chapter 3
Amie1997
LegalandRegulatoryIssues2.pptLegal and Regulatory Issues
HCA 698
PART ONE
4/23/22
WELCOME BACK!
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Ice Breaker: The Law
- Regulations are created at three different levels of government and which regulation(s) would you apply to your business and why?
An Overview
- Healthcare is one of the most regulated industries in the United States
- Therefore an effective manager in health care industries must understand basic legal and ethical principles that influence the work environment, and the legal relationship between the organization and the consumer – the healthcare provider and the patient
- Must have knowledge of basic concepts of law, both civil and criminal healthcare law, tort reform, employment-related legislation, safety in the workplace, workplace ethics, and the provider-patient relationship, healthcare organizational codes of ethics, public health ethics, research ethics, and workplace bullying
Understand Federal Security Rules that Apply
- Understand the federal regulations that apply to the business practice
- Documentation of how the security rule applies to the business practices and how can be used to support compliance
Understand State Security Laws that Apply
- You must review the summary of the state laws that apply to the business practice
- Make sure requirements have already been met before moving forward with your business
- All state law must be implemented
State Laws Preempted
- Make sure you have a check list for preempted State laws
- A preempted analysis is needed and as apply to your business; to determine if it is preempted or more stringent than requirements
Under the doctrine of preemption, which is based on the Supremacy Clause, federal law preempts state law, even when the laws conflict. Thus, a federal court may require a state to stop certain behavior it believes interferes with, or is in conflict with, federal law.
Preempted - take action in order to prevent (an anticipated event) from happening; forestall.
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Identify Business Practices That Are Not Compliant with Business Security
- Identify the business practice(s) or what portion of the practice(s) are not for Federal/State compliant and why the practice is not compliant
Legal Terms Related to Health Care
- Legal capacity (competency): The right and ability to manage one’s own affairs
- Legal incapacity (incompetence): The inability to manage one’s own affairs because of injury or disability, as determined by a legal proceeding
- Clinical incapacity to make health care decision: The inability to make appropriate decision regarding health care or to carry them out, as determined by a doctor or other health care practitioner
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Legal Issues for Hospitals and Health System
- Lawsuits against the mandate to buy health insurance - Keeping the popular protection for people with pre-existing conditions, for example, requires that everyone have insurance. Without such a mandate, people would have no reason to buy coverage until they got sick
- HIPAA and data breaches - the laws vary on what counts as personal information, how notice of the breach has to be made and the amount of fines for noncompliance. In Nov. 2010, California levied a total of $792,000 in fines against six hospitals and a nursing home for failing to prevent unauthorized access to confidential patient information
- Impact of Stark Law on physician-hospital relationships - The Stark Law was enacted to prevent referral sources — namely physicians and physician extenders — from inappropriately profiting from referrals. Under Stark, a physician may not refer a patient for certain services to be reimbursed by federal healthcare programs to an entity with which the physician has an ownership interest or compensation arrangement
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Legal Issues for Hospitals and Health System
- Antitrust Issues and ACOs - The possibility that ACOs could be a means for hospitals to raise prices runs counter to the basic concept of ACOs, which is to bring hospitals together to lower prices, but it could happen
- False claims and whistle-blower suits - The False Claims Act is a federal law that covers fraud involving any federally funded contract or program, including Medicare or Medicaid, allowing healthcare providers to be prosecuted for various actions leading to the submission of a fraudulent claim
- Anti-Kickback and Physician-hospital issues - The Anti-Kickback Statute governs a hospital's financial relationships with physicians. Healthcare organizations can run afoul of the Anti-Kickback Law by providing free services or staff to a practice, paying for unneeded services, providing discounts to practices and paying physicians different amounts than what had been contracted. Recruitment arrangements could also violate the statute. To comply, payments to physicians have to be at fair market value and be commercially reasonable.
