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HEALTH CARE LAWS AND REGULATIONS
ANA JACOBS
HCS/430
August 08, 2016
Instructor Kenneth Pincus
INTRODUCTION
Patient Protection and Affordable Care Act
HIPAA Privacy Rule
Hi Tech Act
Occupational Safety and Health Act of 1970
False Claims Act
Anti-Kickback Statute
Stark Law
Human Subject Research
REGULATORY REQUIREMENTS
THE DEVELOPMENT OF HEALTH CARE POLICIES
HEALTH CARE: LOCAL, STATE, AND FEDERAL LAWS
“Health care regulation exceeds $339 Billion dollars”
(Zachary, 2010).
“The benefits of health services regulation exceeds $170
billion and the net burden of health services regulation is at
$169 Billion” (Zachary, 2010).
• United States Department of Health and Human Services
• NAMFCU National Association of Medicare/Medicaid Fraud Control Units.
• MFCU Medicaid Fraud Control Units (that are also distributed statewide)
• FTC Federal Trade Commission
• HCFAC Health Care Fraud and Abuse Control
• DEA Drug Enforcement Agency
• DOJ Department of Justice
• OIG Office of the Inspector General
• IRS Internal Revenue Service
• FDA Food and Drug Administration
• Financial Fraud Enforcement Task Force
Agencies that currently monitor fraud waste and abuse
REGULATORY ISSUES AND TRENDS
HAVE AN IMPACT ON THE INDUSTRY OF HEALTH CARE
ACCREDITATION AND REGULATORY AGENCIES IN
HEALTH CARE
CONCLUSION
REFERENCES
Centers for Medicare and Medicaid Services. (2016). Retrieved from website on August 1,
2016 from: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-
MLN/MLNProducts/Downloads/Fraud_and_Abuse.pdf
Field, R. I. (2008). Why Is Health Care Regulation So Complex? Pharmacy and Therapeutics,
33(10), 607–608. University of Phoenix student materials HCS/430 August 08, 2016
Mechanic, David, Rogut, Lynn B., and Colby, David C., eds. Policy Challenges in Modern
Health Care. Piscataway, NJ, USA: Rutgers University Press, 2005. ProQuest ebrary. Web. 8 August
2016.
Zachary, C. B. Skin & Allergy News. Jan 2010 v41 i1 p12(1). Regulations overburden
health care. COPYRIGHT 2010 International Medical News Group. University of Phoenix Electronic
Reserve student materials HCS/430. Retrieved August 08, 2016

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Jacobsweek4hcs430august082016 health care laws and regulations

  • 1. HEALTH CARE LAWS AND REGULATIONS ANA JACOBS HCS/430 August 08, 2016 Instructor Kenneth Pincus
  • 3. Patient Protection and Affordable Care Act HIPAA Privacy Rule Hi Tech Act Occupational Safety and Health Act of 1970 False Claims Act Anti-Kickback Statute Stark Law Human Subject Research
  • 4. REGULATORY REQUIREMENTS THE DEVELOPMENT OF HEALTH CARE POLICIES
  • 5. HEALTH CARE: LOCAL, STATE, AND FEDERAL LAWS “Health care regulation exceeds $339 Billion dollars” (Zachary, 2010). “The benefits of health services regulation exceeds $170 billion and the net burden of health services regulation is at $169 Billion” (Zachary, 2010).
  • 6. • United States Department of Health and Human Services • NAMFCU National Association of Medicare/Medicaid Fraud Control Units. • MFCU Medicaid Fraud Control Units (that are also distributed statewide) • FTC Federal Trade Commission • HCFAC Health Care Fraud and Abuse Control • DEA Drug Enforcement Agency • DOJ Department of Justice • OIG Office of the Inspector General • IRS Internal Revenue Service • FDA Food and Drug Administration • Financial Fraud Enforcement Task Force Agencies that currently monitor fraud waste and abuse
  • 7. REGULATORY ISSUES AND TRENDS HAVE AN IMPACT ON THE INDUSTRY OF HEALTH CARE
  • 8. ACCREDITATION AND REGULATORY AGENCIES IN HEALTH CARE
  • 10. REFERENCES Centers for Medicare and Medicaid Services. (2016). Retrieved from website on August 1, 2016 from: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network- MLN/MLNProducts/Downloads/Fraud_and_Abuse.pdf Field, R. I. (2008). Why Is Health Care Regulation So Complex? Pharmacy and Therapeutics, 33(10), 607–608. University of Phoenix student materials HCS/430 August 08, 2016 Mechanic, David, Rogut, Lynn B., and Colby, David C., eds. Policy Challenges in Modern Health Care. Piscataway, NJ, USA: Rutgers University Press, 2005. ProQuest ebrary. Web. 8 August 2016. Zachary, C. B. Skin & Allergy News. Jan 2010 v41 i1 p12(1). Regulations overburden health care. COPYRIGHT 2010 International Medical News Group. University of Phoenix Electronic Reserve student materials HCS/430. Retrieved August 08, 2016

