Ways of developing and maintain compliant IRB policies and procedures

It is imperative for any organization that is carrying out clinical research to have in place thoroughly and properly written and complete policies and procedures. These are the cornerstone for any well-functioning Institutional Review Board (IRB) and Human Research Protection Program (HRPP).

This is a requirement set out by the Office for Human Research Protections (OHRP), which is tasked with protecting the rights, welfare, and wellbeing of human subjects that are involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP is part of the Office of the Assistant Secretary for Health in the Office of the Secretary of HHS.

SOPs should be complete, compliant and up-to-date

Any IRB or HRPP has to have Standard Operating Procedures (SOPs) that are well-defined, clear and in compliance with regulatory requirements. These HRPP policies and procedures should be complete, approved, and up-to-date, and should cover all regulatory requirements.

Most often, organizations carrying out clinical studies falter at meeting these requirements. This happens due to insufficient knowledge of carrying out these procedures in accordance with regulatory requirements.

Learn the ways of getting IRB and HRPP requirements right

A webinar from MentorHealth, a leading provider of professional trainings for the healthcare industry, will offer learning on how to get the IRB and HRPP requirements right.

The speaker at this webinar, Peter Vasilenko, who is the President of his HRPP/IRB consulting company, Apex Ethical Services, LLC, will explain the proper ways by which to write SOPs that meet regulatory requirements, are clear and concise. In order to gain this understanding, all that you need to do is enroll for this webinar, which you can do by visiting

http://www.mentorhealth.com/control/w_product/~product_id=800972LIVE/?Wordpress-SEO

At this webinar, the speaker will explain regulatory requirements and the required guidance on written materials. He will also show how HRPP accreditation Standards can help with writing complete SOPs. He will also show how to include best practices. Peter will describe what SOP’s organizations should have in place based on their type of research, and the format and content of SOP’s.

Also covered is why SOPs should be periodically reviewed and revised, as well as how to use SOPs for IRB education. This session is of high value to professionals who develop or are developing their SOP’s, or are interested in reviewing and improving their existing SOPs, such as IRB personnel who are developing their IRB and HRPP policies and procedures, IRB personnel who want to review and improve their IRB and HRPP SOP’s to ensure regulatory compliance and comprehensive content, Institutional Officials, IRB Managers, IRB Administrators, IRB Coordinators and RB Chairs.

Peter will cover the following areas at this webinar:

• Regulatory requirements and guidance
• How accreditation Standards can help with your SOP’s
• What SOP’s should you have
• Format and content of SOP’s
• Periodic review and revision of SOP’s
• Using SOP’s for education.

Compliance requirements for Medicare Parts C and D sponsors and FDRs

Medicare, a US federal government program whose aim is to provide healthcare to senior citizens and other people who qualify for this program, covers some 56 million Americans. With the cost of healthcare rising exponentially and with 300,000 of the previous generation of Americans, the Baby Boomers, reaching 65 years of age every month, the need for a federal program that addresses the medical needs of these people has gone up.

The Centers for Medicare and Medicaid Services (CMS) has compliance requirements for Medicare Parts C and D sponsors. In simple terms, health plans are Medicare Parts C and D sponsors. Medicare Part C, called Medicare Advantage Plans, is a set of plans offered by private insurance companies which have signed contracts with the federal government.

Medicare Part D is also a prescription drug coverage that came into effect in 2006. Like Medicare Part C, Part D is also managed by private insurance companies, but these should comply with standard guidelines the federal government sets forth. Different medications are offered by each of these plans. No single plan has all kinds of medications under it.

General Compliance and Fraud, Waste and Abuse Training for all of its First-tier, Downstream and Related-entities (FDRs) parts by Parts C and D sponsors is a requirement from the CMS. This has to be done within 90 days of hiring a Part C and D sponsor, and annually after that.

The need for compliance

The CMS attaches high importance to compliance because being compliant is in everyone’s interest. A culture of compliance with the regulatory requirements comes with major advantages.

Firstly, it rules out noncompliance, which can upset the whole process. Secondly, it identifies noncompliance, and thirdly, it rectifies noncompliance. Noncompliance is a deadly sin that delays services, causes difficulty in the use and application of the relevant services by the beneficiaries, denies them benefits and creates obstacles to receiving care.

