With increased denials and recoupments related to medical necessity at the forefront of discussions at this year’s American Health Lawyers Association Institute on Medicare and Medicaid Payment Issues, PYA was prepared to inform and assist providers instituting best practices to address medical necessity denials. PYA Principal Denise Hall-Gaulin co-presented “Medical Status-Current Status/Key Best Practices in Prevention of Medical Necessity Denials and Recoupments” with Michael Spake, VP of External Affairs and Chief Compliance and Integrity Officer at Lakeland Regional Health.
The presentation included:
A discussion of medical necessity—what it means and what it affects
Information regarding medical necessity determinations and criteria for determination
Definitions for categorically excluded services
Criteria for admission (skilled nursing facilities and inpatient rehabilitation facilities included)
Current Trends in Data Protection for Integrated Health, Centralized Peer Rev...PYA, P.C.
A webinar hosted by PYA and the Alliance for Quality Improvement (AQIPS) explored “Current Trends in Data Protection for Integrated Health, Centralized Peer Review Systems, and Other Innovative Programs.” PYA Principal Martie Ross participated in the webinar, which focused on how patient safety organization (PSO) protections can bring value to accountable care organizations and other integrated health systems.
In addition, the webinar provided instruction for using:
Patient Safety and Quality Improvement Act (PSQIA) protections in Medicare Shared Savings Programs, centralized peer review programs, and other collaboratives.
PSQIA protections for new types of clinical analysis, clinical quality reports, and performance tools that contain information that may not be protected under existing state peer review privilege or are shared among an integrated network.
Office of Civil Rights HIPAA Audits Preparing Your Clients and YourselfPYA, P.C.
PYA Consulting Manager Susan Thomas presented “Office of Civil Rights HIPAA Audits – Preparing Your Clients and Yourself” at The Florida Bar’s “Representing the Physician: It Is Harder Than It Looks” conference, February 3, 2017, in Orlando, Florida.
The presentation covered topics that include:
The Health Information Technology for Economic and Clinical Health Act.
Phase 1 audit, privacy, security, and breach notification findings and lessons learned.
Phase 2 audits—scope and recipient selection.
HIPAA audit readiness and steps for preparing.
Personal reflections from an OCR breach investigation.
Audit resources for physician practices.
The Heartaches Associated with Billing for Cardiac DevicesPYA, P.C.
PYA Principal Denise Hall-Gaulin and Consulting Manager Joanna Malcolm presented a free webinar for the Georgia chapter of the Healthcare Financial Management Association, on Tuesday, December 6, 2016.
The presentation was geared toward C-suite hospital leaders, compliance officers, in-house counsel, operational leaders, and patient accounting leadership, and covered:
The criteria for implantable cardioverter defibrillators (ICDs), pacemakers, and other devices
The documentation requirements for payment
The prerequisites for a clean audit
PYA Principal Martie Ross joined University of Kansas Medical Center’s Robert Moser, MD, and CIO Chris Hansen for the keynote presentation at the joint symposium by Heart of America Healthcare Information and Management Systems Society and Missouri Health Information Management Association, September 14, 2016, at Johnson County Community College in Overland Park, Kansas. They discussed insights related to the role of advanced analytics and technology in transforming and transitioning to new payment models.
Big Data: Implications of Data Mining for Employed Physician Compliance Manag...PYA, P.C.
PYA Consulting Manager Kristen Lilly presented “Big Data: Implications of Data Mining for Employed Physician Compliance Management” during a webinar for the Georgia chapter of the Healthcare Financial Management Association (Georgia HFMA), March 31, 2016.
The presentation explored:
Public relations and litigation risk from the public dissemination of data by the government.
Internal use of broad spectrum analytics in employed physician compliance management.
Determination of risk tolerance and the customization of “outside the box” analytics.
Benchmarking, monitoring, and defining physician-focused risk area reviews.
PYA Principal Carol Carden presented “Fundamentals of Healthcare Valuation” at the American Society of Appraisers (ASA) 2015 Advanced Business Valuation Conference. The presentation explored unique characteristics of the healthcare industry, particularly those relevant to appraisers for avoiding common mistakes in assessing risk and projecting cash flow.
Current Trends in Data Protection for Integrated Health, Centralized Peer Rev...PYA, P.C.
A webinar hosted by PYA and the Alliance for Quality Improvement (AQIPS) explored “Current Trends in Data Protection for Integrated Health, Centralized Peer Review Systems, and Other Innovative Programs.” PYA Principal Martie Ross participated in the webinar, which focused on how patient safety organization (PSO) protections can bring value to accountable care organizations and other integrated health systems.
In addition, the webinar provided instruction for using:
Patient Safety and Quality Improvement Act (PSQIA) protections in Medicare Shared Savings Programs, centralized peer review programs, and other collaboratives.
PSQIA protections for new types of clinical analysis, clinical quality reports, and performance tools that contain information that may not be protected under existing state peer review privilege or are shared among an integrated network.
Office of Civil Rights HIPAA Audits Preparing Your Clients and YourselfPYA, P.C.
PYA Consulting Manager Susan Thomas presented “Office of Civil Rights HIPAA Audits – Preparing Your Clients and Yourself” at The Florida Bar’s “Representing the Physician: It Is Harder Than It Looks” conference, February 3, 2017, in Orlando, Florida.
The presentation covered topics that include:
The Health Information Technology for Economic and Clinical Health Act.
Phase 1 audit, privacy, security, and breach notification findings and lessons learned.
Phase 2 audits—scope and recipient selection.
HIPAA audit readiness and steps for preparing.
Personal reflections from an OCR breach investigation.
Audit resources for physician practices.
The Heartaches Associated with Billing for Cardiac DevicesPYA, P.C.
PYA Principal Denise Hall-Gaulin and Consulting Manager Joanna Malcolm presented a free webinar for the Georgia chapter of the Healthcare Financial Management Association, on Tuesday, December 6, 2016.
The presentation was geared toward C-suite hospital leaders, compliance officers, in-house counsel, operational leaders, and patient accounting leadership, and covered:
The criteria for implantable cardioverter defibrillators (ICDs), pacemakers, and other devices
The documentation requirements for payment
The prerequisites for a clean audit
PYA Principal Martie Ross joined University of Kansas Medical Center’s Robert Moser, MD, and CIO Chris Hansen for the keynote presentation at the joint symposium by Heart of America Healthcare Information and Management Systems Society and Missouri Health Information Management Association, September 14, 2016, at Johnson County Community College in Overland Park, Kansas. They discussed insights related to the role of advanced analytics and technology in transforming and transitioning to new payment models.
Big Data: Implications of Data Mining for Employed Physician Compliance Manag...PYA, P.C.
PYA Consulting Manager Kristen Lilly presented “Big Data: Implications of Data Mining for Employed Physician Compliance Management” during a webinar for the Georgia chapter of the Healthcare Financial Management Association (Georgia HFMA), March 31, 2016.
The presentation explored:
Public relations and litigation risk from the public dissemination of data by the government.
Internal use of broad spectrum analytics in employed physician compliance management.
Determination of risk tolerance and the customization of “outside the box” analytics.
Benchmarking, monitoring, and defining physician-focused risk area reviews.
PYA Principal Carol Carden presented “Fundamentals of Healthcare Valuation” at the American Society of Appraisers (ASA) 2015 Advanced Business Valuation Conference. The presentation explored unique characteristics of the healthcare industry, particularly those relevant to appraisers for avoiding common mistakes in assessing risk and projecting cash flow.
Risk-Based Contracting: Background, Assessment, and ImplementationPYA, P.C.
PYA Principal Bob Paskowski presented “Risk-Based Contracting: Assessments and Implementation,” at the National Association of Managed Care Physicians Fall Managed Care Forum, November 10-11, 2016. The presentation allows participants to:
Understand the different types and core elements of risk-based contracting (RBC).
Prepare for additional discussions with key stakeholders regarding RBC assessment and readiness.
Make informed decisions as to next steps while evaluating associated financial risks.
The Changing Healthcare System and Impact of MACRAPYA, P.C.
PYA Principal Lori Foley and Consulting Senior Aaron Elias co-presented “The Changing Healthcare System and Impact of MACRA” at the Physician Insurers Association of America’s CEO/COO Meeting.
The Medicare Access & CHIP Reauthorization Act (MACRA) dramatically affected Medicare reimbursements to healthcare providers, as well as provided a new framework for rewarding quality care and reporting on quality measurements. This incentive-based system has the potential not only to change how medicine is practiced, but influence patient perception of care. The presentation will provide the latest information on MACRA implementation, and will detail how the aforementioned changes will impact miscellaneous professional liability insurers.
The Vicissitudes of Valuing Value--Legal and Valuation Issues Associated with...PYA, P.C.
PYA Principal Carol Carden co-presented “The Vicissitudes of Valuing Value--Legal and Valuation Issues Associated with Value-Based Payment Models” at the 2017 American Health Lawyers Association Physician and Hospitals Law Institute, February 1-3, 2017, in Orlando, Florida.
