Maximizing profits and patient outcomes in the backdrop of declining reimbursements

In the situation of falling revenues from Medicare billing, many practitioners are worried about the state of their future earnings. A very tangible factor that will help them tide over this problem is often overlooked: the Durable Medical Equipment (DME) program.

The DME program is a very reliable and long term source of income for Medicare practitioners. Yet, this is not considered seriously by most of them because of the various misconceptions that are associated with this program. Not only is the DME program absolutely valid legally; it is a terrific means by which practitioners can build a highly lucrative income avenue.

Building a steady revenue stream

Of course, there are a few provisions and conditions that need to be met if the DME program has to become successful. Being compliant with these requirements not only ensures that highly improved patient outcomes by protecting senior patients from unnecessary, debilitating surgeries that their bodies cannot cope up with at such a late stage of life; it also assures practitioners a steady income stream of the range of $10,000 a month, that too, with just one patient a day. This is all the more important in these times of decreasing patient traffic and professional services reimbursements from insurance companies but more so from Medicare, on the one hand, and increasing, even skyrocketing operating costs on the other.

The ways of attaining this kind of revenue stream will be taught at a very valuable webinar on this topic. It is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. The speaker at this session is Gregory Simms, who has provided this DME Revenue Program model successfully across the country for hundreds of medical practices in numerous practice specialties. He is known in industry circles as the man who developed his revolutionary new Durable Medical Equipment Revenue Program in the Healthcare Industry in 2006.

To get to understand what it takes to build a highly effective, compliant and lucrative DME program that meets its desired outcomes, please register for this webinar by logging on to http://www.compliance4all.com/control/w_product/~product_id=501329LIVE?Wordpress-SEO

A full exposition of the DME option

The core purpose of this session is to debunk popular myths about DME practice. For years, practitioners have been depriving themselves of this revenue stream because they have been referring the business to O&P shops, manufacturers or 3rd parties. The reason: The wrong belief that it is illegal and not profitable for them to adapt and implement a DME program.

Gregory will correct this fallacious line of thinking. If done following proper guidelines and regulations with appropriate protocols and processes, these can be developed into a full-fledged, profitable program that greatly enhances the value that practitioners provide to their patients, as well as their own practice.

All the tools needed for setting up a successful, compliant and effective DME program

At this webinar, Gregory will lead participants into the right direction on what is needed to set up a compliant DME program, starting with accreditation. He will show them how to obtain a DME PTAN license to bill Medicare and how to deal with their legal guidelines to prevent audits. He will show participants the ways of complying with Federal Guidelines such as the Stark Act & Anti-Kickback Statue. All these of course, will be carried out while ensuring a high degree of patient convenience and optimization of their clinical outcomes.

Doctors, owners or administrators of either general practice or of the Pain Management, Orthopedic, Neurological, Chiropractic, Podiatry, Physiatry, and Family Practice & Internal Medicine will benefit immensely from this session.

Gregory will cover the following areas at this webinar:

o  Business Opportunities

o  Legality

o  Myths vs. Reality

o  Operational Necessities Guidelines.

Clarifying the misconceptions about DMFs and Quality Agreements

A Drug Master File (DMF) is a file that lists the materials and processes that have gone into a drug. This submission is made by manufacturers of drugs to the FDA, and has to contain everything that goes into the drug, and has to include not only the materials and the processes; but also confidential information pertaining to the facilities in which the drugs are manufactured. All the inputs that have gone into not just the manufacturing, but also the packaging and storing of all human drugs made by the manufacturer, have to be entered in the DMF.

The FDA’s line of thinking is that all this information has to be provided to it so that it will help the manufacturer protect any confidential or proprietary information relating to its manufacturing process by keeping them with the FDA.

The FDA has issued a number of guidances to the industry about the way in which these submissions have to be made in both paper and electronic format. It has detailed information about how each of these is to be made. This format is set to change, because from May 18, 2018; only DMF submissions made in electronic format under the FDA’s Electronic Common Technical Document (eCTD) will be accepted, and the FDA will reject any DMF submissions made in paper format from that date onwards.

The Quality Agreement

A Quality Agreement (QA) is an important document that goes some way in ensuring the quality of drugs and preventing their contamination and counterfeiting. It is an agreement made between the manufacturers of API or intermediate manufacturers and their suppliers to ensure that the responsibilities for assuring the safe supply of materials are safe to be accepted for pharmaceutical use.

A Quality Agreement stipulates and clearly defines the responsibilities of both the manufacturer and the supplier, and states their respective obligations towards ensuring the quality and safe supply of the API or intermediate user. The Quality Agreement is a major component of the API or intermediate user’s supplier qualification program.

