-total-out-of-pocket-costs-&faq_id=370&category_id=.

“what is the annual open enrollment period (aep) for medicare?” q1group llc, https://q1medicare.com/q1group/medicareadvantagepartdqa/faq.php?faq=what-is-the-medicare-annual-open-inrollment-period-aep—&faq_id=557&category_id=.

“what is troop or actual out-of-pocket costs?” q1group llc, https://q1medicare.com/partd-whatis-thetrueoutofpocketexpense.php.

“what is irmaa?

.” tz insurance solutions, inc., April 22, 2021, https://www.medicaresupplement.com/costs/what-is-irmaa/.

your guide to medicare prescription drug coverage. (Centers for Medicare and Medicaid Services Department of Health and Human Services, September 2019). https://www.medicare.gov/pubs/pdf/11109-your-guide-to-medicare-prescrip-drug-cov.pdf.

[1] judith a. Stein, Alfred J. chiplin and kata m. Kertesz, Medicare Handbook, 2021 Edition (Wolters Kluwer, 2020), (11-3).

[2] “15 Years of Access to Health Care: A Look Back,” Patient Access Network Foundation, July 22, 2019, https://www.panfoundation.org/15-years- of-healthcare-access/.

[3] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-3).

[4] 42 u.s.c. §§ 1395w-101(a)(1)(a), 1395w-112(b)(1), and 1395w-151(a)(14)

[5] Your Guide to Medicare Prescription Drug Coverage, (Centers for Medicare and Medicaid Services Department of Health and Human Services, September 2019), 13, https://www.medicare.gov/pubs /pdf/11109-your-guide-to-medicare-prescription-drug-cov.pdf.

[6] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-3).

[7] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-6).

[8] “Medicare Part D Prescription Drug Plans: The Market in 2013 and Key Trends, 2006-2013,” Kaiser Family Foundation, December 11, 2013, https://www.kff.org/ medicare/issue-brief/medicare-part-d-rescription-drug-plans-the-marketplace-in-2013-and-key-trends-2006-2013/.

[9] 42 u.s.c. §§ 1395w-101(a)(1)(a), 1395w-112(b)(1), and 1395w-151(a)(14)

[10] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-4).

[11] Medicare Part D Reporting Requirements, (Centers for Medicare and Medicaid Services Department of Health and Human Services, 2016), 3, https://www.hhs.gov/guidance/sites/ default/files/hhs-guidance-documents/cy2016_part%20d%20reporting%20requirements%2006092016.pdf

[12] “what are mapd plans in medicare?”, healthline media, April 22, 2021, https://www.healthline.com/health/medicare/mapd-medicare.

[13] sullivan, “what are mapd plans in medicare?”.

[14] Medicare Marketing and Communications Guidelines (mcmg), (Centers for Medicare and Medicaid Services, Sep 15, 2018), 4, https://www.cms.gov/medicare/health-plans /managedcaremarketing/downloads/cy2019-medicare-communications-and-marketing-guidelines_updated-090518.pdf.

[15] “private fee-for-service (pffs) plans”, medicare centers & Medicaid Services, https://www.medicare.gov/sign-up-change-plans/types-of-medicare-health-plans/private-fee-for-service-pffs-plans.

[16] Instructions for Completing the 2020 Contract Year Prescription Drug Plan Offer Pricing Tool (Centers for Medicare and Medicaid Services, April 5, 2019), 31, https://www. hhs.gov/guidance/sites/default/files/hhs-guidance-documents/2012215122-op-cy2020_part_d_bpt_instructions_04_05_2019.pdf.

[17] How Medicare Prescription Drug Coverage Works with a Medicare Advantage Plan or Medicare Cost Plan (Centers for Medicare and Medicaid Services, May 2018), 2, https://www.medicare .gov/pubs/pdf /11135-prescription-drug-coverage-with-ma-mcp.pdf.

[18] how medicare prescription drug coverage works with a medicare advantage plan or a medicare cost plan, 2; “how do medicare advantage ppo plans work?”, healthline media, May 5, 2021, https://www.healthline.com/health/medicare/medicare-part-f-cost#takeaway.

[19] how medicare prescription drug coverage works with a medicare advantage plan or a medicare cost plan, 2.

[20] amin, “how do medicare advantage ppo plans work?”.

[21] “medicare advantage special needs plans (snps)”, healthline media, May 3, 2021, https://www.healthline.com/health/medicare/medicare-special-needs-plans.