The presentation addressed:
Emerging alternative payment models (APMs)
The application of fraud and abuse laws and IRS rules to provider network payments
Existing market data and regulatory guidance
Considerations in determining fair market value and commercial reasonableness
Demystifying Commercial Reasonableness in Physician/Hospital TransactionsPYA, P.C.
PYA Principal Lyle Oelrich presented “Demystifying Commercial Reasonableness in Physician/Hospital Transactions” at the Georgia Society of Certified Public Accountants’ (GSCPA) 2016 Healthcare Conference, February 11, 2016, in Atlanta, Georgia.
PYA Principal Jim Lloyd along with Polsinelli’s Douglas Anning presented “Doing the Deal” in which they utilized case studies in analyzing both hospital-hospital transactions and hospital-physician practice transactions. The presentation also covered:
Helping clients successfully negotiate and structure the transaction and keeping the deal on track
Recognizing sample contract provisions common to these types of deals
Working with valuation firms to ensure the transaction terms are within fair market value and commercially reasonable
Evaluating and dealing with potential anti-trust concerns
Dealing with potential compliance issues identified during the due-diligence process
PYA Principal J. Michael Keegan, MD, recently presented “Pacing Volume-to-Value Transition” and “The ROI of Avoiding Antibiotic Overuse” at the AlaHA Annual Meeting, June 8-11, 2016. The presentation focused on the importance of antibiotic stewardship programs (ASP) for population health. The presentation explained:
Why the Centers for Medicare & Medicaid Services is proposing a requirement that hospitals implement ASPs to stem the rise of resistant bacteria.
Why PYA is invested in offering hospitals a proven program for improving patient safety while saving costs.
What constitutes a successful ASP.
Deployment of the Medicare Access and CHIP Reauthorization ActPYA, P.C.
PYA Principal Martie Ross and Senior Manager Graham Fox presented, “Mastering MIPS" at the American College of Healthcare Executives’ Congress on Healthcare Leadership.
Learning objectives included:
Gaining an understanding of MIPS—why it was implemented and how it will impact reimbursement, governance, and strategic planning for healthcare organizations.
Identifying questions organizations must consider during MIPS implementation that will lead to financial and operational success.
PYA Principal Martie Ross presented the keynote address, “The March to MIPS: The Merit-Based Payment System,” at the Kansas Medical Group Management Association 2016 Fall Conference, September 21-23, 2016, at the Overland Park Marriott in Overland Park, Kansas.
The presentation will include:
An introduction to the Medicare Merit-Based Incentive Payment System (MIPS).
A discussion of the four components of the MIPS composite score.
An exploration of the penalties and bonuses associated with the MIPS composite score, as well as the reputational impact of the publicly reported MIPS composite score.
Healthcare Reform and Physician Compensation— Presentation Examines What’s in...PYA, P.C.
Among the many questions facing physicians in the wake of healthcare reform—how will they get paid? PYA Principal David McMillan recently addressed this question at the PKF Healthcare Fly-In with “Current Reform Initiatives and Their Impact on Physician Compensation.”
Surviving the Healthcare World of Risk AdjustmentPYA, P.C.
PYA Principal Bob Paskowski and Senior Staff Consultant Carine Leslie presented a webinar for the Georgia chapter of the Healthcare Financial Management Association Friday, December 16, 2016.
The presentation is tailored for coders in ambulatory/Medicare Advantage settings, providers participating in Medicare Advantage or other risk-based healthcare plans, and leaders in providers’ managed care contracting departments. The webinar is titled “Surviving the Healthcare World of Risk Adjustment.”
The webinar addresses:
• Principles of the Medicare Advantage risk-adjustment model from Medicare Advantage Hierarchical Condition Categories and other risk-based healthcare plans;
• Strategies for reducing compliance risks;
• Methods for accurately, completely, and consistently capturing and documenting a patient’s disease burden to promote effective care management and to reflect the proper risk score.
Maximizing Performance Incentives Through Star RatingsCitiusTech
The main aim of this document is to provide a high level understanding of the Star rating quality program of CMS and it’s impact on plans (at contract level) offered by the payers which are in Medicare Advantage line of business
It describes the various measure categories and their weightages, domains and sources required by CMS to assess quality of care and patient experience.
PYA Monitors Topics on Healthcare Radar at AlaHAPYA, P.C.
PYA recently presented “Blips on the Radar—Ground Clutter or Looming Crisis?” at the 2014 Alabama Hospital Association Annual Meeting. Topics covered included:
ICD-10—What now?
Hospital-Physician Transactions—The compliance wheel
Value-Based Payments—What’s up with that?
Physician Differentiation—What sets doctors apart?
Modern Physician-Hospital Affiliations in an Era of Increased Fraud and Abuse...PYA, P.C.
PYA Senior Manager Chris Beckham co-presented “Modern Physician-Hospital Affiliations in an Era of Increased Fraud and Abuse Scrutiny” with Ross Burris of Polsinelli at the American Health Lawyer Association’s (AHLA) Physicians and Hospitals Law Institute, February 8-10, 2016.
Quality and Outcome Framework (QOF) is a voluntary annual incentive programme for GPs in England, detailing practice achievement results. The primary objective of QOF is to drive the quality of primary care and reduce variations in the quality of care amongst GPs
Transforming Clinical Practice InitiativeCitiusTech
The Transforming Clinical Practice Initiative (TCPI) is designed to help small practices and clinicians achieve large-scale health transformation. The initiative is designed to support more than 140,000 clinician practices over four years duration in sharing, adapting and further developing their comprehensive quality improvement strategies. The TCPI is one part of a unique strategy advanced by the Affordable Care Act to strengthen the quality of patient care and manage health care expenditures, ultimately saving the taxpayer from substantial costs. This document describes the initiative in detail with the type of participants, eligibility and reporting requirements of the participants. Understanding the implementation of this initiative not only helps clinicians, but opens up a huge market for Healthcare IT companies offering the products and services like EHR implementation, Integration, EHR/ Data Migration, Implementation of HIE etc.
Presentation Uncovers Trends in the Unpredictable Healthcare IndustryPYA, P.C.
With the healthcare industry in a state of flux, not much is known about what lies ahead; but trends across the industry have become apparent and are likely to stick. These trends were the subject of a presentation given by PYA Principal David McMillan at the PKF North America Healthcare Fly-In.
The Evolving Role of the Compliance Officer in the Age of Accountable CarePYA, P.C.
Much has been written about new competencies physicians must develop in the face of payment and delivery system reform. But providers are not the only ones seeing their roles change. Compliance officers, who serve as organizations’ internal police officers, will have many new challenges. PYA Principal Martie Ross presented a national Health Care Compliance Association (HCCA) webinar entitled “The Evolving Role of the Compliance Officer In the Age of Accountable Care.”
Enhancing Competitive Advantage through Improved HEDIS Reporting and NCQA Rat...CitiusTech
The objective of this document is to provide a high level understanding of the Healthcare Effectiveness Data and Information Set (HEDIS), which is a tool used by more than 90 percent of America's health plans to measure performance on important dimensions of care and service. This document helps in understanding different components of the HEDIS in terms of the measure sets (what it is meant for health plans, changes to the previous year), different methods of collecting data for HEDIS and key requirements for reporting HEDIS
Medical Necessity-- What it Means and 2018 UpdatePYA, P.C.
This presentation addresses the concerns for instituting best practices in tackling medical necessity denials. Including what it means and what it affects, an update on 2018 CMS medical necessity determinations and new initiatives, and details regarding the types of, and criteria for, medical necessity determinations. Admission criteria for skilled nursing facilities and inpatient rehabilitation facilities, as well as the use of Advanced Beneficiary Notification and Hospital-Issued Notice of Non-Coverage (including the outcomes and penalties for not using ABNs or HINNs) are also discussed.
Risk-Based Contracting: Background, Assessment, and ImplementationPYA, P.C.
PYA Principal Bob Paskowski presented “Risk-Based Contracting: Assessments and Implementation,” at the National Association of Managed Care Physicians Fall Managed Care Forum, November 10-11, 2016. The presentation allows participants to:
Understand the different types and core elements of risk-based contracting (RBC).
Prepare for additional discussions with key stakeholders regarding RBC assessment and readiness.
Make informed decisions as to next steps while evaluating associated financial risks.
The Changing Healthcare System and Impact of MACRAPYA, P.C.
PYA Principal Lori Foley and Consulting Senior Aaron Elias co-presented “The Changing Healthcare System and Impact of MACRA” at the Physician Insurers Association of America’s CEO/COO Meeting.
The Medicare Access & CHIP Reauthorization Act (MACRA) dramatically affected Medicare reimbursements to healthcare providers, as well as provided a new framework for rewarding quality care and reporting on quality measurements. This incentive-based system has the potential not only to change how medicine is practiced, but influence patient perception of care. The presentation will provide the latest information on MACRA implementation, and will detail how the aforementioned changes will impact miscellaneous professional liability insurers.
The Vicissitudes of Valuing Value--Legal and Valuation Issues Associated with...PYA, P.C.
