Physician colleagues often ask me what the future holds for lifestyle medicine and whether they should pursue board certification. My short answer to the second question is "Yes, absolutely!" But first I share why I am confident that lifestyle medicine will become a foundation of all health and healthcare and that clinicians should prepare for it.

Cate Collings, MD

There is increasing recognition among policymakers and health leaders of the unsustainable costs — in human suffering and the $4.1 trillion spent on US healthcare in 2020 — of lifestyle- and diet-related chronic diseases such as type 2 diabetes, obesity, and heart disease. COVID-19 and the worse outcomes associated with underlying chronic conditions contributed to awareness of just how sick Americans have become. The pandemic also shone a light on health disparities related to underlying lifestyle-related chronic disease prevalence and insufficient healthcare resources in many communities. Lifestyle medicine offers a promising path to narrow the health disparities gap.

Notably, for the first time in 50 years, the White House hosted a Conference on Hunger, Nutrition, and Health in September, with the goal to "[e]nd hunger and increase healthy eating and physical activity by 2030, so that fewer Americans experience diet-related diseases."

This growing recognition that we must reduce lifestyle-related diseases and prepare future and practicing clinicians to address the root causes of those diseases will ideally accelerate the US transition to high-value care. Lifestyle medicine leverages behavior changes in nutrition, physical activity, sleep, stress management, social connections, and use of risky substances as the first and primary way to treat many conditions, with medications and procedures as adjunctive treatment. It supports the Quintuple Aim of improved outcomes, lower costs, improved patient satisfaction, and improved provider satisfaction and has the potential to address health equity.

There is a strong case that value is precisely what lifestyle medicine can deliver, and this paves the way for paradigm change.

Health systems are increasing recognizing this value. The Health Systems Council, a collaborative community of health systems interested in integrating lifestyle medicine founded by the American College of Lifestyle Medicine (ACLM) in May 2021, already has more than 70 health system members. Accountable care organizations with a focus on lifestyle medicine have been created to help providers sustainably implement lifestyle behavior interventions. Even the US military is incorporating lifestyle medicine into its medical care for service members.

Momentum is growing for embedding lifestyle medicine into undergraduate medical education and build a new physician workforce tailored to current and future times. In November 2021, Rep. James McGovern introduced House Resolution 784, a resolution that passed the House supporting activities to ensure that health professional training programs, including medical schools, residency programs, and fellowships, incorporate substantive training in nutrition and diet.

The University of South Carolina School of Medicine Greenville is the first school to integrate lifestyle medicine into all 4 years of its curriculum. The Lifestyle Medicine Education Collaborative, a collection of open-access lifestyle medicine curricular resources developed there, provides a curriculum that other medical programs can integrate. Medical students have a hearty appetite for lifestyle medicine, and lifestyle medicine interest groups (LMIGs) for medical and other health professions students have exploded from a single campus in 2009 to 95 LMIGs today.

As of September 1, ACLM's Lifestyle Medicine Residency Curriculum (LMRC), a comprehensive curriculum piloted in 2018 that prepares residents to make evidence-based, lifestyle behavior interventions, is being implemented in 200 residency programs across 96 sites, with 1190 faculty and 4185 residents.

Lifestyle medicine education for physicians who trained 10 or more years ago may have consisted only of a few hours of learning about abject nutrient deficiencies and general suggestions to inspire patients to "exercise more" and "eat better." That's why I strongly urge practicing clinicians to pursue certification in lifestyle medicine. Education and certification will modernize their practice to meet current healthcare system needs.

As health systems or practices embrace lifestyle medicine and work within value-based contracts or population health goals, clinicians prepared with lifestyle medicine tools and knowledge will be valued and sought. More and more physicians and other clinicians are pursing board certification. Since 2017, 2004 US physicians and 778 other health professionals have certified.

Physicians are certified by the American Board of Lifestyle Medicine (ABLM). There are two pathways for physicians to qualify to take the exam. One is the experiential pathway for physicians who are already board-certified by a medical specialty board recognized by the American Board of Medical Specialties or the American Osteopathic Association. Those physicians must be primary board-certified and have practiced medicine for at least 2 years before qualifying to take the ABLM exam.