While this is a laudable intention, it has a side effect: Misunderstanding between manufacturers of pharmaceutical or biologic finished products on the one side, and supplier and contractors, on the other, because the FDA states that all the proprietary information is to be stored with it only.

This has given way to considerable confusion and misconception about the nature of the DMF submission and the way in which the Quality Agreement has to be drafted. Yet, it is important to clear the misconceptions and misunderstandings at an earlier stage of the agreement, because proper understanding of the requirements and responsibilities alone can ensure the proper quality of the final product.

The aim of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, is to clear the many misunderstandings between the supplier and the manufacturer.

The speaker at this webinar is Robert J. Russell, who is President of RJR Consulting, Inc., which is engaged in assisting the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and Quality Assurance. To have misconceptions in the various areas of DMF and QA clarified, please register for this webinar by visiting Regulatory and Processing Responsibilities

This training will combine Quality Agreement and DMF, and is meant for suppliers and drug product manufacturers developing these arrangements together. Robert will discuss the advantages of this system.

He will offer understanding into the nature of the misunderstanding that has arisen over the years. The main reason for this is the lack of a thoroughly drafted agreement that delineates roles and responsibilities. The speaker will explain how this can be corrected by clearly stating the means for resolution of issues.

This will be the agenda of this webinar:

o  What are DMFs?

o  The rationale and preparation process for DMFs

o  DMF Preparation: What you need and why you need it

o  FDA Review: How FDA reviews DMFs and why

o  Components Associated with a DMF

o  Japan DMFs

o  European DMFs

o  Canadian DMFs

o  Change control and maintenance: Why accurately maintaining your DMFs is important

Meeting equipment validation requirements from the FDA and EU

Putting in place a program for calibrating and maintaining test and measurement equipment is a regulatory requirement from both the FDA, under 21 CFR Part 210 and 211, and relevant EU regulations. Both these agencies have regulations that require this program from manufacturers.

The purpose of this equipment validation program is to ensure these among others:

o  The equipment is reliable and is capable of performing the use to which it is being put

o  It is safe

o  It ensures free flow of work

o  Keeps costs of preparing it down

o  Ensures that the company does not spend too much on premature replacements.

These are some of the ingredients of this program:

o  Intervals

o  Scheduling

o  Specific procedures

o  Limits of accuracy/precision, and

o  Remedial action when the equipment does not meet established requirements.

Main aspects of equipment validation

Equipment validation has to be done from these three perspectives:

o  Installation Qualification (IQ)

o  Operational Qualification (OQ)

o  Performance Qualification (PQ)

o  Change control & Requalification

Validation before and after use

Validation has to be done prior to use. An equipment must be validated to ensure that it the product being produced meets its specifications. In addition, there are ways of validating equipment that are already in use.

A thorough and proper understanding of how to plan and implement a program for the validation and maintenance of test and measurement equipment will be the learning a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer.

This webinar will have Jeff Kasoff, a senior Regulatory Affairs professional, who has more than 30 years in Quality and Regulatory management; as speaker. Jeff brings the rich experience of having implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. To gain the benefit of insightful learning from this highly experienced Regulatory Affairs professional, please register for this webinar by visiting Calibration and Preventive Maintenance

All the aspects of calibrating and maintaining test and measurement equipment

At this webinar, Jeff will give participants an understanding of how to calibrate and maintain test and measurement equipment. He will explain all the elements that go into it, namely intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. In addition, he will also offer an understanding of the various ways by which to validate equipment already in use.

Professionals holding positions in companies, whose work involves equipment/process development, such as QA management, Quality Engineering staff, R&D management, Engineering management, Production management, Manufacturing Engineering staff, Design engineers, Reliability engineers, Calibration technicians, and Maintenance personnel will find this session valuable.

Jeff will cover the following areas at this webinar:

o  Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification

o  Preventive Maintenance Requirements

o  Calibration vs. Maintenance: When to use Which One?

o  Remedial Action for Out-of-Calibration Equipment

o  Use of Calibration Standards to Save Cost

o  Equipment Calibration Requirements: Scheduling, Use of External Services, and Documentation.

Why IEC 60825 certification cannot be substituted for 21CFR1040

With a few exceptions, it is necessary for manufacturers, system integrators and importers of lasers or laser containing products to implement best practices for compliance with FDA 21 CFR 1040. This is because The Center for Devices and Radiological Health (CDRH) requests documentation using the current version of their Form 3632 Guide for Preparing Product Reports for Lasers or Products Containing Lasers for laser self-certification submittals, which have to comply with 21 CFR 1040. Per Section 1010.2c, certification has to be based on a test that meets the requirements set out in this standard and has to be in accordance with Good Manufacturing Practices.

