CMS SOM App. W, Tag C-0812

The CAH is in compliance with applicable Federal laws and regulations related to

the health and safety of patients.

Interpretive Guidelines §485.608(a)

Each CAH must be in compliance with applicable Federal laws and regulations related to

the health and safety of patients. This includes other Medicare regulations and Federal

laws and regulations not specifically addressed in the CoPs. State Survey Agencies are

expected to assess the CAH’s compliance with the following Medicare provider

agreement regulation provisions when surveying for compliance with §485.608(a):

Advance Directives

An advance directive is defined at 42 CFR 489.100 as “a written instruction, such as a

living will or durable power of attorney for health care, recognized under State law

(whether statutory or as recognized by the courts of the State), relating to the provision of

health care when the individual is incapacitated.” In accordance with the provisions of

42 CFR 489.102(a), the advance directives regulations apply to CAHs. The CAH patient

(inpatient or outpatient) has the right to formulate advance directives, and to have CAH

staff implement and comply with the individual’s advance directive. The regulation at 42

CFR 489.102 specifies the rights of a patient (as permitted by State law) to make medical

care decisions, including the right to accept or refuse medical or surgical treatment and

the right to formulate, at the individual’s option, advance directives.

In the advance directive, the patient may provide guidance as to his/her wishes

concerning provision of care in certain situations; alternatively, the patient may delegate

decision-making authority to another individual, as permitted by State law. (In addition,

the patient may use the advance directive to designate a “support person,” as specified in

§485.635(f), for purposes of exercising the patient’s visitation rights.) When a patient

who is incapacitated has executed an advance directive designating a particular individual

to make medical decisions for him/her when incapacitated, the CAH must, when

presented with the document, provide the designated individual the information required

to make informed decisions about the patient’s care. The CAH must also seek the

consent of the patient’s representative when informed consent is required for a care

decision. The explicit designation of a representative in the patient’s advance directive

takes precedence over any non-designated relationship and continues throughout the

patient’s inpatient stay or, as applicable, outpatient visit, unless the patient ceases to be

incapacitated and expressly withdraws the designation, either orally or in writing.

§489.102 also requires the CAH to:

• Provide written notice of its policies regarding the implementation of patients’

rights to make decisions concerning medical care, such as the right to formulate

advance directives. If an individual is incapacitated or otherwise unable to

communicate, the CAH may provide the advance directive information required

under §489.100 to the individual’s “family or surrogate in the same manner that it

issues other materials about policies and procedures to the family of the

incapacitated individual or to a surrogate or other concerned persons in accordance

with State law.” (§489.102(e)) §489.102(b)(1) requires that notice of the CAH’s

advance directive policy be provided at the time an individual is admitted as an

inpatient. However, the CAH should also consider providing the advance directive

notice at the time of registration, to outpatients (or their representatives) who are in

the emergency department, who are in an observation status, or who are undergoing

same-day surgery.

• The notice must include a clear and precise statement of limitation if the CAH

cannot implement an advance directive on the basis of conscience. At a minimum, a

statement of limitation should:

• Clarify any differences between institution-wide conscience objections and

those that may be raised by individual physicians or other practitioners;

• Identify the State legal authority permitting such an objection; and

• Describe the range of medical conditions or procedures affected by the

conscience objection.

It should be noted that this provision allowing for certain conscience objections

to implementing an advance directive is narrowly focused on the directive’s

content related to medical conditions or procedures. This provision would not

allow a CAH or individual physician or practitioner to refuse to honor those

portions of an advance directive that designate an individual as the patient’s

representative and/or support person, given that such designation does not

concern a medical condition or procedure.

Issuance of the written notice of the CAH’s advance directive policies to the

patient or the patient’s representative must be documented in the patient’s

medical record.

• Document in a prominent part of the patient’s medical record whether or not the

patient has executed an advance directive;

• Not condition the provision of care or otherwise discriminate against an

individual based on whether or not the individual has executed an advance

directive;

• Assure compliance with requirements of State law concerning advance directives

and inform individuals that complaints concerning the advance directive

requirements may be filed with the State survey and certification agency;

• Provide for the education of staff concerning its policies and procedures on

advance directives. The right to formulate advance directives includes the right to

formulate a psychiatric advance directive (as allowed by State law); and

• Provide community education regarding advance directives and the CAH must

document its efforts.

