Social Security Act of 1965
It was signed into law by President Johnson on July 30, 1965. The law established both Medicare, the health insurance program for Americans over 65 and Medicaid, the health insurance program for low-income Americans.
Health Care Financing Administration (HCFA)
Created in 1977 to combine, under one administration, the oversight of Medicare and Medicaid under the HCFA ( the predecessor of CMS)
Medicare
Signed into law in 1965, Medicare is a Health Insurance Program for the following groups:
-People age 65 or older
-People under age 65 with certain disabilities
-People of all ages with End-Stage Renal Disease (permanent kidney failure requiring dialysis or a kidney transplant)
Medicaid
Medicaid is a medical assistance program jointly financed by State and Federal governments for eligible low-income individuals. The program covers a variety of groups, including the following:
-The needy elderly
-Blind
-Disabled individuals receiving cash assistance under the Supplemental Security Income Program
-Certain infants and low-income pregnant women
-At the option of the State, other low-income individuals with medical bills that qualify them as categorically or medically needy.
Medicaid is a state program that provides medical services to clients of the state public assistance program and, at the State’s option, other needy individuals.
Medicaid also augments the hospital and nursing facility (NF) services mandated under Medicaid.
States may decide on the amount, duration, and scope of additional services, except that care in institutions primarily for the care and treatment of mental health issues, may not included for persons over age 21 and under age 65.
Clinical Laboratory Improvement Amendments (CLIA)
Signed into law in 1988, CLIA regulations include federal standards applicable to all U.S. laboratory facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. The CDC, in partnership with the CMS and FDA supports the CLIA program and clinical laboratory quality.
-The Centers for Disease Control & Prevention is responsible for the CLIA studies, convening the Clinical Laboratory Improvement Amendments Committee (CLIAC) & provides scientific & technical support to CMS.
-A laboratory is defined as any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health.
-CLIA covers approximately 175,000 laboratory entities
-The Food & Drug Administration (FDA) is responsible for test categorization
-The Division of Laboratory Services, within the Survey & Certification Group, under the Center for Medicaid, CHIP and Survey & Certification have the responsibility for implementing the CLIA Program.
Title XVIII of Social Security Act
Title XVIII (18) established regulations for the Medicare program. The Chapter also provides insurance coverage for hospital, post-hospital, home health services, and hospice care for the aged and disabled, regardless of income or health status.
Title XIX (Medicaid) of the Act
Title XIX (19) of the Social Security Act established regulations for the Medicaid program, specifically, the Chapter appropriates money to States for families with dependent children and for aged, blind, or disabled individuals, whose income and resources are insufficient to meet the costs of necessary medical services.
Title XVIII (18) + Title XIX (19) of the Social Security Act
Both titles mandate the establishment of minimum health and safety standards that must be met by providers and suppliers participating in the Medicare and Medicaid programs.
42 CFR Part 431.51
Provides Medicaid recipients with free choice of providers. On a statutory basis, 42 CFR Part 431.51 provides that beneficiaries may obtain services from any qualified Medicaid provider that undertakes to provide the services to them.
PROVIDERS (Medicare Terminology)
In Medicare terminology, providers are resident care institutions such as hospitals, hospices, nursing homes, and home health agencies.
SUPPLIERS
Suppliers are agencies for diagnosis and therapy rather than sustained resident care, such as laboratories, clinics, & physical therapist (PT) offices.
Payment for services under Medicare and Medicaid
The federal government, through designated fiscal intermediaries (FIs) & carriers, makes the payment for services to the providers & suppliers.
Section 1802 of the Act provides that any individual entitled to Medicare may obtain health services from any institution, agency, or person qualified to participate in Medicare if that institution, agency or person provides such services.
CMS Regional Office (RO)
Regional Offices (RO's) are responsible for assuring that health care providers and suppliers participating in the Medicare and Medicaid programs meet applicable Federal requirements.
Medigap
In 1980, coverage of home health services was broadened.
As a result, Medicare supplemental insurance-"Medigap"- was brought under Federal oversight.
