CMS Taking Steps to Modernize Approach to Digital Technologies

May 03, 2019 - CMS is working with other federal agencies and lawmakers in Congress to modernize its approach to coverage for data-driven medical devices and other innovative technologies.

As digital tools, companion apps, and analytics technologies become more commonplace across the industry, CMS hopes to speed up the process of determining payment rates for breakthrough advances in patient care, CMS Administrator Seema Verma said in a speech at the Medical Device Manufacturers Association Annual Meeting this week.

“Our vision is ambitious yet achievable: to protect and secure Medicare and ensure beneficiaries have access to the latest medical technologies,” said Verma.

“The advent of novel medical technologies requires CMS to remove barriers to ensure safe and effective treatments are readily accessible to beneficiaries without delaying patient care.  In essence, keeping new technologies and treatments moving from bench to bedside—and into the hands of those who need them most.”

CMS is anticipating the continued development of medical devices and other products that incorporate advanced analytics, data interoperability, and machine learning to offer actionable insights for patients and providers at the point of care.

Integrating new products and services into the Medicare fee schedule can be a lengthy and complex process, however, said Verma. 

CMS and its Medicare Administrative Contractors (MACs) must first make coverage decisions on a national or local level.  Then the agency must determine if the new technology can be coded for payment with existing codes or if new codes are needed.

Lastly, the agency makes a payment determination, taking into account the site and purpose of use in addition to other criteria.

Medicare can take years to make these decisions.  Oftentimes, coverage for a “new” technology or device can lag behind commercial coverage by as much as a decade.

As the pace of innovation accelerates as the healthcare industry enters the age of artificial intelligence, this snail’s pace is simply no longer acceptable, said Verma, especially as other agencies such as the FDA take proactive steps to modernize their processes.

“With the remarkable number of transformative technologies coming to market — many with unprecedented price tags — Medicare must develop new frameworks that will support tomorrow’s innovations and endure the test of time,” she said.

“Simply put, our goal is to get new innovations to our beneficiaries concurrent with FDA approval by removing government barriers to innovation and harmonizing CMS coverage, coding, and payment processes.”

CMS has proposed several changes to payment policies for medical devices that receive “breakthrough device” designations from the FDA.

“This includes waiving the requirement for ‘substantial clinical improvement,’ which is one of the criteria that must be met for CMS to make additional payments,” said Verma.  “For devices granted Breakthrough-designated FDA approval, real-world data regarding outcomes in different patient populations is often limited at the time of approval, making it hard for innovators to meet this requirement.” 

“Waiving this requirement would provide additional Medicare payment for the technologies for a period of time while real-world evidence is emerging, so Medicare beneficiaries don’t have to wait for access to the latest innovations.”

Medical devices on the market for two years would still have to demonstrate substantial clinical improvement to qualify for a third year of payment, but putting products into the market more quickly will allow patients to benefit from innovations immediately, she added.

By collaborating more closely with the FDA, CMS is repositioning Medicare as an innovation leader instead of a barrier to bringing new devices and technologies to some of the nation’s neediest patients.

“We are also working with Congress on a raft of legislative changes to address the challenges we face in adapting the Medicare program to modern technology,” Verma continued. “For example, the President’s Budget proposes expanding coverage of disposable devices, such as innovative glucose monitors and insulin pumps that substitute for a durable device, for use in the management and treatment of diabetes.”

“If we implement all of these changes, we will ensure beneficiaries have access to the latest technologies in a timely manner; improve the innovator experience with Medicare; create predictable coverage pathways; enhance opportunities for coverage for transformative technologies; reduce wait times for permanent codes; and modernize payment for innovative services.”

These efforts align with Verma’s signature Patients Over Paperwork initiative, which aims to reduce unnecessary complexity for beneficiaries and providers.

“Patients over Paperwork is an agency-wide effort to solicit input from stakeholders on policies that are outdated, redundant, or overly burdensome, and to make updates in response,” she explained.

“We believe these changes clarify and simplify the process, helping to ensure that manufacturers get appropriate therapies and medical devices to patients more efficiently. These improvements respond to stakeholders’ suggestions for more transparency, including multiple opportunities for engagement with CMS and our MACs.”

Making widespread changes to such a large and influential government entity isn’t easy, Verma acknowledged, but collaborating with industry stakeholders and other agencies will help to advance the adoption of cutting-edge analytics and innovative medical devices in a safe and effective manner, she concluded.

