Key Compliance Issues In Clinical Research: What Sites, CROs, and Start-Ups N...Polsinelli PC
Clinical research presents a host of potential compliance and legal risks. This webinar will provide an overview of key legal issues in clinical research applicable to all involved parties, including sponsors, sites and CROs. We will also review recent enforcement activities related to research studies, and provide strategies for addressing issues that arise, both preemptively (through compliance plans) and in response to identified concerns.
Our agenda:
• Understand key rules and regulations and how they apply in the context of clinical research
• Review key areas of compliance risk, ranging from Medicare reimbursement and billing concerns to informed consent and use of equipment and materials in clinical research
• Outline key components of compliance plans and specifics relevant to clinical research
Key Compliance Issues In Clinical Research: What Sites, CROs, and Start-Ups N...Polsinelli PC
Clinical research presents a host of potential compliance and legal risks. This webinar will provide an overview of key legal issues in clinical research applicable to all involved parties, including sponsors, sites and CROs. We will also review recent enforcement activities related to research studies, and provide strategies for addressing issues that arise, both preemptively (through compliance plans) and in response to identified concerns.
Our agenda:
• Understand key rules and regulations and how they apply in the context of clinical research
• Review key areas of compliance risk, ranging from Medicare reimbursement and billing concerns to informed consent and use of equipment and materials in clinical research
• Outline key components of compliance plans and specifics relevant to clinical research
White Paper: How Can we Improve the Prior Authorization Process Today?TransUnion
Prior authorization processes can zap time and resources, wreck your revenue cycle and delay patients’ access to urgent—sometimes life-saving—care.
Download this special report to learn what you can do now to cut costs, elevate the customer experience and reduce revenue leakages.
Secondary Data SourcesThe health record’s primary purpos.docxrtodd280
Secondary Data Sources
The health record’s primary purpose is patient care and reimbursement for encounters.
In order to see trends in a population of patients, you look at the data that is extracted from the records and enter it into databases – registries, indexes, etc.
These data sources are referred to as secondary data sources.
HIM Roles in Managing Secondary Records and DatabasesEstablishing database:
Determining content of database
Ensuring compliance with laws, regulations, and accreditation standards
Data dictionary
Data steward: oversees that data put in database or registery is accurate and complete
Differences Between Primary and Secondary Data Sources
Primary data source: medical record… b/c it contains information about a patient that has been documented by a healthcare professional
Secondary data source: data contained in indexes, registries and similar databases
Ways to classify data:
Patient-specific/identified data
Patient identified within the data. Every fact recorded in the record relates to a patient by name.
Patient identifiable data
If identify of patient can be derived or inferred from the data with or without the assistance of a computer. Can the patient be identified by date of birth, phone #, zip code,
Aggregate data
Data on groups of patients without identifying any particular patient individually
Purposes and Users of Secondary Data SourcesFour major purposes to collect secondary data:
Quality, performance, and patient safety
Research – data entered into databases help researchers determine treatment plans
Population health – require information be reported about certain diseases to prevent spreading
Administration – facilities are required to check physicians in the national database for information on previous malpractice or action against the physician
Internal Users
Users within the organization
Examples: Medical staff, Management staff
Identify patterns and trends that are helpful in patient long term care, benchmarking with other facilities.
External users
Individuals and institutions outside the facility
Examples: State data banks, Federal agencies
Federal government collects data from states on vital events like births and deaths
Types of Secondary Data Sources
Facility-specific indexes: enable health records to be located by diagnosis, procedure, physician. Originally kept on cards, now in computerized databases due to technology.
Broken down into several types… let’s discuss those types!
Master Population /Patient Index (MPI)
Disease and Operation Index
Physician Index
Registries
Purpose: to collect data from health records and to make them available for users
Registries contains more extensive information than indexes.
Index reports created using data from existing facility databases.
Registries contain more extensive data from the patient record.
Each registry must define the cases that will be included: case definition
Case finding used to identify the patients who have bee.
Auditing Healthcare Focus Arrangements for Regulatory CompliancePYA, P.C.
