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The Bleeding Edge and the Unsettling Truth About Medical Devices Today

After its premiere on Netflix, the documentary, The Bleeding Edge,immediately received attention for its critical look inside the billion-dollar medical device industry in the United States. In the documentary, men and women across the country openly discussed how their lives were affected after they used FDA approved medical devices. Most of the critics in the film focused on Bayer’s Essure sterilization device and Johnson & Johnson’s vaginal mesh, while also shedding light on artificial metal hip replacements and Intuitive’s Surgical da Vinci robotic arm. The documentary’s investigation into the FDA’s regulatory process of medical devices shows that more often than not medical devices get on the market without proper testing.

The FDA conducts its regulation pursuant to the Medical Device Amendments of the Federal Food, Drug, and Cosmetic Act, which established three regulatory classes for medical devices. Several of the devices the documentary discussed are Class III devices, which “usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury.” Class III devices are subject to a pre-market approval process where companies must produce research that proves that the new device is safe and effective. Bayer’s Essure, Johnson & Johnson’s vaginal mesh, and artificial metal hips are considered implants, under the Class III definition, but most of these were not subject to this process.

Bayer’s and Johnson & Johnson’s devices made their way through the 510(k) certification, which was created for Class II devices that are less risky to patients. This certification process allows the FDA to certify a company’s new medical device based on evidence that it is “substantially equivalent” to another device already on the market. To be clear, this is not an approval process, instead, this is a clearance process that allows new medical devices to enter the market without requiring device testing.  This process is, in essence, a “loophole” and allows devices to hit the market at a faster rate. Most medical devices are now regulated under this loophole instead of the pre-market approval process.

A serious question still remains: Can we trust that devices are safe and effective when they are cleared but not approved through this certification process? The patients in The Bleeding Edgesay no, yet Bayer and many other companies say yes. Days after the documentary premiered on Netflix, Bayer hit the media calling the allegations in the documentary “inaccurate and [a] misleading picture of Essure” and described the documentary as an “anecdote” created to fit an agenda.

Patients continue to seek better regulation even if the medical device industry and the FDA seem to be unbothered by the film and defend their regulation. However, even before the film aired, Johnson & Johnson and Bayer faced several class action suits due to their products. Specifically, about 16,000 women have sued Bayer in a class action suit. This prompted the FDA to issue a warning to Bayer and ordered the company to conduct risk assessment studies, which in hindsight should have been required. Bayer will now take Essure off the market by the end of this year. This is good news for those affected by this device, but it is not the only one out there causing life-threatening problems.

The FDA has yet to try to bridge the gap in their current regulation of medical devices, but many supporters of the film hope it will encourage movement toward more thorough regulation and safety of medical devices. As technology and innovation continue to advance, regulating medical devices will only get worse unless the FDA closes the holes in its regulatory process and puts patient safety first.

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Telemedicine: Making Health Care a Reality for All

The American Telemedical Association, a leading telehealth association, describes telemedicine as the remote delivery of health care services and clinical information using telecommunications technology including through the internet and cellphones. Telemedicine has seen an exponential increase in the last few years with about 200 telemedicine networks and 3,500 service sites in the United States. Litigation regarding telemedicine issues was somewhat prevalent in the early 2000s, but has not been highly litigated in the last few years. Now the creation of telemedicine networks is keeping people healthy and out of hospitals as physicians and patients are downloading telemedicine apps, making healthcare available with the push of a button. Because of these advances and the lack of litigation and legislation, there may be changes to telemedicine in the near future.

 

Overall telemedicine has benefited people. The increase of health care costs has made it difficult for patients to have the means to see their doctors. Additionally, living in a rural area or not having easy access to transportation can make it hard for patients to access specialized programs. Doctors are trying to find ways to see more patients at lower costs and telemedicine is making this a reality. About two months ago, CVS Health announced that it would offer a telemedicine service through its smartphone app to treat easy-to-diagnose issues like colds, skin issues, and general wellness matters. At first, the service will cost $59 and then insurance coverage will be available in the coming months.