A psychiatric advance directive is akin to a traditional advance directive for health care.

This type of advance directive might be prepared by an individual who is concerned that

at some time he or she may be subject to involuntary psychiatric commitment or

treatment. The psychiatric advance directive may cover a range of subjects, and may

name another person who is authorized to make decisions for the individual if he or she is

determined to be legally incompetent to make his/her own choices. It may also provide

the patient’s instructions about hospitalization, alternatives to hospitalization, the use of

medications, types of therapies, and the patient’s wishes concerning restraint or seclusion.

The patient may designate who should be notified upon his/her admission to the CAH, as

well as who should not be permitted to visit him or her. State laws regarding the use of

psychiatric advance directives vary.

In accordance with State law, a psychiatric advance directive should be accorded the

same respect and consideration that a traditional advance directive for health care is

given. CAHs should carefully coordinate how the choices of a patient balance with the

rights of other patients, staff, and individuals in the event that a dangerous situation

arises.

However, even if State law has not explicitly spoken to the use of psychiatric advance

directives, consideration should be given to them. When the patient is, for whatever

reason, unable to communicate his/her wishes, the preferences expressed in the

psychiatric advance directive can give critical insight to the CAH’s professional staff as

they develop a plan of care and treatment for the patient.

Required CAH Disclosures to Patients:

Physician Ownership

• 42 CFR 489.3 defines a “physician-owned hospital” as any participating hospital,

including a CAH, in which a physician or immediate family member of a physician

(as defined in §411.351) has an ownership or investment interest in the CAH, except

for those satisfying an exception found at §411.356(a) or (b). Surveyors are not

required to make an independent determination regarding whether a CAH meets the

Medicare definition of “physician-owned,” but they must ask whether the CAH is

physician-owned.

• However, the notice requirement does not apply to any physician-owned CAH that

does not have at least one referring physician (as defined at §411.351 of this chapter)

who has an ownership or investment interest in the CAH or who has an immediate

family member who has an ownership or investment interest in the CAH. In such

cases, the CAH must sign an attestation statement that it has no referring physician

with an ownership or investment interest or whose immediate family member has an

ownership or investment interest in the CAH. The CAH must maintain this

attestation in its records.

• 42 CFR 489.20(u)(1) requires that all physician-owned CAHs provide written notice

to their patients at the beginning of each patient’s CAH inpatient stay or outpatient

visit stating that the CAH is physician-owned, in order to assist the patient in making

an informed decision about his or her care.

• A planned inpatient stay or outpatient visit which is subject to the notice

requirement begins with the provision of a package of information regarding

scheduled preadmission testing and registration for a planned CAH admission for

inpatient care or for an outpatient service subject to notice. An unplanned

inpatient stay or outpatient visit subject to the notice requirement begins at the

earliest point at which the patient presents to the CAH.

• The notice must disclose, in a manner reasonably designed to be understood by all

patients, that the CAH is physician-owned and that a list of owners or investors who

are physicians or immediate family members of physicians is available upon request.

If the patient (or someone on behalf of the patient) requests this list, the CAH must

provide it at the time of the request.

• 42 CFR 489.20(u)(2) provides that physician-owned CAHs must require each

physician owner who is a member of the hospital’s medical staff to agree, as a

condition of obtaining/retaining CAH medical staff membership or admitting

privileges, to disclose in writing to all patients they refer to the CAH their ownership

or investment interest or that of any immediate family member in the CAH. The

CAH must require that this disclosure be made at the time of the referral and the

requirement should be reflected in the hospital’s policies and procedures governing

privileges for physician owners.

• The CAH may exempt from this disclosure requirement any physician owner who

does not refer any patients to the CAH.

• 42 CFR 489.12 permits CMS to refuse to enter into a provider agreement with a

physician-owned CAH applicant that does not have procedures in place to notify

patients of physician ownership in the hospital, as required under §483.20(u).

• 42 CFR 489.53(c) permits CMS to terminate the provider agreement of a physician-owned CAH if the CAH fails to comply with the requirements at §489.20(u).