PYA Principal Tynan Kugler and Consulting Manager Susan Thomas presented “Auditing Healthcare Focus Arrangements for Regulatory Compliance: Physicians, Management Services, Post-Discharge Care, Ambulance Services, and Specialty Care.” Their presentation:
- Describes what constitutes a focus arrangement for healthcare organizations.
- Explains the implications of Stark Law and Anti-Kickback violations, along with Corporate Integrity Agreement focus arrangement requirements.
- Discusses essential focus arrangement procedures to facilitate regulatory compliance.
- Provides an example design of an audit plan approach for focus arrangements.
We believe in innovations and learning new technologies to meet the ever changing market dynamics. We perform as trusted partners to our clients in their endeavor to find the right operating model to leverage the offshore-based Process Outsourcing advantage with a promise to deliver the best in industry service at competitive terms.
Watch the Webinar Here! https://compliatric.com/hrsa-hab-audit-tips-for-part-c/
Join us and Dr. Kim Butler Willis for this special webinar on HRSA HAB Audit Tips for Ryan White Part C Grantees!
By the end of this training, participants will be able to:
- Identify at least two reasons why grantees fail federal audits
- Determine which audit component (administrative, clinical, or financial) is their strongest and weakest areas
- Locate appropriate supplemental resources to support a successful federal audit.
Regulatory Compliance, Risk Management, and the Trustee's RolePYA, P.C.
PYA Principal Shannon Sumner and Consulting Manager Susan Thomas presented “Regulatory Compliance, Risk Management, and the Trustee’s Role.” In this presentation, they will:
Describe the evolving compliance and risk management landscape, including government agencies’ expectations for compliance oversight. This presentation will:
- Outline recent government investigations and settlements.
- Provide key takeaways regarding responsibilities for ensuring an effective compliance program.
- Connect trustee duties to specific elements of enterprise risk management.
- Empower trustees with questions to ask leadership teams in preparation for playing a more active role in the compliance program.
Developed in conjunction with the Regional Extension Center for Washington DC (eHealthDC). An archived version of the Financing your EHR System Webinar will be available soon for viewing.
Hidden Risk Area: Grievances- Are you Prepared for a Survey?PYA, P.C.
PYA Consulting Manager Susan Thomas co-presented with Sheila Limmroth of DCH Health System on “Hidden Risk Area: Patient Grievances–Are You Prepared for a Survey?” Their presentation focused on the following objectives:
-Define CMS expectations for a patient grievance process and how to use the guidance as a compliance work plan auditing tool.
-Discuss what state auditors review when they come onsite to assess your patient grievance process.
-Consider the role of compliance in the patient grievance process.
Health Insurance & Prior authorization Requirements: Its Impact and Recommend...mosmedicalreview
Insurers use prior-authorization to ensure medical necessity. Medical peer review can be initiated when a prior authorization request or a claim is denied.
White Paper: How Can we Improve the Prior Authorization Process Today?TransUnion
Prior authorization processes can zap time and resources, wreck your revenue cycle and delay patients’ access to urgent—sometimes life-saving—care.
Download this special report to learn what you can do now to cut costs, elevate the customer experience and reduce revenue leakages.
Secondary Data SourcesThe health record’s primary purpos.docxrtodd280
Secondary Data Sources
The health record’s primary purpose is patient care and reimbursement for encounters.
In order to see trends in a population of patients, you look at the data that is extracted from the records and enter it into databases – registries, indexes, etc.
These data sources are referred to as secondary data sources.
HIM Roles in Managing Secondary Records and DatabasesEstablishing database:
Determining content of database
Ensuring compliance with laws, regulations, and accreditation standards
Data dictionary
Data steward: oversees that data put in database or registery is accurate and complete
Differences Between Primary and Secondary Data Sources
Primary data source: medical record… b/c it contains information about a patient that has been documented by a healthcare professional
Secondary data source: data contained in indexes, registries and similar databases
Ways to classify data:
Patient-specific/identified data
Patient identified within the data. Every fact recorded in the record relates to a patient by name.