 

Medicaid is also accepting telemedicine to cover medical diagnosis, although the administration of the program is left to the states’ discretion. In July 2018, the Centers for Medicare and Medicaid Services (CMS) published a 1,400 page document with new proposed rules indicating that there would likely be changes to the telemedicine system. Comments to the document were due in early September 2018, so we may be breaking new barriers into health care soon. Pursuant to CMS’s proposed rules, patients would need to have a preexisting relationship with the doctor. If CMS expands this program to allow telemedicine between physicians and patients without preexisting relationships, this may open the door for legal issues. However, these new rules should simplify the process even further. They will remove barriers for those who need care so that providers can virtually check on patients and at the same time, spend time with patients who need in-person care. And telemedicine will also help the disabled and elderly who may rely on having someone who can take them to their appointment.

 

The federal government has not made many decisions about telemedicine, even though CMS is starting to make new ground and Congress is starting to look into legislature concerning telemedicine. Therefore, states are starting to pass bills to make telemedicine more prevalent in their states. The Texas legislature overruled its state medical board to enable telemedicine physician-patient relationships to proceed without an initial in-person visit; the Michigan and Indiana legislatures reversed restrictions on telemedicine regarding in-person visits; and telemedicine is seeing support in Pennsylvania and Louisiana.

 

However, there are still some issues that need to be explored before telemedicine can become a truly effective national resource. Since physicians and patients may not be in the same jurisdiction, and jurisdictions tackle certain health care issues differently, there may be an issue in crossing jurisdiction for treatment. Insurance companies will also have to determine how private insurers will cover telemedicine services. Overall, Congress should look into regulating telemedicine so that insurance providers and legislation help achieve the goal of providing healthcare to those who may not have easy access.

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Developments in Drug Pricing and Anti-Kickback Laws

On Wednesday, President Trump signed the Patient Right to Know Drug Prices Act. The bill tackles a number of issues that stand in the way of lowering high drug prices, particularly the discussion over the ‘gag rule’ in interactions between insurers and pharmacists. Under the current provisions of the gag rule, insurers are forbidden from disclosing whether the cash price for a drug is in fact cheaper than the price offered under the patient’s insurance plan. The new law will rescind that prohibition. However, it will only apply to name-brand prescriptions and not generics, but many are hopeful that it will raise an overall awareness for consumers about the actual prices they are paying for their prescriptions.

The Trump Administration is also working to lower drug prices by examining some of the specifics of federal anti-kickback laws that relate to prescription pricing. Under current law, pharmaceutical and insurance companies are not allowed to offer any benefit to physicians to prescribe one particular drug versus another. There is a significant exception in these regulations, however, known as ‘safe harbor rules.’ Under these exceptions, pharmaceutical companies and prescription benefit managers (PBMs), the companies that administer pharmaceutical plans on behalf of insurers, are allowed to negotiate the prices of a particular drug by discussing the different prices the manager will offer the drug for.

This once again has put the spotlight on drug rebates offered by pharmaceutical companies. With rebates, firms offer monetary incentives to encourage insurers to carry their drug, lessening the overall cost for insurers to carry the drug. These rebates are meant to be administered to the consumer, but in many instances are taken by the PBMs to boost their profits. Pharmaceutical companies have recently attempted to combat these strategies, partially in an attempt to deflect some of the criticism towards them on drug pricing, by offering generics with lower prices, so that the PBMs will receive lower rebates on the negotiated drugs. The FDA is currently examining the administration of rebate plans and is considering ending the exceptions they have under anti-kickback statutes.

Ultimately, any of these steps to reduce drug pricing will not be broadly impactful, as expansive steps to allow Medicare to directly negotiate the price of drugs with producers have failed to gather sufficient bipartisan support. Further, much of the controversy surrounding high drug prices have been focused on some of the more infamous instances, such as Sarepta Therapeutics’ $300,000 per year muscular dystrophy treatment . Until successful generics reach the market, these specialized treatments will be under no pressure to lower their prices.

