Federal Regulation of the Nurse Practitioner Profession
The federal government regulates NP practice through statutes enacted by Congress and regulations, policies, and guidelines written by federal agencies. Federal law may preempt state law, and when federal and state law conflict, the state law will not have effect. Where no federal law addresses an issue, or where Congress has expressly given the responsibility to the states to make law on an issue, state law controls.
Federal law addresses:
Care of patients covered by Medicare
Billing Medicare
Care of patients covered by Medicaid
Care of hospitalized patients insofar as participation by hospitals in the Medicare program is contingent on a hospital following certain regulations
Care of residents in nursing homes
In-office and hospital laboratories, under the Clinical Laboratory Improvement Amendments (CLIA)
Self-referral by healthcare providers, under the Stark Acts
Prescription of controlled substances, under the Drug Enforcement Administration (DEA)
Reporting of successful malpractice lawsuits against NPs to the National Practitioner Data Bank (NPDB)
Confidentiality of information about patients under the Health Insurance Portability and Accountability Act (HIPAA)
Discrimination in hiring and firing
Facility access for disabled people
E-prescribing and electronic medical records
Federal law affects NPs by what it says and by what it does not say.
▪ Medicare
Because much of the funding for hospitals and much of the reimbursement for office practice comes from Medicare, federal statutes and regulations and policies from the Center for Medicare and Medicaid Services (CMS) have great impact on the interest of hospitals and medical practices in having NP providers. For example, the Social Security Act, which governs Medicare and Medicaid, was written in 1965, before there were NPs. The Act frequently uses the word physician as if there were no other healthcare provider. Other healthcare providers have had to get acts of Congress to be included in the laws governing Medicare. The Act has been amended many times since the 1960s, but some relevant portions of the Act remain that give permission to physicians and only physicians to provide care.
NPs made progress in 1997 when an act of Congress authorized NPs to be reimbursed directly for the care of Medicare patients. However, the Social Security Act still states that a physician must direct the care of hospitalized patients. In late 1997, HCFA proposed new regulations for hospital participation in Medicare (62 Fed. Reg. 66726-66763). The regulations state that every Medicare patient must be under the care of a physician, dentist, podiatrist, optometrist, chiropractor, or psychologist. The regulation is based on a section of the Social Security Act that states:
“Hospital” means an institution which has a requirement that every patient with respect to whom payment may be made under this title must be under the care of a physician, except that a patient receiving qualified psychologist services … may be under the care of a clinical psychologist with respect to such services to the extent permitted under state law.
Citation: 42 U.S.C.S. § 1395x(e)(4).
The regulation states that physicians, dentists, podiatrists, optometrists, chiropractors, or psychologists may delegate tasks to other qualified healthcare personnel to the extent recognized under state law or a state’s regulatory mechanism [62 FED. REG. 42 C.F.R. § 482.20(a)(1)(i)]. Because the proposed regulation does not use the term nurse practitioner, it is not clear that the regulation contemplates NPs practicing in hospitals. However, it certainly is arguable that NPs are “other qualified healthcare personnel.” Hospitals wishing to serve patients covered by Medicare will want NPs to give care only under delegation from a physician. This may be a limitation for NPs in states where physician collaboration is not required.
NPs may want to lobby Congress for statutory language that specifically authorizes NP participation in the care of Medicare patients in hospitals, at home, in nursing homes, or in offices. Being relegated to the “other qualified personnel” bin is suboptimal for the NP profession. Other providers, most recently psychologists, have successfully lobbied for greater inclusion in the Social Security Act.
With the passage of the Budget Reconciliation Bill of 1997, NPs were authorized to receive direct reimbursement for services to Medicare patients, regardless of the setting or location of the services.
As of the date of publication of this book, the areas of federal law which still have physician-only language are:
Nursing home law, which states that only a physician may be medical director and a physician must perform the initial comprehensive evaluation
Home healthcare law, which states that a physician must order home care
Hospice law, which states that only a physician may be the medical director
Medicare Reimbursement
In 1997, direct reimbursement to NPs, regardless of geographic area of practice, was authorized by Congress. However, the specific procedures by which NPs are reimbursed are frequently revised and clarified as questions arise and answers are developed. For example, the Budget Reconciliation Act of 1997 (1) removed the provision of the prior law that restricted reimbursement of NPs to those practicing in rural areas and (2) set the amount paid to 80% of either the lesser of the actual charge or 85% of the fee schedule amount provided under Section 1848. NPs who work for medical practices and who can fulfill the requirements of “incident to” or shared visit relationships with physicians can submit their work under a physician’s provider number and will receive full fee (not 85% of the physician fee). In general, however, an NP’s work should be billed under the NP’s provider number. Practitioners who are in doubt should seek an opinion from their Medicare payer or from an appropriate attorney.
