Healthcare Reform is Coming

In hopes to end surprise medical billing, Senate health committee chairman Lamar Alexander (Tennessee) and member Patty Murray (Washington) introduced a draft package of legislation. The draft package aims to cut healthcare costs, starting with surprise medical billing and drug prices. The lawmakers believe they can pass the bill on a bipartisan basis. Alexander thinks it can be moved through the health committee in June and have it hit the Senate floor as early as July.

“These are common sense steps we can take, and every single one of them has the objective of reducing the healthcare costs that you pay for out of your own pocket.” Alexander says he is making a move to better the lives of many families and individuals alike.

The proposal would require every practitioner at an in-network hospital to take the patient’s insurance. For providers, that would mean they can choose to join the insurance networks that cover that hospital, or they can choose to send the bill through the hospital rather than sending separate bills to the patient or insurer. The bill also calls for insurers to pay providers the median contracted rate for the same services provided in a geographic area. It also requires insurers or providers initiate an independent dispute resolution process, or arbitration, for surprise bills over $750 (surprise bills under $750, the insurer will pay the median contracted rate). If this passes, surprise billings would be a thing of the past, helping save people money and stress.

Another topic on the proposal was cutting drug costs. The proposal would change the policy to stop drug makers of brand-named drugs from manipulating the system. This could help bring new, lower costing generics or biosimilars into the market. They also want to prevent unnecessary delay of drug approvals to citizens. This also calls for the elimination for loopholes where the first generic drug being submitted to the Food and Drug Administration (FDA) can block other generic drugs from being approved. The proposal calls for educating healthcare providers and patients on biological products and biosimilars (the low-cost version of biological products). This would also help generic drug and biosimilar companies speed up the drug-making process.

Senator Alexander wants to do his part in bettering America and hopefully begin to shine a light on a questionable healthcare system that causes Americans of all statuses to stress about their pocket more than their health.

CDC is Listening

In March of 2016, the Centers for Disease Control and Prevention (CDC) released its guideline in an attempt to control widespread opioid abuse that claimed 20,000 U.S. lives in 2015 alone. The guideline was intended for primary care clinicians and advised them to prescribe other treatments before jumping to opioids for chronic pain outside of active cancer treatment, palliative care, and end-of-life care.

The CDC has since been under pressure from healthcare professionals because of the controversial federal guideline for prescribing opioids. On February 28th of this year, the CDC released a letter (written by Deborah Dowell, M.D., chief medical officer at the CDC’s National Center for Injury Prevention and Control) stating:

“The CDC will revisit the Guideline as new evidence and recommendation become available to determine when gaps have been sufficiently closed to warrant an update.”

In light of this letter, we could be witness to some much-needed changes for the opioid issue, which is a step in the right direction.

Additionally, the letter mentions the use of opioids in the treatment of cancer and sickle cell patients; They make it clear the guideline was never meant to restrict access to pain management for patients with those conditions.

One of many voices heard, Roy Silverstein, M.D., president of the American Society of Hematology, pointed to people with sickle cell disease that suffer from severe, chronic pain,

“which is debilitating on its own without the added burden of having to constantly appeal to the insurance companies every time a pain crisis hits and the initial request is denied.”

As we’ve stated in the past, even in situations where the medical professional would be denied, other forms of treatment besides opioids should be considered. The CDC changing things around could be a massive win for the medical field, professionals and their patients alike. Patients who have been denied their help haven’t gotten any better, and some have taken their lives because of it. Because of these changes, hopefully  now we’ll see more patients getting the much-needed help they deserve.

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A Closer Look at “Surprise Billing”

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.

Another Falsified EHR Vendor Identified

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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The “War on Opioids” Needs to End

“With the first cut of the scalpel, excruciating pain exploded in my foot, and I was shocked speechless. I froze, paralyzed, terrified that any movement would jostle that knife digging into my flesh.” Angelika Byczkowski, a patient suffering from Ehlers-Danlos Syndrome (EDS) has felt multiple surgeries through anesthetics.

