Medicare Plus Choice (M+C): Interim Final Rule
Subpart C–Benefits and Beneficiary Protections
Sec. 422.100 General requirements.
(a) Basic rule. Subject to the
conditions and limitations set forth in this subpart, an M+C
organization offering an M+C plan must provide enrollees in that plan
with coverage of the basic benefits described in Sec. 422.101 (and,
to the extent applicable, the benefits described in Sec. 422.102) by
furnishing the benefits directly or through arrangements, or by
paying for the benefits. HCFA reviews these benefits subject to the
requirements of Sec. 422.100(g) and the requirements in subpart G of
(b) Services of noncontracting providers and
suppliers. (1) An M+C organization must make timely and
reasonable payment to or on behalf of the plan enrollee for the
following services obtained from a provider or supplier that does not
contract with the M+C organization to provide services covered by the
M+C plan: (i) Emergency services as defined in Sec. 422.2. (ii)
Urgently needed services as defined Sec. 422.2. (iii) Renal dialysis
services provided while the enrollee was temporarily outside the
plan’s service area. (iv) Post-stabilization care services that
were– (A) Pre-approved by the organization; or (B) Were not
pre-approved by the organization because the organization did not
respond to the provider of post-stabilization care services’ request
for pre-approval within 1 hour after being requested to approve such
care, or could not be contacted for pre-approval. (v) Services for
which coverage has been denied by the M+C organization and found
(upon appeal under subpart M of this part) to be services the
enrollee was entitled to have furnished, or paid for, by the M+C
organization. (2) An M+C plan (other than an M+C MSA plan) offered by
an M+C organization satisfies paragraph (a) of this section with
respect to benefits for services furnished by a noncontracting
provider if that M+C plan provides payment in an amount the provider
would have received under original Medicare (including balance
billing permitted under Medicare Part A and Part B).
(c) Types of benefits. An M+C plan
may include two types of benefits: (1) Basic benefits as defined in
Sec. 422.2. (2) Supplemental benefits, which consist of– (i)
Mandatory supplemental benefits as defined in Sec. 422.2; and (ii)
Optional supplemental benefits as defined in Sec. 422.2.
(d) Availability and structure of plans.
An M+C organization offering an M+C plan must offer it– (1)
To all Medicare beneficiaries residing in the service area of the M+C
plan; (2) At a uniform premium; and (3) With a uniform level of
cost-sharing, as defined in Sec. 422.2.
(e) Terms of M+C plans. Terms of M+C
plans described in instructions to beneficiaries, as required by Sec.
422.111, will include basic and supplemental benefits and terms of
coverage for those benefits.
(f) Multiple plans in one service area.
An M+C organization may offer more than one M+C plan in the
same service area subject to the conditions and limitations set forth
in this subpart for each M+C plan.
(g) HCFA review and approval of M+C plans.
HCFA reviews and approves each M+C plan to ensure that the
plan does not– (1) Promote discrimination; (2) Discourage
enrollment; (3) Steer specific subsets of Medicare beneficiaries to
particular M+C plans; or (4) Inhibit access to services.
(h) Benefits affecting screening
mammography, influenza vaccine, and pneumococcal vaccine. (1)
Enrollees of M+C organizations may directly access (through
self-referral) screening mammography and influenza vaccine. (2) M+C
organizations may not impose cost-sharing for influenza vaccine and
pneumococcal vaccine. (i) Requirements relating to Medicare
conditions of participation. Basic benefits must be provided through
providers meeting the requirements in Sec. 422.204(a)(3).
(j) Choice of practitioners.
Consistent with the requirements of Sec. 422.204 relating to the
prohibition of discrimination against providers, if more than one
type of practitioner is qualified to furnish a particular service,
the M+C organization may select the type of practitioner to be
Sec. 422.101 Requirements relating to basic benefits.