 The other emerging pathway is educational. Physicians who complete the LMRC through a residency site are eligible to sit for the certification exam, though certification will not be issued until the physician successfully passes the primary board exam.

To prepare for the board exam, ACLM provides a catalogue of on-line courses for continuing medical education as well as a lifestyle medicine board review course. In addition, ACLM recently became a content provider to Ed Hub, the American Medical Association's online learning platform. And the annual ACLM conference is a learning and networking event in the journey towards board certification.

The healthcare landscape is shifting rapidly. Transformative changes are occurring, and I am confident that lifestyle medicine will be at the forefront to address our alarming trajectory of chronic disease and its associated misery and financial impact.

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Dear Liz: I disputed a medical charge for around $350. A few months later I received a collections notice. I then called the medical provider, who said they would suspend the collections while the dispute was being reviewed. There was no further communication for over a year, then out of the blue I received a derogatory remark from the collections agency. I monitor my credit scores via my credit card accounts. Two cards are driven by TransUnion data. One reported a drop from 802 to 706 while the other reported a drop from 809 to 774. My other card provides a score driven by Equifax and that one remained unchanged at 822. I’m curious about the discrepancies in these scores, and also about the length of time it will take for my credit score to recover if I do not try to resolve the derogatory remark or disputed medical bill.

Answer: Credit scoring formulas vary considerably in how they treat medical debt. Some older scoring models treat unpaid medical bills the same as any other collection account. Newer formulas may treat medical debt less harshly, reflecting research that shows these bills aren’t as reliable an indicator of creditworthiness as other collection accounts. Some of the latest formulas ignore paid medical debt entirely.

Earlier this year, the Consumer Financial Protection Bureau questioned whether medical debt should be included on credit reports at all. Less than three weeks later, the three credit bureaus announced that nearly 70% of medical debts would be removed from credit reports by the middle of next year.

Paid medical collections have already been eliminated from people’s credit reports, and unpaid bills won’t be reported to the bureaus for 12 months (an increase from the current six months). By June 30, 2023, the bureaus also will stop reporting any medical debt under $500.

You can wait for that to happen next year, or you can pay the bill and have it removed from your credit reports more promptly.

Dear Liz: What are the implications for Social Security if you plan to work past age 70? If you start at 70, are your benefits reduced because you’re working? Do you get any benefit from delaying past 70?

Answer: Your benefit maxes out at age 70, and your earnings won’t reduce your checks, so there’s no reason to delay your application past that point.

You stop being subjected to the earnings test once you reach your full retirement age, which is currently between 66 and 67. If you apply before that point, the earnings test reduces your benefits by $1 for every $2 you earn over a certain amount ($19,560 in 2022). That money isn’t gone for good — the withheld benefits are gradually added back in to future checks once you’re past full retirement age.

The big incentive to delay your application past full retirement age is the delayed retirement credits that boost your benefit by 8% each year you postpone your application until age 70. And as mentioned in previous columns, benefits also earn cost-of-living increases whether you’ve started them or not. People who are opting to delay the start of their benefits won’t miss out on the 8.7% increase for 2023.

Dear Liz: I looked up my financial advisor’s name in the link you provided to verify someone as a Certified Financial Planner (cfp.net/verify-a-cfp-professional), and he wasn’t there. I went back to his bio and it says he is fee only and he is an AIF (Accredited Investment Fiduciary). Is that the same? Or approximately the same?

Answer: An AIF designation indicates that the advisor has been trained to act as a fiduciary, which is someone committed to putting their clients’ best interests first. Most advisors are held to a lower “suitability” standard that allows them to recommend investments that are more expensive or perform worse than available alternatives, simply because the recommended investments pay the advisor more.

However, an AIF is not equivalent to a Certified Financial Planner credential. All CFPs are held to a fiduciary standard, but they’ve also been trained to offer comprehensive financial planning. The coursework, testing and experience requirements are much more rigorous for a CFP.

A credential that is similar to the CFP is the Personal Financial Specialist, which is a designation earned by certified public accountants. A CPA-PFS has extensive training in comprehensive financial planning, in addition to their tax expertise.

