Frank retired, and he’s spent a large part of his life making sure his family had what they need. Recently he noticed his right knee bothered him. He went to a physical therapist, who explained that his knee problem was caused by degeneration in his spine. The degeneration caused him to lean to the right, and Frank over compensated with his right hip and knee. The physical therapist started a therapy plan that would start with his knee and work to his spine. After weeks of therapy on his knee, Frank’s physical therapist told him that he reached the limit on his Medicare cap for physical therapy. He was told that he could either appeal for an increase in funds, pay for it out of pocket, or be refused the physical therapy treatment he needed.
Frank is not a real person, but the situation described above illustrates a very real problem in the United States. In 1997, Congress passed the Balanced Budget Act, which included an annual cap on physical therapy, and a separate cap on occupational therapy. The therapy caps were designed to be temporary, but they still remain today. (To learn more about the act click here.) However, many have argued that the cap fails to reflect what patients actually need.
Many organizations believe that the cap is arbitrary, and have fought to repeal it. One such opponent of the cap is the American Physical Therapy Association, or APTA. APTA has argued in position papers that this cap was not based on data, quality-of-care concerns, or clinical judgment, but that its sole purpose for existence was to balance the federal budget. APTA argues that various patients are likely to be impacted by the cap, as they are forced to bear 100% of the cost of care once they exceed it. APTA believes the cap is “arbitrary” and prevents beneficiaries from receiving the care they need when they need it.
Congress recognized the flaws associated with the cap, and has acted several times to prevent the implementation of a hard therapy cap. In 2003, Congress authorized the Government Accountability Office to determine whether progress was being made towards correlating outpatient therapy payments to beneficiary needs. The GAO found that the Department of Health and Human Services should allow for exceptions to the cap.
In 2006, Congress passed legislation allowing for exceptions to be made when a patient’s condition would require medically necessary and clinically appropriate physical therapy above the financial limitation. In 2013, Congress extended the allowance for exceptions, and created an automatic exception process when patients reach the $1,920 threshold, and a manual medical review process where a patient requires treatment over $3,700 threshold. While organizations like the APTA have applauded these exceptions, the problem related to receiving treatment when it’s needed as the cap approaches still remains.
The solution to the problems created by the cap may be on the horizon. Various members of Congress from around the country have introduced the Medicare Access to Rehabilitation Services Act (HR 713/S 367). The Act would permanently repeal the therapy cap. If the physical therapy cap was never pegged to patient needs, it should be repealed. The story above about Frank may have been fiction, but access to timely and appropriate care patients need and a repeal of the cap may soon be reality.
Bryan Tiscia earned his Juris Doctorate from Seton Hall University School of Law in May 2014. We are very pleased to welcome him to the blog today.
Here’s this week’s Monday Morning Recap, the post where we call out the drug and device law and policy developments that caught our eye and made us think over the previous week. You can see all of our previous Monday Morning Recap posts here.
1.At Fortune, Ben Geier reports that a federal grand jury in San Francisco has indicted FedEx on drug trafficking charges, with prosecutors alleging that the company has “known for a decade that these illegal businesses were using their services to deliver the drugs, going so far as to set up special credit policies to protect FedEx from losing money if the illegal pharmacies were shut down.” Geier writes: “Couriers for FedEx told federal investigators some pretty scary tales of delivering for the illegal pharmacies, including making deliveries to vacant homes where groups of people would be waiting to collect the parcels.”
2. Generic digoxin was in the news the week before last, and it was in the news again this past week. At the San Francisco Business Times, Ron Leuty reports that the drug “is at the center of an investigation by the Connecticut attorney general’s office over a spike in price. The inquiry . . . is focused on two areas. Authorities will probe if the drug’s price was fixed or if the company violated state antitrust laws by dividing customers or territories for digoxin sales[.]“
3. Turning from the high price of generics to the high price of branded drugs, the Business Standard reports that the Supreme Court of India has “upheld the compulsory licence granted to Hyderabad-based Natco Pharma to manufacture an affordable generic version of Nexavar (sorafenib tosylate), a kidney cancer drug patented by German drug major Bayer AG.“
4. At Bloomberg, Richard Rubin reports on a letter sent by Treasury Secretary Jacob Lew calling on Congress to act “to stop U.S. companies from using cross-border mergers to escape the country’s tax system, the latest trend in corporate deal-making.” As Rubin explains, “[t]he mergers used to legally avoid taxes, known as inversion transactions, have become increasingly popular over the past year, particularly in the pharmaceutical industry. Companies including Minneapolis-based Medtronic Inc. (MDT) and Canonsburg, Pennsylvania-based Mylan Inc. (MYL) have announced plans to move their legal addresses outside the U.S. Pfizer Inc., based in New York, attempted to move its tax address to the U.K. by purchasing London-based AstraZeneca Plc. (AZN).”