MD/DO 24/7 On-Site Presence

42 CFR 489.20(w) mandates that if there is no doctor of medicine or osteopathy present

in the CAH 24 hours per day, seven days per week the CAH must provide written notice

to all inpatients at the beginning of a planned or unplanned inpatient stay, and to

outpatients for certain types of outpatient visits. The purpose of the requirement is to

assist the patient in making an informed decision about his/her care. CAHs that have an

MD/DO (including residents who are MDs or DOs) on-site 24/7 do not need to issue any

disclosure notice about emergency services capability.

• The notice must be provided to all inpatients and to those outpatients who are under

observation or who are having surgery or any other procedure using anesthesia.

• The notice must be provided at the beginning of the planned or unplanned inpatient

stay, or applicable outpatient visit.

• A planned inpatient stay or outpatient visit which is subject to the notice requirement

begins with the provision of a package of information regarding scheduled

preadmission testing and registration for a planned CAH admission for inpatient care

or for an outpatient service subject to notice. An unplanned inpatient stay or

outpatient visit subject to the notice requirement begins at the earliest point at which

the patient presents to the CAH.

• Individual notices are not required in the CAH’s dedicated emergency department

(DED) (as that term is defined in 42 CFR 489.24(b)), but the DED must post a notice

conspicuously, in a place or places likely to be noticed by all individuals entering the

dedicated emergency department. The posted notice must state that the CAH does

not have a doctor of medicine or a doctor of osteopathy present in the hospital 24

hours per day, 7 days per week, and must indicate how the CAH will meet the

medical needs of any patient with an emergency medical condition, as defined in 42

CFR 489.24(b) [the EMTALA definition], at a time when there is no doctor of

medicine or doctor of osteopathy present in the CAH. If an emergency department

patient is determined to require admission, then the individual notice provisions of 42

CFR 489.20(w) would apply to that patient.

• Before admitting an inpatient or providing outpatient services requiring notice, the

CAH must obtain a signed acknowledgement from the patient stating that he/she

understands that a doctor of medicine or doctor of osteopathy may not be present

during all hours services are furnished to him/her.

• In the event of an unplanned surgery or inpatient admission to treat an emergency

medical condition, it may in some cases be necessary in the interest of the

patient’s safety to proceed with treatment before the required notice can be given

and acknowledgement can be obtained. In such circumstances the CAH must

provide notice and obtain acknowledgement as soon as possible after the patient’s

stay or visit begins.

• For a CAH that participates in Medicare with multiple campuses providing inpatient

services (e.g., a main provider campus and a separate remote location for a

psychiatric or rehabilitation distinct part unit (DPU)) under one CMS Certification

Number) a separate determination is made for each campus/location with inpatient

services as to whether the disclosure notice is required. For example, if a CAH has a

main campus with 25 inpatient beds and a remote location with 10 psychiatric DPU

beds and 10 rehabilitation DPU beds, and a physician is present 24/7 on the main

campus, but not at the DPU remote location, the CAH is required to provide the

disclosure notice at the DPU location. No notice is required for patients coming to

the main provider campus. In this same example, if the CAH also has a provider-based, off-campus ambulatory surgery department, no notice is required at that off-campus surgery site, since the CAH’s main campus does have an MD/DO present

24/7.

• 42 CFR 489.53(c) permits CMS to terminate a provider agreement with a CAH if the

CAH fails to comply with the requirements at §489.20(w) when it does not have an

MD or DO on-site 24/ 7.

Other Federal Requirements

Other Federal requirements also apply to patient health and safety in the CAH. For

example, Federal laws and regulations govern both the disposal of medical waste and

occupational health. However, surveyors are not expected to be knowledgeable about the

requirements of other Federal agencies and therefore do not assess compliance with non-CMS regulations. A surveyor who suspects a CAH may not be in compliance with other

Federal requirements may refer the matter to the appropriate Federal agency. If CMS is

notified or becomes aware of another Federal agency’s final enforcement action, action

will be taken only if the final enforcement action remains in effect.