Social Security Act, Section 1864(a)
Directs the Secretary of the Department of Health & Human Services (DHHS) to use the help of state health agencies or other appropriate agencies when determining whether health care entities meet Federal standards
A) Functions that state agencies perform include the following:
-Identifying potential participants
-Conducting investigations & fact-finding surveys
-Certifying & rectifying
-Explaining requirements
-Operating toll-free home health hotline
B) The state agencies (SA) are authorized to perform numerous other functions under a blanket clause of the state agency agreement, by exclusive agreement, or by statue. These functions include the following:
-Identifying Prospective Payment System (PPS) excluded institutions
-Participating in validation surveys of accredited entities
-Monitoring proficiency testing
-Directing data entry
-Nurse Aid Training
-Nurse Aide Registry
-Resident Assessment Instrument (RAI)
-Records & Reports
State Agency function--Title XVIII, Section 1864(a): Identifying Prospective Payment System (PPS) excluded institutions
Certification information helps in identifying institutions or components of institutions that meet special requirements that qualify them to be excluded from the Medicare PPS.
State Agency function--Title XVIII, section 1864(a): Participating on validation surveys of accredited entities
Ensures validation surveys of accredited entities; surveys finish DHHS and Congress with a monitoring ability of CoPs. Survey establish the validity of "deeming" that accredited entities meet the CoPs.
State Agency function--Title XVIII, Section 1864(a): Monitoring proficiency testing
This function allows state agencies to monitor programs of proficiency testing in laboratories and contribute laboratory compliance findings for use in the CLIA Laboratory Certification Program.
State Agency function--Title XVIII, Section 1864(a): Directing data entry
State agencies are responsible for entering data from surveys. conducting follow-up visits, and conducting complaint investigations into the OSCAR/ODIE system-the national mainframe computer system that is used for maintaining & retrieving certification data.
State agencies are also responsible for updating information about providers, suppliers, and CLIA laboratories in the system when indicated.
OSCAR/ODIE System
Online Survey Certification and Reporting System (OSCAR)
Online Data Input and Edit (ODIE)
ODIE is a subsystem of the Online Survey Certification & Reporting (OSCAR) system, which is a database & retrieval program
OSCAR and ODIE are the original system name under the CLIA data system. The most current release is known as the Automated Survey Processing Environment/Quality Information Enterprise System (ASPEN/QIES) for CLIA.
State Agency function--Title XVIII, Section 1864(a): NURSE AID TRAINING
State agencies are required to specify, review, and certify Nurse Aide Training and Competency Evaluation Programs (NATCEPs).
NATCEP
Nurse Aide Training and Competency Evaluation Program
State Agency function--Title XVIII, Section 1864(a): Nurse Aide Registry
The Nurse Aid Registry is a listing of nurse aides who have met Federal and state training and competency requirements necessary for employment in nursing homes.
All state agencies are required to established and maintain a registry for all individuals who have satisfactorily completed Nurse Aide Training and Competency Evaluation Program (NATCEP) or a nurse Aide Competency Evaluation Program (NACEP).
References:
-SOM Ch. 4, $4145
-SSA 1819 (e)(2)
-SSA 1919 (e)(2)
State Agency function--Title XVIII, Section 1864(a): Resident Assessment Instrument (RAI)
State agencies are required to specify a RESIDENT ASSESSMENT INSTRUMENT (RAI) for use in the LTC facilities participating in Medicare and Medicaid.
REFERENCE:
-SOM Chapter 4, 4145.4
State Agency function--Title XVIII, Section 1864(a): Records & Reports
State agencies must maintain pertinent survey, certification, statistical, and other records for a period of at least FOUR years
State agencies must make reports in the form and content as the Secretary may require.
Title XXIX (19) of the Social Security act, Section 1902(a)(9)(A) - MEDICAID
Requires that a State use this same agency to set and maintain additional standards for the State Medicaid program.
Title XXIX (19) of the Social Security act, Section 1902(a)(33)(B)
This section of the SSA requires the state to use the same agency utilized for Medicare.