Except as specified in Sec. 422.264 (for entitlement that begins
or ends during a hospital stay) and Sec. 422.266 (with respect to
hospice care), each M+C organization must–
(a) Provide coverage of, through the provision of or payment for,
all services that are covered by Part A and Part B of Medicare (if
the enrollee is entitled to benefits under both parts) or by Medicare
Part B (if entitled only under Part B) and that are available to
beneficiaries residing in the geographic area in which services are
covered under the M+C plan (or to Part A and Part B services obtained
outside the geographic area if it is common practice to refer
patients to sources outside that geographic area); and
(b) Comply with– (1) HCFA’s national coverage decisions; and (2)
Written coverage decisions of local carriers and intermediaries with
jurisdiction for claims in the geographic area in which services are
covered under the M+C plan.
Sec. 422.102 Supplemental benefits.
(a) Mandatory supplemental benefits.
(1) Subject to HCFA’s approval, an M+C organization may require
Medicare enrollees of an M+C plan other than an MSA plan to accept
and pay for services in addition to those included in the basic
benefits described in Sec. 422.101. (2) If the M+C organization
imposes mandatory supplemental benefits, it must impose them on all
Medicare beneficiaries enrolled in the M+C plan. (3) HCFA approves
mandatory supplemental benefits if it determines that imposition of
the mandatory benefits will not substantially discourage Medicare
beneficiaries from enrolling in the M+C plan.
(b) Optional supplemental benefits.
Except as provided in Sec. 422.104 in the [[Page 35078]] case
of MSA plans, each M+C organization may offer (for election by the
enrollee and without regard to health status) services that are in
addition to those included in the basic benefits described in Sec.
422.101 and any mandatory supplemental benefits described in
paragraph (a) of this section. Optional supplemental benefits must be
offered to all Medicare beneficiaries enrolled in the M+C plan.
Sec. 422.103 Benefits under an M+C MSA plan.
(a) General rule. An M+C organization
offering an M+C MSA plan must make available to an enrollee, or
provide reimbursement for, at least the services described under in
Sec. 422.101 after the enrollee incurs countable expenses equal to
the amount of the plan’s annual deductible.
(b) Countable expenses. An M+C
organization offering an M+C MSA plan must count toward the annual
deductible at least all amounts that would be paid for the particular
service under original Medicare, including amounts that would be paid
by the enrollee as deductibles or coinsurance.
(c) Services after the deductible.
For services received by the enrollee after the annual
deductible is satisfied, an M+C organization offering an M+C MSA plan
must pay, at a minimum, the lesser of the following amounts: (1) 100
percent of the expense of the services. (2) 100 percent of the
amounts that would have been paid for the services under original
Medicare, including amounts that would be paid by the enrollee as
deductibles and coinsurance.
(d) Annual deductible. The annual
deductible for an M+C MSA plan– (1) For contract year 1999, may not
exceed $6,000; and (2) For subsequent contract years may not exceed
the deductible for the preceding contract year, increased by the
national per capita growth percentage determined under Sec.
Sec. 422.104 Special rules on supplemental benefits for M+C MSA
(a) An M+C organization offering an M+C MSA plan may not provide
supplemental benefits that cover expenses that count towards the
deductible specified in Sec. 422.103(d).
(b) In applying the limitation of paragraph (a) of this section,
the following kinds of policies are not considered as covering the
deductible: (1) A policy that provides coverage (whether through
insurance or otherwise) for accidents, disability, dental care,
vision care, or long-term care. (2) A policy of insurance in which
substantially all of the coverage relates to liabilities incurred
under workers’ compensation laws, tort liabilities, liabilities
relating to use or ownership of property, and any other similar
liabilities that HCFA may specify by regulation. (3) A policy of
insurance that provides coverage for a specified disease or illness
or pays a fixed amount per day (or other period) of
Sec. 422.105 Special rules for point of service option.
(a) A POS benefit is an option that an M+C
organization may offer in an M+C coordinated care plan or
network M+C MSA plan to provide enrollees with additional choice in
obtaining specified health care services from individuals or entities
that do not have a contract with the M+C organization to provide
service through the M+C coordinated care plan or network M+C MSA plan
offering the POS option. The plan may offer a POS option– (1) Under
a coordinated care plan only as an additional benefit as described in
Sec. 422.312; (2) Under a coordinated care plan only as a mandatory
supplemental benefit as described in Sec. 422.102(a); or (3) Under a
coordinated care plan or network MSA plan as an optional supplemental
benefit as described in Sec. 422.102(b).
