Editorial Note on Part 422
Editorial Note: Nomenclature changes to part 422 appear at 70 FR 4741, Jan. 28, 2005.

§ 422.111 Disclosure requirements. ( a ) *Detailed description.* An MA organization must disclose the information specified in paragraph (b) of this section in the manner specified by CMS— ( 1 ) To each enrollee electing an MA plan it offers;
( 2 ) In clear, accurate, and standardized form; and
( 3 ) At the time of enrollment and at least annually thereafter, by the first day of the annual coordinated election period.
( b ) *Content of plan description.* The description must include the following information: ( 1 ) *Service area.* The MA plan's service area and any enrollment continuation area.
( 2 ) *Benefits.* The benefits offered under a plan, including applicable conditions and limitations, premiums and cost-sharing (such as copayments, deductibles, and coinsurance) and any other conditions associated with receipt or use of benefits; and to the extent it offers Part D as an MA-PD plan, the information in § 423.128 of this chapter; and for purposes of comparison- ( i ) The benefits offered under original Medicare, including the content specified in paragraph (f)(1) of this section;
( ii ) For an MA MSA plan, the benefits under other types of MA plans; and
( iii ) By a dual eligible special needs plan, prior to enrollment, for each prospective enrollee, a comprehensive written statement describing cost sharing protections and benefits that the individual is entitled to under title XVIII and the State Medicaid program under title XIX.
( iv ) The availability of the Medicare hospice option and any approved hospices in the service area, including those the MA organization owns, controls, or has a financial interest in.
( 3 ) *Access.* ( i ) The number, mix, and distribution (addresses) of providers from whom enrollees may reasonably be expected to obtain services; each provider's cultural and linguistic capabilities, including languages (including American Sign Language) offered by the provider or a skilled medical interpreter at the provider's office; any out-of-network coverage; any point-of-service option, including the supplemental premium for that option; and how the MA organization meets the requirements of §§ 422.112 and 422.114 for access to services offered under the plan.
( ii ) The process MA regional plan enrollees should follow to secure in-network cost sharing when covered services are not readily available from contracted network providers.
( 4 ) Out-of-area coverage provided under the plan, including coverage provided to individuals eligible to enroll in the plan under § 422.50(a)(3)(ii).
( 5 ) *Emergency coverage.* Coverage of emergency services, including— ( i ) Explanation of what constitutes an emergency, referencing the definitions of emergency services and emergency medical condition at § 422.113;
( ii ) The appropriate use of emergency services, stating that prior authorization cannot be required;
( iii ) The process and procedures for obtaining emergency services, including use of the 911 telephone system or its local equivalent; and
( iv ) The locations where emergency care can be obtained and other locations at which contracting physicians and hospitals provide emergency services and post-stabilization care included in the MA plan.
( 6 ) *Supplemental benefits.* Any mandatory or optional supplemental benefits and the premium for those benefits.
( 7 ) *Prior authorization and review rules.* Prior authorization rules and other review requirements that must be met in order to ensure payment for the services. The MA organization must instruct enrollees that, in cases where noncontracting providers submit a bill directly to the enrollee, the enrollee should not pay the bill, but submit it to the MA organization for processing and determination of enrollee liability, if any.
( 8 ) *Grievance and appeals procedures.* All grievance and appeals rights and procedures.
( 9 ) *Quality improvement program.* A description of the quality improvement program required under § 422.152.
( 10 ) Disenrollment rights and responsibilities.
( 11 ) *Catastrophic caps and single deductible.* MA organizations sponsoring MA regional plans are required to provide enrollees a description of the catastrophic stop-loss coverage and single deductible (if any) applicable under the plan.
( c ) *Disclosure upon request.* Upon request of an individual eligible to elect an MA plan, an MA organization must provide to the individual the following information: ( 1 ) The information required in paragraph (f) of this section.
( 2 ) The procedures the organization uses to control utilization of services and expenditures.
( 3 ) The number of disputes, and the disposition in the aggregate, in a manner and form described by the Secretary. Such disputes shall be categorized as ( i ) Grievances according to § 422.564; and
( ii ) Appeals according to § 422.578 et. seq.
( 4 ) A summary description of the method of compensation for physicians.
( 5 ) Financial condition of the MA organization, including the most recently audited information regarding, at least, a description of the financial condition of the MA organization offering the plan.
( d ) *Changes in rules.* If an MA organization intends to change its rules for an MA plan, it must: ( 1 ) Submit the changes for CMS review under procedures of subpart V of this part.
