As the dilemma of “surprise billing” at hospitals around the nation gains scrutiny from the White House and Congress, many major hospital groups indicated they want a hand in shaping the conversation. In a letter sent to the Congressional leaders, from the American Hospital Association and the Federation of American Hospitals, laid out principles they want legislators to consider as they seek to address the problem. Their solutions aimed at policies for health payers and asked for protection for the patients. Notably, however, they also opposed the controversial practice of balance billing by providers.

These “surprise bills” or “balance bills” can devastate patients. Every little thing can be charged because a patient needed emergency help, but they were at an out of network hospital or received surgery from an out of network doctor. The bill can skyrocket and leave the patient in a financial crisis. This issue has created a “back and forth” in the industry over who is to blame for the surprise medical bills or the practice of charging patients for care that is more costly than the actual amount or not covered by their insurance. A group of insurance, business, and consumer groups announced in December that they would band together to push for stronger patient protections and released their principles for the conversation.

The letter from the hospital groups stated, “We are fully committed to protecting patients from “surprise bills” that result from unexpected gaps in coverage or medical emergencies.” This also included America’s Essential Hospitals, the Association of American Medical Colleges, the Catholic Health Association of the United States and the Children’s Hospital Association. They added, “We appreciate your leadership on this issue and look forward to continuing to work with you on a federal legislative solution.”

The group wants a definition of “surprise bills” agreed upon, and under this definition, call for more financial help to the patient. They also want protection for patients who are denied payment by a payer if, for example, the health plan determines the instance was not an emergency. Another massive principle pushed for is ensuring patients have access to comprehensive provider networks and accurate network information through their health plans. The “surprise bill” is something that happens one out of every five medical emergencies that take place. For the sake of the patient, it should be a priority to solve these issues and form a resolution.

Greenway Health, A Tampa-based electronic health record (EHR) company has falsely obtained EHR certification and incentivized clients in exchange for promoting or recommending its products to prospective new customers, and because of this act, the company will be dishing out $57.25 million.

In a statement provided by the company, Richard Atkin, Greenway Health CEO, said the Department of Justice (DOJ) settlement is an admission of wrongdoing and insured that all Greenway products remain ONC-certified.

Atkin also stated, “This agreement allows us to focus on innovation while collaborating with our customers to improve the delivery of healthcare and the health of our communities.” So, to Greenway Health this deficit will help them better their future.

This settlement by the DOJ is the second time federal prosecutors have taken legal action against an EHR vendor for falsifying Meaningful Use certification. Not even two years prior, in May of 2017, a Massachusetts-based company, eClinicalWorks agreed to pay $155 million to settle allegations that they violated the False Claims Act by falsely claiming their software met Meaningful Use requirements. The Meaningful Use Program was put into play to encourage healthcare providers to show “meaningful use” of certified EHR. The U.S. Department of Health and Human Services made incentive payments available to eligible healthcare providers that adopted certified EHR technology and met the requirements relating to their use of the technology.

“Many people saw the eClinicalWorks settlement as a wake-up call,” said Matt Fisher, a partner with Boston-based law firm Mirick O’Connell and chair of the firm’s health law group, also stating that this second DOJ settlement could lead to more findings of false claims.

Just like the complaint toward eClinicalWorks, the complaint filed against Greenway Health by the DOJ under the False Claims Act alleges that the company made its users submit false claims to the government by misrepresenting the capabilities of their EHR product, Prime Suit. This resulted in overpaying or improper payments to healthcare providers under the Meaningful Use Program. Greenway Health also violated the Anti-Kickback Statute by paying its clients or providing other incentives for them to recommend their product.

With these two settlements taking place, Christina E. Nolan, an United States Attorney for the District of Vermont, said that EHR companies should consider themselves “on notice.” EHR companies are now on watch by the US government and should make sure that what they are doing is legitimate.

Nolan also stated, “In the last two years, my office has resolved two matters against leading EHR developers where we alleged significant fraudulent conduct. These are the two largest recoveries in the history of this District and represent the return of over $212 million of fraudulently-obtained taxpayer monies. These cases are important, not only to prevent theft of taxpayer dollars but to ensure that the promise of health technology is realized in the form of improved patient safety and efficient healthcare information flow.”