(b) Approval required. An M+C
organization may not implement a POS benefit until it has been
approved by HCFA.
(c) Ensuring availability and continuity of
care. An M+C network plan that includes a POS benefit must
continue to provide all benefits and ensure access as required under
(d) Enrollee information and disclosure.
The disclosure requirements specified in Sec. 422.111 apply in
addition to the following requirements: (1) Written rules. M+C
organizations must maintain written rules on how to obtain health
benefits through the POS benefit. (2) Evidence of coverage document.
The M+C organization must provide to beneficiaries enrolling in a
plan with a POS benefit an “evidence of coverage” document, or
otherwise provide written documentation, that specifies all costs and
possible financial risks to the enrollee, including– (i) Any
premiums and cost-sharing for which the enrollee is responsible; (ii)
Annual limits on benefits and on out-of-pocket expenditures; (iii)
Potential financial responsibility for services for which the plan
denies payment because they were not covered under the POS benefit,
or exceeded the dollar limit for the benefit; and (iv) The annual
maximum out-of-pocket expense an enrollee could incur.
(e) Prompt payment. Health benefits payable under the POS benefit
are subject to the prompt payment requirements in Sec. 422.520.
Sec. 422.106 Special arrangements with employer groups.
An M+C organization may negotiate with an employer group to
provide benefits to members of the employer group who are enrolled in
an M+C plan offered by the organization. While these negotiated
employer group benefits may be designed to complement the benefits
available to Medicare beneficiaries enrolled in the M+C plan, they
are offered by the employer group independently as the product of
private negotiation. Examples of such employer-benefits include the
(a) Reductions in the portion of the premium that the M+C
organization charges to the beneficiary.
(b) Reductions in portion of other cost sharing amounts the M+C
organization charges to the beneficiary.
Sec. 422.108 Medicare secondary payer (MSP) procedures.
(a) Basic rule. HCFA does not pay for
services to the extent that Medicare is not the primary payer under
section 1862(b) of the Act and part 411 of this chapter.
(b) Responsibilities of the M+C
organization. The M+C organization must, for each M+C plan–
(1) Identify payers that are primary to Medicare under section
1862(b) of the Act and part 411 of this chapter; (2) Determine the
amounts payable by those payers; and (3) Coordinate its benefits to
Medicare enrollees with the benefits of the primary payers.
(c) Charges to other entities. The
M+C organization may charge, or authorize a provider to charge, other
individuals or entities for covered Medicare services [[Page 35079]]
for which Medicare is not the primary payer, as specified in
paragraphs (d) and (e) of this section.
(d) Charge to other insurers or the
enrollee. If a Medicare enrollee receives from an M+C
organization covered services that are also covered under State or
Federal workers’ compensation, any no-fault insurance, or any
liability insurance policy or plan, including a self- insured plan,
the M+C organization may charge, or authorize a provider to charge
any of the following– (1) The insurance carrier, the employer, or
any other entity that is liable for payment for the services under
section 1862(b) of the Act and part 411 of this chapter. (2) The
Medicare enrollee, to the extent that he or she has been paid by the
carrier, employer, or entity for covered medical expenses.
(e) Charge to group health plans (GHPs) and
large group health plans (LGHPs). An M+C organization may
charge a GHP or LGHP for services it furnishes to a Medicare enrollee
who is also covered under the GHP or LGHP and may charge the Medicare
enrollee to the extent that he or she has been paid by the GHP or
Sec. 422.109 Effect of national coverage determinations
(a) If HCFA determines and announces that an
NCD meets the criteria for “significant cost” described in
paragraph (c) of this section, an M+C organization is not required to
assume risk for the costs of that service until the contract year for
which the annual M+C capitation rate is determined on a basis that
includes the cost of the NCD service.