[22] larger, “medicare advantage special needs plans (snps)”.

[23] “registration & Disenrollment in Medicare Advantage Plans,” California Health Advocates, https://cahealthadvocates.org/medicare-advantage/enrollment-disenrollment-in-medicare-advantage-plans/.

[24] “general program information”, medicare centers & Medicaid Services, May 8, 2020, https://www.rds.cms.hhs.gov/?q=common-questions/general-program-information#cq1001.

[25] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-3).

[26] 42 c.f.r. § 423.30(a)(1)(i)

[27] 42 u.s.c. §1395w-101(b)(1)(b)(i)

[28] “Chapter 3: Eligibility, Enrollment, and Disenrollment,” in the Medicare Prescription Drug Benefits Handbook (Centers for Medicare & Medicaid Services, 2021), 15.

[29] 42 c.f.r. §§ 423.4 and 423.40(a)(1)

[30] 42 c.f.r. §§ 423.4 and 423.40(a)(1)

[31] “can i join a 2021 medicare advantage plan even if i have end stage renal disease (esrd)?”, q1group llc, https://q1medicare.com/q1group/medicareadvantagepartdqa/faq.php?faq = can-i-join-a-medicare-advantages-plan-2021-even-i-have-end-stage-renal-disease-esrd-&faq_id=75&category_id=; “Medicare Advantage Eligibility for People with ESRD,” Medicare Interactive, https://www.medicareinteractive.org/get-answers/medicare-health-coverage-options/medicare-and-end-stage-renal-disease-esrd /medicare-advantage-eligibility-for-people-with-esrd.

[32] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-5).

[33] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-5).

[34] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-6).

[35] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-7).

[36] “drugs never covered by medicare”, priority health, https://www.priorityhealth.com/medicare/compare-plans/prioritymedicare-2020/drug-coverage/covered-drugs/never-covered.

[37] Medicare Part D Immunizations, (Centers for Medicare and Medicaid Services, Dec 2020), 3, https://www.cms.gov/outreach-and-education/medicare-learning- network-mln/ mlnproducts/downloads/vaccines-part-d-factsheet-icn908764textonly.pdf.

[38] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-5).

[39] “Chapter 6: Part D Drugs and Formulary Requirements,” in the Medicare Prescription Drug Benefits Handbook (Centers for Medicare & Medicaid Services, Jan 15, 2016), p. 5.

[40] “part d information for pharmaceutical manufacturers”, centers of medicare & medicaid services, June 28, 2021, https://www.cms.gov/medicare/prescription-drug-coverage/prescriptiondrugcovgenin/pharma.

[41] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-6).

[42] 42 c.f.r. §§ 423.120(b) and 423.272(b)

[43] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-6).

[44] “Chapter 6 – Part D Drugs and Formulary Requirements,” 21.

[45] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-7).

[46] “Chapter 6 – Part D Drugs and Formulary Requirements,” 21.

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[47] “exceptions”, medicare centers & medicaid services, September 24, 2019, https://www.cms.gov/medicare/appeals-and-grievances/medprescriptdrugapplgriev/exceptions.

[48] “Chapter 6: Part D Drugs and Formulary Requirements,” 21.

[49] cynthia g. Tudor, Transition to Part D Benzodiazepine and Barbiturate Coverage Beginning in 2013 (Centers for Medicare & Medicaid Services, Oct 12, 2012), 1, https://www.cms.gov/medicare/prescription- drug-coverage/prescriptiondrugcovcontra /descargas/benzoybarbituracosen2013.pdf.

[50] “Chapter 6: Part D Drugs and Formulary Requirements,” 10.

[51] “Chapter 6: Part D Drugs and Formulary Requirements,” 13.

[52] “Chapter 6: Part D Drugs and Formulary Requirements,” 14.

[53] “Chapter 6: Part D Drugs and Formulary Requirements,” 13.

[54] “Chapter 6: Part D Drugs and Formulary Requirements,” 13.

[55] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-5)-(11-6).

[56] “Chapter 6: Part D Drugs and Formulary Requirements,” 13.

[57] “Chapter 6: Part D Drugs and Formulary Requirements,” 8.

[58] “Chapter 6: Part D Drugs and Formulary Requirements,” 13-14.

[59] “Chapter 6 – Part D Drugs and Formulary Requirements,” 15.

[60] “Chapter 6: Part D Drugs and Formulary Requirements,” 17.