Patient identifiable data
If identify of patient can be derived or inferred from the data with or without the assistance of a computer. Can the patient be identified by date of birth, phone #, zip code,
Aggregate data
Data on groups of patients without identifying any particular patient individually
Purposes and Users of Secondary Data SourcesFour major purposes to collect secondary data:
Quality, performance, and patient safety
Research – data entered into databases help researchers determine treatment plans
Population health – require information be reported about certain diseases to prevent spreading
Administration – facilities are required to check physicians in the national database for information on previous malpractice or action against the physician
Internal Users
Users within the organization
Examples: Medical staff, Management staff
Identify patterns and trends that are helpful in patient long term care, benchmarking with other facilities.
External users
Individuals and institutions outside the facility
Examples: State data banks, Federal agencies
Federal government collects data from states on vital events like births and deaths
Types of Secondary Data Sources
Facility-specific indexes: enable health records to be located by diagnosis, procedure, physician. Originally kept on cards, now in computerized databases due to technology.
Broken down into several types… let’s discuss those types!
Master Population /Patient Index (MPI)
Disease and Operation Index
Physician Index
Registries
Purpose: to collect data from health records and to make them available for users
Registries contains more extensive information than indexes.
Index reports created using data from existing facility databases.
Registries contain more extensive data from the patient record.
Each registry must define the cases that will be included: case definition
Case finding used to identify the patients who have bee.
Auditing Healthcare Focus Arrangements for Regulatory CompliancePYA, P.C.
PYA Principal Tynan Kugler and Consulting Manager Susan Thomas presented “Auditing Healthcare Focus Arrangements for Regulatory Compliance: Physicians, Management Services, Post-Discharge Care, Ambulance Services, and Specialty Care.” Their presentation:
- Describes what constitutes a focus arrangement for healthcare organizations.
- Explains the implications of Stark Law and Anti-Kickback violations, along with Corporate Integrity Agreement focus arrangement requirements.
- Discusses essential focus arrangement procedures to facilitate regulatory compliance.
- Provides an example design of an audit plan approach for focus arrangements.
We believe in innovations and learning new technologies to meet the ever changing market dynamics. We perform as trusted partners to our clients in their endeavor to find the right operating model to leverage the offshore-based Process Outsourcing advantage with a promise to deliver the best in industry service at competitive terms.
Watch the Webinar Here! https://compliatric.com/hrsa-hab-audit-tips-for-part-c/
Join us and Dr. Kim Butler Willis for this special webinar on HRSA HAB Audit Tips for Ryan White Part C Grantees!
By the end of this training, participants will be able to:
- Identify at least two reasons why grantees fail federal audits
- Determine which audit component (administrative, clinical, or financial) is their strongest and weakest areas
- Locate appropriate supplemental resources to support a successful federal audit.
Regulatory Compliance, Risk Management, and the Trustee's RolePYA, P.C.
PYA Principal Shannon Sumner and Consulting Manager Susan Thomas presented “Regulatory Compliance, Risk Management, and the Trustee’s Role.” In this presentation, they will:
Describe the evolving compliance and risk management landscape, including government agencies’ expectations for compliance oversight. This presentation will:
- Outline recent government investigations and settlements.
- Provide key takeaways regarding responsibilities for ensuring an effective compliance program.
- Connect trustee duties to specific elements of enterprise risk management.
- Empower trustees with questions to ask leadership teams in preparation for playing a more active role in the compliance program.
Developed in conjunction with the Regional Extension Center for Washington DC (eHealthDC). An archived version of the Financing your EHR System Webinar will be available soon for viewing.
Hidden Risk Area: Grievances- Are you Prepared for a Survey?PYA, P.C.
PYA Consulting Manager Susan Thomas co-presented with Sheila Limmroth of DCH Health System on “Hidden Risk Area: Patient Grievances–Are You Prepared for a Survey?” Their presentation focused on the following objectives:
-Define CMS expectations for a patient grievance process and how to use the guidance as a compliance work plan auditing tool.
-Discuss what state auditors review when they come onsite to assess your patient grievance process.
-Consider the role of compliance in the patient grievance process.