If such agency is not the state agency responsible for licensing health institutions, it requires the state to use the agency responsible for such licensing in order to determine whether institutions meet all applicable Federal health standards for Medicaid participation. Licensing under this section is subject to validation by Secretary.
Chapter 1865 of SSA establishes five different nationally approved accreditation organizations. List them:
1) The Joint Commission (TJC)
2) American Osteopathic Association (AOA)
3) Community Health Accreditation Program (CHAP)
4) Accreditation Association for Ambulatory Healthcare, Inc. (AAAHC)
5) American Association for Accreditation for Ambulatory surgery Facilities (AAAASF)
The providers that may be deemed as meeting Medicare conditions of participation based on their accreditation include:
Home Health Agencies (HHAs)
Ambulatory Surgical centers (ASCs)
Hospices
Critical Access Hospitals (CAHs)
Section 1865(b) of the SSA
1865(b) allows providers accredited as critical Access Hospitals (CAHs) by The Joint Commission (TJC) or the American Osteopathic Association (AOA) to be deemed to meet the CoPs.
Hospitals
Section 1865(a) of the Act states that hospitals accredited by The Joint Commission (TJC) are deemed to meet to meet the CoPs.
Section 1865(a) of the Act allows hospitals accredited by the American Osteopathic Association (AOA) to be deemed to meet the CoPs.
Hospitals accredited by TJC and AOA as of 1965 are deemed to meet the Medicare CoPs.
Exceptions to State Agency certification
-The utilization review (UR) condition
-The two special Conditions for psychiatric hospitals
-Special requirements for hospital providers on long term care services (i.e., swing beds)
-A standard promulgated by the secretary which is a higher than accreditation requirement
-Any higher than national standards approved by the Secretary & applied in a State
Center for Medicare Management (CMM)
CMM serves as Medicare Beneficiary Ombudsman, as well as the focal point for all Agency interactions with sea;tjcare providers, intermediates, and carriers representing fee-for-service polices and operations.
Center for Beneficiary Choices (CBC)
CBC serves as Medicare Beneficiary Ombudsman, as well as the focal point for all CMS interactions with the people who use our programs, their families, care givers, health care providers, and others operating on their behalf.
Center for Medicaid, CHIP and Survey & certification (CMCS)
CMCS serves as the focal point for all Agency activities related to Medicaid, including the following programs:
-The State Children's Health Insurance Program (SCHIP)
-The Clinical Laboratory Improvement Act (CLIA)
CMS is also responsible for the survey and certification of health facilities and all interactions with State and local governments (including the Territories).
Additional exceptions to State Agency certification (1 of 2)
Federal & Indian Health Institutions:
Because of questions of intergovernmental jurisdiction, the survey and certification of a hospital or SNF that is either owned or operated by the Indian Health Service (IHS)- and therefore considered to be a Federal provider of services- is handled by the CMS regional office (RO).
***the state agency is responsible for determining whether the facility meets Medicaid certification requirements.***
The state agency may accept Medicare certification as sufficient evidence pf meeting Medicaid requirements, or the state agency may conduct a survey.
The Indian health tribal facilities are not considered to be Federal providers and are surveyed by the STATE AGENCY.
Additional exceptions to State Agency certification (2 of 2)
Section 1861(e) of the Act includes in the definition of “hospital,” a Christian Science Sanatorium that is operated or listed and certified by the First Church of Christ Scientist, based out of Boston, Massachusetts.
Section 1861(e) also deals with respect to certain items and hospital services furnished to inpatients.
Section 1861(y) includes sanatoria with respect to items and service furnished to inpatients in a long term car setting.
All approvals are handled by the Boston RO (CMS).
***No state agency certification are necessary. The State may also include these services under the State plan for Medicaid.***
Exemption of Laboratory Licensed by States
CLIA will exempt laboratories in State that have been determined to have laws and regulations in effect that are equal to or more stringent that CLIA requirements.
Exempt laboratories must hold a vials State license within the exempt State.
CFR Part 488.6 Eligibility for Mediad Facilities
Eligibility for Medicaid participation can be established through Medicaid deemed status for providers and suppliers that are not required under Medicaid regulations to comply with any requirements for that provider or supplier type.