(b) The M+C organization must furnish,
arrange or pay for an NCD “significant cost” service prior to
the adjustment of the annual M+C capitation rate. The following rules
apply to such services: (1) Medicare payment for the service is: (i)
In addition to the capitation payment to the M+C organization; and
(ii) Made directly by the fiscal intermediary and carrier to the M+C
organization in accordance with original Medicare payment rules,
methods, and requirements. (2) NCD costs for which HCFA
intermediaries and carriers will not make payment and are the
responsibility of the M+C organization are– (i) Services necessary
to diagnose a condition covered by the NCD; (ii) Most services
furnished as follow-up care to the NCD service; (iii) Any service
that is already a Medicare-covered service and included in the annual
M+C capitation rate; and (iv) Any service, including the costs of the
NCD service itself, to the extent the M+C organization is already
obligated to cover it as an additional benefit under Sec. 422.312 or
supplemental benefit under Sec. 422.102. (3) NCD costs for which HCFA
intermediaries and carriers make payment are– (i) Costs relating
directly to the provision of services related to the NCD that were
noncovered services prior to the issuance of the NCD; and (ii) A
service that is not included in the M+C per capita payment rate. (4)
If the M+C organization does not provide or arrange for the service
consistent with HCFA’s NCD, enrollees may obtain the services through
qualified providers not under contract to the M+C organization, and
the organization will pay for the services consistent with Sec.
422.109(c). (5) Beneficiaries are liable for Part A deductible and
any applicable coinsurance amounts.
(c) The term “significant cost” as it
relates to a particular NCD means either of the following: (1) The
average cost of furnishing a single service exceeds a cost threshold
that– (i) For calendar years 1998 and 1999, is $100,000; (ii) For
calendar year 2000 and subsequent calendar years, is the preceding
year’s dollar threshold adjusted to reflect the national per capita
growth percentage described in Sec. 422.254(b). (2) The estimated
cost of all of Medicare services furnished nationwide as a result of
a particular NCD represents at least 0.1 percent of the national
standardized annual capitation rate (see Sec. 422.254(f)), multiplied
by the total number of Medicare beneficiaries nationwide for the
applicable calendar year.
Sec. 422.110 Discrimination against beneficiaries
(a) General prohibition. Except as
provided in paragraph (b) of this section, an M+C organization may
not deny, limit, or condition the coverage or furnishing of benefits
to individuals eligible to enroll in an M+C plan offered by the
organization on the basis of any factor that is related to health
status, including, but not limited to the following: (1) Medical
condition, including mental as well as physical illness. (2) Claims
experience. (3) Receipt of health care. (4) Medical history. (5)
Genetic information. (6) Evidence of insurability, including
conditions arising out of acts of domestic violence. (7) Disability.
(b) Exception. An M+C organization
may not enroll an individual who has been medically determined to
have end-stage renal disease. However, an enrollee who develops
end-stage renal disease while enrolled in a particular M+C
organization may not be disenrolled for that reason. An individual
who is an enrollee of a particular M+C organization, and resides in
the M+C plan service area at the time he or she first becomes M+C
eligible, is considered to be “enrolled” in the M+C organization for
purposes of the preceding sentence.
Sec. 422.111 Disclosure requirements.
(a) Detailed description of plan provisions.
An M+C organization must disclose the information specified in
Sec. 422.64 and in paragraph (b) of this section– (1) To each
enrollee electing an M+C plan it offers; (2) In clear, accurate, and
standardized form; and (3) At the time of enrollment and at least
(b) Content of plan description. The
description must include the following information: (1) Service area.