PYA Principal Carol Carden co-presented “The Vicissitudes of Valuing Value--Legal and Valuation Issues Associated with Value-Based Payment Models” at the 2017 American Health Lawyers Association Physician and Hospitals Law Institute, February 1-3, 2017, in Orlando, Florida.
The presentation addressed:
Emerging alternative payment models (APMs)
The application of fraud and abuse laws and IRS rules to provider network payments
Existing market data and regulatory guidance
Considerations in determining fair market value and commercial reasonableness
Demystifying Commercial Reasonableness in Physician/Hospital TransactionsPYA, P.C.
PYA Principal Lyle Oelrich presented “Demystifying Commercial Reasonableness in Physician/Hospital Transactions” at the Georgia Society of Certified Public Accountants’ (GSCPA) 2016 Healthcare Conference, February 11, 2016, in Atlanta, Georgia.
PYA Principal Jim Lloyd along with Polsinelli’s Douglas Anning presented “Doing the Deal” in which they utilized case studies in analyzing both hospital-hospital transactions and hospital-physician practice transactions. The presentation also covered:
Helping clients successfully negotiate and structure the transaction and keeping the deal on track
Recognizing sample contract provisions common to these types of deals
Working with valuation firms to ensure the transaction terms are within fair market value and commercially reasonable
Evaluating and dealing with potential anti-trust concerns
Dealing with potential compliance issues identified during the due-diligence process
PYA Principal J. Michael Keegan, MD, recently presented “Pacing Volume-to-Value Transition” and “The ROI of Avoiding Antibiotic Overuse” at the AlaHA Annual Meeting, June 8-11, 2016. The presentation focused on the importance of antibiotic stewardship programs (ASP) for population health. The presentation explained:
Why the Centers for Medicare & Medicaid Services is proposing a requirement that hospitals implement ASPs to stem the rise of resistant bacteria.
Why PYA is invested in offering hospitals a proven program for improving patient safety while saving costs.
What constitutes a successful ASP.
Deployment of the Medicare Access and CHIP Reauthorization ActPYA, P.C.
PYA Principal Martie Ross and Senior Manager Graham Fox presented, “Mastering MIPS" at the American College of Healthcare Executives’ Congress on Healthcare Leadership.
Learning objectives included:
Gaining an understanding of MIPS—why it was implemented and how it will impact reimbursement, governance, and strategic planning for healthcare organizations.
Identifying questions organizations must consider during MIPS implementation that will lead to financial and operational success.
PYA Principal Martie Ross presented the keynote address, “The March to MIPS: The Merit-Based Payment System,” at the Kansas Medical Group Management Association 2016 Fall Conference, September 21-23, 2016, at the Overland Park Marriott in Overland Park, Kansas.
The presentation will include:
An introduction to the Medicare Merit-Based Incentive Payment System (MIPS).
A discussion of the four components of the MIPS composite score.
An exploration of the penalties and bonuses associated with the MIPS composite score, as well as the reputational impact of the publicly reported MIPS composite score.
Healthcare Reform and Physician Compensation— Presentation Examines What’s in...PYA, P.C.
Among the many questions facing physicians in the wake of healthcare reform—how will they get paid? PYA Principal David McMillan recently addressed this question at the PKF Healthcare Fly-In with “Current Reform Initiatives and Their Impact on Physician Compensation.”
Surviving the Healthcare World of Risk AdjustmentPYA, P.C.
PYA Principal Bob Paskowski and Senior Staff Consultant Carine Leslie presented a webinar for the Georgia chapter of the Healthcare Financial Management Association Friday, December 16, 2016.
The presentation is tailored for coders in ambulatory/Medicare Advantage settings, providers participating in Medicare Advantage or other risk-based healthcare plans, and leaders in providers’ managed care contracting departments. The webinar is titled “Surviving the Healthcare World of Risk Adjustment.”
The webinar addresses:
• Principles of the Medicare Advantage risk-adjustment model from Medicare Advantage Hierarchical Condition Categories and other risk-based healthcare plans;
• Strategies for reducing compliance risks;
• Methods for accurately, completely, and consistently capturing and documenting a patient’s disease burden to promote effective care management and to reflect the proper risk score.
Maximizing Performance Incentives Through Star RatingsCitiusTech
The main aim of this document is to provide a high level understanding of the Star rating quality program of CMS and it’s impact on plans (at contract level) offered by the payers which are in Medicare Advantage line of business
It describes the various measure categories and their weightages, domains and sources required by CMS to assess quality of care and patient experience.
PYA Monitors Topics on Healthcare Radar at AlaHAPYA, P.C.
PYA recently presented “Blips on the Radar—Ground Clutter or Looming Crisis?” at the 2014 Alabama Hospital Association Annual Meeting. Topics covered included:
ICD-10—What now?
Hospital-Physician Transactions—The compliance wheel
Value-Based Payments—What’s up with that?
Physician Differentiation—What sets doctors apart?
Modern Physician-Hospital Affiliations in an Era of Increased Fraud and Abuse...PYA, P.C.
PYA Senior Manager Chris Beckham co-presented “Modern Physician-Hospital Affiliations in an Era of Increased Fraud and Abuse Scrutiny” with Ross Burris of Polsinelli at the American Health Lawyer Association’s (AHLA) Physicians and Hospitals Law Institute, February 8-10, 2016.
Quality and Outcome Framework (QOF) is a voluntary annual incentive programme for GPs in England, detailing practice achievement results. The primary objective of QOF is to drive the quality of primary care and reduce variations in the quality of care amongst GPs
Transforming Clinical Practice InitiativeCitiusTech
The Transforming Clinical Practice Initiative (TCPI) is designed to help small practices and clinicians achieve large-scale health transformation. The initiative is designed to support more than 140,000 clinician practices over four years duration in sharing, adapting and further developing their comprehensive quality improvement strategies. The TCPI is one part of a unique strategy advanced by the Affordable Care Act to strengthen the quality of patient care and manage health care expenditures, ultimately saving the taxpayer from substantial costs. This document describes the initiative in detail with the type of participants, eligibility and reporting requirements of the participants. Understanding the implementation of this initiative not only helps clinicians, but opens up a huge market for Healthcare IT companies offering the products and services like EHR implementation, Integration, EHR/ Data Migration, Implementation of HIE etc.
Presentation Uncovers Trends in the Unpredictable Healthcare IndustryPYA, P.C.
With the healthcare industry in a state of flux, not much is known about what lies ahead; but trends across the industry have become apparent and are likely to stick. These trends were the subject of a presentation given by PYA Principal David McMillan at the PKF North America Healthcare Fly-In.
The Evolving Role of the Compliance Officer in the Age of Accountable CarePYA, P.C.
Much has been written about new competencies physicians must develop in the face of payment and delivery system reform. But providers are not the only ones seeing their roles change. Compliance officers, who serve as organizations’ internal police officers, will have many new challenges. PYA Principal Martie Ross presented a national Health Care Compliance Association (HCCA) webinar entitled “The Evolving Role of the Compliance Officer In the Age of Accountable Care.”
Enhancing Competitive Advantage through Improved HEDIS Reporting and NCQA Rat...CitiusTech
The objective of this document is to provide a high level understanding of the Healthcare Effectiveness Data and Information Set (HEDIS), which is a tool used by more than 90 percent of America's health plans to measure performance on important dimensions of care and service. This document helps in understanding different components of the HEDIS in terms of the measure sets (what it is meant for health plans, changes to the previous year), different methods of collecting data for HEDIS and key requirements for reporting HEDIS
Medical Necessity-- What it Means and 2018 UpdatePYA, P.C.
This presentation addresses the concerns for instituting best practices in tackling medical necessity denials. Including what it means and what it affects, an update on 2018 CMS medical necessity determinations and new initiatives, and details regarding the types of, and criteria for, medical necessity determinations. Admission criteria for skilled nursing facilities and inpatient rehabilitation facilities, as well as the use of Advanced Beneficiary Notification and Hospital-Issued Notice of Non-Coverage (including the outcomes and penalties for not using ABNs or HINNs) are also discussed.
Appropriate Level of Care and the 2– Midnight Rule Where It Stands as of NOWBESLER
This article from the December 2014 issue of the Lone Star Express, a publication of the Lone Star chapter of HFMA, reviews the current state of the 2-Midnight rule. It reviews key elements of the rule, the focus of Medicare documentation requirements, and best practices for compliance.
Appropriate Level of Care and the 2-Midnight RuleBESLER
Understand the CMS background & regulatory requirements
Difference between the 2-Midnight presumption vs. benchmark
Physician certification requirements for inpatient hospital services
IPPS and OPPS 2015
Best Practices for financial and operational performance
Analysis of the medicare three day inpatient hospital stay rule...Philip McCarley
Policy analysis of the Medicare three day inpatient hospital stay rule for determining eligibility for post-hospital care in skilled nursing facilities with further considerations of the impact of increased utilization of observation status classification.