What Is “Incident to”?
The full term is “incident to a physician’s professional service.” “Incident to” is a Medicare phrase, meaning services furnished as an “integral, although incidental, part of the physician’s personal professional services in the course of diagnosis or treatment of an injury or illness.”1 To qualify under this definition, the services of nonphysicians must be rendered under a physician’s “direct personal supervision.” Nonphysicians must be employees of a physician or physician group, leased employees, or have an independent contractor relationship with a physician or physician group. Services must be furnished during a course of treatment where a physician performs an initial service and subsequent services of a frequency that reflects the physician’s active participation in and management of a course of treatment. Direct personal supervision in the office setting does not mean that a physician must be in the same room.
However, to bill an incident to a physician’s service, the physician must be in the same suite in an office as the nurse practitioner at the time the nurse practitioner is performing the service to be billed under the physician’s provider number.
Here is an example:
Patient covered by Medicare visits a physician for the first time and the physician diagnoses high blood pressure. The physician asks the patient to
return in a month for a follow-up visit with a nurse practitioner employed by the physician. The patient visits the nurse practitioner, while the physician is in another room in the office. The nurse practitioner evaluates and manages the patient’s high blood pressure. Under the incident to rules, the nurse practitioner’s service (office visit, established patient) may be billed under the physician’s provider number and the practice will receive 100% of the Physician Fee Schedule rate.
return in a month for a follow-up visit with a nurse practitioner employed by the physician. The patient visits the nurse practitioner, while the physician is in another room in the office. The nurse practitioner evaluates and manages the patient’s high blood pressure. Under the incident to rules, the nurse practitioner’s service (office visit, established patient) may be billed under the physician’s provider number and the practice will receive 100% of the Physician Fee Schedule rate.
“Shared visits” refer to hospital services. If an NP and a physician who work for the same employer both see a patient on the same day, their services may be billed to Medicare under the physician’s name. The 1997 law change that gave NPs direct Medicare reimbursement, while remaining the most significant national-level advance in years for NPs, changed the language in only a few of the ways needed if NPs are to practice without barriers.
Federal Definition of Collaboration
For example, in federal law the term collaboration means:
A process in which a nurse practitioner works with a physician to deliver healthcare services within the scope of the practitioner’s professional expertise, with medical direction and appropriate supervision as provided for in jointly developed guidelines or other mechanism as defined by the law of the State in which the services are performed.
Citation: 42 U.S.C.S. § 1395x(aa)(6).
The emergence of an NP as a primary provider rather than a supervised helper is not reflected in the Social Security Act. In the act, an NP is someone to whom a physician may delegate certain tasks. Although state law either does not require collaboration or calls for “collaboration” and defines collaboration without using the term supervision, federal law requires, through its definition of collaboration, “supervision.”
The Balanced Budget Act of 1997 gives direct reimbursement to NPs for Medicare patients but does not change the law quoted above, which will take another act of Congress.
Medicare Fraud
CMS makes the rules regarding the care of Medicare patients and the billing of Medicare. The US Justice Department enforces the rules. NPs who do not follow CMS’s rules can expect to do poorly on audits and can possibly be charged with Medicare fraud and/or abuse.
In the past few years, CMS has reevaluated Medicare’s payment system, upgrading the reimbursement for some evaluation and management functions and downgrading the reimbursement for other functions. At the same time, CMS has clarified how providers, hospitals, and medical groups should bill, based on the services
provided. Of particular interest to NPs are the guidelines jointly developed by CMS and the American Medical Association for coding office visits. (See the appendices to this chapter.)
provided. Of particular interest to NPs are the guidelines jointly developed by CMS and the American Medical Association for coding office visits. (See the appendices to this chapter.)
NPs can expect that their Medicare billing choices will be audited, and they will be expected to know the rules for choosing appropriate evaluation and management codes that correlate with the type of visit performed and the documentation recorded. NPs also can expect that the rules for Medicare will soon be the rules for billing in general. Recently, NPs have been audited and in some cases CMS has demanded the return of many thousands of dollars.