[61] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-12).; 42 c.f.r. §423.120(a)(9).

[62] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-12).; 73 fed. record 20,486 (April 15, 2008).

[63] Analysis of Part D Beneficiary Access to Preferred Cost-Sharing Pharmacies (PCSPS), (Centers for Medicare and Medicaid Services, Apr 28, 2015), 4, https://www. cms.gov/medicare/ prescription drug coverage/prescriptiondrugcovcontra/downloads/pcsp-key-results-report-final-v04302015.pdf.

[64] “How Medicare Part D Works,” AARP, October 2016, https://www.aarp.org/health/medicare-insurance/info-11-2009/how_medicare-part_d_drug_coverage_works.html.

[65] “what exactly is troop or total out of pocket expenses?”, q1group llc, https://q1medicare.com/q1group/medicareadvantagepartdqa/faq.php?faq=what-exactly-is-the -troop -o-pocket-expenses-total-&faq_id=370&category_id=.

[66] “what are drug utilization management restrictions?”, q1group llc, https://q1medicare.com/q1group/medicareadvantagepartdqa/faq.php?faq=what-are-drug-utilization- management-restrictions-&faq_id=668&category_id=.

[67] “Chapter 6: Part D Drugs and Formulary Requirements,” 25-26.

[68] “Chapter 6 – Part D Drugs and Formulary Requirements,” 33.

[69] “Chapter 6: Part D Drugs and Formulary Requirements,” 32.

[70] “Chapter 6: Part D Drugs and Formulary Requirements,” 32-33.

[71] “Chapter 6 – Part D Drugs and Formulary Requirements,” 33.

[72] “Chapter 6 – Part D Drugs and Formulary Requirements,” 33.

[73] Medicare Transition Policy and Procedures, 3-4, https://beonbrand.getbynder.com/m/31a9f3367dd2a8a9/original/part-d-transition-policy.pdf; “Chapter 6 – Part D Drugs and Formulary Requirements,” 141.

[74] “Chapter 6 – Part D Drugs and Formulary Requirements,” 39.

[75] “Chapter 6: Part D Drugs and Formulary Requirements,” 41, 45.

[76] “Chapter 6 – Part D Drugs and Formulary Requirements,” 41.

[77] “costs in the coverage gap”, medicare centers & Medicaid Services, https://www.medicare.gov/drug-coverage-part-d/costs-for-medicare-drug-coverage/costs-in-the-coverage-gap#:~:text=most%20medicare % 20%20drug%20plans%20have,some%20amount%20for%20%20drugs%20covered.

[78] suzanne m. Kirchhoff, Medicare Part D Prescription Drug Benefit (Congressional Research Service, Dec 18, 2020), 1, https://fas.org/sgp/crs/misc/r40611.pdf.

[79] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-8).

[80] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-8).

[81] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-8).

[82] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-8)-(11-9).

[83] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-9).

[84] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-9).

[85] Kirchhoff, Medicare Part D Prescription Drug Benefit, 23.

[86] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-9).

[87] kirchhoff, medicare part d prescription drug benefit, 23.

[88] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-9).

[89] “Medicare Part D Cost Sharing Chart,” National Council on Aging, Inc., Aug 28, 2020, https://www.ncoa.org/article/medicare-part- d-cost-sharing -box; Stein, Chiplin, and Kertesz, Medicare Handbook, 2021 Edition, (11-8), (11-9), (11-11); “2021 Medicare Part D Outlook,” q1group llc, https://q1medicare.com/partd-the-2021-medicare-part-d-outlook.php.

[90] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-10).

[91] kirchhoff, medicare part d prescription drug benefit, 20.

[92] suzanne m. Kirchhoff, Medicare Coverage of End-Stage Renal Disease (ESRD) (Congressional Research Service, Aug 16, 2018), 7, https://fas.org/sgp/crs/misc/r45290.pdf.

[93] “initial irmaa determination”, medicare centers & Medicaid Services, https://www.medicare.gov/forms-help-resources/mail-you-get-about-medicare/initial-irmaa-determination.

[94] “Part D Late Enrollment Penalties,” Medicare Interactive, https://www.medicareinteractive.org/get-answers/medicare-prescription-drug-coverage-part-d/medicare-part- d-enrollment /part-d-late-enrollment-penalties; “what is irmaa?

”, tz insurance solutions, inc., April 22, 2021, https://www.medicaresupplement.com/costs/what-is-irmaa/.