Admission Disposition: Inpatient or Outpatient Observationampeterson03
This was a staff presentation for Rio Grande Hospital staff in 2012 regarding the correct admission status for patients, billing, and the impact that RACs auditors have on the hospital
US Medical Billing A Comprehensive Overview for Healthcare Providers.pdfmedquikhelathsolutio
The intricate world of medical billing can feel like a labyrinth for healthcare providers. Between deciphering complex medical codes, navigating insurance regulations, and ensuring timely reimbursements, it's easy to get overwhelmed.
Presentation by David Farber, FDA Life Science Partner at King & Spalding, about US Reimbursement.
I. Introduction
• II. FDA Approval vs. Reimbursement
• a. Different Standards
b. Clinical Evidence Needed
• III. The Three Keys to Reimbursement
A. Coverage
B. Coding
C. Payment
• IV. What’s New for 2019
• V. Reimbursement for MedTech AI Solutions
• VI. Tips for Successful Reimbursement
US Healthcare Reimbursement for MedTech & Digital HealthLevi Shapiro
Overview of the US healthcare reimbursement framework as it relates to MedTech and Digital Health companies by David Farber, Senior Partner, King & Spalding law firm. Includes Introduction FDA Approval vs. Reimbursement; Different Standards; Clinical Evidence Needed; The Three Keys to Reimbursement Coverage; Coding; Payment; What’s New for 2019 Reimbursement for MedTech; AI Solutions Tips for Successful Reimbursement
Clinicspectrum is a healthcare service/consulting company helping Medical offices, Hospitals and ACOs to reduce operational cost up to 30% with its unique Hybrid Workflow Model™ with use of back office services and technology products.
We are happy to launch our unique web-based Chronic Care Management Platform and discuss details about Chronic Care Management in this presentation.
“CARES Act Provider Relief Fund: Opportunities, Compliance, and Reporting”PYA, P.C.
PYA Principal Martie Ross spoke at the virtual North Carolina Healthcare Association Critical Access Hospital Statewide Meeting. The two-day event, “Quality Focus is a Finance Focus,” provided critical access hospital leaders with the opportunity to network and review data-informed strategies as well as updates to the Medicare Flexibility Program Project. It also provided guidance on federal compliance and tracking of Provider Relief Funds.
In “CARES Act Provider Relief Fund: Opportunities, Compliance, and Reporting,” Martie gave an overview of the history of distribution of those funds as well as regulations and guidelines including:
Statutory Language
Reporting Requirements
Use of Funds Calculation
Expenses
Risk Management
Martie presented Thursday, March 4, 2021.
If you would like guidance related to Provider Relief Fund regulations, or for assistance with any matter related to strategy and integration, compliance, or valuation, contact one of our PYA executives at (800) 270-9629.
PYA Presented on 2021 E/M Changes and a CARES Act Update During GHA Complianc...PYA, P.C.
The Georgia Hospital Association (GHA) Compliance Officers Roundtable, an active GHA group that meets quarterly and includes educational sessions featuring government representatives, industry experts, and other thought leaders speaking about compliance-related issues, conducted their latest meeting virtually. PYA Principals Lori Foley, Tynan Kugler, and Valerie Rock were among the presenters at this quarter’s event. In their session, they:
Described key elements associated with 2021 E/M changes, and strategies for preparation and implementation.
Explained the impact of 2021 E/M changes on physician compensation and contracting, including potential mitigation approaches.
Presented key components of Stark Law and Anti-Kickback Statute final rules.
Provided an update on the CARES Act.
The Compliance Certification Board offered CEUs for this event, which took place on Friday, December 4, 2020.
Webinar: “Trick or Treat? October 22nd Revisions to Provider Relief Fund Repo...PYA, P.C.
On October 22nd, the Department of Health and Human Services released revised Provider Relief Fund (PRF) reporting requirements. Under HHS’ September 19 directive, “lost revenue” was defined narrowly as a negative change in year-over-year patient care operating net income. Now, HHS will permit providers to use PRF funds to cover the difference between their 2019 and 2020 actual patient care revenue with some adjustments for COVID-related expenses. The October 22nd notice is available here.
PYA Principals Martie Ross and Michael Ramey hosted a complimentary 30-minute webinar, “Trick or Treat? October 22nd Revisions to Provider Relief Fund Reporting Requirements” on Thursday, October 29th.
“Regulatory Compliance Enforcement Update: Getting Results from the Guidance” PYA, P.C.
PYA Principal and Chief Compliance Officer Shannon Sumner and Consulting Senior Manager Susan Thomas presented “Regulatory Compliance Enforcement Update: Getting Results from the Guidance” at the virtual 2020 Montana Healthcare Conference. They reviewed the sources of regulatory enforcement and investigation information—guidelines, statutory updates, best practices, settlements, case studies, etc.—available to healthcare organizations. They will also discuss how to interpret and implement the guidance in order to strengthen the compliance function and protect the organization. The presentation covered:
Compliance regulatory requirements for healthcare organizations.
Guidance available for consideration in organizational compliance programs.
Internal and external reporting to ensure regulatory requirements are met.
Best practices for implementation of guidance.
Case studies for illustration of guidance implementation.
“Federal Legislative and Regulatory Update,” Webinar at DFWHCPYA, P.C.
The Dallas Fort Worth Hospital Council (DFWHC) and PYA co-hosted an exclusive complimentary webinar, “Federal Legislative and Regulatory Update,” on Wednesday, September 23.
DFWHC President/CEO Stephen Love hosted a discussion with PYA Senior Manager Kathy Reep about concerns that have dropped from the radar during the last four months of COVID-19, addressing issues for which hospitals must prepare in approaching 2021. This session focused on these key areas:
Appropriate use criteria
Transparency
Site neutral payments
The future of the Medicare Trust Fund
The federal budget
Key provisions of the final rule for the inpatient prospective payment system for FY2021 and the proposed outpatient rule for CY2021
On-Demand Webinar: Compliance With New Provider Relief Funds Reporting Requir...PYA, P.C.
On September 19, the Department of Health and Human Services (HHS) published its Post-Payment Notice of Reporting Requirements. The Notice details the reporting requirements for all Provider Relief Fund (PRF) recipients that have received $10,000 or more in aggregate payments.
Under the PRF Terms and Conditions, a recipient may use the funds only for healthcare-related expenses and lost revenue attributable to coronavirus. The Notice provides the clearest direction to date regarding permissible uses of PRF funds.
PYA offered a 45-minute complimentary webinar that explained the new reporting requirements and delved into permissible uses. While many questions remain, we provided practical advice on the next steps in the reporting process.
The webinar took place Monday, October 5 at 11 a.m. EDT.
Webinar: “While You Were Sleeping…Proposed Rule Positioned to Significantly I...PYA, P.C.
You likely know from the headlines that the 2021 Medicare Physician Fee Schedule (MPFS) Proposed Rule slashes payments for surgical specialists. But the impact of the Proposed Rule is far broader, reflecting a fundamental realignment driven by the transition to value-based payments. In our webinar, “While You Were Sleeping…Proposed Rule Positioned to Significantly Impact Physician Compensation,” PYA experts addressed these proposals, helping you understand and prepare for the changes ahead.
Following this presentation, attendees were able to:
Understand how a handful of wRVU changes would alter Medicare reimbursement for nearly all physicians.
Appreciate the operational impact of these changes.
Recognize the challenges to existing physician compensation models.
Identify strategies and tactics to prepare for and manage these impacts.
Presenters include PYA Principals Angie Caldwell, Martie Ross, and Valerie Rock. The webinar took place Thursday, September 10 and was hosted in conjunction with the Florida Hospital Association.
If you have additional questions about the MPFS Proposed Rule and its impact on physician compensation or need assistance with any matter involving physician compensation, valuation, strategy and integration, or compliance, contact a PYA executive below at (800) 270-9629.
Webinar: “Cybersecurity During COVID-19: A Look Behind the ScenesPYA, P.C.
Cybersecurity breaches have been in the news almost daily for some time now. COVID-19 has amplified the problem, as “bad actors” seize upon the opportunity to take advantage of hospitals at their most vulnerable time. Given this climate and an aging HIPAA rule, it is difficult to anticipate and prepare for the future.
PYA Principal Barry Mathis presented “Cybersecurity During COVID-19: A Look Behind the Scenes,” on Wednesday, August 12, 2020. This one-hour, complimentary webinar was hosted by PYA in conjunction with the Montana Hospital Association as Part 2 of the Frontier States Town Hall Meeting.
Barry covered information related to HIPAA, cybersecurity, and a special behind-the-scenes view into the tradecraft of bad actors. This unique presentation included:
Recent enforcement trends by the Office for Civil Rights.
The current environment for ransomware.
An opportunity to watch as Barry logs onto the Dark Web and shows you first-hand how bad actors operate.
Ideas for managing cybersecurity threats.
On Friday, August 21, 2020, a webinar co-hosted by PYA prepared hospitals for a new rule taking effect on January 1, 2021, to address price transparency in healthcare. The Centers for Medicare & Medicaid Services published a rule in November 2019 requiring hospitals to establish, update, and make public a list of their standard charges for items and services they provide. In addition to the current requirement to post standard charges on their websites, the Final Rule requires hospitals to publish online, in a machine-readable format, their payer-specific negotiated rates for 300 “shoppable” services and their standard charges for all items and services provided, defined as the gross charge, payer-specific negotiated charges, discounted cash price, and the de-identified minimum and maximum charges.