Liz Weston, Certified Financial Planner, is a personal finance columnist for NerdWallet. Questions may be sent to her at 3940 Laurel Canyon, No. 238, Studio City, CA 91604, or by using the “Contact” form at asklizweston.com.

REGULATORY OUTLOOK

McRoberts

Ohyama

Kambeitz

Amended Legislation for Medical Devices

The PAL is the most important legislation for foreign device firms hoping to sell products in the Japanese market. In July 2002, the Japanese House of Representatives passed the amended PAL, which is applicable to all medical devices, drugs, quasidrugs, and cosmetics entering the Japanese market. It became effective April 1, 2005, and has the following objectives:

• To enhance safety measures for medical devices sold in Japan.
• To strengthen postmarketing safety measures for medical devices.
• To align Japan's medical device regulatory system with prevailing international systems.

In order to apply for the necessary regulatory clearance to market a device, manufacturers outside of Japan must appoint a marketing authorization holder (MAH) as their representative in Japan. The MAH may be a subsidiary of the manufacturer through common ownership or may be an independent entity, but the manufacturer must establish a detailed contract with the MAH in accordance with the requirements of the amended PAL and related ministerial ordinance (MO).

If a manufacturer wishes to have its subsidiary or sales office as the MAH, then the subsidiary must be licensed as an MAH by the appropriate prefecture (comparable to county) government in Japan in accordance with MOs 135 and 136. This enables the MAH to be accredited by MHLW to apply for PAL certification. Only these legal license holders can apply for and hold PAL certification of medical devices. For a foreign manufacturer to become an MAH on its own, it must be accredited as a special MAH by the Pharmaceuticals and Medical Devices Agency (PMDA), an executive arm of MHLW also known as Kiko. The manufacturer must also nominate a representative in Japan.

Under the amended PAL, foreign manufacturers of all classes of medical devices are also required to obtain foreign manufacturing accreditation for their manufacturing facilities. This accreditation can only be obtained by applying through the MAH to PMDA. MO 2 outlines the requirements for accreditation. Manufacturers that sold products in Japan before the PAL was amended may have been granted temporary foreign manufacturing accreditation, which means they can delay their application for accreditation until 2008. After 2008, foreign manufacturing facilities must be reaccredited under the new regulation (MO 2).

The Quality Management Systems Ministerial Ordinance on Medical Devices and In Vitro Diagnostics (MO 169, also known as the QMS ordinance), implemented in 2005, lacked certain requirements integral to ISO 13485:2003. These requirements, which outlined management responsibility, risk management in production, design controls (if applicable), criteria for suppliers, process validation, and analysis of data, were not mandatory in Japanese regulations until April 2007. Therefore, it is possible that early accreditation assessments to MO 169 did not include these elements. Manufacturers with a current Japanese QMS and those submitting new applications should ensure that these requirements are properly satisfied in time for surveillance visits.

Out of the 4044 total device types identified by MHLW, only 1785 are designated as Class II, and less than half of those are currently designated as controlled medical devices eligible for third-party approval. The JIS conformity assessment standard and essential requirements are designated by MHLW by device type, which enables third-party assessment of such Class II devices. Article 41 of the revised PAL requires the minister to establish necessary standards after seeking the opinion of the Pharmaceutical Affairs Food and Sanitation Council (also called Bukai). The list of devices eligible for third-party approval is continually growing as MHLW approves additional essential-principles checklists.

An application for a Class II device license requires an assessment of the quality management system of the device manufacturer (including foreign manufacturers) to the requirements of MO 169. This ordinance is based entirely on ISO 13485:2003, with some additional requirements for the Japanese market. Manufacturers of Class II active medical devices may include or exclude requirements for design and development depending on the designation by MHLW. This assessment may be carried out by local assessors trained on Japanese requirements and qualified by the third party. Some third parties, because of the location of their audit staff, must dispatch their assessors from Japan and coordinate logistics, including travel and lodging for the audit team and its translators.