The M+C plan’s service area and any enrollment continuation area. (2)
Benefits. The benefits offered under the 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 for purposes of
comparison– (i) The benefits offered under original Medicare,
including the content specified in Sec. 422.64(c); (ii) For an M+C
MSA plan, the benefits under other types of M+C plans; and (iii) The
availability of the Medicare hospice option and any approved hospices
in the service area, including those the M+C organization owns,
controls, or has a financial interest in. (3) Access. The number,
mix, and distribution (addresses) of providers from whom enrollees
may obtain services; any out-of network coverage; any
point-of-service option, including the supplemental premium for that
[[Page 35080]] option; and how the M+C organization meets the
requirements of Secs. 422.112 and 422.114 for access to services
offered under the plan. (4) Out-of-area coverage. Out-of-area
coverage provided by the plan. (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 Sec. 422.2; (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 M+C 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 M+C 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 M+C organization for processing and determination of
enrollee liability, if any. (8) Grievance and appeals procedures. All
grievance and appeals rights and procedures. (9) Quality assurance
program. A description of the quality assurance program required
under Sec. 422.152. (10) Disenrollment rights and responsibilities.
(c) Disclosure upon request. Upon
request of an individual eligible to elect an M+C plan, an M+C
organization must provide to the individual the following
information: (1) The information required under Sec. 422.64(c). (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 Sec. 422.564; and (ii) Appeals according to Sec. 422.578
et. seq. (4) A summary description of the method of compensation for
physicians. (5) Financial condition of the M+C organization,
including the most recently audited information regarding, at least,
a description of the financial condition of the M+C organization
offering the plan.
(d) Changes in rules. If an M+C
organization intends to change its rules for an M+C plan, it must–
(1) Submit the changes for HCFA review under the procedures of Sec.
422.80; and (2) Give notice to all enrollees 30 days before the
intended effective date of the changes.
(e) Changes to provider network. The
M+C organization must make a good faith effort to provide written
notice of a termination of a contracted provider within 15 working
days of receipt or issuance of a notice of termination, as described
in Sec. 422.204(c)(4), to all enrollees who are patients seen on a
regular basis by the provider whose contract is terminating,
irrespective of whether the termination was for cause or without
cause. When a contract termination involves a primary care
professional, all enrollees who are patients of that primary care
professional must also be notified.
Sec. 422.112 Access to services.
(a) Rules for coordinated care plans and
network M+C MSA plans. An M+C organization that offers an M+C
coordinated care plan or network M+C MSA plan may specify the
networks of providers from whom enrollees may obtain services if the
following conditions are met: (1) The M+C organization ensures that
all covered services, including additional or supplemental services
contracted for by (or on behalf of) the Medicare enrollee, are
available and accessible under the plan. To do this, the M+C
organization must do the following: (i) Maintain and monitor a
network of appropriate providers that is supported by written
agreements and is sufficient to provide adequate access to covered
services to meet the needs of the population served. These providers
are typically utilized in the network as primary care providers
(PCPs), specialists, hospitals, skilled nursing facilities, home
health agencies, ambulatory clinics, and other providers. (ii) Select
the panel of PCPs from which the enrollee selects a PCP. (iii)
Provide or arrange for necessary specialty care, and in particular–
(A) Women enrollees may choose direct access to a women’s health
specialist within the network for women’s routine and preventive
health care services provided as basic benefits (as defined in Sec.
422.2) while the plan maintains a PCP or some other means for
continuity of care; and (B) Plans must have procedures approved by
HCFA for– (1) Identification of individuals with complex or serious
medical conditions; (2) Assessment of those conditions, including
medical procedures to diagnose and monitor them on an ongoing basis;
and (3) Establishment and implementation of a treatment plan
appropriate to those conditions, with an adequate number of direct
access visits to specialists to accommodate the treatment plan.