Get to understand the dynamics of CMS compliance requirements for Medicare Parts C & D sponsors

MentorHealth, a leading provider of professional trainings for the healthcare industry, will be organizing a webinar on the details of CMS compliance requirements for Medicare Parts C & D sponsors.

At this webinar, Gail Madison Brown, who is a registered nurse and an attorney with over 25 years of experience in healthcare, will be the speaker. To understand the whole gamut of Medicare Parts C and D compliance requirements, as well as to get a grasp of the responsibilities of the sponsor FDR Entities; please register for this webinar by visiting

http://www.mentorhealth.com/control/w_product/~product_id=800964LIVE/?Wordpress-SEO

All aspects of Medicare Parts C and D compliance and FDR

At this session, Gail will discuss best practices for meeting all criteria, and how FDR’s need to document and share them with their sponsors. She will discuss the implications of non-compliance with the CMS requirements, and offer advice on how to be proactive while negotiating compliance requirements for managed care agreements.

Gail will impart an understanding of Medicare Part C & D compliance requirements for sponsors and FDR’s, with the help of which, participants will be able to assess whether their compliance program meets Medicare Managed Care Contract requirements. Important people in charge of Medicare Parts C and D compliance and FDR, such as Credentialing Personnel, Contracts Personnel, Business Office, Compliance Officers and Compliance Staff, will benefit from this course.

At this session, the following areas will be covered:

• Discuss Medicare Part C & D managed care compliance requirements for “1st Tier, Downstream and Related Entities” and how to comply with them
• Discuss potential consequences of non-compliance
• Discuss negotiating the compliance program requirements with your managed care contractors.

HIPAA compliance in 10 easy steps

The Health Insurance Portability and Accountability Act (HIPAA) sets out the standards which Business Associates and Covered Entities have to comply with, in order to ensure security of Protected Health Information (PHI). An organization that deals with PHI should make sure that it has taken all the security measures relating to the physical, network and process to ensure PHI’s security.

Business Associates and Covered Entities are the main players in HIPAA compliance. A Business Associate is one who has access to patient information and is involved in providing support in any of these areas: treatment for the patient, payments or operational aspects.

Covered Entities are those who provide treatments to patients or are involved in payments or operations. The associates through whom Business Associates get their work done, namely subcontractors, also come under the provisions of the HIPAA and must comply with them.

The acute need for HIPAA compliance

Why is compliance with the provisions of the HIPAA necessary for Business Associates and Covered Entities? Apart from helping them to meet the main intent of HIPAA, namely ensuring data privacy; compliance with HIPAA is necessary also for the reason that data breach is taken very seriously and is handed severe penalties.

A webinar that will unravel the complexities of HIPAA compliance for Business Associates and Covered Entities is being organized by MentorHealth, a very well-known provider of professional trainings for the healthcare industries.

Jim Sheldon Dean, who is Director of Compliance Services at Lewis Creek Systems, LLC; a Vermont-based consulting firm that has been providing information privacy and security regulatory compliance services to healthcare firms and businesses throughout the Northeast and nationally since its establishment in 1982, will be the speaker at this power packed webinar.

Attendance at this highly educative and valuable session will be of immense help to those involved in HIPAA compliance. All that is needed to participate in this valuable learning session is to visit

http://www.mentorhealth.com/control/w_product/~product_id=801009?/Wordpress and register.

Clear explanation of HIPAA compliance in 10 steps

Jim will set out a clear 10-step HIPAA compliance process for Business Associates and Covered Entities. During these 90 minutes, Jim will compress 10 days of learning to set out the 10 steps for HIPAA compliance. This training session will condense how to use these as a foundation for the longer version of HIPAA compliance. It will summarize HIPAA compliance in 10 easy and clear, abridged steps.