Obtaining a device license also involves an evaluation of the technical documentation for the medical device. This is similar to the requirements outlined in the Global Harmonization Task Force's Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices document. Japanese regulations may also require additional information, such as proof of compliance with the JIS performance standard. The MAH is required to present this information in Japanese to the third-party assessor.

Selecting a Third-Party Approval Body

There are a variety of services provided by third parties. By carefully choosing a third-party approval body, an MAH can take advantage of additional accreditations and services that the third-party organizations offer. Some third parties allow the supporting documents, which demonstrate a device's conformity to the applicable JIS or IEC standards, to be assessed in English (to supply a degree of confidence) before undergoing a costly translation process. Foreign manufacturers may want to consider this service when their original technical file has already been approved by another public health authority. Allowing supporting documents to be assessed in English would ensure that all requirements of the Japanese regulations are included in a device's technical file, since some requirements may be specific to the Japanese regulatory system.

A medical device company should also consider testing requirements when choosing its third party. Not all JIS standards are based on IEC requirements. If a device has already been tested for markets outside of Japan, it is possible that some of the mechanical and engineering decisions can be made based on previous tests, especially if the device is not electrical (nonactive) or if a switching power supply is used. (It is important to note that the electrical system in Japan is 100 V ac at both 50 and 60 Hz.)

Manufacturers that want to market devices in Japan should consider that marketing goal in their design phase and incorporate flexibility into their design to meet the country's requirements. This gives them a better opportunity to have EN (European Union), NRTL (United States and Canada), and JIS testing done simultaneously. Although additional samples and time may be needed to complete the JIS testing, a third party that is accredited in all of the company's current and anticipated sales markets can minimize redundant tests whenever possible.

As mentioned, the revised PAL brought with it a requirement to manufacture under an audited quality management system, which ensures conformity with JGMP requirements. When a device manufacturer chooses a third party, it should also consider the location of the JGMP-qualified auditors and whether the JGMP audit can be combined with the quality management system audits required by the United States, Canada, and the European Union.

FDA's accredited persons inspection program audits to 21 CFR 820 requirements, but the program is only open to those companies that are not under FDA scrutiny (i.e., increased FDA attention owing to nonconformities, product recalls, etc.). Because low-risk device manufacturers are only periodically audited by FDA and these audits cost very little, the only incentive for FDA establishments to use a third party for inspections is the predictability of the audit.

The European Union allows an ISO 13485–based audit to meet Annex V requirements under the Medical Devices Directive and Annex IV under the In Vitro Diagnostic Directive. The Canadian Medical Devices Conformity Assessment System is strictly based on ISO 13485. Therefore, many manufacturers maintain an ISO 13485 registration with many clauses and elements similar to JGMP requirements. As a result, third parties that offer accreditations for all of these regulatory programs can offer integrated audits, which are less time-consuming, less intrusive, and potentially less costly to the manufacturer.

Other considerations the MAH should make in choosing a third party are experience, trust, and the MAH's relationship with the organization. Bear in mind that all applications for device licensing to a third party can only be made through the MAH located in Japan to the third-party certification body in Japan. However, the value of local support for foreign manufacturers is worth considering in understanding the requirements these manufacturers must meet.

The Goal of Alignment

As indicated, one of the goals of the revised PAL was to align Japan's medical device regulatory system with those of other advanced nations, namely those of the United States and the European Union. Because these nations produce and consume the majority of the world's medical devices, the regulatory practices in these regions are generally the ones accepted and adopted by device manufacturers worldwide. Just as with the regulatory systems from these regions, Japan's revised PAL allows third parties to conduct assessments of Class II medical devices for certification to market and sell in a particular region. Both EU and U.S. health authorities also require an audit of each manufacturing location to ensure that the quality system conforms to GMPs. The last similarity is the identification of an in-country representative—the MAH in Japan, the agent in the United States, and the authorized representative (AR) in the European Union. The biggest difference is that the MAH, as the name implies, takes over ownership and responsibility for certification, whereas the AR and the agent work on behalf of the manufacturer.