It is unlikely that there will be any unified support to take more aggressive steps to lower drug prices, but pharmaceutical companies seem to recognize to some degree the public backlash to these prices and have taken steps to cap drug prices, most notably beginning with Allergan’s promise to increase drug prices by no more than 10% year-to-year.

In his statement at the bill signing, President Trump spoke of the bipartisan nature of lowering prescription drug prices. He also spoke generally about upcoming steps the Department of Health and Human Services will begin to take to further bring down prices. It remains to be seen what further steps will be taken, but is likely both Congress and the Trump Administration will continue to evaluate how they can change many of the regulations on drug prices that keep them so high.

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What Could Brett Kavanaugh do to Women’s Health Law?

President Trump’s Supreme Court nominee, Judge Brett M. Kavanaugh, has been a constant conservative presence on the United States Court of Appeals for the District of Columbia Circuit for twelve years.  Judge Kavanaugh has made it a point to stress textual limitations of the Constitution while often supporting corporations over regulators, and the government over individuals claiming violations of their rights.  With seldom exceptions, his position is to the right.  With his nomination, Americans are concerned that long standing precedents may be overturned, and Kavanaugh’s appointment could mean huge changes especially when it comes to women’s health.

When President Trump nominated Judge Kavanaugh on July 9, 2018, the President spoke highly of him as a person, a father, and a judge.  Judge Kavanaugh has stated that he had no intentions of overturning Roe v. Wade precedent during yet has eluded to a narrower interpretation  of when a woman can exercise that right.  In this time of “fake news,” a term coined by the President himself, it is unsettling as a woman to trust Kavanaugh’s statement as a promise.  His actions and opinions thereafter have raised even more concern.

In a notable decision in the fall of 2017, the DC Circuit voted to allow an undocumented pregnant seventeen year-old girl in an immigration detention center to obtain an abortion without delay. Judge Kavanaugh dissented.  He noted that while the Court of Appeals was obliged to follow Supreme Court rulings that recognized the Constitutional protection of a woman’s right to choose an abortion, those precedents left room for the government to apply “reasonable regulations that do not impose an undue burden.” Judge Kavanaugh sided with the Trump Administration, who argued that the young women should first be transferred to an adult sponsor for guidance, and argued that it was reasonable to choose a transfer to a sponsor instead of “forcing the minor to make the decision in an isolated detention camp with no support network available. . . . The majority’s decision represents a radical extension of the Supreme Court’s abortion jurisprudence,” he wrote.

Many Democrat political figures, like Elizabeth WarrenJeff Merkley, Dianne Feinstein, and Kamala D. Harris have expressed their grave concerns with a Kavanaugh appointment and made it clear that, in their opinion, Judge Kavanaugh does not intend to maintain Roe v. Wade precedent.  Senator Harris said, in response to Judge Kavanaugh’s remark equating birth control to “abortion inducing drugs,” tweeted on September 7, 2018, “Kavanaugh chooses his words very carefully, and this is a dog whistle for going after birth control. He was nominated for the purpose of taking away a woman’s constitutionally protected right to make her own health care decisions. Make no mistake – this is about punishing women.”

As disconcerting as anything unknown, only time will tell if Judge Kavanaugh will be given Supreme Court decision making power with the hearings on the sexual assault allegations delaying the vote.  In moments like these, it is paramount we realize how influential these types of nominations and appointments can really be in our country.