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Legal Issues for Hospitals and Health System
- Recovery Audit Contractors – Hospitals and practices can appeal RAC determinations, but they must choose their fights wisely because appeals are expensive and time-consuming. That said, providers have good changes of winning an appeal against a Medicare RAC if they can show their claim filings met CMS payment criteria
- Compliance requirements for tax-exempt hospitals - The Patient Protection and Affordable Care Act contains specific requirements for hospitals that wish to receive or maintain tax-exempt status under section 501(c)(3) of the Internal Revenue Code, changing the "community benefit standard" upon which tax-exempt hospitals have been judged for 40 years
- Co-management arrangements - These arrangements can be structured to meet many objectives, such as lowering hospital costs, achieving operational efficiencies, improving quality and outcomes, adherence to evidence-based medicine and increasing profitability, patient satisfaction, physician recruitment and even emergency call coverage
Legal Issues for Hospitals and Health System
- Changes is Reimbursement - Reimbursement rates have shifted under PPACA, significantly lowering reimbursements for some providers while increasing rates for others
- Labor and Employment Issues – e.g. : Age discrimination, disabilities and etc.
- Mergers and antitrust law - Hospital mergers are heating up and so are concerns that some of them violate antitrust law. Merger and acquisition volume for the third quarter of 2010 was 20% higher than for the third quarter of 2009. Enforcement agencies have been leery of hospital mergers, suspecting that market power, rather than increased efficiency, is the real motivation behind them
- Medical Malpractice and Tort Reform - Currently, nearly all states require that physicians have liability insurance, and even in states that don't, physicians usually have to have insurance coverage in order to gain hospital privileges. Hospitals and other healthcare facilities purchase their own insurance separate from physicians and physician practices, and hospitals that directly employ physicians generally buy policies that cover both the hospital and its medical staff
Regulatory Issues
- Regulatory Affairs division is responsible for keeping abreast of current federal regulations and government policies that affect an agency's day to day operations as well as its long term business planning.
- For example, the regulatory staff is often the first to learn of regulatory changes that have both direct and indirect effects on the home health and hospice industry. This up to the minute tracking of key regulatory events enables members to stay ahead of the curve in a rapidly changing health care environment.
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Definition of Gap Analysis
- Formally means to identify and correct gaps between desired levels and actual levels of performance
- Used by organizations to analyze certain processes of any division of their company
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- Gaps are indicators of corrective action and improvements
- In manufacturing, it could be difference between desired and existing conformance levels
Stages in Gap Analysis
Gaps Model
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Gaps Model
- There are items which can be rated
- i.e. modern looking equipment, prompt service, understanding of needs, etc.
- These items are broken up into 5 dimensions:
- Tangibles (Items 1-4)
- Reliability (Items 5-9)
- Responsiveness (Items 10-13)
- Assurance (Items 14-17)
- Empathy (Items 18-22)
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Tangibles: appearance of physical facilities, equipment, personnel, and communication materials
Reliability: ability to perform the promised service dependably and accurately
Responsiveness: willingness to help customers and provide prompt service
Assurance: knowledge and courtesy of employees and their ability to convey trust and confidence
Empathy: the caring, individualized attention the firm provides its customers
- Reliability is the most important dimension
- Tangibles is the least important dimension
- There is a shared importance between Reliability and Responsiveness
Gaps Model
- High Training needed
negative = in certain
rating dimension
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- High Dimension is OK,
positive = no training
rating needed
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- If the average rating is negative there is a need for action
- As the rating gets lower below zero, the more stress must be placed on that process
- If the average rating is above zero, the requirements have been met and no action is needed
Gap Analysis Tool
- Phase 1: Identify Gaps
- Phase 2: Fill Gaps
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- The Praxion Research Group’s Gap Analysis Tools is made up of 2 phases:
- Identification of Gaps
- Filling of Gaps
- These Phases will be broken down in the next few slides
Within the Period of One Year?
Within the Period of One Year?
Gap Analysis Tool
Fill Gaps:
- Once all actions are performed and gaps are filled, the organization will have a
Gary Garcia 2021 Compliant
Quality Management System Report
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- After all remedial actions are set into motion and recorded in alignment with the ISO standards the date is recorded and after the actions take place the organization’s processes are soon on their way to becoming ISO 9001 2000 compliant.
Summary of Gap Analysis
- Gaps can be found in any process of an organization’s operations
- Gap Analysis is one of the best procedures to help lead a company to not only improve their processes, but recognize which processes are in need of improvement.
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Bibliography
Foster, S. Thomas, Managing Quality: An Integrative Approach. Prentice Hall, 2001: pg. 132-134, 231-234.
Conclusion
Top Government Regulations for Business in 2019
- Tax code Business Regulations
- Employment and Labor Laws
- Antitrust Regulations
- Advertising Regulations
- Environmental Regulations
- Privacy Regulation
- State Licensing Regulation
Business Loans & Grant
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