Treatment plans must be time-specific and updated periodically by the
PCP. (2) In the case of involuntary termination of an M+C plan or
specialist(s) for a reason other than for cause, the M+C organization
must do the following: (i) Inform beneficiaries, at the time of
termination, of their right to maintain access to specialists. (ii)
Provide the names of other M+C plans in the area that contract with
specialists of the beneficiary’s choice, as well as an explanation of
the process the beneficiary would need to follow should he or she
decide to return to original Medicare. (iii) If seeking a service
area expansion for an M+C plan, demonstrate that the number and type
of providers available to plan enrollees are sufficient to meet
projected needs of the population to be served. (iv) Demonstrate to
HCFA that its providers in an M+C plan are credentialed through the
process set forth at Sec. 422.204(a). (v) Establish written standards
for– (A) Timeliness of access to care and member services that meet
or exceed standards established by HCFA. Timely access to care and
member services within a plan’s provider network must be continuously
monitored to ensure compliance with these standards, and the M+C
organization must take corrective action as necessary; (B) Policies
and procedures (coverage rules, practice guidelines, payment
policies, and utilization management) that allow for individual
medical necessity determinations; and (C) Provider consideration of
beneficiary input into the provider’s proposed treatment plan. (vi)
Ensure that the hours of operation of its M+C plan providers are
convenient to the population served by the plan and do not
discriminate against Medicare enrollees. (vii) Ensure services are
provided in a culturally competent manner to all enrollees, including
those with limited [[Page 35081]] English proficiency or reading
skills, diverse cultural and ethnic backgrounds, and physical or
mental disabilities. (viii) Make plan services available 24 hours a
day, 7 days a week, when medically necessary. (ix) Provide coverage
for emergency and urgent care services in accordance with paragraph
(b) of this section. (3) The M+C organization must ensure continuity
of care and integration of services through arrangements that
include, but are not limited to– (i) Use of a practitioner who is
specifically designated as having primary responsibility for
coordinating the enrollee’s overall health care; (ii) Policies that
specify whether services are coordinated by the enrollee’s primary
care practitioner or through some other means; (iii) An ongoing
source of primary care, regardless of the mechanism adopted for
coordination of services; (iv) Programs for coordination of care that
coordinate services with community and social services generally
available through contracting or noncontracting providers in the area
served by the M+C plan, including nursing home and community-based
services; (v) Procedures to ensure that the M+C organization and its
provider network have the information required for effective and
continuous patient care and quality review, including procedures to
ensure that– (A) An initial assessment of each enrollee’s health
care needs is completed within 90 days of the effective date of
enrollment. (B) Each provider, supplier, and practitioner furnishing
services to enrollees maintains an enrollee health record in
accordance with standards established by the M+C organization, taking
into account professional standards; and (C) Appropriate and
confidential exchange of information among provider network
components; (vi) Procedures to ensure that enrollees are informed of
specific health care needs that require follow-up and receive, as
appropriate, training in self-care and other measures they may take
to promote their own health; and (vii) Systems to address barriers to
enrollee compliance with prescribed treatments or regimens.
(b) Special rules for all M+C organizations
for emergency and urgently needed services. (1) The M+C
organization covers emergency and urgently needed services– (i)
Regardless of whether the services are obtained within or outside the
organization; and (ii) Without required prior authorization. (2) The
M+C organization may not deny payment for a condition that– (i) Is
an emergency medical condition as defined in Sec. 422.2; or (ii) A
plan provider or other M+C organization representative instructs an
enrollee to seek emergency services within or outside the plan. (3)
The physician treating the enrollee must decide when the enrollee may
be considered stabilized for transfer or discharge, and that decision
is binding on the M+C organization. (4) For emergency services
obtained outside the M+C plan’s provider network, the organization
may not charge the enrollee more than $50 or what it would charge the
enrollee if he or she obtained the services through the organization,
whichever is less.
Sec. 422.114 Access to services under an M+C private
(a) Sufficient access. (1) An M+C
organization that offers an M+C private fee-for-service plan must
demonstrate to HCFA that it has sufficient number and range of
providers willing to furnish services under the plan. (2) HCFA finds
that an M+C organization meets the requirement in paragraph (a)(1) of
this section if, with respect to a particular category of health care
providers, the M+C organization has– (i) Payment rates that are not
less than the rates that apply under original Medicare for the
provider in question; (ii) Contracts or agreements with a sufficient
number and range of providers to furnish the services covered under
the M+C private fee- for-service plan; or (iii) A combination of
paragraphs (a)(2)(i) and (a)(2)(ii) of this section.