[95] “part d costs for people with higher incomes,” medicare interactive, https://www.medicareinteractive.org/get-answers/medicare-prescription-drug-coverage-part-d/medicare- part-d-costs/part-d-costs-for-those-with-higher-incomes.

[96] “monthly premium for drug plans”, medicare centers & Medicaid Services, https://www.medicare.gov/drug-coverage-part-d/costs-for-medicare-drug-coverage/monthly-premium-for-drug-plans.

[97] “monthly premium for drug plans.”

[98] 2020 Part D Income-Related Monthly Premium Adjustment, (Centers for Medicare and Medicaid Services, Sep 27, 2019), 2, https://www.cms.gov/medicare /health-plans/medicareadvtgspecratestats /downloads/partdirmaa2020.pdf; 2021 Part D Income-Related Monthly Premium Adjustment, (Centers for Medicare and Medicaid Services, Nov 6, 2020), 2, https://www.cms.gov/files/document/2021-part -d-income-related -monthly-premium-adjustment.pdf.

[99] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-10).

[100] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-8).

[101] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-8).

[102] “Medicare Part D Plans and the Coverage Gap for 2021,” Insurance Connection USA, October 11, 2020, https://insuranceconnectionusa.com/medicare-part-d-plans-and-the -coverage-gap-for-2021/.

[103] “The Part D Coverage Gap,” Medicare Interactive, https://www.medicareinteractive.org/get-answers/medicare-prescription-drug-coverage-part-d/medicare-part- d-costs /the-part-d-donut-hole.

[104] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-9).

[105] Stein, Chiplin, and Kertesz, Medicare Handbook, 2021 Edition, (11-11); “what are the true out-of-pocket expenses,” q1group llc, https://q1medicare.com/partd-whatis-thetrueoutofpocketexpense.php; your guide to medicare prescription drug coverage, 48, 65-66.

[106] “what exactly is troop or total out of pocket expenses?”.

[107] “Phases of Part D Coverage,” Medicare Interactive, https://www.medicareinteractive.org/get-answers/medicare-prescription-drug-coverage-part-d/medicare-part- d-costs /phases-of-part-d-coverage.

[108] “explanation of benefits (eob)”, medicare interactive, https://www.medicareinteractive.org/get-answers/medicare-denials-and-appeals/medicare-advantage-appeals/explanation-of- benefits-eob.

[109] your guide to medicare prescription drug coverage, 16.

[110] “Help Paying for Prescription Drugs,” Medicare Advocacy Center, November 30, 2015, https://medicareadvocacy.org/finding-help-to-get-prescription-drugs/.

[111] “The 2010 Medicare Part D Donut Hole Rebate,” q1group llc, https://q1medicare.com/partd-the_250_dollar_donut_hole_rebate.php.

[112] “the medicare part d donut hole discount (2011 to 2020)”, q1group llc, https://q1medicare.com/partd-medicarepartd_donuthole_discount.php.

[113] “the medicare part d donut hole discount (2011 to 2020)”.

[114] “what exactly is troop or total out of pocket expenses?”.

[115] “what is the actual troop or out-of-pocket costs.”

[116] “are you eligible for the $250 part d refund? cms publishes questions and answers,” California Health Advocates, May 24, 2010, https://cahealthadvocates.org/part-d-250-rebate-questions/.

[117] Health Reform and Medicare: The $250 Donut Gap Reimbursement, (medicare rights center, June 11, 2010), 1, https://www.medicarerights.org/pdf/health- reform-$250-doughnut-hole-refund.pdf.

[118] “part d information for pharmaceutical manufacturers.”

[119] “coverage gap costs.”

[120] “what are medicare part d “cross claims”?”, q1group llc, https://q1medicare.com/q1group/medicareadvantagepartdqa/faq.php?faq=what-are-medicare -part-d-straddle-claims-&faq_id=368&category_id=.

[121] “what are medicare part d ‘cross claims’?”.

[122] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-13).

[123] “what is medicare’s annual open enrollment period (aep), q1group llc, https://q1medicare.com/q1group/medicareadvantagepartdqa/faq.php?faq=what-is-the -medicare- aep-annual-open-enrollment-period—&faq_id=557&category_id=.

[124] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-17).; 42 c.f.r. § 423.38(b).

[125] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-17).