For the guidelines for coding office visits covered by Medicare, see Appendix 4-A. For more information on Medicare reimbursement in general, see Chapter 9. For more information on how to avoid Medicare fraud and abuse, see Chapter 8. For information on specific questions regarding Medicare billing, consult the Medicare Manuals, which can be downloaded from the CMS website (www.cms.hhs.gov).
▪ Medicaid
The federal government has given most of the rule-making and administrative duties for Medicaid to the individual states, and, in most situations, state law controls Medicaid activities. However, the states must follow the Federal Code 42 U.S.C.A. § 1396 in such matters as ensuring access to care and offering a choice of providers. Federal law provides that Medicaid will cover the services of pediatric NPs and family NPs, whether or not the NP is employed by or supervised by a physician [42 U.S.C.S. § 1396d(a)(xi)(21)].
The states also must follow CMS rules and regulations regarding administration of Medicaid. For example, states wishing to enroll all Medicaid recipients in managed care have had to apply to CMS for waivers that specify how the managed care programs will be handled. It has been important for NPs in states that have applied for waivers to ensure that NPs are permitted to be “primary care providers.” If NPs are not included as providers in the language of state waivers approved by CMS, they are in the position of being able to care for Medicaid patients covered by traditional Medicaid but not to care for patients in managed care. If all patients are in managed care, NPs who can care only for patients covered by traditional, fee-for-service Medicaid will find that there are no such patients.
NPs must apply to their state agency administering Medicaid for Medicaid provider numbers. For more information on billing Medicaid, see Chapter 9. For specific questions on Medicaid issues, contact the state Medicaid agency.
▪ Nursing Homes
Under federal law addressing patients covered by Medicare, the care of residents of a skilled nursing facility must be under the supervision of a physician [42 U.S.C.S. § 1395i-3(b)(6)(A)]. The law states, “Skilled nursing facilities must require that the
medical care of every resident be provided under the supervision of a physician” [42 U.S.C.S. § 1395i-3(b)(6)(A)] and “provide for having a physician available to furnish necessary medical care in case of emergency” [42 U.S.C.S. § 1395i-3(b)(6)(B)]. Physicians may delegate tasks to other qualified healthcare providers (42 C.F.R. 483).
medical care of every resident be provided under the supervision of a physician” [42 U.S.C.S. § 1395i-3(b)(6)(A)] and “provide for having a physician available to furnish necessary medical care in case of emergency” [42 U.S.C.S. § 1395i-3(b)(6)(B)]. Physicians may delegate tasks to other qualified healthcare providers (42 C.F.R. 483).
Under federal law addressing patients covered by Medicaid, the care of nursing home residents may be provided under the supervision of an NP. Medicaid law states:
A nursing facility must require that the health care of every resident be provided under the supervision of a physician, or, at the option of a state, under the supervision of a nurse practitioner, clinical nurse specialist, or physician assistant who is not an employee of the facility but who is working in collaboration with a physician.
Citation: 42 U.S.C.S. § 1396r(b)(6)(A).
Even if the care is supervised by an NP or a PA, a nursing facility must have a physician “available to furnish necessary medical care in case of emergency” [42 U.S.C.S. § 1396r(b)(6)(B)]. And, as of the publication date of this book, only a physician may admit a patient to a skilled nursing facility.
▪ In-Office and Hospital Laboratories under CLIA
Office laboratories, no matter how small or limited in scope, are subject to federal oversight under the Clinical Laboratory Improvement Amendments (CLIA). State health departments often require office laboratories to meet certain requirements as well. Office laboratories are subject to state and federal inspection and approval. In offices where laboratory tests are limited to fecal occult blood (hemocult), urine pregnancy test, blood glucose, urinalysis (urine dip), and office microscopy, practices may obtain exemption from inspection. Nevertheless, offices must apply to CLIA for a letter of exemption.
▪ Self-Referral by Healthcare Providers, Under the Stark Acts
CMS has released rules regarding “Physicians’ Referrals to Health Care Entities With Which They Have Financial Relationships.” These rules relate to the Ethics in Patient Referral Act of 1989 (42 U.S.C. § 1395nn), which was amended by the Omnibus Budget and Reconciliation Act of 1993 and incorporated into the Social Security Act [Social Security Act, 42 U.S.C.A. § 1877 and 1903(s)]. The acts are commonly referred to as the “Stark Acts.”