“A modernized CMS, with stronger inter-agency collaborations with FDA and NIH, will unleash innovation for years to come, and be a catalyst for improving quality, enhancing access, increasing efficiency, and lowering costs.”

Epic to jump into medical billing, currently hiring for new unit

A want ad recently appeared on the website of Verona, Wisconsin-based electronic health record colossus Epic Systems Corp. for "bright, motivated individuals to join our new billing services team as we enter the world of medical billing."

The ad notes that Epic is seeking billers who have good communication and customer service skills; are familiar with medical terminology and remittance/denial codes; are knowledgeable about Medicaid, Medicare, and other insurance guidelines, and have a coding certification or background. Applicants should also live within 45 minutes of the Verona campus.

"Our goal is to simplify the payment process by helping Epic organizations with the complexities of submitting claims and posting payments," according to the ad. "Attention to detail is vital as you'll be posting payments and denials; reconciling payment files, claims, and statements; resolving posting errors; and calling payers to follow up on outstanding or unpaid claims."

The ability to offer billing could be a boon for Epic's efforts to grow its business with resource-strapped small hospitals and physician practices.

The company is targeting organizations such as those as it rolls out the new streamlined EHR versions it announced earlier this year: a mid-range "utility" version, and a system called Sonnet whose scaled-back features and lower price point could make it appealing to smaller providers.

"We’re finding that people need different things," Epic CEO Judy Faulkner told Healthcare IT News at HIMSS17 in February. "If you are a critical access hospital, you don’t need the full Epic."

The value-add of billing service could make the choice for a simpler EHR that much more appealing.

"With a billing presence across all 50 states, Epic is well-positioned and excited to share our best practices and take on some of the billing work, and associated IT functions, for our Resolute Professional Billing customers," said Epic spokesperson Meghan Roh.

"Launching later this year, this new offering will help those who are struggling to scale their billing services, looking to keep a light operational footprint, or those who are just simply hoping to step away from revenue cycle management," she said.

Apple reveals plans to put health records on the iPhone

Apple has been in talks with hospitals and other healthcare organizations to explore the possibility of bringing health records together via iPhones, media outlets reported. 

The effort to make all personal health information available via its devices would be a first for Apple, which until now has focused it healthcare work on fitness and wellness with its Apple HealthKit. Apple has been typically mum on the developments and CNBC, which first reported Apple’s latest intentions for healthcare, said the works has thus far been “secretive.” 

[Also: Will Apple buy athenahealth? Jonathan Bush calls rumor baseless]

Unnamed sources told CNBC Apple is looking at startups in the cloud-hosting space to give it a foothold in healthcare. 

The company has already acquired personal health data startup Gliimpse, which has a secure platform for consumers to manage and share their own medical records.

The entrepreneur Anil Sethi, who built Gliimpse and sold it to Apple three years later, is now working at Apple. His title, according to his LinkedIn page, is Director, Apple Health.

More recently, Apple recruited Sumbul Desai, MD, from Stanford, where she has been involved in several successful digital projects. Apple executives have not released what role Desai will play, whether she might join the team working on ResearchKit, HealthKit and CareKit, or work on another project altogether. 

Also, Apple insiders reportedly talked with people at The Argonaut Project, which is promoting the adoption of open standards for health information, and to "The Carin Alliance," an organization that advocates for giving patients a central role in controlling their own medical data

Google to crack down on medical records in search results

Google added "confidential, personal medical records of private people" to its removal policy, signaling the company's first step to eliminating sensitive health information from its search results.

The tech giant updated the list of content it reserves the right to remove from search results June 22, according to Bloomberg. Under the revision, private medical records will be considered "sensitive personal information," which also includes information like individuals' Social Security, bank account and credit card numbers.

Prior to June 22, Google's most recent change to its removal policy took place in 2015, when it added a category related to "nude or sexually explicit images that were uploaded or shared without ... consent," according to The Guardian.

The decision follows several information security incidents that demonstrated how medical records may be posted online. A pathology lab in India unintentionally uploaded more than 43,000 patient records in December, according to Bloomberg, which were indexed in Google's search results.

The removal policy targets personal information that "creates significant risks of identity theft, financial fraud or other specific harms," according to Google. The search engine applies its right to remove content on a case-by-case basis, in part by reviewing individual requests submitted online.

Click here to view Google's removal policy.