[126] “medicare enrollment periods,” medicarefaq.com, July 2, 2021, https://www.medicarefaq.com/original-medicare/medicare-enrollment-periods/.

[127] “medicare advantage disenrollment period (madp)”, ehealthinsurance services, inc., January 25, 2021, https://www.ehealthmedicare.com/medicare-enrollment-articles/medicare-advantage-disenrollment- period -madp/.

[128] “Medicare Advantage Disenrollment Period (MADP) Explained,” Agent Pipeline, Inc., https://www.agentpipeline.com/2011/01/medicare-advantage-disenrollment-period-madp- explained/.

[129] Section 17005, 21st Century Cures Act (pub. l. no. 114-255), signed into law by President Obama on December 13, 2016.

[130] “medicare enrollment periods”.

[131] 42 cf. § 423.44.

[132] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-16).

[133] “An Overview of the Medicare Part D Prescription Drug Benefit,” Kaiser Family Foundation, Oct. 14, 2020, https://www.kff.org/medicare/fact-sheet /an-overview-of- the-medicare-part-d-prescription-drug-benefit/#:~:text=enrolling%20in%20medicare%20part%20d,a%20plan%20in%20your%20own .

[134] “an overview of the medicare part d prescription drug benefit.”

[135] “an overview of the medicare part d prescription drug benefit.”

[136] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-19).

[137] 42 u.s.c. §1395w-113(b)(4); 42 c.f.r. § 423.56.

[138] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-19).

[139] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-19)-(11-20).

[140] “an overview of the medicare part d prescription drug benefit.”

[141] Special Enrollment Periods for Medicare Advantage Plans and Medicare Part D Drug Plans (Medicare Rights Center, January 2020), 13, https://www.medicareinteractive.org/pdf/ sep-chart.pdf.

[142] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-18).

[143] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-18)-(11-19).

[144] “Chapter 4: Creditable Coverage Period Determinations and Late Enrollment Penalty,” in Medicare Prescription Drug Benefits Handbook (Centers for Medicare and Medicaid Services, Jan 5, 2018), pg . 6; Stein, Chiplin, and Kertesz, The Medicare Handbook, 2021 Edition, (11-19).

[145] “late enrollment penalty (lep) appeals”, medicare centers & Medicaid Services, May 20, 2021, https://www.cms.gov/medicare/appeals-and-grievances/medprescriptdrugapplgriev/late-enrollment-penalty-lep-appeals.

[146] special enrollment periods for medicare advantage plans and medicare part d drug plans.

[147] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-20).

[148] “can i have my medicare premiums deducted from my social security payments?”, aarp, May 12, 2021, https://www.aarp.org/retirement/social-security/ questions-answers/medicare-premiums-deducted-ss.html.

[149] “evidence of coverage (eoc)”, medicare centers & Medicaid Services, https://www.medicare.gov/forms-help-resources/mail-you-get-about-medicare/evidence-of-coverage-eoc.

[150] Medicare Marketing Guidelines, (Centers for Medicare and Medicaid Services, Jun 10, 2016), 9.

[151] “evidence of coverage (eoc)”.

[152] “evidence of coverage (eoc)”.

[153] “medicare savings program”, medicare centers & Medicaid Services, https://www.medicare.gov/medicare-savings-programs.

[154] “Medicare Low Income Subsidy: Get Extra Help Paying for Part D,” National Council on Aging, Inc., Nov. 10, 2020, https://www.ncoa.org/article /medicare-low-income-subsidy-get-extra-help-paying-for-part-d.

[155] “medicare savings program”.

[156] “medicare savings program”.

[157] “medicare savings program”.

[158] “Qualified Disabled and Working Individuals (QDWI) Program,” benefits.gov, https://www.benefits.gov/benefit/6180.

[159] “medicare low income subsidy: get extra help paying for part d”.

[160] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-23).

[161] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-22).

[162] Announcement of medicare advantage (ma) calendar year (cy) 2021 capitation rates and part c and part d payment policies, (centers for medicare and medicaid services, april 6 2020), https://www .cms.gov/files/document/2021-announcement.pdf.; 42 c.f.r. § 423.782 (b).

[163] “Part D Low Income Subsidy/Extra Help Eligibility and Coverage Chart,” National Council on Aging, Inc., Jan 26, 2021, https://www.ncoa.org /article/part-d- low-income subsidy extra help coverage and eligibility chart.

[164] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-23).

[165] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-23).