These are what Jim will offer by way of instruction at this 10-step HIPAA compliance process:

Step One: Researching how to use PHI and understanding what policies and procedures are in place for Privacy, Security, and Breach Notification

Step Two: An understanding of the limitations on uses and disclosures of PHI that Business Associates have to establish according to the Privacy Rule

Step Three: Patient Rights under HIPAA

Step Four: HIPAA Risk Analysis

Step Five: HIPAA Security Safeguards, at which the ways of understanding and implementing physical, technical, and administrative safeguards are imparted

Step Six: HIPAA Security and Breach Notification Policies and Procedures

Step Seven: The proper way of documenting policies and procedures, at which the Business Associate or Covered Entity can show compliance

Step Eight: Training the staff on the policies and procedures related to HIPAA sections on privacy, security, and breach notification

Step Nine: Verification and audits of compliance, which includes HIPAA Privacy, Security, and Breach Notification compliance that should be implemented and regularly evaluated for ensuring that policies are being followed and systems are secured

Step Ten: Long Term Compliance Planning and Risk Management.

In the course of explaining these 10 steps to HIPAA compliance, Jim will cover the following areas:

• Find out how to relate your office’s activities to the regulations
• Learn what are the ways you can share information under HIPAA, and the ways you may not
• Find out about HIPAA requirements for access and patient preferences, as well as the requirements to protect PHI
• Learn how to use an information security management process to evaluate risks and make decisions about how best to protect PHI and meet patient needs and desires
• Find out what policies and procedures you should have in place for dealing with e- mail and texting, as well as any new technology
• Learn about the training and education that must take place to ensure your staff uses e- mail and texting properly and does not risk exposure of PHI
• Find out the steps that must be followed in the event of a breach of PHI

Learn about how the HIPAA audit and enforcement activities are now being increased and what you need to do to survive a HIPAA audit.

Diligence is required while entering into Physician Employment Agreements

Physician Employment Agreements are an important kind of contract between a physician and the healthcare setting that employs her. The Physician Employment Agreements spell out the nature of employment relationship between the two. Because of this reason, the Physician Employment Agreement has to be well thought about and carefully scrutinized. It should be free from the use of any wording that is ambiguous.

The basis for any legal relationship between parties has to be formal written contracts. A clearly written Physician Employment Agreement not only establishes the legal relationship between the healthcare setting and the physician; it also clearly states the terms and conditions of the relationship. It also spells out the rights and obligations of each party. Even as a Physician Employment Agreement endorses the intentions and relationships of the parties that enter into this relationship; it clears the uncertainties in areas such as mutual rights, obligations, and relationships.

Clarity is of the essence

If the parties to the Physician Employment Agreement stick to everything contained in the agreement at the time it was signed and abide by it in letter and spirit, the need for formal documents would hardly be felt. This explains why there is a need for Physician Employment Agreements that are drafted clearly, comprehensively and unambiguously.

Such a Physician Employment Agreement has an important role in protecting against disputes that could arise in the future. The language in a Physician Employment Agreement should thus be very precise and accurate and never vague, which would leave the agreement vulnerable to all kinds of interpretations.

Get to understand the nature of Physician Employment Agreements

William Mack Copeland, president of Executive & Managerial Development Group, will be the speaker at a webinar that MentorHealth, a leading provider of professional trainings for the healthcare industry, is organizing. The objective of this webinar is to clear the lack of clarity that could sometimes seep into a Physician Employment Agreement, making it susceptible to becoming a bone of legal contention.

To understand the nitty-gritty of Physician Employment Agreement, please register for this webinar by logging on to

http://www.mentorhealth.com/control/w_product/~product_id=800952?/Wordpress

What to include and what to exclude

At this webinar, William will offer clarity on a number of important elements of the Physician Employment Agreement. He will explain what needs to go and what does not need to go into a Physician Employment Agreement. He will help participants understand and avoid vague and interpretative terms in Physician Employment Agreements, because these serve no purpose when disputes over the meaning of a party’s rights or obligations arise.

The speaker of this webinar on Physician Employment Agreement will review the various elements of the physician employment agreement. He will focus on the pitfalls and the problems that can develop when the Physician Employment Agreement does not offer a clearly comprehensible definition of the relationship, and/or when the parties fail to get a clear and full understanding of what is being agreed to.

Professionals in the healthcare industry, to whom Physician Employment Agreements are crucial, such as Physicians, Healthcare executives, and Physician practice managers will derive huge benefit from this learning session.

At this session, William will cover the following areas:

• Corporate practice of medicine
• Term and termination
• Termination for Cause
• Severance pay
• Provision allowing physician to terminate for cause
• Severance pay
• Duties of the physician
• Standards for the provision of professional services
• Referral to hospital
• Continuing medical education.