Under the Stark Acts, a physician cannot refer a patient covered by Medicare to a clinical laboratory where the physician or an immediate family member of the physician has a financial relationship. Nor may a physician refer a patient to certain designated health services when the physician has a financial relationship with the facility
offering the services. The designated health services include: (1) physical therapy services; (2) occupational therapy services; (3) radiation therapy services; (4) radiology services; (5) durable medical equipment and supplies; (6) parenteral and enteral nutrients; (7) prosthetics, orthotics, and prosthetic devices; (8) home health services; (9) outpatient prescription drugs; and (10) inpatient and outpatient hospital services. The Stark laws originally were aimed at physicians who own an interest in, for example, medical equipment companies or laboratories, and are in a position to profit when the physician refers patients for additional services. However, the Stark laws are being interpreted very broadly and now are being used to prohibit hospitals from rewarding physicians who refer patients to the hospitals.
offering the services. The designated health services include: (1) physical therapy services; (2) occupational therapy services; (3) radiation therapy services; (4) radiology services; (5) durable medical equipment and supplies; (6) parenteral and enteral nutrients; (7) prosthetics, orthotics, and prosthetic devices; (8) home health services; (9) outpatient prescription drugs; and (10) inpatient and outpatient hospital services. The Stark laws originally were aimed at physicians who own an interest in, for example, medical equipment companies or laboratories, and are in a position to profit when the physician refers patients for additional services. However, the Stark laws are being interpreted very broadly and now are being used to prohibit hospitals from rewarding physicians who refer patients to the hospitals.
For the purposes of the Stark Acts, referral is defined broadly. A physician may make a referral simply by including a service in the plan of care.
The Stark Acts have wide-ranging application. It is still unclear, however, just how Stark applies to many situations.
CMS rules allow for certain exceptions from the self-referral prohibitions. For example, there is an exception for ownership and compensation for physicians’ services “provided personally by or under the personal supervision of another physician in the same group practice … as the referring physician” [Social Security Act, 42 U.S.C.A. § 1877(b)(1)]. In other words, a physician may refer a patient to another physician in the same group practice without violating the self-referral law.
How Might Stark Affect NPs?
The Stark Acts are not aimed at nurse practitioners, but at physicians. However, if a physician requires a nurse practitioner employee to refer to an entity with which the physician employer has a financial relationship, then a nurse practitioner may become involved in an activity that violates the Stark Acts. If the referrals were found to be a violation of the Stark Act, the referrals would be imputed to the physician employing the nurse practitioner, rather than the nurse practitioner. On the other hand, if a nurse practitioner employee is free to refer to the entity of his or her choice, and the nurse practitioner independently chooses to refer to an entity in which his or her employer has a financial relationship, it is not clear that a Stark violation has taken place. The Office of the Inspector General has said that in such a case it would evaluate the specific facts of the situation.
Nurse practitioners and other healthcare providers wanting to start businesses that might lead to questions regarding the issues described above should consult an attorney.
Anti-kickback Statutes
Under federal law, there are criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit, or receive remuneration (i.e., anything of value, in cash or in kind) in order to induce the referral of business reimbursable by a federal healthcare program. Violations of the anti-kickback statute also may result in
civil money penalties. The statute has been in existence since 1977. It applies to all kinds of healthcare providers and suppliers.
civil money penalties. The statute has been in existence since 1977. It applies to all kinds of healthcare providers and suppliers.
The law was enacted because Congress believed that payments tied to referrals increase the likelihood of overutilization of items and services, increase the cost of healthcare programs, lead to inappropriate referrals, and make competition unfair.
Examples of kickbacks include:
Waiving deductibles and copayments for Medicare patients
Paying a nurse practitioner or physician a fee for referring a patient
Accepting a fee for referring a patient
Implications for NPs
The federal prohibition on kickbacks applies to nurse practitioners. For example, what if a nurse practitioner started a practice, asked a physician to be the collaborator, and promised to refer at least 50 patients per year to the physician as compensation for the services involved in being the collaborator? The promise to refer, combined with the actual referral of patients covered by Medicaid or Medicare, may be evidence of kickbacks in violation of federal law.
▪ Prescription of Controlled Substances Under the DEA
The Drug Enforcement Administration (DEA) licenses healthcare providers who prescribe controlled dangerous substances. The DEA licenses NPs as “mid-level practitioners” (21 C.F.R. § 1301, 1304, and 1306.3). The DEA will assign an NP a DEA number if the NP has no felony on record, if the NP has a practice site, and if state law permits NPs to prescribe controlled substances. Controlled substances may be issued only by a practitioner who is authorized to prescribe controlled substances by the jurisdiction in which the practitioner is licensed to practice and either registered or exempted from registration.
