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.”

Top 8 EHR-EMR Vendor U.S. Hospital Market Share Breakdown

Top 8 EHR-EMR Vendor U.S. Hospital Market Share Breakdown!

1. Epic - Number of hospitals using products: 1,363, 25.8% of market

2. Cerner - Number of hospitals using products: 1,303, 24.7% of market

3. MEDITECH - Number of hospitals using products: 877, 16.6% of market

4. CPSI - Number of hospitals using products: 572, 10.8% of market

5. McKesson - Number of hospitals using products: 243, 4.6% of market

6. MEDHOST - Number of hospitals using products: 213, 4% of market

7. Allscripts - Number of hospitals using products: 183, 3.5% of market

8. AthenaHealth - Number of hospitals using products: 82, 1.6% of market (relatively new to market) Source: Data derived from KLAS US Hospital EMR Market (2017)

Ascension to purchase Presence Health

Ascension, the country’s largest Catholic health system, has signed a letter of intent to purchase Presence Health, the largest Catholic system in Illinois.

Under the agreement, Presence Health would become part of AMITA Health, a joint venture between Ascension’s Alexian Brothers Health System and Adventist Midwest Health, the two health organizations announced. All Presence Health facilities would be added to AMITA save for Presence Life Connections, which will instead be added to Ascension’s senior care subsidiary, Ascension Living.

Mark Frey, CEO of AMITA Health and senior vice president of Ascension Healthcare, said in the announcement that Presence was a “perfect fit” for AMITA.

“Since we brought together Alexian Brothers Health System and Adventist Midwest Health to form AMITA Health two years ago, we’ve always looked for opportunities to add like-minded partners with similar values to our system,” Frey said.

The healthcare industry’s merger mania has shown no signs of slowing down this year. A Kaufman Hall analysis shows that merger and acquisition activity increased by 15% in the second quarter of 2017 when compared with the second quarter in 2016.

Six transactions between healthcare organizations with $1 billion or more in revenue were announced in the first half of this year, including the the megamerger between Steward Health Care and IASIS Healthcare LLC, which would make Steward the largest for-profit healthcare group in the country.

Ascension expects the merger to move forward successfully, according to the announcement, and it said that the addition of Presence would increase patient access and allow it to more strongly operate AMITA’s accountable care organization.

“We look forward to working together to engage in this joint effort to expand, and continue to deliver, quality care for our patients and residents, as well as provide additional clinical opportunities and patient care resources to all our physicians and associates,” said Michael Englehart, Presence’s CEO.

EHR-EMR Market Landscape & Leaders (July 2017): By Marketshare & Revenue

EHR-EMR Vendor Growth Considerations:

- 51.4% of healthcare provider organizations are considering EHR vendor

Epic, up from 45.1 percent in 2016

- 25.7% of providers looking for a new outpatient records system or seeking

to replace or upgrade a system are considering Athenahealth, up from just 7.4

percent in 2016

- 17.1% of providers are considering Cerner, down from 21.3 percent in 2016

- 15.7% are looking at eClinicalWorks, up slightly from 15.6

percent in 2016. eClinicalWorks was recently fined with a large legal

settlement by the U.S. Department of Justice, 34% of providers with an

eClinicalWorks EMR plan to migrate to another vendor, however, only 4%

specifically stated they are considering a switch due to the large fine and

settlement

- 14.3 percent are considering Allscripts, up from 13.9 percent in 2016

Sources: HIMSS, KLAS, Medscape

Allscripts Will Acquire McKesson’s EIS Business for $185 Million

Allscripts announced this afternoon that it will acquire McKesson’s Enterprise Information Solutions health IT business for $185 million in cash.

The products acquired include the Paragon EHR, Star, Series, Healthquest, Lab Analytics and Blood Bank, and OneContent.

Allscripts CEO Paul Black said in a statement, “Adding these assets to Allscripts existing portfolio enables us to better serve our clients, increase our scale and further drive our investment in innovation. This transaction is expected to directly benefit our existing clients and our shareholders, as well as the Enterprise Information Solutions clients and team members we’ll welcome to our family. Allscripts is a critical strategic partner to thousands of healthcare organizations and our highest priority is to successfully meet their highly complex needs of today and in the future, as we enable them to lead the change to smarter care. The healthcare IT market remains highly fragmented. Today’s announcement is a proactive and strategic measure to maintain Allscripts long-term leadership and position Allscripts for continued growth.”

Allscripts says it will continue to offer Paragon to small hospitals while continuing to sell Allscripts Sunrise to larger health systems.

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.

7,000+ people affected in New York hospital data breach: 4 things to know

At least 7,000 medical records from New York City-based Bronx-Lebanon Hospital Center were exposed by a third-party vendor, NBC News reports.

Here are four things to know.

1. A team of security researchers at MacKeeper Security Research Center discovered the breach earlier this month. Researcher Bob Diachenko told NBC News private patient information was viewable online due to a misconfigured backup server hosted by iHealth, a records management technology provider.

2. The exposed patient information included names, home addresses and medical diagnoses — along with addiction histories, mental health diagnoses, HIV statuses and sexual assault reports — of patients who visited the hospital between 2014 and 2017. Mr. Diachenko told NBC News it's unclear how long patient records were viewable online.

3.iHealth told NBC News it conducted an internal review upon learning of the breach. The vendor said one unauthorized person accessed the data, although there is no evidence that data has been misused.

"While iHealth continues to work with a leading IT security firm to validate its analysis, at this time, iHealth believes that the issue has been contained," iHealth told NBC News.

4. Bronx-Lebanon Hospital Center confirmed the exposed patient records in an emailed statement to NBC News and said it is cooperating with law enforcement agencies to address the breach.

Epic, Cerner hold 50% of hospital EHR market share: 8 things to know

In 2016, Epic and Cerner led the EHR market space for acute care hospitals in the United States, with Meditech following close behind, according to the new KLAS US Hospital EMR Market Share 2017.

The data in this study is based on acute care EMR purchasing activity that occurred in the United States from Jan. 1 to Dec. 31, 2016.

Here are eight things to know:

1. Epic held 25.8 percent of the U.S. acute care hospital market share, with Cerner (24.6 percent) and Meditech (16.6 percent) coming in a close second and third.

2. All other EHR vendors held 10 percent or less of the market share.

3. Thirteen of 23 contracts for integrated delivery networks (multi-hospital organizations) went to Epic.

4. Small community hospitals — with less than 200 beds — drove EHR purchasing decisions in 2016, accounting for 80 percent of all hospital EHR decisions in the country.

5. The increase in EHR adoption by small hospitals was fueled by the community-specific platforms from Cerner and Epic; acquisition and EHR-standardization activity of larger organizations; as well as an increased interest in athenahealth's new offering.

6. However, customers did complain about the lack of customization capabilities in both Epic and Cerner platforms.

7. While Cerner proved to be the most popular vendor among small hospitals in 2016, athenahealth grew the most.

8. The number of hospitals that contracted with athenahealth more than doubled in 2016, and one-third of the new hospitals included more than 25 beds.