As we approach January 2021, it is vital that hospitals understand the requirements of the pricing transparency rule and options for compliance. It is unlikely that this rule will “go away”–court decisions are always subject to appeal, and there is even concern that Congress is considering action that would transform these requirements from regulation to legislation.
During the complimentary webinar, PYA Senior Manager Kathy Reep discussed hospital requirements related to pricing transparency, and Chris Kenny, Partner in the Washington, D.C., office of King & Spalding, addressed concerns related to compliance and the legal challenges associated with the final transparency rule.
This webinar was presented in conjunction with:
Dallas-Fort Worth Hospital Council
Florida Hospital Association
Georgia Hospital Association
Kansas Hospital Association
Louisiana Hospital Association
Montana Hospital Association
Not a surprise to most — healthcare is making headlines on an international level. Though not front and center, still of importance to the hospital community are issues working their way through government agencies and the legislature.
As one of the keynote speakers of this year’s virtual Florida Institute of CPAs Health Care Industry Conference, PYA Senior Manager Kathy Reep presented a “Federal Legislative and Regulatory Update.” She covered a number of current issues affecting healthcare providers, including:
Price transparency.
Congressional action on surprise billing.
The Administration’s budget for 2021.
Medicare proposed rules related to hospital inpatient payments and post-acute care for FY2021.
The virtual event took place June 23-24, 2020.
Webinar: Post-Pandemic Provider Realignment — Navigating An Uncertain MarketPYA, P.C.
The COVID-19 pandemic will materially affect U.S. provider industry structure, as financial weaknesses are exposed, risk tolerances are tested, and uncertainties persist. As a result, provider mergers-and-acquisitions (M&A) activities across industry sectors will likely spike in the short- to medium-term future. Providers of all types need to be aware of, and prepared for, the changes they will face.
In this 45-minute joint webinar, PYA Principal Brian Fuller and Juniper Advisory Managing Director Jordan Shields provided a real-time assessment of the COVID-19 pandemic, as well as shared predictions for what the extending crisis means in coming years for M&A activity in the provider space.
The webinar took place Thursday, August 6, 2020, at 11 a.m. EDT.
Since March, PYA experts have closely tracked and carefully evaluated the pandemic’s impact on employed physician compensation. During this complimentary one-hour webinar, PYA Principals Angie Caldwell and Martie Ross highlighted five immediate considerations for hospitals and health systems to manage the storm. They also explored five longer-term considerations impacting future planning.
This webinar took place Friday, July 24, 2020, at 11 a.m. EDT, and was held in conjunction with:
Dallas-Fort Worth Hospital Council
Florida Hospital Association
Kansas Hospital Association
Montana Hospital Association
The COVID-19 pandemic has exposed organizational and industry weaknesses. To build a more resilient delivery system, leaders now must engage their governing boards in re-calibrating strategic plans, re-evaluating investments, and re-imagining hospitals’ and health systems’ roles in their communities.
In this 45-minute webinar, PYA Principals Martie Ross and Brian Fuller provided a framework for these critical discussions including root-cause analysis, market assessment, new realities, guiding principles, and strategic and operational priorities.
This webinar originally took place on Wednesday, June 24, 2020.
Webinar: Free Money with Strings Attached – Cares Act Considerations for Fron...PYA, P.C.
PYA, in conjunction with the Montana Hospital Association, recently co-hosted a Frontier States Town Hall Meeting webinar, “Free Money With Strings Attached: CARES Act Considerations for Frontier States’ Healthcare Provider Organizations.” Principals Lori Foley, Martie Ross, and David McMillan introduced the CARES Act Provider Relief Fund including distribution formulas, the attestation process, the verification and application process, and ongoing recordkeeping requirement. They also answered attendees’ numerous questions regarding these matters.
Webinar: “Got a Payroll? Don’t Leave Money on the Table”PYA, P.C.
Under the CARES Act, every employer with a payroll has an opportunity to retain cash–whether they have a PPP loan or not. What employers need to know right now.
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) along with the Payroll Protection Program (PPP) offer all business owners relief, but the details can be confusing or overlooked.
Perhaps you don’t fully understand how the deferral of the employer’s share of Social Security taxes works. Maybe you wonder if the deferral even applies to you—good news, it does if you have a payroll!
Failure to fully understand your options could cost you money, at a time when “cash is king.”
As part of PYA’s ongoing commitment to sharing helpful guidance, Tax Principals Debbie Ernsberger and Mark Brumbelow outlined issues and opportunities within the CARES Act, and answered questions during a one-hour webinar that originally aired on Wednesday, May 20, 2020.
Webinar: So You Have a PPP Loan. Now What?PYA, P.C.
The CARES Act provides relief to small businesses through Paycheck Protection Program (PPP) loans, but receiving the loan is only the first part of the equation. PYA discussed what businesses need to know and do next.
Failure to fully understand the requirements for PPP loan forgiveness could cost employers money, at a time when every penny counts. Employers need to stay up-to-date on recent activities regarding the PPP loan forgiveness application, necessary documentation, and other best practices to ensure they are well-prepared for the next steps under the PPP.
As part of PYA’s ongoing commitment to sharing helpful guidance, Tax Principals Debbie Ernsberger and Mark Brumbelow outlined PPP loan forgiveness requirements and answered questions during a one-hour webinar on Wednesday, June 3, 2020.
Webinar: “Making It Work—Physician Compensation During the COVID-19 Pandemic”PYA, P.C.
What to do with your physician compensation plan in the face of the COVID-19 pandemic? It’s a question that leaves administrators searching for answers.
PYA Principal Angie Caldwell and Senior Manager Katie Culver introduced several key considerations for provider compensation during and after the COVID-19 pandemic. In PYA’s complimentary webinar, they:
Summarized the current environment impacting physician compensation associated with the pandemic.
Provided an overview of the Stark Blanket Waivers and opportunities created for physician compensation.
Described restoration and recovery strategies for physician resources.
PYA hosted this one-hour webinar Tuesday, April 28, 2020, at 11 a.m. EDT in conjunction with the Florida Hospital Association.
Webinar: “Provider Relief Fund Payments – What We Know, What We Don’t Know, W...PYA, P.C.
The federal government is now making CARES Act Relief Fund payments to Medicare providers. These payments are not loans—they do not have to be repaid or forgiven. However, this money comes with strings attached.
During PYA’s 30-minute webinar, Provider Relief Fund Payments—What We Know, What We Don’t Know, What To Do Now, PYA Principals Martie Ross and Lori Foley discussed:
The source of the funds.
The required attestation process.
Compliance, tax, and audit concerns.
The webinar took place Friday April 17, 2020.
Webinar: “Hospitals, Capital, and Cashflow Under COVID-19”PYA, P.C.
Hospitals and providers need to think creatively, strategically, and long-term about capital and cashflow under the pressures of the COVID-19 pandemic. A one-hour webinar hosted by PYA discussed the current state of capital markets for non-profit healthcare systems, and considerations for capital management, including the role of real estate assets.
PYA Principal Michael Ramey joined Realty Trust Group Senior Vice-President Michael Honeycutt and Ponder & Company Managing Director Jeffrey B. Sahrbeck to present “Hospitals, Capital, and Cashflow, Under COVID-19” In this webinar, they covered:
Hospital industry capital market updates and trends, including how the capital markets are responding to the crisis.
Access to capital under recent regulations.
Cash preservation techniques for hospitals considering real estate operations and assets.
The webinar took place Thursday, April 9, 2020, at 11 a.m. EDT.
PYA Webinar: “Additional Expansion of Medicare Telehealth Coverage During COV...PYA, P.C.
Late on March 30, CMS released an interim rule which, among other things, significantly expands Medicare telehealth coverage, even beyond the initial Section 1135 waivers. PYA’s complimentary one-hour webinar explained these changes and how they make telehealth an even more attractive option in response to the COVID-19 pandemic.
PYA Principals Martie Ross and Valerie Rock addressed the latest developments, including:
New reimbursement for telephone-only services.
Broader coverage for remote patient monitoring.
New payments for rural health clinics and federally qualified health centers.
Use of telehealth to meet supervision requirements.
New rules regarding coding and billing as well as the changed payment rates for telehealth services.
The webinar took place Friday April 3, 2020, at 11 a.m. EDT.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
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.
India Clinical Trials Market: Industry Size and Growth Trends [2030] Analyzed...Kumar Satyam
According to TechSci Research report, "India Clinical Trials Market- By Region, Competition, Forecast & Opportunities, 2030F," the India Clinical Trials Market was valued at USD 2.05 billion in 2024 and is projected to grow at a compound annual growth rate (CAGR) of 8.64% through 2030. The market is driven by a variety of factors, making India an attractive destination for pharmaceutical companies and researchers. India's vast and diverse patient population, cost-effective operational environment, and a large pool of skilled medical professionals contribute significantly to the market's growth. Additionally, increasing government support in streamlining regulations and the growing prevalence of lifestyle diseases further propel the clinical trials market.