Health Insurance & Prior authorization Requirements: Its Impact and Recommend...mosmedicalreview
Insurers use prior-authorization to ensure medical necessity. Medical peer review can be initiated when a prior authorization request or a claim is denied.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
The Importance of Community Nursing Care.pdfAD Healthcare
NDIS and Community 24/7 Nursing Care is a specific type of support that may be provided under the NDIS for individuals with complex medical needs who require ongoing nursing care in a community setting, such as their home or a supported accommodation facility.
Medical Technology Tackles New Health Care Demand - Research Report - March 2...pchutichetpong
M Capital Group (“MCG”) predicts that with, against, despite, and even without the global pandemic, the medical technology (MedTech) industry shows signs of continuous healthy growth, driven by smaller, faster, and cheaper devices, growing demand for home-based applications, technological innovation, strategic acquisitions, investments, and SPAC listings. MCG predicts that this should reflects itself in annual growth of over 6%, well beyond 2028.
According to Chris Mouchabhani, Managing Partner at M Capital Group, “Despite all economic scenarios that one may consider, beyond overall economic shocks, medical technology should remain one of the most promising and robust sectors over the short to medium term and well beyond 2028.”
There is a movement towards home-based care for the elderly, next generation scanning and MRI devices, wearable technology, artificial intelligence incorporation, and online connectivity. Experts also see a focus on predictive, preventive, personalized, participatory, and precision medicine, with rising levels of integration of home care and technological innovation.
The average cost of treatment has been rising across the board, creating additional financial burdens to governments, healthcare providers and insurance companies. According to MCG, cost-per-inpatient-stay in the United States alone rose on average annually by over 13% between 2014 to 2021, leading MedTech to focus research efforts on optimized medical equipment at lower price points, whilst emphasizing portability and ease of use. Namely, 46% of the 1,008 medical technology companies in the 2021 MedTech Innovator (“MTI”) database are focusing on prevention, wellness, detection, or diagnosis, signaling a clear push for preventive care to also tackle costs.
In addition, there has also been a lasting impact on consumer and medical demand for home care, supported by the pandemic. Lockdowns, closure of care facilities, and healthcare systems subjected to capacity pressure, accelerated demand away from traditional inpatient care. Now, outpatient care solutions are driving industry production, with nearly 70% of recent diagnostics start-up companies producing products in areas such as ambulatory clinics, at-home care, and self-administered diagnostics.
CRISPR-Cas9, a revolutionary gene-editing tool, holds immense potential to reshape medicine, agriculture, and our understanding of life. But like any powerful tool, it comes with ethical considerations.
Unveiling CRISPR: This naturally occurring bacterial defense system (crRNA & Cas9 protein) fights viruses. Scientists repurposed it for precise gene editing (correction, deletion, insertion) by targeting specific DNA sequences.
The Promise: CRISPR offers exciting possibilities:
Gene Therapy: Correcting genetic diseases like cystic fibrosis.
Agriculture: Engineering crops resistant to pests and harsh environments.
Research: Studying gene function to unlock new knowledge.
The Peril: Ethical concerns demand attention:
Off-target Effects: Unintended DNA edits can have unforeseen consequences.
Eugenics: Misusing CRISPR for designer babies raises social and ethical questions.
Equity: High costs could limit access to this potentially life-saving technology.
The Path Forward: Responsible development is crucial:
International Collaboration: Clear guidelines are needed for research and human trials.
Public Education: Open discussions ensure informed decisions about CRISPR.
Prioritize Safety and Ethics: Safety and ethical principles must be paramount.
CRISPR offers a powerful tool for a better future, but responsible development and addressing ethical concerns are essential. By prioritizing safety, fostering open dialogue, and ensuring equitable access, we can harness CRISPR's power for the benefit of all. (2998 characters)
CHAPTER 1 SEMESTER V PREVENTIVE-PEDIATRICS.pdfSachin Sharma
This content provides an overview of preventive pediatrics. It defines preventive pediatrics as preventing disease and promoting children's physical, mental, and social well-being to achieve positive health. It discusses antenatal, postnatal, and social preventive pediatrics. It also covers various child health programs like immunization, breastfeeding, ICDS, and the roles of organizations like WHO, UNICEF, and nurses in preventive pediatrics.
