MedKaz Issues Public Comment on Centers for Medicare & Medicaid Services Proposed Rule

WASHINGTON, Sept. 29 -- Merle J. Bushkin, founder and CEO of MedKaz by Health Record Corp., Brownsville, Vermont, has issued a public comment on the Centers for Medicare and Medicaid Services proposed rule entitled "Medicare Program: Medicare Coverage of Innovative Technology and Definition of Reasonable and Necessary". The comment was written on Sept. 14, 2020, and posted on Sept. 23, 2020:

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I am pleased to submit the following comments to your proposed rule: Medicare Coverage of Innovative Technology CMS-3372-P.

As Founder and CEO of a tech startup, MedKaz(R) by Health Record Corporation, I greatly appreciate any and all steps HHS and CMS take to bring "new and innovative technologies to [Medicare] beneficiaries sooner."

Without such assistance, it is well-nigh impossible for an innovative solution, no matter how good or effective, to overcome what Administrator Verma calls "a chicken and egg issue" and gain CMS coverage approval.

First, I'll respond to your request for comments. Then, I'll address the scope of the proposed rule.

DEFINITIONS

Reasonable and Necessary -- We agree with your proposed definition that an item or service be considered "reasonable and necessary if it is--(1) safe and effective; (2) not experimental or investigational; and (3) appropriate for Medicare patients, including the duration and frequency that is considered appropriate for the item or service, in terms of whether it is --

* "Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member;

* "Furnished in a setting appropriate to the patient's medical needs and condition;

* "Ordered and furnished by qualified personnel;

* "One that meets but does not exceed, the patient's medical need; and

* "At least as beneficial as an existing and available medically approved appropriate alternative."

We also agree that other items or services, such as commercial insurance products should be included under (3) where and when appropriate, but we would go even further and include other products and services as well.

As explained below, we recommend adding under this definition, breakthrough medical record devices and applications NOT regulated by the FDA that facilitate interoperability of medical records that, as you propose: "provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions, and that the device or application must satisfy one of the following elements: it represents a breakthrough technology; no approved or cleared alternatives exist; it offers significant advantages over existing approved or cleared alternatives, including additional conditions outlined in the statute (the 21st Century Cures Act - 21 U.S.C. 360e-3); or device availability is in the best interest of patients...."

Breakthrough Devices -- We respectfully but strongly disagree with your proposed definition of a breakthrough device, and urge you to broaden it to specifically include breakthrough medical record devices and applications NOT regulated by the FDA that facilitate medical record interoperability.

By limiting the definition as you propose to "a medical device that receives such designation by the FDA ... you are excluding all other breakthrough devices and applications that meet the intent, spirit and letter of Executive Order 13890, namely, to bring "new and innovative technologies to [Medicare] beneficiaries sooner."

SCOPE OF PROPOSED MEDICARE COVERAGE OF INNOVATIVE TECHNOLOGY RULE

Virtually everyone interested in improving healthcare quality and reducing healthcare costs recognizes that medical records MUST be interoperable. This has been a primary goal of government policy since 2004, when President George W Bush established the Office of the National Coordinator of Healthcare IT, and it remains a primary goal to this day even though we are far from achieving it with today's approach. In addition to the need for interoperability being addressed in EO 13980, it also is expressly covered by CMS-9115-F and EO 13813.

CMS-9115-F

"We believe patients should have the ability to move from payer to payer, provider to provider, and have both their clinical and administrative information travel with them throughout their journey. When a patient receives care from a new provider, a record of their by health information should be readily available to that care provider, regardless of where or by whom care was previously provided. When a patient is discharged from a hospital to a post-acute care (PAC) setting there should be no question as to how, when, or where their data will be exchanged."

"We are committed to working with stakeholders to solve the issue of interoperability and patient access in the U.S. health care system while reducing administrative burdens on providers and are taking an active approach using all available policy levers and authorities to move participants in the health care market toward interoperability and the secure and timely exchange of health care information."