Growing Prevalence of Lifestyle Diseases
The rising incidence of lifestyle diseases such as diabetes, cardiovascular diseases, and cancer is a major trend driving the clinical trials market in India. These conditions necessitate the development and testing of new treatment methods, creating a robust demand for clinical trials. The increasing burden of these diseases highlights the need for innovative therapies and underscores the importance of India as a key player in global clinical research.
Telehealth Psychology Building Trust with Clients.pptxThe Harvest Clinic
Telehealth psychology is a digital approach that offers psychological services and mental health care to clients remotely, using technologies like video conferencing, phone calls, text messaging, and mobile apps for communication.
Antibiotic Stewardship by Anushri Srivastava.pptxAnushriSrivastav
Stewardship is the act of taking good care of something.
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
WHO launched the Global Antimicrobial Resistance and Use Surveillance System (GLASS) in 2015 to fill knowledge gaps and inform strategies at all levels.
ACCORDING TO apic.org,
Antimicrobial stewardship is a coordinated program that promotes the appropriate use of antimicrobials (including antibiotics), improves patient outcomes, reduces microbial resistance, and decreases the spread of infections caused by multidrug-resistant organisms.
ACCORDING TO pewtrusts.org,
Antibiotic stewardship refers to efforts in doctors’ offices, hospitals, long term care facilities, and other health care settings to ensure that antibiotics are used only when necessary and appropriate
According to WHO,
Antimicrobial stewardship is a systematic approach to educate and support health care professionals to follow evidence-based guidelines for prescribing and administering antimicrobials
In 1996, John McGowan and Dale Gerding first applied the term antimicrobial stewardship, where they suggested a causal association between antimicrobial agent use and resistance. They also focused on the urgency of large-scale controlled trials of antimicrobial-use regulation employing sophisticated epidemiologic methods, molecular typing, and precise resistance mechanism analysis.
Antimicrobial Stewardship(AMS) refers to the optimal selection, dosing, and duration of antimicrobial treatment resulting in the best clinical outcome with minimal side effects to the patients and minimal impact on subsequent resistance.
According to the 2019 report, in the US, more than 2.8 million antibiotic-resistant infections occur each year, and more than 35000 people die. In addition to this, it also mentioned that 223,900 cases of Clostridoides difficile occurred in 2017, of which 12800 people died. The report did not include viruses or parasites
VISION
Being proactive
Supporting optimal animal and human health
Exploring ways to reduce overall use of antimicrobials
Using the drugs that prevent and treat disease by killing microscopic organisms in a responsible way
GOAL
to prevent the generation and spread of antimicrobial resistance (AMR). Doing so will preserve the effectiveness of these drugs in animals and humans for years to come.
being to preserve human and animal health and the effectiveness of antimicrobial medications.
to implement a multidisciplinary approach in assembling a stewardship team to include an infectious disease physician, a clinical pharmacist with infectious diseases training, infection preventionist, and a close collaboration with the staff in the clinical microbiology laboratory
to prevent antimicrobial overuse, misuse and abuse.
to minimize the developme
Explore our infographic on 'Essential Metrics for Palliative Care Management' which highlights key performance indicators crucial for enhancing the quality and efficiency of palliative care services.
This visual guide breaks down important metrics across four categories: Patient-Centered Metrics, Care Efficiency Metrics, Quality of Life Metrics, and Staff Metrics. Each section is designed to help healthcare professionals monitor and improve care delivery for patients facing serious illnesses. Understand how to implement these metrics in your palliative care practices for better outcomes and higher satisfaction levels.
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
Addressing Medical Necessity Denials and Recoupments
1. Presentation prepared for
AHLA Medicare and Medicaid Institute
March 29-31, 2017
Medical Necessity – Current Status/
Key Best Practices in Prevention of
Medical Necessity Denials and
Recoupments
2. Page 1Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Agenda
• A discussion of medical necessity – what it means and what it affects
• Details regarding the types of medical necessity determinations and
the criteria for determining medical necessity
• An explanation of categorically excluded services
• Admission criteria [to include Skilled Nursing Facilities (SNF) and
Inpatient Rehabilitation Facilities (IRF)]
• The use of Advanced Beneficiary Notification (ABN) and Hospital-
Issued Notice of Non-Coverage (HINN), and the outcomes and
penalties for not using ABNs or HINNs
4. Page 3Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Types of Medical Necessity
Clinical medical necessity
Documentation by “a physician or other practitioner (“ordering
practitioner”) who is: (a) licensed by the state to admit inpatients to
hospitals, (b) granted privileges by the hospital to admit inpatients to that
specific facility, and (c) knowledgeable about the patient’s hospital
course, medical plan of care, and current condition at the time of
admission.)” Hospital Inpatient Admission Order and Certification, CMS
(January 30, 2014)
Coding documentation for medical necessity
The admitting Diagnosis Code is the condition identified by the ordering
practitioner at the time of the patient’s admission to the hospital (this can
include signs/symptoms on admission)
5. Page 4Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Medical Necessity
Medically necessary
Healthcare services or supplies needed to
diagnose or treat an illness, injury, condition,
disease, or its symptoms that meet
accepted standards of medicine
Services that must meet criteria for National
Coverage Determinations (NCD) and Local
Coverage Determinations (LCD)
“[C]omplex medical judgment which can be
made only after the physician has
considered a number of factors . . . .” BPM
(CMS Pub. 100-02), ch. 1, § 10 (2012)
6. Page 5Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Medical Necessity
Two-Midnight Standard
Under the Two-Midnight Rule, other than for procedures that appear on the Medicare
“inpatient only” list codified at 42 C.F.R. § 419.22(n), surgical procedures, diagnostic
tests, and other treatments are generally appropriate for inpatient payment under Part
A only “when the physician expects the patient to require a stay that crosses at least 2
midnights and admits the patient to the hospital based on that expectation.” (78 Fed.
Reg. at 50506)
Conversely, if the physician does not expect the patient to stay across two midnights, then
inpatient care would generally be inappropriate under Part A
This coverage standard has been codified in regulations at 42 C.F.R. § 412.3(e)
In making a decision as to whether a patient is expected
to require a stay that crosses two midnights,
physicians are to look at factors such as:
Patient history and comorbidities
Severity of signs and symptoms
Current medical needs and risk of adverse event
The Two-Midnight Rule applies to all hospitals
except IRFs
7. Page 6Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Two-Midnight Rule
Exception to the Two-Midnight Rule: “Rare
and Unusual Circumstances:” Since adoption
of the Two-Midnight Rule, CMS has stated in
guidance that there may be “rare and unusual”
circumstances in which an inpatient admission
for a service not on the inpatient-only list may be
reasonable and necessary in the absence of an
expectation of a two-midnight stay
The rationale for such an exception is not stated, but
the presumption is that certain “rare and unusual”
cases may be severe enough to warrant the need for
the type of medical care and services that can only
be furnished safely and effectively on an inpatient
basis regardless of how long those inpatient services
are required
8. Page 7Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Two-Midnight Rule (continued)
CMS states that the following factors (among others)
would be relevant to determining whether a patient
requires inpatient admission under the expanded “rare
and unusual” exception:
The severity of the signs and symptoms exhibited by the patient
The medical predictability of something adverse happening to the
patient
The need for diagnostic studies that appropriately are outpatient
services (that is, their performance does not ordinarily require the
patient to remain at the hospital for 24 hours or more)
Source: 80 Fed. Reg. at 70541
9. Page 8Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Physician Admission Orders
Orders are entitled to no presumptive weight: CMS has codified CMS
Ruling 93-1 which rejects application of the “treating physician rule” to
Medicare inpatient stays; in FY 2014, CMS adopted a regulation which
states that “[n]o presumptive weight shall be assigned to the physician’s
order . . . in determining the medical necessity of inpatient hospital
services. . . .” The rule is codified at 42 C.F.R. § 412.46(b)
Possible exception to the written order requirement and the ability
to submit claims with missing or defective orders: Despite this
regulatory requirement, CMS has stated in guidance published in
January 2014, that it will allow its contractors to consider the written
order requirement to be fulfilled in the case of defective or missing
written orders where it is clear in the medical record that the physician
intended to admit the beneficiary as an inpatient; hospitals with missing
or defective written orders, therefore, should evaluate the circumstances
of the affected inpatient admission to determine whether a claim for Part
A reimbursement may still be submitted
10. Page 9Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Medicare Outpatient Observation Notice
Medicare Outpatient Observation Notice (MOON)
The development of MOON was to inform all Medicare
beneficiaries when they are outpatients receiving
observation services, and are not inpatients of the
hospital or critical access hospital (CAH)
Must be delivered to Original Medicare (fee-for-service) and
Medicare Advantage enrollees who receive observation services
for more than 24 hours with delivery no later than 36 hours after
observation begins
Oral notification as well as written notification must be provided to
confirm the beneficiary understands and is given opportunity for
questions
The beneficiary or his/her representative must sign and date the
MOON and a copy must be given to the beneficiary as well as