( 2 ) For changes that take effect on January 1, notify all enrollees at least 15 days before the beginning of the Annual Coordinated Election Period defined in section 1851(e)(3)(B) of the Act.
( 3 ) For all other changes, notify all enrollees at least 30 days before the intended effective date of the changes.
( e ) *Changes to provider network.* The MA organization must provide enrollees notice of a termination of a contracted provider, irrespective of whether the termination was for cause or without cause, in accordance with § 422.2267(e)(12). The MA organization must make a good faith effort to provide enrollees notice of a for-cause termination of a contracted provider within the timeframes required by this paragraph (e). For all terminations, the MA organization must meet the following requirements: ( 1 ) For contract terminations that involve a primary care or behavioral health provider: ( i ) Provide written notice and make one attempt at telephonic notice to those enrollees identified in paragraph (e)(1)(iii) of this section who have not opted out of calls regarding plan business as described in § 422.2264(b),
( ii ) At least 45 calendar days before the termination effective date, and
( iii ) To all enrollees who are currently assigned to that primary care provider and to enrollees who have been patients of that primary care or behavioral health provider within the past three years.
( 2 ) For contract terminations that involve specialty types other than primary care or behavioral health: ( i ) Provide written notice,
( ii ) At least 30 calendar days before the termination effective date, and
( iii ) To all enrollees who are patients seen on a regular basis by the provider whose contract is terminating. The phrase “enrollees who are patients seen on a regular basis by the provider whose contract is terminating” means enrollees who are assigned to, currently receiving care from, or have received care within the past three months from a provider or facility being terminated.
( f ) *Disclosable information* — ( 1 ) *Benefits under original Medicare.* ( i ) Covered services.
( ii ) Beneficiary cost-sharing, such as deductibles, coinsurance, and copayment amounts.
( iii ) Any beneficiary liability for balance billing.
( 2 ) *Enrollment procedures.* Information and instructions on how to exercise election options under this subpart.
( 3 ) *Rights.* A general description of procedural rights (including grievance and appeals procedures) under original Medicare and the MA program and the right to be protected against discrimination based on factors related to health status in accordance with § 422.110.
( 4 ) *Potential for contract termination.* The fact that an MA organization may terminate or refuse to renew its contract, or reduce the service area included in its contract, and the effect that any of those actions may have on individuals enrolled in that organization's MA plan.
( 5 ) *Benefits.* ( i ) Covered services beyond those provided under original Medicare.
( ii ) Any beneficiary cost-sharing.
( iii ) Any maximum limitations on out-of-pocket expenses.
( iv ) In the case of an MA MSA plan, the amount of the annual MSA deposit.
( v ) The extent to which an enrollee may obtain benefits through out-of-network health care providers.
( vi ) The types of providers that participate in the plan's network and the extent to which an enrollee may select among those providers.
( vii ) The coverage of emergency and urgently needed services.
( 6 ) *Premiums.* ( i ) The MA monthly basic beneficiary premiums.
( ii ) The MA monthly supplemental beneficiary premium.
( iii ) The reduction in Part B premiums, if any.
( 7 ) The plan's service area.
( 8 ) *Quality and performance indicators* for benefits under a plan to the extent they are available as follows (and how they compare with indicators under original Medicare): ( i ) Disenrollment rates for Medicare enrollees for the 2 previous years, excluding disenrollment due to death or moving outside the plan's service area, calculated according to CMS guidelines.
( ii ) Medicare enrollee satisfaction.
( iii ) Health outcomes.
( iv ) Plan-level appeal data.
( v ) The recent record of plan compliance with the requirements of this part, as determined by the Secretary.
( vi ) Other performance indicators.
( 9 ) *Supplemental benefits.* Whether the plan offers mandatory and optional supplemental benefits, including any reductions in cost sharing offered as a mandatory supplemental benefit as permitted under section 1852(a)(3) of the Act (and implementing regulations at § 422.102) and the terms, conditions, and premiums for those benefits.
( 10 ) The names, addresses, and phone numbers of contracted providers from whom the enrollee may obtain in-network coverage in other parts of the service area.
( 11 ) If an MA organization exercises the option in § 422.101(b)(3) or (b)(4) related to an MA plan, then it must make the local coverage determination that applies to members of that plan readily available to providers, including through a web site on the Internet.
( g ) CMS may require an MA organization to disclose to its enrollees or potential enrollees, the MA organization's performance and contract compliance deficiencies in a manner specified by CMS.