See 42 CFR Part 488.6
SOM, Ch.6
CLIA Laboratories
Each accrediting organization that has revived deeming authority (under CLIA) is approved for specific laboratory specialties / subspecialties.
Refer to Chapter 6 of the State Operations Manual (SOM) for additional information on accrediting organizations.
CLIA Laboratories approved for distinct specialties and sub specialties:
-American Association of Blood Banks
-American Osteopathy Association
-American Society of Histocompatibility & Immunogenetics
-The Joint Commission
-College of American Pathologists
-Commission on Office Laboratory Accreditation
CERTIFICATION
Certification is a recommendation made by the State Agency (SA) on the compliance of provides and suppliers with conditions of participation, requirements, and conditions of coverage.
State Agencies officially certify the findings that health care entities do the following:
-Meet the Act’s provider or supplier definitions
-Comply with standards rehired by Federal regulations
CMS Headquarters
-Located in Baltimore, MD
-Overall policy-making responsibility is centralized at CMS Baltimore headquarters
-In Baltimore HQ, all aspects of the Medicare program and oversight of the State Medicaid programs are coordinated
-Establishing operational policy for the certification process
-Conveying operational instructions and official interpretations of policy to the State Agencies (SA) and the CMS regional offices (ROs)
CMS Regulations Offices (RO’s)
Responsible for assuring health care providers and suppliers participating in the a Medicare + Medicaid programs meet applicable Federal requirements.
10 CMS Regional Offices (pt 1)
-Interpret CMS guidelines, policies, & procedures applicable to certification activities
-Provide liaison, direction, & technical assistance to SAs in the day to day management of the certification process
-Evaluate the performance of State agencies (SAs) in interpreting & applying health & safety standards, their assessments of providers & suppliers for compliance with standards, & their use of appropriate administrative procedures
-Make final determinations of provider and supplier eligibility for participation in the Medicare program.
-Assemble information on all determinants of eligibility
-Approved, denies, or terminated provider agreements and supplier participation
-Arrange for FI tie in with new providers
10 CMS Regional Offices (pt 2)
-Conduct Federal surveys of providers & suppliers to ensure that standards & procedures are being applied in a uniform & consistent manner
-Prepare data based on SA survey findings for input into CMS’s Online Data Input & Edit (ODIE) system
-***ODIE is a subsystem of the Online Survey Certification & Reporting (OSCAR) system, which is a database & retrieval program***
-Analyze OSCAR data, provide feedback to SAs on certification information tracked by the system
-Conduct surveillance and assessments of SA operations and assist SAs in developing the capability to provide direct assistance to providers and suppliers, review SA certification actions, and provide feedback to States
-Conduct FEDERAL surveys of providers and suppliers to ensure that standards and procedures are being applied in a uniform and consistent manner
Clinical Laboratory Improvement Amendments Committee (CLIAC)
The Centers for Disease Control & Prevention is responsible for the CLIA studies, convening the Clinical Laboratory Improvement Amendments Committee (CLIAC) and provided scientific & technical support to CMS.
Which Congressional Act established quality standards for all laboratory testing to ensure the accuracy, reliability, and timelines of resident test results regardless of where the test was performed? What was the purpose of such legislation?
CLIA- Clinical Laboratory Improvement Amendments of 1988 (CLIA) established quality standards for all laboratory testing to ensure the accuracy, reliability & timeliness of resident test results regardless of where the test was performed.
The following activities are included in CMS’s Mission:
-Regulating all laboratory testing (expect research) performed on humans in the United States
-Helping millions of Americans & small companies get and keep health insurance coverage with the Department of Labor & Treasury
-Administering the State Children’s Health Insurance Program (SCHIP) with the Health Resources & Services Administration
-Helping to eliminate discrimination based on health status for people buying health insurance
QUIZ QUESTION:
Select ALL the statements about the 1864 Agreement with States that are TRUE:
ANSWERS:
The Governors of reach state designate SAs; the lifetime of agreements in unlimited;
the State Agencies must keep the necessary and appropriate records to be furnished as required by delegates of the Secretary;
the Federal Government provides the funds for the costs of performing the functions authorized by the agreements.