placed in the medical record
11. Page 10Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Criteria for Determining Medical Necessity
InterQual and MCG (formerly
Milliman)
• Evidence-based care
guidelines for assessing the
medical necessity
appropriateness of admission
and continued stay
• How does the Two-Midnight
Rule change the use of
these resources for
Medicare inpatients
National Coverage
Determinations (NCDs)
• An evidence-based process,
with opportunities for public
participation; in some cases,
CMS' own research is
supplemented by an outside
technology assessment
and/or consultation with the
Medicare Evidence
Development & Coverage
Advisory Committee
(MEDCAC); in the absence of
a national coverage policy, an
item or service may be
covered at the discretion of
the Medicare contractors
based on an LCD
• Hyperbaric Oxygen Therapy
(20.29), June 19, 2006
• Implantable Automatic
Defibrillators (20.4), January
27, 2005
Local Coverage
Determinations (LCDs)
• A determination by a
Medicare Administrative
Contractor or a carrier under
Part A or Part B, as
applicable, respecting
whether or not a particular
item or service is covered on
an intermediary- or carrier-
wide basis under such parts,
in accordance with section
1862(a)(1)(A)
12. Page 11Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Technical Denials
Denial of payment by Medicare for failure to meet coverage
requirements, including:
Failure to meet a condition of payment required by the regulations such as:
Self-administered drugs
Ambulance services such as transport from a hospital to an SNF when the patient
is not bedridden
Air ambulance services when the medical record supports the patient could have
been safely and effectively transported by ground transport
SNFs admission not preceded by the required 3-day inpatient hospitalization
Payment for home health services because they were not ordered on a plan of
care treatment or subsequent amendment
Services that do not meet all qualifying requirements for NCDs and LCDs
Incorrect code selection or insufficient documentation to support the code billed
14. Page 13Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Categorically Excluded Services
Medicare identifies the following four categories of
items and services that are not covered under the
Medicare Program
1) Services and supplies that are not medically
reasonable and necessary
2) Non-covered items and services
3) Services and supplies denied as bundled or included
in the basic allowance of another service
4) Items and services reimbursable by other
organizations or furnished without charge
15. Page 14Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Categorically Excluded Services
Services and supplies that are not medically
reasonable and necessary
Services provided in a hospital that could have been
furnished in a lower-cost setting/lower level of care
Hospital services that exceed Medicare length-of-stay
limitations
Evaluation and management services that exceed those
considered medically reasonable and necessary
Therapy or diagnostic procedures that exceed Medicare
usage limits
Screening tests, examinations, and therapies for which the
beneficiary has no symptoms or documented conditions
(The use of MRIs and CTs might fall into this category)
Services such as acupuncture, transcendental meditation,
and assisted suicide
16. Page 15Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Categorically Excluded Services
Non-covered items and services
This is a very large and general section which
includes areas such as:
Items and services provided outside of the U.S.
Items and services required as a result of war
Personal comfort items and services; items and services
furnished by the beneficiary’s immediate relatives and
members of the beneficiary’s household; cosmetic surgery
Routine physical check-ups; eye exams; hearing aids and
exams; and certain immunizations (not associated with an
identified sign, symptom, or complaint)
Custodial care
Custodial care is personal care that does not require the
continuing attention of trained medical or paramedical personnel
and services to assist an individual in activities of daily living such
as:
Walking; getting in and out of bed; bathing; dressing; feeding;
using the toilet; preparing special diets; and supervising the
administration of self-administered medicines
17. Page 16Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Categorically Excluded Services
Services and supplies denied as bundled or
included in the basic allowance of another
service
Fragmented services included in the basic
allowance of the initial service
Prolonged care (indirect)
Case management services (e.g., phone calls
to and from the beneficiary)
Supplies included in the basic allowance of a
procedure
18. Page 17Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Categorically Excluded Services
Items and services reimbursable by other
organizations or furnished without charge
Payment will not be made for items and services when
a payment has been made or can reasonably be
expected to be paid promptly under:
Automobile insurance
No-fault insurance
Liability insurance
Workers’ Compensation law or plan of the U.S. or state
Defective equipment or medical devices covered under warranty
20. Page 19Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Investigational Drugs
Current federal law requires that a drug be the subject of an approved marketing application before
it is transported or distributed across state lines
The Investigational New Drug application (IND) is the means through which the sponsor technically
obtains this exemption from the FDA in order to distribute or transport across state lines to clinical
investigators
During a new drug's early preclinical development, the sponsor's primary goal is to determine if the
product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological
activity that justifies commercial development
There are three IND types:
Investigator IND – submitted by a physician who both initiates and conducts an investigation,
and under whose immediate direction the investigational drug is administered or dispensed
Emergency Use IND – allows the FDA to authorize use of an
experimental drug in an emergency situation that does not
allow time for submission of an IND in accordance with
21CFR, Sec. 312.23
Treatment IND – submitted for experimental drugs showing
promise in clinical testing for serious or immediately
life-threatening conditions while the final clinical work is
conducted and the FDA review takes place
There are two IND categories:
Commercial
Research (noncommercial)
21. Page 20Prepared for AHLA Institute on Medicare and Medicaid Payment Issues
Investigational Drugs (continued)
• Preclinical data to permit an assessment as to whether the product is reasonably safe
for initial testing in humans
• Any previous experience with the drug in humans (often foreign use)
Animal Pharmacology and Toxicology Studies
• Pertaining to the composition, manufacturer, stability, and controls used for
manufacturing the drug substance and the drug product
• This information is assessed to ensure that the company can adequately produce and
supply consistent batches of the drug
Manufacturing Information
• Detailed protocols for proposed clinical studies to assess whether the initial phase
trials will expose subjects to unnecessary risks
• Information on the qualifications of clinical investigator professionals (generally
physicians) who oversee the administration of the experimental compound to assess
whether they are qualified to fulfill their clinical trial duties
• Commitments to obtain informed consent from the research subjects, to obtain review
of the study by an institutional review board (IRB), and to adhere to the investigational
new drug regulations
Clinical Protocols and Investigator Information
The IND application must contain information from three broad areas:
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Admission Criteria
Skilled Nursing Facilities (SNF)
3-day hospital stay to qualify for additional SNF care
A minimum of three consecutive, medically necessary inpatient days in an acute care setting
Skilled services
Skilled nursing services, physical therapy, and occupational therapy which are provided daily
under the supervision of a professional
Preadmission Screening and Resident Review (PASRR)
A federal requirement to help ensure that individuals are not inappropriately placed in nursing
homes for long-term care (LTAC); this is required prior to admission into an SNF or LTAC, and
services should not be provided or billed without this being submitted and placed on the
patient chart
Practical Matter
The physician must declare the need for skilled services, through physician certification and
admission orders to skilled nursing; the physician provides the diagnoses and skilled services
required; this must be on the patient chart upon admission and must take into consideration
economy and efficiency--the daily skilled service can only be provided on an inpatient basis in
an SNF
Minimum Data Set (MDS)*
“U.S. federally mandated process for clinical assessment of all residents in Medicare or
Medicaid certified nursing homes. This process provides a comprehensive assessment of
each resident's functional capabilities and helps nursing home staff identify health”
* Source: https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/Minimum-Data-Set-3-0-Public-
Reports/index.html
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Admission criteria (continued)
Inpatient Rehabilitation Facilities (IRF)
Qualifying Condition
At least 60% of the patient population in the IRF must have 1 of 13 determined diagnoses
Preadmission Screening
Conducted immediately 48 hours preceding IRF admission
Post-admission physician evaluation
Completed within the first 24 hours of admission
Medical supervision by a physician with specialized training in rehabilitation services
Physician progress notes documented in the medical record at least every 2 to 3 days
Individual overall Plan of Care (PoC)
Detail of the patient's medical prognosis, anticipated interventions, functional outcomes, and
discharge destination
Inpatient Rehabilitation Facility, Patient Assessment Instrument (IRF-PAI)
Intensive level of rehabilitation services
To begin within 36 hours from midnight of the day of admission to IRF
Intensive level of therapy 3 hours/day at least 5 days/week or 15 hours/week in a 7-
consecutive day period
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Admission Criteria (continued)
Inpatient Rehabilitation Facilities (IRF)
Multidisciplinary team approach to delivery of program
Minimum requirement includes: physician, rehabilitation nurse, social worker or case
manager, and licensed or certified therapist
Coordinated Program of Care/Team Conference
Documentation supports team conference held at least once a week
Documentation indicates assessment of progress or problems impeding progress,