(b) Freedom of choice. M+C
fee-for-service plans must permit enrollees to obtain services from
any entity that is authorized to provide services under Medicare Part
A and Part B and agrees to provide services under the terms of the
Sec. 422.118 Confidentiality and accuracy of enrollee
For any medical records or other health and enrollment information
it maintains with respect to enrollees, an M+C organization must
establish procedures to do the following:
(a) Safeguard the privacy of any information
that identifies a particular enrollee. Information from, or
copies of, records may be released only to authorized individuals,
and the M+C organization must ensure that unauthorized individuals
cannot gain access to or alter patient records. Original medical
records must be released only in accordance with Federal or State
laws, court orders, or subpoenas.
(b) Maintain the records and
information in an accurate and timely manner.
(c) Ensure timely access by enrollees
to the records and information that pertain to them.
Sec. 422.128 Information on advance directives.
(a) Each M+C organization must maintain
written policies and procedures that meet the requirements for
advance directives, as set forth in subpart I of part 489 of
this chapter. For purposes of this part, advance directive has the
meaning given the term in Sec. 489.100 of this chapter.
(b) An M+C organization must maintain
written policies and procedures concerning advance directives
with respect to all adult individuals receiving medical care by or
through the M+C organization. (1) An M+C organization must provide
written information to those individuals with respect to the
following: (i) Their rights under the law of the State in which the
organization furnishes services (whether statutory or recognized by
the courts of the State) to make decisions concerning their medical
care, including the right to accept or refuse medical or surgical
treatment and the right to formulate advance directives. Providers
may contract with other entities to furnish this information but
remain legally responsible for ensuring that the requirements of this
section are met. The information must reflect changes in State law as
soon as possible, but no later than 90 days after the effective date
of the State law. (ii) The M+C organization’s written policies
respecting the implementation of those rights, including a clear and
precise statement of limitation if the M+C organization cannot
implement an advance directive as a matter of conscience. At a
minimum, this statement must do the following: (A) Clarify any
differences between institution-wide conscientious objections and
those that may be raised by individual physicians. [[Page 35082]] (B)
Identify the state legal authority permitting such objection. (C)
Describe the range of medical conditions or procedures affected by
the conscience objection. (D) Provide the information specified in
paragraph (a)(1) of this section to each enrollee at the time of
initial enrollment. If an enrollee is incapacitated at the time of
initial enrollment and is unable to receive information (due to the
incapacitating condition or a mental disorder) or articulate whether
or not he or she has executed an advance directive, the M+C
organization may give advance directive information to the enrollee’s
family or surrogate in the same manner that it issues other materials
about policies and procedures to the family of the incapacitated
enrollee or to a surrogate or other concerned persons in accordance
with State law. The M+C organization is not relieved of its
obligation to provide this information to the enrollee once he or she
is no longer incapacitated or unable to receive such information.
Follow-up procedures must be in place to ensure that the information
is given to the individual directly at the appropriate time. (E)
Document in a prominent part of the individual’s current medical
record whether or not the individual has executed an advance
directive. (F) Not condition the provision of care or otherwise
discriminate against an individual based on whether or not the
individual has executed an advance directive. (G) Ensure compliance
with requirements of State law (whether statutory or recognized by
the courts of the State) regarding advance directives. (H) Provide
for education of staff concerning its policies and procedures on
advance directives. (I) Provide for community education regarding
advance directives that may include material required in paragraph
(a)(1)(i) of this section, either directly or in concert with other
providers or entities. Separate community education materials may be
developed and used, at the discretion of the M+C organization. The
same written materials are not required for all settings, but the
material should define what constitutes an advance directive,
emphasizing that an advance directive is designed to enhance an
incapacitated individual’s control over medical treatment, and
describe applicable State law concerning advance directives. An M+C
organization must be able to document its community education
efforts. (2) The M+C organization– (i) Is not required to provide
care that conflicts with an advance directive; and (ii) Is not
required to implement an advance directive if, as a matter of
conscience, the M+C organization cannot implement an advance
directive and State law allows any health care provider or any agent
of the provider to conscientiously object. (3) The M+C organization
must inform individuals that complaints concerning noncompliance with
the advance directive requirements may be filed with the State survey
and certification agency.
Sec. 422.132 Protection against liability and loss of
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