Leading the Way in Nephrology: Dr. David Greene's Work with Stem Cells for Ki...Dr. David Greene Arizona
As we watch Dr. Greene's continued efforts and research in Arizona, it's clear that stem cell therapy holds a promising key to unlocking new doors in the treatment of kidney disease. With each study and trial, we step closer to a world where kidney disease is no longer a life sentence but a treatable condition, thanks to pioneers like Dr. David Greene.
Defecation
Normal defecation begins with movement in the left colon, moving stool toward the anus. When stool reaches the rectum, the distention causes relaxation of the internal sphincter and an awareness of the need to defecate. At the time of defecation, the external sphincter relaxes, and abdominal muscles contract, increasing intrarectal pressure and forcing the stool out
The Valsalva maneuver exerts pressure to expel faeces through a voluntary contraction of the abdominal muscles while maintaining forced expiration against a closed airway. Patients with cardiovascular disease, glaucoma, increased intracranial pressure, or a new surgical wound are at greater risk for cardiac dysrhythmias and elevated blood pressure with the Valsalva maneuver and need to avoid straining to pass the stool.
Normal defecation is painless, resulting in passage of soft, formed stool
CONSTIPATION
Constipation is a symptom, not a disease. Improper diet, reduced fluid intake, lack of exercise, and certain medications can cause constipation. For example, patients receiving opiates for pain after surgery often require a stool softener or laxative to prevent constipation. The signs of constipation include infrequent bowel movements (less than every 3 days), difficulty passing stools, excessive straining, inability to defecate at will, and hard feaces
IMPACTION
Fecal impaction results from unrelieved constipation. It is a collection of hardened feces wedged in the rectum that a person cannot expel. In cases of severe impaction the mass extends up into the sigmoid colon.
DIARRHEA
Diarrhea is an increase in the number of stools and the passage of liquid, unformed feces. It is associated with disorders affecting digestion, absorption, and secretion in the GI tract. Intestinal contents pass through the small and large intestine too quickly to allow for the usual absorption of fluid and nutrients. Irritation within the colon results in increased mucus secretion. As a result, feces become watery, and the patient is unable to control the urge to defecate. Normally an anal bag is safe and effective in long-term treatment of patients with fecal incontinence at home, in hospice, or in the hospital. Fecal incontinence is expensive and a potentially dangerous condition in terms of contamination and risk of skin ulceration
HEMORRHOIDS
Hemorrhoids are dilated, engorged veins in the lining of the rectum. They are either external or internal.
FLATULENCE
As gas accumulates in the lumen of the intestines, the bowel wall stretches and distends (flatulence). It is a common cause of abdominal fullness, pain, and cramping. Normally intestinal gas escapes through the mouth (belching) or the anus (passing of flatus)
FECAL INCONTINENCE
Fecal incontinence is the inability to control passage of feces and gas from the anus. Incontinence harms a patient’s body image
PREPARATION AND GIVING OF LAXATIVESACCORDING TO POTTER AND PERRY,
An enema is the instillation of a solution into the rectum and sig
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
One of the most developed cities of India, the city of Chennai is the capital of Tamilnadu and many people from different parts of India come here to earn their bread and butter. Being a metropolitan, the city is filled with towering building and beaches but the sad part as with almost every Indian city
Health Education on prevention of hypertensionRadhika kulvi
Hypertension is a chronic condition of concern due to its role in the causation of coronary heart diseases. Hypertension is a worldwide epidemic and important risk factor for coronary artery disease, stroke and renal diseases. Blood pressure is the force exerted by the blood against the walls of the blood vessels and is sufficient to maintain tissue perfusion during activity and rest. Hypertension is sustained elevation of BP. In adults, HTN exists when systolic blood pressure is equal to or greater than 140mmHg or diastolic BP is equal to or greater than 90mmHg. The
2. Definition of Managed Care
A system of health care delivery that tries to manage the cost of
health care, the quality of health care, and the access to that care.
Common denominators include a panel of contracted providers that
is less than the entire universe of available providers, some type of
limitations on benefits to subscribers who use noncontracted
providers (unless authorized to do so), and some type of
authorization system. Managed health care is actually a spectrum
of systems, ranging from so-called managed indemnity through
PPOs, POS plans, open panel HMOs, and closed panel HMOs.
