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Compliance Regulations and Guidance Affecting your Industry
Get trained on regulations affecting your industry through online webinars, learn the best practices, and download quality standards, checklists and news articles. Listen to experts on best practices to streamline quality and compliance processes and meet the regulatory demands.Categories
Compliance Trainings
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Chief Compliance Officer: What does it take to do the job? The Organization's and CCO's Responsibilities
By - Laura S Hargraves
On Demand Access Anytime
By - Laura S Hargraves
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Structuring Physician Practice Acquisitions: Key Stark Law Considerations
By - Joseph Wolfe
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By - Joseph Wolfe
On Demand Access Anytime
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Preventative Medicine: Is it Time to Streamline Your Physician Enterprise Structure so it Stands the Test of Time
By - Joseph Wolfe
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By - Joseph Wolfe
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Contracted Services: Ensuring Compliance with the CMS Hospital CoP Standards, Joint Commission and DNV
By - Sue Dill Calloway
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By - Sue Dill Calloway
On Demand Access Anytime
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Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development ....
- Industry: Healthcare Compliance (Hospitals)
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.'' This guidance describes how FDA reviews and evaluates patient-reported outcome (PRO) instruments used to measure treatment benefit in medical product clinical trials. It also provides recommendations on how sponsors can use study results measured by PRO instruments to support claims in approved medical product labeling. This guidance finalizes the draft guidance published on February 3, 2006. DATES: Submit written or electronic comments on agency guidances at any time.
The Genetic Information Nondiscrimination Act of 2008 Information for Researchers and Health Ca ....
- Industry: Healthcare Compliance (Hospitals)
The Genetic Information Nondiscrimination Act of 2008 (P.L. 110-233, 122 Stat. 881)1, also referred to as GINA, is a new Federal law that prohibits discrimination in health coverage and employment based on genetic information. The President signed the act into law on May 21, 2008. The section of the law relating to health coverage (Title I) generally will take effect between May 22, 2009, and May 21, 2010.2 The sections relating to employment (Title II) will take effect on November 21, 2009. GINA requires regulations pertaining to both titles to be completed by May 2009.
How does the Federal law affect state laws?
GINA provides a baseline level of protection against genetic discrimination for all Americans. Many states already have laws that protect against genetic discrimination in health insurance and employment situations. However, the degree of protection they provide varies widely, and while most provisions are less protective than GINA, some are more protective. All entities that are subject to GINA must, at a minimum, comply with all applicable GINA requirements, and may also need to comply with more protective State laws.
Effective Date:This rule is effective April 6, 2009
Centers for Medicare & Medicaid Services (CMS), HHS.
- Industry: Healthcare Compliance (Hospitals)
This rule finalizes our proposal to delay enforcement of certain clarifications regarding standards for determining hold harmless arrangements in the final rule entitled, ‘‘Medicaid Program; Health Care- Related Taxes’’ from the expiration of a Congressional moratorium on enforcement from July 1, 2009 to June 30, 2010
Effective Date:This rule is effective July 1, 2009.
Medicare Program; Hospice Wage Index for Fiscal Year 2010
- Industry: Healthcare Compliance (Hospitals)
This final rule will set forth the hospice wage index for fiscal year 2010. The final rule adopts a MedPAC recommendation regarding a process for certification and recertification of terminal illness. In addition, this final rule will also revise the phase-out of the wage index budget neutrality adjustment factor (BNAF), with a 10 percent BNAF reduction in FY 2010. The BNAF phase-out will continue with successive 15 percent reductions from FY 2011 through FY 2016
Effective Date:This rule is effective October 1, 2009.
Medicaid Program: State Flexibility forMedicaid Benefit Packages and Premiums and Cost Sharing
- Industry: Healthcare Compliance (Hospitals)
This final rule temporarily delays the effective date of the November 25, 2008 final rule entitled, ‘‘Medicaid Program; Premiums and Cost Sharing’’ and the December 3, 2008 final rule entitled, ‘‘Medicaid Program; State Flexibility for Medicaid Benefit Packages’’ until July 1, 2010
Effective Date:This rule is effective December 31, 2009.
Medicare Program; Hospice Wage Index for Fiscal Year 2010
- Industry: Healthcare Compliance (Hospitals)
This final rule will set forth the hospice wage index for fiscal year 2010. The final rule adopts a MedPAC recommendation regarding a process for certification and recertification of terminal illness. In addition, this final rule will also revise the phase-out of the wage index budget neutrality adjustment factor (BNAF), with a 10 percent BNAF reduction in FY 2010. The BNAF phase-out will continue with successive 15 percent reductions from FY 2011 through FY 2016
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