( h ) *Provision of specific information.* Each MA organization must have mechanisms for providing specific information on a timely basis to current and prospective enrollees upon request. These mechanisms must include all of the following: ( 1 ) A toll-free customer service call center that meets all of the following: ( i ) ( A ) Is open during usual business hours.
( B ) For coverage beginning on and after January 1, 2022, is open at least from 8:00 a.m. to 8:00 p.m. in all service areas served by the Part C plan, with the following exceptions: ( 1 ) From October 1 through March 31 of the following year, a customer call center may be closed on Thanksgiving Day and Christmas Day so long as the interactive voice response (IVR) system or similar technology records messages from incoming callers and such messages are returned within one (1) business day.
( 2 ) From April 1 through September 30, a customer call center may be closed any Federal holiday, Saturday, or Sunday, so long as the interactive voice response (IVR) system or similar technology records messages from incoming callers and such messages are returned within one (1) business day.
( ii ) Provides customer telephone service in accordance with standard business practices. ( A ) For coverage beginning on and after January 1, 2022, limits average hold time to no longer than 2 minutes. The hold time is defined as the time spent on hold by callers following the interactive voice response (IVR) system, touch-tone response system, or recorded greeting, before reaching a live person.
( B ) For coverage beginning on and after January 1, 2022, answers 80 percent of incoming calls within 30 seconds after the interactive voice response (IVR), touch-tone response system, or recorded greeting interaction.
( C ) For coverage beginning on and after January 1, 2022, limits the disconnect rate of all incoming calls to no higher than 5 percent. The disconnect rate is defined as the number of calls unexpectedly dropped divided by the total number of calls made to the customer call center.
( iii ) ( A ) Provides interpreters for non-English speaking and limited English proficient (LEP) individuals.
( B ) For coverage beginning on and after January 1, 2022, interpreters must be available for 80 percent of incoming calls requiring an interpreter within 8 minutes of reaching the customer service representative and be made available at no cost to the caller.
( iv ) At a minimum, for coverage beginning on and after January 1, 2022: ( A ) Provides effective real-time communication with individuals using auxiliary aids and services, including TTYs and all forms of Federal Communication Commission-approved telecommunications relay systems, when using automated-attendant systems. See 28 CFR 35.161 and 36.303(d).
( B ) Establishes contact with a customer service representative within 7 minutes on no fewer than 80 percent of incoming calls requiring TTY services.
( 2 ) An Internet Web site that includes, at a minimum the following: ( i ) The information required in paragraph (b) of this section.
( ii ) Copies of its evidence of coverage and information (names, addresses, phone numbers, and specialty) on the network of contracted providers. Posting does not relieve the MA organization of its responsibility under paragraph (a) of this section to provide hard copies to enrollees upon request.
( iii ) Posting does not relieve the MA organization of its responsibility under paragraph (a) of this section to provide hard copies of the Summary of Benefits to enrollees when CMS determines hard copy delivery of the Summary of Benefits is in the best interest of the beneficiary.
( 3 ) The provision of information in writing, upon request.
( i ) *Provision of information required for access to covered services.* MA plans must issue and reissue (as appropriate) member identification cards that enrollees may use to access covered services under the plan. The cards must comply with standards established by CMS.
( j ) *Safe disposal of certain prescription drugs.* Information regarding the safe disposal of prescription drugs that are controlled substances and drug takeback programs must be provided in the case of an individual enrolled under an MA plan who is furnished an in-home health risk assessment on or after January 1, 2022. For purposes of this paragraph (j), a health risk assessment furnished to an individual who is residing in an institutional setting, such as a nursing facility, that has the primary responsibility for the disposal of unused medications, is not considered an in-home health risk assessment. As part of the in-home health risk assessment, the enrollee must be furnished written supporting materials describing how to safely dispose of medications that are controlled substances as well as a verbal summary of the written information as described at paragraphs (j)(1) through (6) of this section when possible. The written information furnished to enrollees about the safe disposal of medications and takeback programs must include the following information for enrollees: ( 1 ) Unused medications should be disposed of as soon as possible.
( 2 ) The U.S. Drug Enforcement Administration (DEA) allows unused prescription medications to be mailed back to pharmacies and other authorized sites using packages made available at such pharmacies or other authorized sites. Include a web link to the information available on the DEA website at *www.deatakeback.com* and the web link to the DEA search engine which enables beneficiaries to identify drug take back sites in their community at the following web address: *https://apps2.deadiversion.usdoj.gov/pubdispsearch/spring/main?execution=e2s1 .*
( 3 ) Community take back sites are the preferred method of disposing of unused controlled substances.