The unforgettable recollection above was from a procedure that was done on her foot to remove a plantar wart. She also felt pain when she received stitches, which had anesthetics applied. Her doctor told her it was impossible that she was feeling pain, so she stuck to it and all the while, feeling extreme amounts of pain run through her body, she sat there quietly because she did not want to question authority. She thought she was going crazy. However, once she was 54 years old, she was finally diagnosed with EDS. EDS in many patients has brought them pain even after being numbed through local anesthetics. However, now that the medical world has gotten more advanced, we can help people with EDS with what is called by many a last resort: Opioids.

There is a four-step procedure to be taken before providers prescribe opioids:

Step 1: Initial Assessment

An Evaluation of the patient’s pain, which should include; location of pain, duration of pain, characteristic of pain, what relieves the pain, and what time of day the pain occurs. There should also be a check on how the patient’s past treatments and medication have worked out. A look at the patients personal and family history of alcohol or substance abuse should be taken into precaution.

Step 2: Informed Consent and Treatment Agreement

Before prescribing opioids for the treatment of chronic pain, a practitioner should obtain an informed consent agreement and a treatment agreement.

Step 3: Initiating and Monitoring Treatment

Once the decision has been made to initiate the opioid treatment, it should start as a therapeutic trial for a defined period (not to exceed 30 days). The patient should know that the trail will be carefully monitored to assess the benefits and harm that may occur and to evaluate the level of and change in pain.

Step 4: Red Flags and Aberrant/Diversionary Behavior

There is no exhaustive list of behaviors that might be considered red flags. However, it is a must for practitioners to recognize such behaviors and to document them in the medical record as well as what actions have been taking, including discontinuance of opioid treatment or discharging the patient.

With all of that in mind, opioids are there to help the patient try to function normally in day to day life. It should not be the medical professional’s fault for the patient’s actions. The war on opioids is not helping anyone in this situation because it can cause more problems for the patient by not giving them the drug sooner. Medical professionals are doing everything they can to help their patients; it’s their job, and most often their passion. The war on opioids has been causing more problems than solutions in the medical field and has even led to medical professionals to be questioned.

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Big Hospitals Sue HHS

Hospitals are beginning to follow in the footsteps of the American Hospital Association and are suing the Trump Administration for its decision to institute site-neutral payments.

The change, which is part of the Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System rule-making for 2019, would lower reimbursements for hospital outpatient department services to match rates set by the physician fee schedule for clinic visits. This would mean lower costs for a patient’s insurance. However, hospitals would lose about $380 million in 2019 alone and possibly up to $760 million in 2020.  The colossal loss of money is causing an uproar with (as of right now) 38 hospitals signing the lawsuit.

This isn’t even helping the patient from what CMS Administrator Seema Verma says, “It doesn’t make sense for taxpayers, and it certainly doesn’t make sense for patients because they end up having to pay more depending on the site of service.”

However, this can be looked at as taking down the money hungry hospitals. University of Michigan health law professor Nicholas Bagley was among the observers who praised the Trump administration for the proposal, saying CMS is “picking a fight with powerful hospitals because it’s the right thing to do.” The site-neutral payments would mean, hospitals would have to offer the same care at lower prices.

The previous system had Medicare paying higher rates for services provided at the hospitals outpatient facilities. The Centers for Medicare & Medicaid Services projects the policy change will save the beneficiaries $150 million in co-payments annually; dropping the average copay from $23 to $9.

“The different payment rates also pushed hospitals to purchase independent practices to increase their reach and take advantage of the higher reimbursement rates,” Verma said. “Neutralizing payments would increase provider competition.” Competition could potentially turn into one hospital bettering the others, just because they have more resources and more funding.

However, Farzad Mostashari, MD, co-founder, and CEO of Aledade, said in a series of tweets that hospitals will fight the OPPS rule “bitterly” but that there could be a long-term benefit for them in it.

“The truth is that this proposal could help hospitals be more competitive in value-based contracts/ alternative payment models, and they should embrace the changes,” Mostashari wrote. “If rural hospitals or AMCs need subsidies, then we should do it directly, not through distorting payment policies.”

Here at Emerald Coast Medical Association, we care about your health too. Since 1981, over 50 local physicians banded together to create a Physician’s Security and Benefit plan.