▪ Reporting to the National Practitioner Data Bank
Under federal law (42 C.F.R. § 60), malpractice insurers must report damage awards paid on behalf of physicians, dentists, NPs, and some other healthcare providers to the National Practitioner Data Bank (NPDB), a national repository of information on healthcare providers. For more about the NPDB, see Chapter 7.
▪ Patient Confidentiality
Federal law requires NPs and other healthcare providers to protect patient privacy and confidentiality. Specific federal laws protect the privacy of patients with substance abuse problems (42 U.S.C. § 290dd-2), patients with mental health problems
(42 U.S.C. § 9501), and patients who are residents of nursing homes [42 U.S.C. § 1395e-3(C)(x)(A)(iv)].
(42 U.S.C. § 9501), and patients who are residents of nursing homes [42 U.S.C. § 1395e-3(C)(x)(A)(iv)].
Patient Privacy
Congress mandated the Department of Health and Human Services to promulgate rules governing privacy in health care under the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Incidents which inspired Congress to pass the privacy protection requirements include:
A health system in Michigan accidentally posted the medical records of thousands of patients on the Internet (1999 report).
A businessman purchased at auction the medical records of patients at a family practice in South Carolina, and attempted to sell them back to the former patients (1991 report).
Johnson & Johnson marketed a list of five million elderly women who had been treated for incontinence (1998 report).
Under the Final Rule, any individual, organization, or facility which meets the definition of “covered entity” must:
Appoint a privacy officer.
Assess the office, hospital, or facility for potential for breaches of patient privacy.
Issue policies regarding handling of and protection of patient information.
Conduct training for staff about the policies.
Monitor office or facility procedures for compliance with policies.
Get patients to authorize, in writing, any release of their individually identifiable information for marketing purposes.
Notify patients, in writing, of their rights under the rules, and make a good faith effort to get patients to sign an acknowledgment that they have received notice of their rights.
“Covered entities” include the following:
Health plans
Healthcare clearinghouses
Healthcare providers who transmit any health information in electronic form in connection with a transaction
“Healthcare providers” include:
Hospitals
Skilled nursing facilities
Comprehensive outpatient rehabilitation facilities
Home health agencies
Hospice programs
Nurse practitioners
Certified nurse-midwives
Clinical nurse specialists
Psychologists
Clinical social workers
Certified registered nurse anesthetists
Physicians and physician assistants
“… [A]nd any other person or organization who furnishes, bills, or is paid for health care in the normal course of business.”
An individual healthcare provider—a nurse practitioner, for example—need not personally transmit health information in electronic form for the rules to apply. If information is transmitted on the provider’s behalf or by the provider’s agency, the rules apply. The rules also apply to “business associates” of healthcare providers.
Basic requirements of the privacy rule are as follows:
Providers and their staff are restricted to conveying the “minimum necessary information” about patients. “Minimum necessary” must be defined by organizational policy. Providers must establish policies that (a) identify the persons or classes of persons in the workforce who need access to protected patient information to do their jobs, (b) specify the information these workers may access, and (c) specify how information is protected from inspection by unauthorized individuals.
If a provider wants to release patient information for marketing purposes, the provider must first explain to the patient how the information will be used, to whom it will be disclosed, and the time frame. The patient needs to authorize use of the information, in writing. If the provider will be paid for releasing the patient’s information, the provider must inform the patient of that fact.
Providers may disclose health information to oversight agencies, such as the Center for Medicare and Medicaid Services (CMS) without patient authorization. No authorization is required for victims of abuse, neglect, or domestic violence when state law mandates that the provider report abuse. No separate authorization is required when information is used for public health purposes, or for organ and tissue donation. No authorization is required under certain circumstances involving law enforcement.
There are special rules for psychotherapy notes. In general, patient authorization is required in order to disclose psychotherapy notes to carry out treatment, payment, or healthcare operations. Patients may authorize disclosure of their entire record. Such authorizations must include the name or class of the persons authorized to disclose and an expiration date or event.
Providers must notify patients about how personal medical information may be used and disclosed, and how individuals may access their own information. Individuals have no right to three types of information about themselves:
psychotherapy notes, information compiled in anticipation of civil or criminal litigation, and certain clinical laboratory information covered by the Clinical Laboratory Improvement Amendments.
Providers must accommodate reasonable requests from patients who want to restrict use of their information.