EO13813

"On October 12, 2017, President Trump issued Executive Order 13813 to Promote Healthcare Choice and Competition Across the United States. Section 1(c)(iii) of Executive Order 13813 states that the Administration will improve access to, and the quality of, information that Americans need to make informed health care decisions, including information about health care prices and outcomes, while minimizing reporting burdens on impacted providers, and payers, meaning providers and payers subject to this rule." (This led to creation of MyHealthEData in March 2018.)

The "new rule impacts patients, clinicians and hospitals, and payers:"

Patients: "Enabling patients to access their health information electronically without special effort by requiring the payers subject to this final rule to make data available through an application programming interface (API) to which third-party software applications connect to make data available to patients for their personal use. This encourages patients to take charge of and better manage their health care, and thus these initiatives are imperative to improving a patient's long-term health outcomes."

Clinicians and Hospitals: "Ensuring that health care providers have ready access to health information about their patients, regardless of where the patient may have previously received care. We are also implementing policies to prevent health care providers from inappropriately restricting the flow of information to other health care providers and payers. Finally, we are working to ensure that better interoperability reduces the burden on health care providers."

Coordinating with ONC with the "clear objectives of improving patient access and care, alleviating provider burden, and reducing overall health care costs, all while taking steps to protect the privacy and security of patients' personal health information."

"the rule creates and implements new mechanisms to enable patients to access their own health care information through third-party software applications, thereby providing them with the ability to decide how, when, and with whom to share their information."

RECOMMENDATION

Given the great importance of and need for interoperability, we believe proposed rule CMS3372-P should include an accelerated pathway for breakthrough products, systems and applications that achieve interoperability. In our opinion, not doing so would be a glaring omission!

Thus, we urge you to broaden the MCIT definition of breakthrough products to include products, systems, and applications that achieve medical record interoperability. This can be accomplished either by waiving the requirement that MCIT cover only FDA regulated products and services, by including them under requirement (3) of your definition of reasonable and necessary, or by including them under another category covered by Medicare, such as Electronic Data Exchange, Telehealth, Wellness or Transitional Care Management Services.

By including products, services and applications that provide interoperability under accelerated Medicare coverage as provided by the MCIT program, a product and service like our patented MedKaz(R) patient-focused personal health record system would bypass the "chicken and egg" issues Adminstrator Verma described, and would give Medicare beneficiaries and their care providers access to a breakthrough technology that provides what we call "total interoperability" -- instant access to a patient's lifetime health record from all his or her providers, and more.

The following description of our MedKaz system will help you understand the type of powerful innovative technology waiting on the sidelines that can be unleashed to help Medicare patients under a more inclusive MCIT Rule.

THE MEDKAZ(R) SYSTEM

MedKaz(R) accomplishes what no other program or effort to achieve interoperability is able to do: it provides total interoperability today, and everyone -- including our economy -- benefits financially.

1. It gives patients control of their records, and the application to manage them, on a MedKaz minidrive which they carry on their key ring or wear as a pendant. They use it to understand and better manage their own care and share with their providers when needed. It also enables them to automatically share one provider's records with their other providers, and with loved ones and others they choose, including researchers. It is updated for them following each visit.

2. Their providers -- whether in an exam room, ER, ambulance or during a telehealth visit -- use it to instantly search for and access specific records so they can deliver better care and avoid costly medical errors and unnecessary visits, tests, procedures. In addition, it saves them time with each patient. Immediately following the encounter, they upload copies of their notes to our MedKaz Server using CDA technology and secure DirectMessaging.

3. When our Server has processed the record and made it searchable, it emails the patient and other designated recipients to download the record to their MedKaz or computer. (It "pushes" the record to designated care providers.) When they have done so, we erase it from our Server so it cannot be hacked or corrupted.

4. Patients save deductibles and copays. Providers earn new income for uploading copies of their notes (or perhaps other incentives, see below). Health insurance payers like Medicare pay this upload incentive; they can afford to do so because they enjoy the savings generated during each encounter. Given the waste and excessive costs in our system, their ROI can be extraordinary.