( 4 ) The location of two or more drug take back sites that are available in the community where the enrollee resides.
( 5 ) Instructions on how to safely dispose of medications in household trash or of cases when a medication can be safely flushed. Include instructions on removing personal identification information when disposing of prescription containers. If applicable, the instructions may also include information on the availability of in-home drug deactivation kits in the enrollee's community.
( 6 ) Include a web link to the information available on the United States Department of Health and Human Services website identifying methods for the safe disposal of drugs available at the following web address: *www.hhs.gov/opioids/prevention/safely-dispose-drugs/index.html*
( k ) *Claims information.* MA organizations must furnish directly to enrollees, in the manner specified by CMS and in a form easily understandable to such enrollees, a written explanation of benefits, when benefits are provided under this part. ( 1 ) *Information requirements for the reporting period.* Claims data elements presented on the explanation of benefits must include all of the following for the reporting period: ( i ) The descriptor and billing code for the item or service billed by the provider, and the corresponding amount billed.
( ii ) The total cost approved by the plan for reimbursement.
( iii ) The share of total cost paid for by the plan.
( iv ) The share of total cost for which the enrollee is liable.
( 2 ) *Information requirements for year-to-date totals.* Claims data elements presented on the explanation of benefits must include specific year-to-date totals as follows: ( i ) The cumulative amount billed by all providers.
( ii ) The cumulative total costs approved by the plan.
( iii ) The cumulative share of total cost paid for by the plan.
( iv ) The cumulative share of total cost for which the enrollee is liable.
( v ) The amount an enrollee has incurred toward the MOOP limit, as applicable.
( vi ) The amount an enrollee has incurred toward the deductible, as applicable.
( 3 ) *Additional information requirements.* ( i ) Each explanation of benefits must include clear contact information for enrollee customer service.
( ii ) Each explanation of benefits must include instructions on how to report fraud.
( iii ) Each EOB that includes a denied claim must clearly identify the denied claim and provide information about enrollee appeal rights, but the EOB does not replace the notice required by §§ 422.568 and 422.570.
( 4 ) *Reporting cycles for explanation of benefits.* MA organizations must send an explanation of benefits on either a monthly cycle or a quarterly cycle with per-claim notifications. ( i ) A monthly explanation of benefits must include all claims processed in the prior month and, for each claim, the information in paragraphs (k)(1) and (2) of this section as of the last day of the prior month. ( A ) The monthly explanation of benefits must be sent before the end of each month that follows the month a claim was filed.
( B ) [Reserved]
( ii ) A quarterly explanation of benefits must include all claims processed in the quarter and, for each claim, the information in paragraphs (k)(1) and (2) of this section as of the last day of the quarter; a per-claim notification must include all claims processed in the prior month and, for each claim, the information specified in paragraph (k)(1) of this section as of the last day of the prior month. ( A ) MA organizations that send the explanation of benefits on a quarterly cycle with per-claim notifications must send the quarterly explanation of benefits before the end of each month that follows the quarter in which a claim was filed.
( B ) MA organizations that send the explanation of benefits on a quarterly cycle with per-claim notifications must send the per-claim notification before the end of each month that follows the month in which a claim was filed.
( 5 ) *Exceptions.* MA organizations are not required to send the explanation of benefits to dual-eligible enrollees.
( l ) *Mid-year notice of unused supplemental benefits.* Beginning January 1, 2026, MA organizations must send notification annually, no sooner than June 30 and no later than July 31, to each enrollee with unused supplemental benefits consistent with the requirements of § 422.2267(e)(42).
[63 FR 35077, June 26, 1998, as amended at 64 FR 7980, Feb. 17, 1999; 65 FR 40321, June 29, 2000; 68 FR 50857, Aug. 22, 2003; 70 FR 4722, Jan. 28, 2005; 70 FR 52026, Sept. 1, 2005; 73 FR 54220, 54249, Sept. 18, 2008; 75 FR 19805, Apr. 15, 2010; 76 FR 21563, Apr. 15, 2011; 77 FR 22167, Apr. 12, 2012; 80 FR 7959, Feb. 12, 2015; 83 FR 16724, Apr. 16, 2018; 84 FR 15828, Apr. 16, 2019; 86 FR 6095, Jan. 19, 2021; 88 FR 22329, Apr. 12, 2023; 89 FR 30818, Apr. 23, 2024]