▪ Discrimination in Hiring and Firing
Federal law prohibits discrimination based on race, color, sex, national origin, age, and disability. Title VII of the Civil Rights Act of 1964, which prohibits discrimination based on race, color, or national origin, applies to government employers and private employers with more than 15 employees. The Age Discrimination Act of 1967 prohibits discrimination based on age above 40 and applies to employers with more than 20 employees. The Equal Pay Act of 1963 prohibits wage discrimination between men and women and applies to most employers.
▪ People with Disabilities Under the ADA
Title I of the Americans with Disabilities Act of 1990 prohibits private employers from discriminating against qualified individuals in hiring, firing, advancement, compensation, job training, and conditions of employment. A disabled person is one who has a physical or mental impairment that substantially limits one or more major life activities. The act applies to employers with more than 15 employees.
Note
1. Medicare Benefit Policy Manual, Chapter 15, Sections 60.1-60.3. https://www.cms.gov/manuals/Downloads/bp102c15.pdf. Retrieved December 15, 2010.
Appendix 4-A
Documentation Guidelines for Evaluation and Management Services
This is an update of the guidelines jointly produced by the American Medical Association (AMA) and the Health Care Financing Administration (HCFA) in May 1997. It appears on the Center for Medicare and Medicaid Services (CMS) website at www.cms.gov. It incorporates revisions to the gastrointestinal section of the general multisystem exam and the skin section of the single-organ system exam of the skin. These revisions were approved by the AMA and CMS in November 1997. This is not the final version of the guidelines. This version of the guidelines will be reviewed and may be amended before Medicare carriers begin to use it in compliance activities. Nurse practitioners should check the CMS website periodically to determine whether revisions have been published.
▪ Foreword
These guidelines were developed jointly by the American Medical Association (AMA) and the Health Care Financing Administration (HCFA), now known as the Center for Medicare and Medicaid Services (CMS). The stated goal was to provide physicians and claims reviewers with advice about preparing or reviewing documentation for Evaluation and Management services. In developing and testing the validity of these guidelines, special emphasis was placed on assuring that they:
Are consistent with the clinical descriptors and definitions contained in Current Procedural Terminology (CPT);
Would be widely accepted by clinicians and minimize any changes in recordkeeping practices; and
Would be interpreted and applied uniformly by users across the country.
This edition contains a substantial amount of new material and a number of significant revisions in material that appeared in the first edition. Because of the extensive changes, the section on examination should be read in its entirety. In this edition:
The content of general multisystem examinations has been defined with greater clinical specificity.
Documentation requirements for general multisystem examinations have been changed.
For the first time, content and documentation requirements have been defined for examinations pertaining to ten organ systems. The content of these examinations was developed with the assistance of representatives from the specialties that frequently perform these examinations.
Several editorial changes have been made in the definitions of the four types of examinations. This text also appears in CPT itself in the section headed “Evaluation and Management (E/M) Services Guidelines.”
The definition of an extended history of present illness has been expanded to include information about chronic or inactive conditions.
▪ I. Introduction
What Is Documentation and Why Is It Important?
Medical record documentation is required to record pertinent facts, findings, and observations about an individual’s health history including past and present illnesses, examinations, tests, treatments, and outcomes. The medical record chronologically documents the care of the patient and is an important element contributing to high quality care. The medical record facilitates:
The ability of the physician and other healthcare professionals to evaluate and plan the patient’s immediate treatment, and to monitor his/her health care over time;
Communication and continuity of care among physicians and other healthcare professionals involved in the patient’s care;
Accurate and timely claims review and payment;
Appropriate utilization review and quality of care evaluations; and
Collection of data that may be useful for research and education.
An appropriately documented medical record can reduce many of the “hassles” associated with claims processing and may serve as a legal document to verify the care provided, if necessary.
What Do Payers Want and Why?
Because payers have a contractual obligation to enrollees, they may require reasonable documentation that services are consistent with the insurance coverage provided. They may request information to validate:
The site of service;
The medical necessity and appropriateness of the diagnostic and/or therapeutic services provided; and/or
That services provided have been accurately reported.
▪ II. General Principles of Medical Record Documentation
The principles of documentation listed below are applicable to all types of medical and surgical services in all settings. For Evaluation and Management (E/M) services, the nature and amount of physician work and documentation varies by type of service, place of service, and the patient’s status. The general principles listed below may be modified to account for these variable circumstances in providing E/M services.
The medical record should be complete and legible.
The documentation of each patient encounter should include:
Reason for the encounter and relevant history, physical examination findings, and prior diagnostic test results;
Assessment, clinical impression, or diagnosis;
Plan for care; and
Date and legible identity of the observer.