Since the CDRH does not approve form 3632 reports or the products being reported; it is incumbent upon the manufacturer, system integrator or importer to assume responsibility for certification. However, if the FDA detects gaps or deficiencies in the applicant’s quality control or testing program; the CDRH is empowered to take actions that are of a very harsh nature. It may:

o  Ask the manufacturer to halt introduction of the product into the US until the faults are corrected

o  Require the manufacturer to start a corrective action program for products that have already been released into the market

o  Impose fines of up to $300,000 for non-compliance with the requirements laid out in 21 CFR 1040.

What are the consequences of recalls?

When laser products that the FDA determines do not meet the regulatory requirements are recalled, it can have serious consequences for the business. It invites lawsuits from the user of such products. This can result in monetary losses that eat into the business’ profits. It can also damage the company’s reputation, which is something that is very difficult to overcome and compensate for.

So, the ideal course to follow for manufacturers of laser products is to be compliant in letter and spirit with the regulations laid out in 21 CFR 1040. The ways of achieving this and implementing best practices for compliance with FDA 21 CFR 1040 will be the teaching a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

The speaker at this webinar is Tony Imm; a nationally recognized laser engineer with a background in medical device manufacturing, whose company, Laser Guardian LLC provides a wide range of laser safety and process support. To understand the ways by which to achieve compliance with FDA 21 CFR 1040 by implementing best practices; please register for this webinar by visiting Best Practices for Compliance with FDA 21CFR1040

Complete understanding of implementing best practices

Tony will give comprehensive understanding of the ways by which the test documentation system with the CDRH works. He will show how to generate form 3632 document, how to complete the form, what supporting data to attach with it and how, and then explain recommended methodologies to test and record the emission output and interlock performance of the laser systems. This session is extremely useful to those involved in working with laser products, such as Engineering Managers, Laser Engineers, Safety Manager, Safety Engineers, and personnel responsible for FDA communications.

Tony will cover the following areas at this webinar:

o  What is self-certification and when is it required

o  Methods for submitting a product report

o  Major sections of the product report

o  Why IEC 60825 certification cannot be substituted for 21CFR1040

o  What are best practices and why use them

o  Where to apply best practices and what they should encompass.

Webinar Calendar of Upcoming Courses – May to Jun 2017

webinar-training-online-education.jpgBelow is the event description content:

Compliance4All webinars are just what professionals in the regulatory

compliance areas need for scaling up in their careers. With a collection of

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Compliance4All’s experts help you unravel all the knowledge you need in all

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implement the regulations and stay updated, so that regulatory compliance

causes no stress for you. Compliance4All’s experts offer their insightful

analysis into the issues that are of consequence to regulatory professionals

in their daily work. Their thoughts help you implement the best practices of

the industry into your work. They also offer updates on the latest regulatory

requirements arising out of a host of the laws and issues related to

regulatory compliance, such as Pharmaceuticals, Biologics, Healthcare, Food

and Beverages, Software, Embedded Technologies, Energy and Utility,

Payment Card Industry (PCI), and lots more.
Take a look at our upcoming webinars from Compliance4All, which will put

you on the road to learning about any area that is of importance to your

profession. You can plan your learning from Compliance4All by looking at

our events in the next few weeks. You can choose from a whole range of

topics. See which among these trainings suit you: FDA Regulation of

Medical Device Software, Conducting Successful Product Complaint

Investigations, CAPA, Failure Investigation and Root Cause Analysis, 1099

and W-9 Update, Laboratory-Developed Tests, avoiding an FDA 483,

Equipment Validation, and much more!

For more Calendar Webinars http://www.compliance4all.com/control/webinars_home

About 7 decades since the FDA was first formulated in its earliest avatar

Considering the slew of regulations that exist for medical devices today –to the extent that this is among the areas of the highest regulation from the FDA –it is rather ironical that the US Congress had not empowered the FDA to regulate medical devices till as recently as mid-1976. This is when the Medical Device Amendments were added to the Federal Food, Drug, and Cosmetic Act (FDCA). This was about seven decades since the FDA was first formulated in its earliest avatar.

The reason for which medical device software started getting regulated during this time is that it was in the mid-1970’s that computer software started to grow and evolve into a field of its own. Being in a state of infancy for most of that decade; it was only towards the end of the next decade that software began to get used in medical devices, albeit in a manner that appears rather crude by today’s standards. Because of this, the FDA did not have the need to create a software regulatory policy.

Separate regulations based on the nature of devices and software

Since then, however, software has made giant strides in its uses in medical devices. The growth has been so fast and wide-ranging that today, there are regulations for:

o  Software that can be a device by itself (i.e., stand-alone, or what the FDA calls Software as a Medical Device or SaMD)

o  Software that is incorporated into another device as a component, part or accessory.

