CRCR Regulatory and Compliance Knowledge 2 — Questions and Answers
Question 1: What is a covered entity under HIPAA?
- Any business that employs healthcare workers
- Health plans, healthcare clearinghouses, and healthcare providers that transmit health information electronically (Correct answer)
- All businesses that collect personal data
- Only hospitals and physician practices
Correct answer: Health plans, healthcare clearinghouses, and healthcare providers that transmit health information electronically
HIPAA's covered entity definition includes health plans, clearinghouses, and any provider that transmits PHI electronically in connection with standard transactions.
Under HIPAA covered entities are: health plans including health insurance companies, HMOs, and government programs like Medicare and Medicaid; healthcare clearinghouses; and healthcare providers that transmit health information electronically in connection with HIPAA standard transactions. Covered entities are directly subject to HIPAA's Privacy and Security Rules.
Question 2: What are the potential penalties for a HIPAA breach resulting from willful neglect that is not corrected?
- No penalty if the organization apologizes
- Up to $1.9 million per violation category per year plus potential criminal charges (Correct answer)
- Only a written warning for a first offense
- A $100 fine per affected patient
Correct answer: Up to $1.9 million per violation category per year plus potential criminal charges
HIPAA's tiered penalty structure imposes the highest fines for willful neglect that is not corrected.
HIPAA civil monetary penalties are tiered based on culpability. The highest tier, willful neglect not corrected, carries penalties of $50,000 to $1.9 million per violation category per calendar year. In addition to civil penalties the DOJ can pursue criminal charges for knowing violations. The HHS Office for Civil Rights enforces HIPAA civil penalties.
Question 3: What do the Conditions of Participation refer to in healthcare compliance?
- Patient consent forms required before surgery
- Federal standards that healthcare facilities must meet to participate in the Medicare and Medicaid programs (Correct answer)
- State licensing requirements for physicians
- The terms of a hospital's private insurance contracts
Correct answer: Federal standards that healthcare facilities must meet to participate in the Medicare and Medicaid programs
CoPs are CMS's baseline standards for quality and patient safety that must be met for facilities to participate in Medicare and Medicaid.
Conditions of Participation are federal requirements established by CMS that healthcare organizations including hospitals, critical access hospitals, home health agencies, and hospices must meet to participate in Medicare and Medicaid. CoPs cover patient rights, nursing and medical staff standards, infection control, quality improvement, and discharge planning.
Question 4: What is the role of CMS in US healthcare compliance?
- To prosecute healthcare fraud on behalf of the DOJ
- To administer Medicare and Medicaid, set coverage policies, issue billing regulations, and establish quality standards for participating providers (Correct answer)
- To license physicians and other healthcare professionals
- To investigate insurance company rate increases
Correct answer: To administer Medicare and Medicaid, set coverage policies, issue billing regulations, and establish quality standards for participating providers
CMS is the federal agency responsible for operating Medicare and Medicaid and setting the regulatory framework for both programs.
The Centers for Medicare and Medicaid Services is the federal agency within HHS responsible for administering the Medicare and Medicaid programs. CMS sets coverage policies, establishes billing and coding rules, publishes fee schedules and payment systems, issues Conditions of Participation, and monitors quality through value-based purchasing programs.
Question 5: What is exclusion from Medicare and Medicaid participation and what triggers it?
- A patient's inability to use Medicare due to age
- A federal sanction that bars an individual or entity from billing Medicare or Medicaid triggered by fraud convictions, license revocations, or other specified conduct (Correct answer)
- A voluntary decision by a provider to leave the Medicare network
- A temporary suspension of billing privileges for late claims
Correct answer: A federal sanction that bars an individual or entity from billing Medicare or Medicaid triggered by fraud convictions, license revocations, or other specified conduct
OIG exclusion bars individuals and entities from participation in federal healthcare programs which is one of the most serious compliance sanctions available.
Exclusion from Medicare and Medicaid is a federal sanction administered by the OIG that bars an individual or entity from billing any federal healthcare program. Mandatory exclusions are triggered by felony convictions related to healthcare fraud, patient abuse, or controlled substances. Employing an excluded individual even in a non-clinical role can expose the organization to significant penalties.
Question 6: What is the Medicare Appeals Council in the context of the Medicare appeals process?
- The first level of appeal after a Medicare denial
- The fourth level of the Medicare appeals process following an ALJ hearing where Medicare beneficiaries and providers can appeal ALJ decisions (Correct answer)
- A private review organization contracted by CMS
- A CMS committee that approves new Medicare coverage policies
Correct answer: The fourth level of the Medicare appeals process following an ALJ hearing where Medicare beneficiaries and providers can appeal ALJ decisions
The Medicare Appeals Council is the fourth of five levels of Medicare appeals for Part A and Part B disputes.
The Medicare appeals process for Part A and Part B claims has five levels: redetermination by the Medicare Administrative Contractor, reconsideration by a Qualified Independent Contractor, hearing before an Administrative Law Judge, review by the Medicare Appeals Council, and judicial review in federal district court. Each level has defined timeframes for requesting the appeal and for the reviewing body to issue a decision.
What is a covered entity under HIPAA?