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The ACA Twilight Zone

Death by a thousand cuts has been the Trump Administration’s approach to the Affordable Care Act (ACA).  To be sure, President Trump  tweeted on April 23, 2017 that “ObamaCare is in serious trouble.”  On October 13, 2017, he tweeted, “ObamaCare is a broken mess. Piece by piece we will now begin the process of giving America the great HealthCare it deserves!”  On May 30, 2018, he stated: “For the most part, we will have gotten rid of a majority of Obamacare.”  And on June 4, 2018, he tweeted, “We had Repeal & Replace done (and the saving to our country of one trillion dollars) except for one person, but it is getting done anyway. Individual Mandate is gone and great, less expensive plans will be announced this month.”

In the courts, the ACA has certainly been no stranger to the artful attack.  But two lawsuits, one filed in Texas and the other in Maryland, have gained nationwide traction and hold nationwide consequences.  The first suit, Texas v. US, made its way to U.S. District Court Judge Reed O’Connor’s bench in the Northern District of Texas.  The 20-state GOP led suit was filed on February 26, 2018 by Texas Attorney General Ken Paxton.  It argues that since the ACA was only upheld by the Supreme Court in NFIB v. Sebelius because the individual mandate was a tax, and now that the Tax Cut and Jobs Act of 2017 (TCJA) zeroed-out the individual mandate penalty, the entire ACA is unconstitutional.  The Plaintiff-states also argue that since the ACA does not have a severability clause – a clause that would allow the rest of the statute to live if one part is stricken – the ACA as a whole must fall.

Under Attorney General Jeff Sessions direction, the government will not defend the ACA’s constitutionality.  Defending the ACA, and its patient protections like the prohibition on insurers from discriminating against patients with pre-existing conditions, are 17 Democratic attorneys general representing their respective states as Intervenor-Defendants.  A slew of patient groups and scholars filed amicus briefs in support of the Intervenor-Defendants, but only Citizens United filed as amicus in favor of the Plaintiff-States.  The American Cancer Society Cancer Action Network filed as amicus, urging the court to uphold the ACA and to “recognize Congress’s clear intent to improve access to lifesaving health care for millions of Americans.”  A bipartisan group of law professors filed as amicus, arguing that “[t]he arguments of both the plaintiff States and the United States on the severability of the insurance mandate from the other provisions of the ACA are inconsistent with settled law.”  On July 19, 2018, Senate Democrats introduced a Senate resolution that would authorize Senate Legal Counsel to intervene in Texas v. US to defend the ACA’s patient protections for people with pre-existing conditions.

The second suit, City of Columbus v. Trump, filed on August 2, 2018 by the Cities of Baltimore, Chicago, Columbus, and Cincinnati in the U.S. District Court for the District of Maryland alleges that the Trump Administration’s actions over the last several years amount to an unconstitutional sabotage of the law the President is required to faithfully execute.  The suit makes two claims: the first claim that the Administration is acting arbitrarily and capriciously, and the second that President Trump is violating the “Take Care” Clause of the Constitution.  Under the Take Care Clause of the U.S. Constitution, the President and his or her Administration must “take care that the laws be faithfully executed.” U.S. Const. art. II, § 3.  The suit cites a range of administrative actions taken to sabotage the ACA and have the aim and effect of weakening ACA exchanges, driving up premiums, and driving out issuers, ultimately increasing the rate of the uninsured and underinsured.

Judge O’Connor, after first announcing that oral arguments in Texas v. US would take place on Monday, September 10, moved up oral arguments to Wednesday, September 5, at 9:30 a.m.  At the same time in Washington, D.C., Supreme Court nominee Brett Kavanaugh will be testifying before the Senate Judiciary Committee for potential confirmation.  As some have noted, the fate of the ACA could turn on Kavanaugh’s appointment to the Supreme Court.  Kavanaugh’s preeminent views on separation of powers and his textualist-meets-originalist approach to statutory interpretation is consistent and can be expected to appear in his opinions, but is alarming to health care advocates and patients.  Kavanaugh’s jurisprudence shows that he cares deeply about administrative law and is unlikely to “deconstruct the administrative state,” but he is likely to “put a tighter leash on the regulatory state.”  In all, the fate of the ACA remains to be seen.

 

 

 

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