In 1973, fewer than one in every 25 privately insured Americans
were enrolled in a managed care plan, now two out of every three
privately insured Americans are in such a plan.
3. Reasons for an Authorization
System
Case review for medical necessity by the medical
management function of the plan.
Direct care to the most appropriate setting.
(Inpatient vs. Outpatient or in the provider’s office)
Provide timely information to the concurrent review
utilization system and the case management system.
Assist in the finance estimate of the accruals for
medical expenditures each month.
4. Authorization System
Has to define what services require
authorization and what do not.
Determine who has the authority to
authorize services for members:
PCPs
Plan’s Medical Director
The tighter the authorization process the
stronger the utilization management by
the payer/plan.
5. Authorization Types
Prospective
Issued before ay service is rendered
Concurrent
Allows for timely data collection and the
ability to impact the outcome
Retrospective
Issued after services are rendered
“Emergency Situations”
6. Authorization Types (cont.)
Pended (for review)
Determine the status of an authorization:
Medical necessity
Eligibility
Administrative review
Denial
Subauthorizations
Common with hospital based services
(Radiology, Pathology, Anesthesia)
7. Common Authorization Data Elements
Member’s name
Member’s birth date
Member’s plan identification number
Eligibility status
PCP
Referral provider’s name and specialty
Outpatient data elements
Referral or service date
Diagnosis (ICD-9-CM)
Number of visits authorized
Specific procedures authorized (CPT-4)
8. Common Authorization Data Elements (cont)
Inpatient data elements
Name of institution
Admitting physician
Admission or service date
Diagnosis (ICD-9-CM)
Discharge date
Subauthorizations
Hospital based providers
Other specialists
Other procedures/studies
Free text to be submitted to the claims dept.
9. Methods of Communication
Paper-Based System
Pre-printed paper forms through the mail
Telephone-Based System
Phone tag, busy signals, waiting on hold
Busy fax machines
Electronic System
Built in edits on-line
Claims submission most common
Authorization & Eligibility information available
Dedicated lines connected
10. Problems with Authorization Systems
Lack of standardization of required
information and format between the
insurance plans
Coordination among the players of the
paperwork
Ongoing changes
Administrative costs
Declining reimbursement
12. Application Service Providers
Integration of eligibility, authorization, referrals
Physician Offices and MCOs
Cost Savings
Medical Mutual of Ohio – reduce 10-12 FTEs = $600,000.
Time Savings
Authorizations from 30 minutes to 10 minutes
Reduction in errors
Improved Patient Satisfaction
One-Stop-Shopping
Diffuse Costs
13. Regulatory Issues
HIPAA – Health Insurance and
Accountability Act
Adminitrative Simplification
Standardization of Claims/Referral data
Format modified on every 12 Months
14. Web ROAR
ROAR – Referral or Authorization
Request
Keystone
Ranked 8th in Nation’s 25 Largest Individual
HMO Plans
1,151,224 members (1998)
16. Web ROAR Functionality
Submit referral and authorization
requests
Verify patient membership
Search for specialists, providers,
hospitals, or other facilities
List historical referrals/authorizations for
patients or practice
Track utilization patterns for practice
17. Web ROAR Main Menu
Request for Services
View Messages
Member History
Office History
Member Check
Specialist Check
Facility Check
Procedure Look up
Diagnosis Look up
Report Selection
Bulletin Board
Case/Disease Management
18. Web ROAR Flow
Web Roar Flow
Active Member
Search Window
Request for
Services Window
Summary/Verification
Window
ROAR
ConfirmationWindow
Fax/Hardcopy
Request Window
Specialty
Windows
Procedure Code
Search Window
Diagnosis Code
Search Window
CDM Referral
Entry Window
2 a
2b
4a
19. Web ROAR Limitations
Only Highmark enrollees
Carved Out MRI, Nuclear Cardiology, CT
scans
Primary Care offices – NOT hospitals,
specialists, or ancillary service providers
20. At Last……Managed Care
A system of health care delivery that tries to
manage the cost of health care, the quality of
health care, and the access to that care….
Without the wait and paperwork
hassle!!!!!!!!!!