consideration of possible resolutions, and reassessment of rehab goals
Expectation of significant practical improvement
Documentation of reasonable expectation of significant practical improvement
Beneficiary must classify into one of the Case Mix Groups payable by Medicare under the IRF
Prospective Payment System (PPS)
Realistic goals
Documentation of rehabilitation goals to support the patient's return to a maximum level of
function based on the patient's overall condition and previous level of independence
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Advanced Beneficiary Notification (ABN)
Advance Beneficiary Notice of Noncoverage
A written notice must be given to a Fee-For-Service Medicare beneficiary
before items or services that are usually covered by Medicare, but are not
expected to be paid in a specific instance (e.g., lack of medical necessity), are
provided
These notices allow the beneficiary to make an informed decision about
whether to get the item or service dependent on their potential financial
liability
The following notices are approved:
Advance Beneficiary Notice of Noncoverage (ABN), Form CMS-R-131
Skilled Nursing Facility Advance Beneficiary Notice of Noncoverage
(SNFABN), Form CMS=10055
Hospital-Issued Notice of Noncoverage (HINN)
The Home Health Advance Beneficiary Notice, Form CMS-R-296 was
discontinued December 9, 2013, and the ABN is used in its place as liability
notification
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ABN (continued)
Hospital-Issued Notice of Non-Coverage for inpatient admissions
A HINN letter is issued at preadmission, admission, or during the continued
stay of an inpatient hospitalization when the stay is considered not to be
medically necessary
As a part of Regulation 42 CFR Part 476.71, Quality Improvement
Organizations (QIOs) are required to review the hospital medical necessity of
discharges and admissions
The beneficiary has the right to request a review by the QIO to rule on the
appropriateness of admission; the beneficiary is liable for all customary
services during the QIOs review if the QIO agrees the admission is not
necessary
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ABN (continued)
Outcomes and Penalties for not using ABNs
The ABN is to be provided before the item or service is provided
A copy of the ABN must be kept in the medical record and a copy must be
given to the beneficiary
If a provider fails to issue the ABN or uses an outdated version, the provider
risks being held liable for the services or items in question
Providers are prohibited from systematically issuing ABNs and must have
specific, identifiable reasons for asserting non-coverage through the use of
an ABN
Providers and suppliers may charge their usual and customary fee for the
items or services they furnish to the beneficiary if (a) the supplier/provider
furnishes a proper ABN, (b) the beneficiary agrees to pay, and (c) Medicare
denies the claim
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Billing Decisions for Medically Unnecessary Services
Condition Code 44 (CC-44)
When a patient is admitted to a hospital as an inpatient but, upon internal review, the
hospital determines the services did not meet inpatient criteria and the admission is
changed to observation; this rule has become informally known as condition code 44;
after meeting a series of specific and rigid requirements, the patient stay can be billed
as observation
Provider Liability
When Medicare Part A payment cannot be made because an inpatient admission is
found to be not reasonable and necessary and the beneficiary should have been
treated as a hospital outpatient rather than a hospital inpatient, Medicare will allow
payment under Part B of all hospital services that were furnished and would have been
reasonable and necessary if the beneficiary had been treated as a hospital outpatient,
rather than admitted to the hospital as an inpatient, except for those services that
specifically require an outpatient status, provided the beneficiary is enrolled in
Medicare Part B and provided the allowed timeframe for submitting claims is not
expired; the policy applies to all hospitals and CAHs participating in Medicare
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Recoupments and Self-Disclosure Protocol
Self disclosure
A process for healthcare providers to voluntarily identify, disclose, and resolve instances of
potential fraud involving the federal healthcare programs (as defined in section 1128B[f] of the
Social Security Act [the “Act”], 42 U.S.C. 1320a–7b[f])
Good faith disclosure of potential fraud and cooperation with the OIG’s review and resolution
process are typically indications of a robust and effective compliance program
Institution of a presumption against requiring integrity agreement obligations in exchange for a
release of the OIG’s permissive exclusion authorities in resolving an SDP matter
Entities that use the SDP and cooperate with the OIG during the SDP process deserve to pay a
lower multiplier on single damages than would normally be required in resolving a government-
initiated investigation
Settlements of SDP matters generally require a minimum multiplier of 1.5 times the single damages
Requirement that a Medicare or Medicaid overpayment be reported and returned by the latter of (1)
the date that is 60 days after the date on which the overpayment was identified or (2) the date any
corresponding cost report is due, if applicable
All healthcare providers, suppliers, or other individuals or entities who are subject to the OIG’s CMP
authorities found at 42 C.F.R. Part 1003 are eligible to use the SDP
The OIG expects disclosing parties to disclose with a good faith willingness to resolve all liability
within the Civil Monetary Penalties Law’s (CMPL’s) six-year statute of limitations as described in
section 1128A(c)(1) of the Act
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Recoupments and Self-Disclosure Protocol
Sample determination
Estimation of damages must consist of a review of either: (1) all the claims affected by the
disclosed matter or (2) a statistically valid random sample of the claims that can be projected to the
population of claims affected by the matter
When using a sample to estimate damages, the disclosing party must use a sample of at least 100
items and use the mean point estimate to calculate damages; if a probe sample was used, those
claims may be included in the 100-item sample if statistically appropriate
To avoid an unreasonably large sample size, the disclosing party may select an appropriate sample
size to estimate damages as long as the sample size is at least 100 items; as a general rule,
smaller sample sizes (closer to 100) will suffice where the population has a high level of
homogeneity, and larger sample sizes will be necessary where the population contains a more
diverse mixture of claim types
Extrapolation of error rate
After review of sample, calculate a correct payment for the claims requiring adjustment
Extrapolation is a sampling methodology which uses a mathematical formula to take the audit
results from a random sample of Medicare or Medicaid paid claims in order to project those results
over a much larger universe of claims often producing overpayments
The error rate shall be the percentage of net overpayments identified in the sample; the net
overpayments shall be calculated by subtracting all underpayments identified in the sample from all
gross overpayments identified in the sample; the error rate is calculated by dividing the net
overpayment identified in the sample by the total dollar amount associated with the paid claims in
the sample
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Resources and References
Centers for Medicare & Medicaid Services, CMS Manual System Publication 100-02 Medicare Benefit Policy, Transmittal 232, Date: December 22, 2016,
Change Request 9930
Centers for Medicare & Medicaid Services, CMS Manual System, Publication 100-04 Medicare Claims Processing, Transmittal 299; September 10, 2004,
Subject: Use of Condition Code 44, “Inpatient Admission Changed to Outpatient”
Centers for Medicare & Medicaid Services, “Medicare National Coverage Determinations Manual”, revised December 10,
2015,https://www.cms.gov/Regulations-and Guidance/Guidance/Manuals/Downloads/ncd103c1_Part1.pdf
Centers for Medicare & Medicaid Services, Medicare Learning Networks, Items and Services That Are Not Covered Under the Medicare Program; ICN
906765, January 2015
Centers for Medicare & Medicaid Services, Therapy Caps Manual Medical Review of Therapy Claims Above the $3,700 Threshold
H.R. 1868 – 99th Congress (1985-1986): Medicare and Medicaid Patient and Program Protection Act of 1986
https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2015-Fact-sheets-items/2015-07-01-2.html
https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-and-Systems/Minimum-Data-Set-3-0-Public-Reports/index.html
Medicare Benefit Policy Manual, Chapter 1 – Inpatient Hospital Services Covered Under Part A (Rev. 232, 12-22-16); 110-Inpatient Rehabilitation Facility
(IRF) Services
Medicare Benefit Policy Manual, Chapter 8, Coverage of Extended Care (SNF) Services Under Hospital Insurance (Rev. 228, 10-13-16); 10-
Requirements -General; 20 -Prior Hospitalizations and Transfer Requirements; 30 -Skilled Nursing Facility Level of Care-General; 40 -Physician
Certification and Recertification for Extended Care Services; 50 -Covered Extended Care Services
Medicare Claims Processing Manual, Chapter 30, Financial Liability Protections; 400.2 Scope, (Rev. 3695, Issued: 01-20-17, Effective 02-21-17,
Implementation: 02-21-17)
Medicare Claims Processing Manual, Chapter 30, Financial Liability Protections, (Rev. 2878, 02-21-14; Rev. 3698, 10-27-17)
Medicare and Medicaid Amendments of 1979 Report of the Committee on Ways and Means U.S. House of Representatives H.R. 4000; November 5,
1979
State Operations Manual, Appendix A – Survey Protocol, Regulations and Interpretive Guidelines for Hospitals; (Rev. 151, 11-20-15); §482.30 Condition
of Participation: Utilization Review
U.S. Department of Health and Human Services, Office of the Inspector General; OIG’s Provider Self-Disclosure Protocol, issued April 17, 2013 (updated
Provider Self-Disclosure Protocol)
U.S. Department of Health and Human Services; U.S. Food & Drug Administration, CPG Sec. 460.100 Hospital Pharmacies – Status as Drug
Manufacturer, Issued 10/1/80; Page last updated: 03/20/2015
U.S. Department of Health and Human Services; U.S. Food & Drug Administration, Investigational New Drug (IND) Application
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Questions
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Contact Information
Denise Hall-Gaulin, RN
Principal
PYA
dgaulin@pyapc.com
Michael Spake, MHA, JD
Vice President of External Affairs and
Chief Compliance & Integrity Officer
Lakeland Regional Health
Michael.Spake@myLRH.org