If not documented, the rationale for ordering diagnostic and other ancillary services should be easily inferred.
Past and present diagnoses should be accessible to the treating and/or consulting physician.
Appropriate health risk factors should be identified.
The patient’s progress, response to and changes in treatment, and revision of diagnosis should be documented.
The CPT and ICD-9-CM codes reported on the health insurance claim form or billing statement should be supported by the documentation in the medical record.
▪ III. Documentation of E/M Services
This publication provides definitions and documentation guidelines for the three key components of E/M services and for visits that consist predominately of counseling or coordination of care. The three key components—history, examination, and medical decision making—appear in the descriptors for office and other outpatient services, hospital observation services, hospital inpatient services, consultations, emergency department services, nursing facility services, domiciliary care services, and home services. While some of the text of CPT has been repeated in this publication, the reader should refer to CPT for the complete descriptors for E/M services and instructions for selecting a level of service. Documentation guidelines are identified by the symbol •DG.
The descriptors for the levels of E/M services recognize seven components that are used in defining the levels of E/M services. These components are:
History,
Examination,
Medical decision making,
Counseling,
Coordination of care,
Nature of presenting problem, and
Time.
The first three of these components (i.e., history, examination, and medical decision making) are the key components in selecting the level of E/M services. In the case of visits that consist predominantly of counseling or coordination of care, time is the key or controlling factor to qualify for a particular level of E/M service.
Because the level of E/M service is dependent on two or three key components, performance and documentation of one component (e.g., examination) at the highest level does not necessarily mean that the encounter in its entirety qualifies for the highest level of E/M service.
These documentation guidelines for E/M services reflect the needs of the typical adult population. For certain groups of patients, the recorded information may vary slightly from that described here. Specifically, the medical records of infants, children, adolescents, and pregnant women may have additional or modified information recorded in each history and examination area.
As an example, newborn records may include under history of the present illness (HPI) the details of mother’s pregnancy and the infant’s status at birth; social history will focus on family structure; family history will focus on congenital anomalies and hereditary disorders in the family. In addition, the content of a pediatric examination will vary with the age and development of the child. Although not specifically defined in these documentation guidelines, these patient group variations on history and examination are appropriate.
Documentation of History
The levels of E/M services are based on four types of history (Problem Focused, Expanded Problem Focused, Detailed, and Comprehensive). Each type of history includes some or all of the following elements:
Chief complaint (CC)
History of present illness (HPI)
Review of systems (ROS)
Past, family, and/or social history (PFSH)
The extent of history of present illness, review of systems, and past, family, and/or social history that is obtained and documented is dependent upon clinical judgment and the nature of the presenting problem(s). The chart below shows the progression of the elements required for each type of history. To qualify for a given type of history all three elements in the table must be met. (A chief complaint is indicated at all levels.)
DG: The CC, ROS, and PFSH may be listed as separate elements of history, or they may be included in the description of the history of the present illness.
History of Present Illness (HPI)
Review of Systems (ROS)
Past, Family, and/or Social History (PFSH)
Type of History
Brief
N/A
N/A
Problem Focused
Brief
Problem
Pertinent
N/A
Expanded Problem
Focused
Extended
Extended
Pertinent
Detailed
Extended
Complete
Complete
Comprehensive
DG: An ROS and/or a PFSH obtained during an earlier encounter does not need to be rerecorded if there is evidence that the physician reviewed and updated the previous information. This may occur when a physician updates his or her own record or in an institutional setting or group practice where many physicians use a common record. The review and update may be documented by:
Describing any new ROS and/or PFSH information or noting there has been no change in the information; and
Noting the date and location of the earlier ROS and/or PFSH.
DG: The ROS and/or PFSH may be recorded by ancillary staff or on a form completed by the patient. To document that the physician reviewed the information, there must be a notation supplementing or confirming the information recorded by others.
DG: If the physician is unable to obtain a history from the patient or other source, the record should describe the patient’s condition or other circumstance that precludes obtaining a history.
Definitions and specific documentation guidelines for each of the elements of history are listed below.
Chief Complaint (CC)
The CC is a concise statement describing the symptom, problem, condition, diagnosis, physician recommended return, or other factor that is the reason for the encounter, usually stated in the patient’s words.
DG: The medical record should clearly reflect the chief complaint.
History of Present Illness (HPI)
The HPI is a chronological description of the development of the patient’s present illness from the first sign and/or symptom or from the previous encounter to the present. It includes the following elements:
Brief and extended HPIs are distinguished by the amount of detail needed to accurately characterize the clinical problem(s).