Survey Procedures §485.608(a)

Assessing Compliance with Advance Directives Requirements

• Review the CAH’s advance directive notice. Does it advise inpatients or applicable

outpatients, or their representatives, of the patient’s right to formulate an advance

directive and to have CAH staff comply with the advance directive (in accordance

with State law)? Does it include a clear, precise, and valid statement of limitation if

the CAH cannot implement an advance directive on the basis of conscience?

• Review the records of a sample of patients for evidence of CAH compliance with

advance directive notice requirements. Does every inpatient or applicable outpatient

record contain documentation that notice of the CAH’s advance directives policy

was provided at the time of admission or registration? Is there documentation of

whether or not each patient has an advance directive? For those patients who have

reported an advance directive, has a copy of the patient’s advance directive been

placed in the medical record?

• What mechanism does the CAH have in place to allow patients to formulate an

advance directive or to update their current advance directive? Is there evidence that

the CAH is promoting and protecting each patient’s right to formulate an advance

directive?

• Determine to what extent the CAH complies, as permitted under State law, with

patient advance directives that delegate decisions about the patient’s care to a

designated individual.

• Determine to what extent the CAH educates its staff regarding advance directives.

• Interview staff to determine their knowledge of the advance directives of the patients

in their care.

• Determine to what extent the CAH provides education for the patient population

regarding one’s rights under State law to formulate advance directives.

Assessing Required Disclosures

Physician Ownership

• If the CAH indicates that it is physician-owned but is exempt under §489.20(v)

from the disclosure requirement of §489.20(u)(2), ask to see the signed attestation

that it does not have any referring physicians with an ownership/investment interest

or whose immediate family member was has an ownership/investment interest in

the CAH. (As with any other on-the-spot correction of a deficiency during a

survey, creation of an attestation at the time of a survey does not mean that there

was no deficiency and that the CAH would not be cited.)

• If the CAH is physician-owned but not exempt from the physician ownership

disclosure requirements:

• Verify that appropriate policies and procedures are in place to assure that

written notices are provided to all patients at the beginning of an inpatient or

outpatient stay.

• Review the notice the CAH issues to each patient to verify that it discloses, in a

manner reasonably designed to be understood by all patients, that the CAH

meets the Federal definition of “physician-owned,” that a list of owners and

investors who are physicians or immediate family members of physicians is

available upon request, and that such list is provided to the patient at the time

the request is made by or on behalf of the patient.

• Determine through staff interviews, observation, and a review of policies and

procedures whether the CAH furnishes its list of physician owners and

investors at the time a patient or patient’s representative requests it.

• Determine through staff interviews and review of policies, procedures, and

staff records whether a physician-owned CAH’s medical staff membership and

admitting privileging requirements include a requirement that, as a condition of

continued membership or admitting privileges, physician owners who refer

patients to the CAH agree to provide written disclosure of their own or any

immediate family member’s ownership or investment interest to all patients at

time of the referral to the CAH.

MD/DO 24/7 On-site Presence

• Determine through interviews, observation, and medical record review whether an

MD/DO is present in the CAH 24 hours per day, 7 days per week. For each required

location where an MD/DO is not present:

• Verify that appropriate policies and procedures are in place to assure that written

notices that a MD/DO is not present at all times are provided at the beginning of

a planned or unplanned inpatient stay or outpatient visit to all inpatients and to

all outpatients receiving observation services, surgery or another procedure

requiring anesthesia.

• Verify that there is a signed acknowledgement by the patient of such disclosure,

obtained by the CAH prior to the patient’s admission or before applicable

outpatient services were provided.

• Ask a sample of inpatients and affected outpatients whether they were provided

notice about an MD/DO not being present at all times in the CAH.

• Verify that the CAH’s emergency department has signage with the appropriate

disclosure information.

• Review the notice the CAH issues to verify that it indicates how the CAH will

meet the medical needs of any patient who develops an emergency medical

condition at a time when no physician is present at that CAH, including any

remote location.

Other Federal Requirements

Surveyors do not assess compliance with Medicare payment provisions or non-Medicare

requirements. However, a surveyor may refer suspected noncompliance with Federal

laws and regulations to the appropriate agency having jurisdiction (e.g., hazardous

chemical and waste issues to EPA, blood-borne pathogens and TB control to OSHA,

etc.).