The Civil Division’s Commercial Litigation Branch, Northern Districts of Georgia and the HHS Office of Inspector General, and the U.S. Attorney’s Offices for the District of Vermont conducted this investigation.

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Recently the Food and Drug Administration has been planning to make changes to its medical device clearance process. These changes they are planning on implementing would mean they would rely far less on older predicate devices so that they could offer a modernized pathway for high-tech medical innovations.

The changes made represent a significant shift in how the FDA will approve devices for marketing in the U.S. The original process for approving devices was first introduced more than 40 years ago, so this is a major step for the FDA. A specific change the agency plans on making is the 510(k) pathway required for new medical devices to account for advances in medical technology. In 2017, 82% of all medical devices were cleared through the 510(k) pathway.

The FDA has stated that they firmly believe in the merits of the 510(k) process, but that they also believe the framework needs to be modernized because there have been so many advances in technology. The 510(k) process was first adopted in 1976, so it does appear to be time to modernize this process. A significant change would be shifting the companies reliance away from comparisons to older predicate devices. Manufacturers usually use comparative testing against those predicate devices to show that a newer device is safe and effective. According to FDA Commissioner Scott Gottlieb, M.D., and director of the Center for Devices and Radiological Health Jeff Shuren, M.D., one in five 501(k) approvals were cleared based on comparisons to a device that was more than a decade old.

Taking all of this into consideration, the company does not believe that devices that rely on old predicates are unsafe, just that new devices could facilitate competition among manufacturers. It also would incentivize device makers to use more modern predicates and ensure new devices align with modern technology. The FDA plans to move forward with the proposals outlined in its Medical Device Action Plan, which was issued earlier this year. In addition to this, in early 2019 they plan to finalize guidance establishing an alternative 510(k) pathway called “The Safety and Performance-Based Pathway.” This plan will require that manufacturers meet performance-based criteria that reflect current technological principles. The changes made are expected to increase the number of De Novo device approval applications used for new unclassified devices. A proposal will be issued in the next few weeks to clarify procedures and requirements for De Novo applications.

Emerald Coast Medical Association aims to keep our members up to date on the newest legal changes. CMS listened to doctors and decided to delay any changes to codes for Medicare patient visits until 2021. According to the Centers for Medicare & Medicaid Services, doctors were worried that the plan would cut revenue for physicians who care for Medicare patients. Although CMS made changed to its plan, it did decide to continue with its plan to consolidate codes for Medicare patient visits.

Seema Verma, a CMS Administrator, said that they would consolidate codes for “evaluation and management” (E/M) visits to three, maintaining the level 5 code that is used for physicians who see the sickest patients who require more services. The agency will work with doctors to iron out the details, which will delay implementation to 2021. The E/M changes are part of a final rule that outlines the physician fee schedule for 2019. Along with that also come changes to the third year of the physician payment system implemented under MACRA.

The American Medical Association is on board with the revisions of the original proposed E/M policies. They are grateful that the administration is not moving forward with the payment collapse of E/M codes in 2019. The two-year window allows time for an AMA-convened workgroup to look over and make recommendations on this controversial topic.

Effective January 1, 2019, CMS will finalize several burden-reduction proposals that were supported by doctors. The final rule, though, will include revisions that preserve access to care for complex patients, equalize certain payments for primary and specialty care, and allow the delay in implementation of E/M coding reforms until 2021.

The original implementation would have been much sooner, but CMS received over 15,000 comments on a proposed rule that was released in July. Most of the 15,000 comments were in opposition to the change. This change would have collapsed payment rates for eight office visit services for new and established patients down to two each, a massive cut in the overall scheme of things. In addition to that, it also was said it could underpay doctors who treat the sickest patients, which more than 150 medical groups opposed and sent letters disputing the plan to consolidate E/M codes. CMS has released fact sheets with more details about the physician fee schedule, and one outlining changes to the quality payment program under MACRA.

These changes can impact each of our members significantly, which is why we like to make our members aware of them.

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