Other factors to be taken into consideration

So, the FDA’s regulations on medical device software are based on its thinking that there is a distinction between stand-alone software and software that is a component, part or accessory to a device. Also, software validation is a major theme for most manufacturers of medical devices. Software validation of medical devices has to be not just satisfied; it has to be evidenced from a number of stringent perspectives. There is a clear distinction between medical device software and medical device hardware. Additionally, there are design user requirements to be met, and off-the-shelf software and automated equipment have to be validated.

In the realm of clinical valuation of an SaMD; the FDA requires medical device manufacturers to meet and demonstrate reasonable assurance of safety, performance and effectiveness since these devices have a very major impact on the health and safety of its users. This clinical evaluation has to thus be thorough and systematic, and should be well planned. The FDA’s clinical valuation of an SaMD should meet the following:

o  Clinical validity

o  Scientific validity

o  Clinical performance

o  Analytical validity

Deep and clear understanding

Professionals who work in the field of medical devices and whose work is related in some or another way to medical devices need to be aware of the FDA’s regulation of medical devices. This requires detailed understanding of the regulations as they exist, as well as the knowledge needed to interpret and apply them into medical devices or software, whatever the case may be.

This is the understanding a webinar from Compliance4All, a leading provider of professional trainings for the areas of regulatory compliance, will be offering. Thomas E. Colonna, who provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics, medical device software and biotechnology-based products, and holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia, will be the speaker at this webinar.

To gain complete understanding of the FDA’s thinking on medical device regulation and to get a grasp of how to apply it for practical use, please register for this webinar by logging on to FDA’s Regulation of Medical Device Software

At this webinar, Dr. Thomas E. Colonna will offer fundamental understanding of FDA regulation of medical device software. Expectedly, this session will be of immense benefit to professionals at various levels in the field of medical devices and medical device software, such as Compliance Managers, Validation Managers, Regulatory Managers, QC Managers and QA Managers.

At this session, Dr. Colonna will cover the following areas:

o  Definition of medical device software

o  FDA’s medical device software regulatory scheme

o  Software validation

o  Level of concern.

Meeting labeling requirements of various drug products

Both the FDA and the European Medicines Agency (EMA) have regulations that cover the labeling requirements of both prescription and over-the-counter (OTC) drugs, cosmetics, generics, medical devices, nutraceuticals and other related products. These regulations have to be strictly complied with. 21 CFR under its various parts, the Federal Food, Drug, and Cosmetic Act (FD&C Act) and Fair Packaging and Labeling Act (FP&L Act) are the laws that manufacturers of these products need to comply with in order to meet labeling requirements of these products. These laws are separately made for a number of products and their subcategories, such as drugs, cosmetics, cosmetics that are also drugs, and so on. In addition, the regulations set out by the EMA also need to be complied with by manufacturers of these products, if they plan to market to the EU markets.

One of the elementary requirements of the FDA is that the ingredients of the cosmetics must be declared prominently. By this definition, the prominence should be such that users should be able to see the declaration when they purchase and see the product. The FDA prescribes that the letters in the ingredient declaration should be not less than 1/16 of an inch in height. In cases where the total package surface available for labeling is less than 12 sq. inches, the height of the letters must be at least 1/32 of an inch.

Particular about the specifications

The FDA also requires that the ingredients must be declared in descending order of importance. Color additives must be declared too, but does not require an order of prominence. The active ingredients, as well as the additives, must be clearly declared. Labels should carry warnings when they carry ingredients that are likely to cause damage to some or another part of the body. Products such as aerosols, deodorant sprays used by females, and soaps and other cosmetics used by children have their own labeling requirements.

If all this is a snapshot of the only the prominent labeling requirements for just cosmetics, imagine the kind and variety of requirements that need to be met for all other related products such as medical devices, drugs, vitamin supplements and many others. And what about understanding the EMA’s requirements?

Knowledge of the labeling requirements of the products need not be intimidating, because this is the content of a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Learning session on labeling

The speaker at this webinar is Salma Michor, who is founder and CEO of Michor Consulting Schweiz GmbH, which serves such clients as Johnson & Johnson, Novartis, Shire, Pfizer and Colgate Palmolive. The full extent of Salma’s experience will come into play at this webinar. To register for this session and to benefit from the wealth of Salma’s experience, please register by logging on to Labeling Drug Products

This webinar will focus its attention on the ways by which to remain compliant with the labeling requirements of the various regulatory bodies vis-à-vis a number of products. Salma will explain the challenges associated with remaining compliant with the labeling requirements of products such as generics, prescription drugs, OTC drugs, medical devices, vitamin supplements, traditional herbal remedies, foods, cosmetics and biocides, and will suggest ways of dealing with them. She will focus in particular on the EU requirements for labeling of these products. Regulatory Affairs and labeling specialists will understand the intricate details of the labeling requirements for these products at this webinar.