The primary goals are:

  • Provide affordable health insurance to employees, physicians, and their families
  • Upon the death of a physician, provide insurance for the spouse and children of the physician
  • Use each others’ premium dollars to pay claims for those physicians and their family members who had serious medical conditions
  • To provide a premium-rating schedule that did not discriminate against those physicians and their employees who had incurred large medical claims
  • Avoid implementing “gatekeeper” type “managed care” features
  • Promote access to virtually all providers in and out of the state
  • Establish a stable alternative to those carriers who often abandon the insurance marketplace

You can get all this and more for being an Emerald Coast Medical Association Member.

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Surprise, Unexpected Medical Bills!


The recent legal changes increased national attention to financial difficulties arising from patients receiving surprise, unexpected medical bills has led to a group of insurance, business and consumer groups announcing they have joined forces in an attempt to create solutions to reduce the frequency of this occurrence.

With potential changes including patients being notified when care is considered out-of-network or prior knowledge to charges along with alternative potential medical options and their costs being discussed, this new legislation has the potential to greatly alter the methods and efficiency at which medicine is currently practiced. Other guiding principles in this legislation include a policy to protect patients from increasing premiums as a result of policies enacted to protect them from surprise bills and a federal standard for payments to out-of-network doctors to help protect patients in self-funded health plans. The nine member coalition leading the charge in creating these new regulations consists of the following organizations: America’s Health Insurance Plans, National Business Group on Health and Consumers Union, American Benefits Council, the Blue Cross Blue Shield Association, the ERISA Industry Committee, Families USA, the National Association of Health Underwriters and the National Retail Federation.

There has been much debate on who is truly at fault for these surprise medical bills. A common practice in hospitals called balanced billing has been recently put at received a majority of the blame where patients are financially responsible for the difference between the hospital and insurer perceived cost of care.

Hospital groups stating that this coalition has incorrectly blamed them for these surprise bills have challenged this theory. American Hospital Association CEO Rick Pollack and American Hospitals President and CEO Chip Kahn emphasized in a joint statement a priority of hospitals and health systems is to eliminate surprise bills. The importance of the alliance of consumers, health insurers, employers, and hospitals working together was also brought to the forefront as a solution to prevent these unexpected charges according to these two high ranking officials in the hospital system.

Continuing with the different viewpoints of this problem, a group of physicians earlier this year also formed a multispecialty alliance regarding the problem. The Physicians for Fair Coverage was created and has been pushing for more widespread adoption of legislation. This coalition has been noted to place a majority of the blame on the insurers.

The creation of these various coalitions will hopefully continue to lead to discussions regarding surprise medical bills and will ultimately end in a solution that will benefit all parties involved.

Original Article –

FDA Moves Forward With New Technology


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.

CMS Modifies Proposed Changes to E/M Codes

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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Easing Restriction on Medication-Assisted Addiction Treatment

The Department of Health and Human Services and the Drug Enforcement Administration have recently been working together to increase access to medication-assisted addiction treatment (MAT). The HHS and DEA are aware that doctors able to prescribe these medications are in short supply, which is one of the reasons they are looking to ease restrictions on MAT.
Due to these restrictions being mitigated, doctors are now able to prescribe buprenorphine through a virtual platform. Along with this new rule, if a clinician is present, including practice providers who are not doctors, the waivered provider is legally allowed to prescribe buprenorphine even though they are not present. Late last year the White House’s opioid commission issued a slew of recommendations, one of which being that MAT becomes more accessible.

Although the waiver adjustments to MAT were made earlier this year, HHS is now making sure that providers are aware of the telemedicine options for opioid treatment. Once the HHS realized that steps were being taken to address the opioid crisis, they decided to be proactive about making the public aware. According to the Substance Abuse and Mental Health Services Administration, in 2017, there was a decline in people abusing opioids and more people got into treatment for opioid use disorder. However, the report also stated that more than 11 million Americans abused opioids in 2017.

HHS has made it one of their top priorities to tackle the opioid crisis. The secretary of the HHS, Alex Azar, has also made it one of his central agenda items. The HHS has released $1 billion in grants to approach this impending epidemic.

For the HHS to have an impact on this crisis, it is necessary not only for the HHS to be involved, but also the Department of Justice, the Department of Housing and Urban Development, and the Department of State, among many others. The Trump administration must take a multi-agency approach to this issue, which is why so many departments are involved. These steps being taken are a significant advancement towards defeating this terrible epidemic.

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