Editor's Notes

  1. Introduction “The multidimensionality of health care issues— along with the public-private nature of U.S. health care financing and delivery systems— means that major bills are often highly complex. It is not uncommon for major reform proposals to include provisions that simultaneously attempt to expand coverage, contain costs, and address the quality of care— not to mention provisions designed to appeal to policymakers holding diametrically opposed preferences about markets and government. Complexity and ambiguity are necessary to forge compromises in the U.S. political system, which allows many players to exert vetoes as legislation proceeds. Yet when legislation addresses multiple aspects of an issue, it can also become increasingly tricky to reach closure. Choices regarding which element to address first create more avenues for strategic maneuvering, affecting possibilities for success and leading to continuing struggles in the aftermath of both enacted and failed legislation.” (Mechanic et al, 2005). The presentation considers the impact health care regulation and policies have on the industry and the patient population. What impact does local, state, and federal laws have on the health care industry? Role of accreditation and regulatory agencies in the health care industry. Impact legal and regulatory requirements have on the development of organizational health care policies. Regulatory issues and trends that have an impact on the health care industry.
  2. “The FCA protects the government from being overcharged or sold substandard goods or services. The FCA imposes civil liability on any person who knowingly submits, or causes the submission of, a false or fraudulent claim to the Federal government. The “knowing” standard includes acting in deliberate ignorance or reckless disregard of the truth related to the claim. Example: A physician submits claims to Medicare for a higher level of medical services than actually provided or that the medical record documents.”(www.cms.gov, 2016). “Penalties: Civil penalties for violating the FCA can include fines of $5,500–$11,000 per false claim and up to three times the amount of damages sustained by the government as a result of the false claims. There is also a criminal FCA statute by which individuals or entities that submit false claims can face criminal penalties.” (cms.gov, 2016).
  3. Health care regulations that have an impact on the industry are well intended to promote access to health care, equity, quality; and safety, while lowering costs. All of the factors are benefits of health care regulations, however – enacting health care laws, amending health care regulations; and implementing health care policy is costly to the government. The facts mentioned leaving many to wonder is it really worth it. “We need to consider scrapping all regulations that have a negative cost/benefit ratio and regulations for which there is no evidence-based rationale. The emphasis cannot be simply on reducing costs; it needs to be based on factual evidence and improved quality of health care. “ (Zachary, 2010).
  4. “In essence, the system benefits by receiving regulatory input from varying perspectives. State and local agencies are often closest to the actual provision of health care and the most sensitive to regional needs. Federal oversight is usually necessary to provide national coordination, for example, to prevent physicians who have been disciplined by a medical board from gaining licensure in another state. Private organizations offer the deepest expertise in the clinical aspects of care.” (Field, 2008).
  5. All of the above listed agencies some of which are headed by the United States Department of Health and Human Services - have a hand in combatting health care fraud, waste, and abuse.
  6. On the state level, regulations are in place to prevent any health care worker that has been disciplined – from practicing on a suspended license or without certification. Regulations on the local, and state levels may vary slightly from state to state. Regulations on every level have a significant impact on the delivery of health care to the patient population and the health industry as a whole. “I don't mind having health care regulations if they provide a benefit to society or more efficient practice. What I can't stand is wasting money on health care regulations that serve no purpose. While we are being required to practice evidence-based medicine, we need to insist that the federal government practice evidence-based regulation. “ (Zachary, 2010). There are so many regulatory bodies that govern health care – some of which seem to be dipping into government funding for the same purpose – the prevention of fraud, waste, and abuse – seemingly defeating the whole purpose of such monitoring systems.
  7. “As a result of this network of oversight bodies, those individuals and organizations subject to regulation must turn to multiple competing authorities for guidance. Two examples illustrate this dynamic.” (Field, 2008). Each of the competitors have standards, guidelines, and regulations that complement each other, and are also a duplicative process. “The path to practicing medicine is paved with an array of regulatory hurdles implemented by an assortment of bureaucracies. A potential physician must attend a medical school that has received accreditation by a private body, take a national examination administered by another nongovernmental organization, obtain licensure from a state medical board, complete a hospital residency that is funded and governed by the federal Medicare program, achieve certification from a private specialty board, and obtain clinical privileges at a hospital that may operate as either a private or public entity. To receive payment for services and actually earn a living, it is often also necessary for a physician to qualify for participation in Medicare and in the network of a managed care organization (MCO).” (Field, 2008).
  8. Health care regulation and laws can have a positive impact on the health industry to contain the costs of providing patient care and the cost of insurance for patients. When there is abuse of government funds on every level, all of these regulations defeat their intended purposes. “Although no precise measure of health care fraud exists, those intent on abusing the system can cost taxpayers billions of dollars while putting beneficiaries’ health and welfare at risk. Medicare fraud and abuse increases the strain on the Medicare Trust Fund. The impact of these losses and risks magnify as Medicare continues to serve a growing number of people.” (cms.gov, 2016). It goes without saying that to cover the cost of implementing health care regulations as they are endlessly unfurled onto the health care industry and the patient population, the cost of health care will continue to rise. In 2016, health care issues continue to plague the population of patients and as well as the industry of health care. “Any talk of health care reform must include a discussion of the money we're currently wasting on health care regulation. Recent data suggest that 47-60 million Americans are without health insurance. Many people avoid seeking health care because it is too costly. If they do seek care, many become burdened by high costs.” (Zachary, 2010). These discussions on health care regulations must be a non-conclusive continuous discussion that is open – ended, and on-going.