A brief HPI consists of one to three elements of the HPI.
DG: The medical record should describe one to three elements of the present illness (HPI).
An extended HPI consists of at least four elements of the HPI or the status of at least three chronic or inactive conditions.
DG: The medical record should describe at least four elements of the present illness (HPI), or the status of at least three chronic or inactive conditions.
Review of Systems (ROS)
An ROS is an inventory of body systems obtained through a series of questions seeking to identify signs and/or symptoms that the patient may be experiencing or has experienced.
For purposes of ROS, the following systems are recognized:
Constitutional symptoms (e.g., fever, weight loss)
Eyes
Ears, nose, mouth, throat
Cardiovascular
Respiratory
Gastrointestinal
Genitourinary
Musculoskeletal
Integumentary (skin and/or breast)
Neurological
Psychiatric
Endocrine
Hematologic/lymphatic
Allergic/immunologic
A problem pertinent ROS inquires about the system directly related to the problem(s) identified in the HPI.
DG: The patient’s positive responses and pertinent negatives for the system related to the problem should be documented.
An extended ROS inquires about the system directly related to the problem(s) identified in the HPI and a limited number of additional systems.
DG: The patient’s positive responses and pertinent negatives for two to nine systems should be documented.
A complete ROS inquires about the system(s) directly related to the problem(s) identified in the HPI plus all additional body systems.
DG: At least ten organ systems must be reviewed. Those systems with positive or pertinent negative responses must be individually documented. For the remaining systems, a notation indicating all other systems are negative is permissible. In the absence of such a notation, at least ten systems must be individually documented.
Past, Family, and/or Social History (PFSH)
The PFSH consists of a review of three areas:
Past history (the patient’s past experiences with illnesses, operations, injuries, and treatments),
Family history (a review of medical events in the patient’s family, including diseases which may be hereditary or place the patient at risk), and
Social history (an age appropriate review of past and current activities).
For certain categories of E/M services that include only an interval history, it is not necessary to record information about the PFSH. Those categories are subsequent hospital care, follow-up inpatient consultations, and subsequent nursing facility care.
A pertinent PFSH is a review of the history area(s) directly related to the problem(s) identified in the HPI.
DG: At least one specific item from any of the three history areas must be documented for a pertinent PFSH.
A complete PFSH is a review of two or all three of the PFSH history areas, depending on the category of the E/M service. A review of all three history areas is required for services that by their nature include a comprehensive assessment or reassessment of the patient. A review of two of the three history areas is sufficient for other services.
DG: At least one specific item from two of the three history areas must be documented for a complete PFSH for the following categories of E/M services: office or other outpatient services, established patient; emergency department; domiciliary care, established patient; and home care, established patient.
DG: At least one specific item from each of the three history areas must be documented for a complete PFSH for the following categories of E/M services: office or other outpatient services, new patient; hospital observation
services; hospital inpatient services, initial care; consultations; comprehensive nursing facility assessments; domiciliary care, new patient; and home care, new patient.
Documentation of Examination
The levels of E/M services are based on four types of examination:
Problem Focused—a limited examination of the affected body area or organ system.
Expanded Problem Focused—a limited examination of the affected body area or organ system and any other symptomatic or related body area(s) or organ system(s).
Detailed—an extended examination of the affected body area(s) or organ system(s) and any other symptomatic or related body area(s) or organ system(s).
Comprehensive—a general multisystem examination or complete examination of a single organ system and other symptomatic or related body area(s) or organ system(s).
These types of examinations have been defined for general multisystems and the following single organ systems:
Cardiovascular
Ears, nose, mouth, and throat
Eyes
Genitourinary (female)
Genitourinary (male)
Hematologic/lymphatic/immunologic
Musculoskeletal
Neurological
Psychiatric
Respiratory
Skin
A general multisystem examination or a single organ system examination may be performed by any physician regardless of specialty. The type (general multisystem or single organ system) and content of examination are selected by the examining physician and are based upon clinical judgment, the patient’s history, and the nature of the presenting problem(s).
The content and documentation requirements for each type and level of examination are summarized next and described in detail in tables beginning on page 171. In the tables, organ systems and body areas recognized by CPT for purposes of describing examinations are shown in the left column. The content, or individual elements, of
the examination pertaining to that body area or organ system are identified by bullets (•) in the right column.
the examination pertaining to that body area or organ system are identified by bullets (•) in the right column.
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