MedKaz accomplishes these breakthrough results by reimagining how to manage records.

1. Rather than trying to force providers to standardize their record systems, formats and data fields and then trying to link them together via geographic- or vendor-based health information exchanges (HIEs), MedKaz does what Google, Bing, Yahoo and other search engines do to manage disparate data and documents.

Using both well-established and the latest technologies, our server turns every document into a pdf document that you read in a browser. But MedKaz does two more things: it makes every document searchable! And it creates an XML-formatted copy of the document so providers can download it to their EMR system as either a searchable pdf or structured data.

2. By assembling a patient's lifetime health record in one place, on a device the patient owns, carries with him or her, and gives to a provider when needed anytime, anywhere, the patient's records are always available even during computer or power outages, or natural disasters.

3. When the patient sees a provider and the provider logs on to her patient's MedKaz, the provider reads an up-to-date Health Summary which saves her some three to six minutes getting up to speed about her patient's issues.

4. Then, as the provider examines her patient and wants to access specific records from her patient's other providers, she enters a search term on her patient's MedKaz. The most recent document containing the term opens in a browser to the first page containing the term, which is highlighted. (This avoids having to rummage through masses of paper or virtual paper records, or access multiple portals. The provider merely clicks from highlighted term to highlighted term, and from document to document going back in time, until she finds the specific information she's looking for.)

5. The MedKaz approach also avoids the need to create and manage costly patient registries, networks and other mechanisms.

6. Other MedKaz advantages include: it is secure, password controlled to two levels, easy to use, affordable, requires no special training -- if you can log into a computer, perform a search and read a document in a browser, you can use MedKaz. Even tech-challenged seniors and low-income earners can own and use MedKaz. It doesn't require an expensive smartphone, and can be used by the 27+- million seniors and 30+- million low-income earners who don't have a smartphone.

To encourage patients and providers to embrace MedKaz, we propose Medicare offer financial incentives to them. (These will be dwarfed by the healthcare savings Medicare will enjoy.)

1. For patients, we recommend Medicare pay the cost of the annual MedKaz subscription. This incentivizes patients to embrace MedKaz. It would cost only $4 per month, or $45 annually, per insured. (If all 62 million Medicare insureds had a Medkaz which their providers used to coordinate their care and thereby save an average of $200/insured/year -- the cost of a simple blood test, Medicare would enjoy net annual savings of $9.6 billion.)

2. For providers, we recommend Medicare pay an incentive tied to their use of MedKaz with their patients. One example would be to pay the provider a premium -- perhaps $3 or $4 -- over their normal reimbursement rate for an office visit when they upload the records of a patient encounter to our MedKaz Server. This would give providers a strong incentive both to use a patient's MedKaz and to urge patients to have a MedKaz.

As you can imagine, despite all MedKaz's advantages, gaining adoption is difficult. It requires the support of all parties -- patients, providers and payers -- but each prefers to wait until the others have embraced it. It's the classical "chicken and egg" issue -- the very problem MCIT is designed to solve!

By including the breakthrough MedKaz in the MCIT program, these barriers to adoption would be overcome and Medicare patients, providers, Medicare itself and the entire healthcare system, would benefit materially.

CONCLUSION

It is clear that MedKaz and other systems that provide interoperability are "reasonable and necessary" and meet the spirit, intent and letter of CMS-9115-F, EO 13813, as well as EO 13890 which triggered proposed rule CMS-3372-P.

Accordingly, we urge you to broaden your definition of "breakthrough devices" so patients, providers and Medicare can enjoy critically-needed interoperability today!

Respectfully,

Merle Bushkin, Founder & CEO

MedKaz(R)

My Lifetime Health Record

PO Box 638

Brownsville, VT 05037

Tel: 877 580-4500

Fax: 802 484-0247

Skype: mbushkin

Web site: medkaz.com

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The proposed rule can be viewed at: https://www.regulations.gov/document?D=CMS-2020-0098-0002

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