QUIZ QUESTION: Which of the following functions do the SAs perform under the agreements in 1864 of the Act?
ANSWER:
Under the agreements in 1864 of the Act:
-State Agencies explain the requirements to providers and potential providers;
-Operate Toll-Free Home Health Hotline;
-Certify and Re-certify;
-Identify potential participants;
-Conduct investigations and fact-finding surveys
QUIZ QUESTION: Which of the following are nationally approved accreditation organizations under 1865 of the Act?
ANSWER:
There are five nationally approved accreditation organizations under 1865 if the Act. They are as follows:
-The American Association for Accreditation for Ambulatory Surgery Facilities (AAAASF);
-The American Osteopathic Association (AOA);
-The Community Health Accreditation Program (CHAP);
-The Joint Commission (TJC); and the Accreditation Association for Ambulatory Healthcare, Inc. (AAHC).
QUIZ QUESTION: ALL of the statements are TRUE
ANSWER:
The following statements are true about certification:
-State Agencies officially certify their findings as to whether health care entities meet the Act’s provider or supplier definitions;
-State Agencies officially certify their findings as to whether the entities comply with standards required by Federal regulations;
-A facility must be in operation to obtain Federal certification.
QUIZ QUESTION: The date of compliance is based on which three requirements?
ANSWER:
The date of compliance is based on the following:
-Compliance with all applicable Conditions of Participation (CoP)
-Substantial compliance with the requirements for SNFs & NFs
-Compliance with applicable Conditions for Coverage for suppliers
QUIZ QUESTION: How are Federal regulations developed?
ANSWER:
CMS analysts and lawyers review the law and conference report; then CMS drafts a proposed rule. The Rule is published in the Federal Register and the public may comment during the comment period (usually 60 days). CMS analysts & lawyers review all of the public comments received. Any suggested changes that will improve the quality of the regulation are incorporated. The final rule is published in the Federal Register.
QUIZ QUESTION: What purpose is served by a review of the Conference Report?
ANSWER:
The Conference Report contains how the law was introduced and may contain detailed information that sheds light on the legislator’s intent.
QUIZ QUESTION: How often are final rules published in the Federal Register incorporated into the Code of Federal Regulations?
ANSWER:
The final rules published in the Federal Register are incorporated into the Code of Federal Regulations once a year.
QUIZ QUESTION: Why is the survey and certification process necessary?
ANSWER:
The Survey and certification process is necessary because of the following reasons:
-The population that is age 65 or over is growing, creating a higher demand for long term care
-To ensure that the 16,800+ nursing homes meet applicable Federal requirements
-To protect the more than 2.9 million residents who reside in our nation’s nursing homes form poor standards of care
-To protect nursing home residents from abuse and neglect.
QUIZ QUESTION: Which groups of people are covered by Title XVIII of the Social Security Act?
ANSWER:
Title XVIII (18) of the Social Security Act provides coverage for the following groups:
-People age 65 or older
-People under age 65 with certain disabilities
-People of all ages with End Stage Renal Disease.
QUIZ QUESTION: Which Congressional Act established quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of resident test results regardless of where the test was performed?
ANSWER:
CLIA- The Clinical Laboratory Improvement Amendments of 1988 (CLIA) established quality standards for all laboratory testing to ensure the accuracy, reliability & timeliness of resident test results regardless of where the test was performed.
QUIZ QUESTION: CMS’s mission is to assure health care security for beneficiaries. Which of the following activities are included in CMS’s mission?
ANSWER:
CMS’s mission includes all of the following:
-Regulating all laboratory testing (expect research) performed on humans in the United States
-Helping millions of Americans and small companies get and keep health insurance coverage with the Departments of Labor and Treasury
-Administering the State Children’s Health Insurance Program (SCHIP) with the Health Resources and Services Administration
-Helping to eliminate discrimination based on health status for people buying health insurance.