Conclusion

Although the revised PAL aligns more closely with general international requirements for medical devices, demonstrating conformance with the PAL still requires manufacturers to invest time and effort to understand its requirements. Once the regulatory process is defined, manufacturers must still contend with the challenges and cost of device-specific processes for reimbursement, distribution, and packaging. However, if the Japanese medical device market continues to grow and maintains its need for foreign medical devices, meeting PAL and MHLW requirements may be a worthwhile investment for device manufacturers.

Steve McRoberts is Underwriters Laboratories' (UL) global principal engineer for medical regulatory programs. Seiko Ohyama is a lead engineering associate working for UL-Japan Inc. Tara Kambeitz is the global marketing manager for UL's medical business unit. She can be reached at [email protected].

Copyright ©2008 Medical Device & Diagnostic Industry

WEST PALM BEACH, Fla., Sept. 28, 2022 /PRNewswire/ -- Global Healthcare Accreditation (GHA) announces the launch of a new certification program for medical travel facilitators to assist in building patient trust. 

GHA's Medical Travel Facilitator Certification focuses on validating the capacity of medical tourism facilitator companies to provide appropriate services to clients that enhance safety and patient experience along the entire medical travel patient journey as appropriate to the facilitator company's business model.

Medical travel facilitators have for many years played an important role as intermediaries between patients and healthcare providers. Their services include providing information about the medical provider, handling travel logistics, and ensuring a smooth care journey.  For many patients, the medical travel facilitator is the main motivator or reason why they choose a specific destination provider. However, medical travel facilitation is an unregulated industry; therefore, it is not always easy for patients to distinguish between a facilitator with experience and high-quality partnerships versus another that has a beautiful website but little experience – or worse, is not focused on the patient's best interests.

According to Wiliam Cook, Global Healthcare Accreditation's Director of Business Development and Marketing, "The Medical Travel Facilitator Certification provides a trusted third-party validation that demonstrates to patients and healthcare providers that a facilitator's services meet the highest standards and align with international best practices. Patients no longer have to rely on anecdotes or unverified testimonials to make medical travel decisions, they can look to the Medical Travel Facilitator Certification as a metric to evaluate and validate a facilitator's capacity to provide the requisite services to ensure an excellent patient care journey."

The Medical Travel Facilitator Certification is conducted conveniently online, includes access to training, and evaluates a facilitator across 15 key competencies, including business ethics, sustainability and quality improvement, financial transparency, client services, oversight of contracts and agreements, and risk management, which underline a company's capacity to deliver excellent services.

For medical travel facilitator companies, the benefits of this certification include:

• Enhance patient care experience along the entire care continuum
• Provide a framework on which facilitators can implement or strengthen sound operational policies, procedures, and processes that align with global best practices
• Offer a third-party validation that builds trust and confidence with prospective clients and health buyers
• Increase brand awareness and visibility
• Mitigate risks and vulnerabilities for clients and for the facilitator business

"Expect an increasing number of patients to look for accreditation or certification as the determinant in selecting a medical travel agent," said Bill Cook. "GHA's Medical Travel Facilitator Certification assures patients that a facilitator has been vetted by a globally recognized third-party accreditor, affirming that the company has the required protocols, processes, and staff training to deliver a safe and high-quality treatment journey and experience."

Visit https://www.globalhealthcareaccreditation.com/medical-travel-facilitator-certification to learn more about GHA's Medical Travel Facilitator Certification.

Founded in 2016, Global Healthcare Accreditation is the only accrediting body focused solely on medical travel and well-being services. GHA's international standards and professional norms for medical travel were developed in consultation with leading global experts in the industry, including providers, insurers, and employers committed to establish best practices in medical tourism, health tourism, and well-being, which support providers in validating quality and patient experience, increasing visibility, and implementing a sustainable business model for providers along the entire medical travel care continuum. GHA received ISQua's International Society for Quality in Health Care External Evaluation Association (IEEA) accreditation in 2019.

Organizations interested in contacting Global Healthcare Accreditation (GHA) can make a request at info@ghaccreditation.com | www.GlobalHealthcareAccreditation.com

View original content to get multimedia:https://www.prnewswire.com/news-releases/new-gha-certification-helps-medical-tourism-facilitators-build-patient-trust-301634985.html

SOURCE Global Healthcare Accreditation

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