[166] 75 fed. registration 10,677 (April 15, 2020) (amending 42 c.f.r. § 423.773(c)(2).

[167] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-23).

[168] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-25).

[169] 42. usc. § 1396u-5(d)(1).

[170] 42 u.s.c. §1396u-5(c)(6).

[171] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-26).; 75 fed. record 1967 (April 15, 2010).

[172] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-26).

[173] “mma state file of dual eligible beneficiaries”, medicare centers & Medicaid Services, December 22, 2020, https://www.cms.gov/medicare-medicaid-coordination/medicare-and-medicaid-coordination/medicare-medicaid-coordination-office/datastatisticalresources/statemmafile.

[174] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-26).

[175] “state mma file of beneficiaries with dual eligibility”.

[176] “Chapter 13: Low-Income Premiums and Cost-Sharing Subsidies,” in Medicare Prescription Drug Benefits Handbook (Centers for Medicare and Medicaid Services, Oct 1, 2018), 33 .

[177] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-23).

[178] 75 fed. record 1967 (January 13, 2010).

[179] “facilitated enrollment notice”, medicare centers & Medicaid Services, https://www.medicare.gov/forms-help-resources/mail-you-get-about-medicare/facilitated-enrollment-notice.

[180] “medicare limited income net program”, human, https://www.humana.com/provider/pharmacy-resources/medicare-limited-income-net-program.

[181] Pharmacy Newsletter: Medicare Limited Income Net Program: Low Income Subsidy Requirement, (Humana), https://apps.humana.com/marketing/documents.asp?file =2549222

[182] “net medicare limited income program”, centers for medicare & Medicaid Services, December 17, 2018, https://www.cms.gov/medicare/eligibility-and-enrollment/lowincsubmedicareprescov/medicarelimitedincomenet.

[183] ​​Frequently Asked Questions and Answers for Pharmacy Providers, (Humana), 6, https://apps.humana.com/marketing/documents.asp?file=2584998.

[184] 42 cf. §§ 423.454 and 423.464(e)(1).

[185] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-30).

[186] 42 u.s.c. 6 1395w-104(f).

[187] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-34).

[188] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-31).

[189] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-39).

[190] “exceptions”.

[191] “exceptions”.

[192] “exceptions”.

[193] “independent review entity reconsiderations”, medicare centers & Medicaid Services, May 20, 2021, https://www.cms.gov/medicare/appeals-and-grievances/medprescriptdrugapplgriev/reconsiderations.

[194] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-23).

[195] “exceptions”.

[196] 42 cf. § 423.566.

[197] “exceptions”.

[198] “reconsiderations by the independent review entity.”

[199] “part d plan sponsor redetermination”, medicare centers & medicaid services, February 11, 2020, https://www.cms.gov/medicare/appeals-and-grievances/medprescriptdrugapplgriev/redetermination.

[200] “reconsiderations by the independent review entity.”

[201] “decision of the office of medicare hearings and appeals (omha)”, centers of medicare & medicare services, February 3, 2021, https://www.cms.gov/medicare/appeals-and-grievances/medprescriptdrugapplgriev/aljhearing.

[202] 42 c.f.r. § 423.2016.

[203] “medicare appeals board review”, medicare centers & medicaid services, Jan. 8, 2020, https://www.cms.gov/medicare/appeals-and-grievances/medprescriptdrugapplgriev/medicareappealscouncil.

[204] “medicare program; Application of Certain Appeal Provisions to the Medicare Prescription Drug Appeal Process”, Centers for Medicare & Medicaid Services, December 9, 2009, https://www.federalregister.gov/documents/2009/12/09/e9-28710/medicare-program-application-of-certain-appeals-provisions-to-the- medicare- prescription drug appeals.

[205] “review by a federal district court”, medicare centers & medicaid services, Feb. 3, 2021, https://www.cms.gov/medicare/appeals-and-grievances/medprescriptdrugapplgriev/federalcourtreview.

[206] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-30).

[207] stein, chiplin, and kertesz, medicare handbook, 2021 edition, (11-30).

[208] 42 c.f.r. § 423.564.

[209] parts c & d Member Claims, Organization/Coverage Determinations, and Appeals Guide (Centers for Medicare and Medicaid Services, 2020), 19, https://www.cms.gov/medicare/appeals-and-grievances/mmcag/downloads/ parts -c-and-d-enrollee-grievances-organization-coverage-determinations-and-appeals-guidance.pdf.

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