Filed under: Drugs & Devices, Food and Drug Administration (FDA)
More and more it seems mobile smart technology is becoming a permanent fixture in our daily routine. Need to check bus times? There’s an app for that. Need to pay a bill? There’s an app for that, too. Scanner? GPS? Calendar? Check. Check. Check.
With mobile answers to so many of life’s questions, it’s no surprise that there is a rapidly expanding market for medical applications. The apps in this category range from simple (for example, a body mass index calculator) to complex (for example, a program that turns an iPhone into a sonogram). Though the advent of medical apps undoubtedly represents progress, it isn’t without flaws. Because these apps deal with health and medicine, lives are at stake.
To illustrate, a patient with cardiac disease might rely on an ECG app to monitor his heartbeat for irregularities. If this app delivers faulty information, there is a serious risk the misinformation will be relied on in making critical medical decisions. Perhaps the patient feels mild chest pains, yet his trusty app shows a normal heartbeat. Unbeknownst to him, he is suffering a heart attack, but, because of the app’s reading, decides not to go to the hospital. This type of nightmare scenario has kept compliance officers awake at night because until recently, explicit regulation of medical apps was virtually nonexistent. Without clear guidance, attracting investors becomes difficult and as a consequence, innovation is hindered.
To grease the works, the FDA recently issued Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. The FDA’s authority to recommend medical app guidelines comes from the Food, Drug and Cosmetics Act. The FDCA tasks the FDA with regulating medical devices, giving a broad definition that covers accessories, components and software. Ultimately, whether a specific app falls within this definition depends on the objective intent of the person legally responsible for labeling it. The labeler’s intent is determined through statements, labeling claims and advertisements. If the device is intended for use in “the diagnosis…cure, mitigation, treatment, or prevention of disease” or to “affect the structure or any function of the body of man” the app is a device, subject to FDA regulation.
The new guidelines clarify that entities exclusively distributing apps are not considered ‘labelers’ for these purposes. The owners of the iTunes App Store can breathe easy. For manufacturers whose apps qualify as medical devices, the guidelines divide into two broad categories: apps subject to regulation and apps subject to “enforcement discretion”. Put simply, enforcement discretion means the FDA could regulate the app under the FDCA, but is choosing not to. Under the guidelines, apps subject to enforcement discretion are those that pose little risk of serious harm, even when used improperly. For instance, an app that encourages the user to maintain a healthy weight would be subject to enforcement discretion.
On the other side of the regulatory spectrum are apps subject to FDA regulation. These apps are divided into three subcategories. The first covers apps that are an extension of an existing regulated medical device. For example, an app that creates a remote display for a blood pressure monitor. The second covers attachments that transform a mobile platform into a regulated medical device. An example of this would be an attachment that turns a smart phone into a blood glucose strip reader. The third subcategory embraces apps providing patient specific diagnosis or treatment recommendations. An app using a patient’s information to calculate radiation dosage would fall into this category.
In the health industry, innovation is absolutely paramount. The new Guidelines lend insight and predictably to the regulatory future of medical apps, allowing continued progress. With clear language and numerous examples, they serve as an excellent starting point for attorneys counseling medical app manufacturers.
Matthew Siti earned his Juris Doctorate from Seton Hall University School of Law in May 2014. We are very pleased to welcome him to the blog today.
Photo Credit: Juhan Sonin
A day late but not a dollar short, here’s this week’s Monday Morning Recap, the post where we call out the drug and device law and policy developments that caught our eye and made us think over the previous week. You can see all of our previous Monday Morning Recap posts here. Credit for the format goes to Seton Hall Law alum Jordan T. Cohen, who used it to great effect in his series of Reform Rodeo posts.
1. The battle over Zoyhdro (which I blogged about here) continued this past week. After Massachusetts’ ban on prescribing and dispensing the drug was struck down, the state promulgated emergency regulations setting forth a set of conditions that physicians must meet before prescribing the drug and a set of conditions that pharmacists must meet in order to dispense it. Zohydro’s manufacturer, Zogenix, challenged these regulations, arguing that they amounted to a de facto ban and so were preempted for the same reasons that the total ban was. As Kurt Karst explains at FDA Law Blog, Zogenix won in part–the judge preliminarily enjoined the requirement that prescribers prepare a letter of medical necessity in support of each Zohydro prescription–and Massachusetts won in part–the judge denied, for now, Zogenix’ challenge to the regulations governing pharmacists. Per Karst: “So it’s not quite ‘goodbye’ to this controversy, but rather – and quite literally – ‘auf Wiedersehen’ (until we meet again).”
2. In related news, last week, Purdue Pharma announced that the Food & Drug Administration has granted Priority Review designation to a drug the company is developing that has the same active ingredient as Zohydro but which, unlike Zohydro, incorporates “abuse-deterrent properties designed to make the product more difficult to manipulate for the purpose of misuse or abuse by various routes of administration (e.g., chewing, snorting and intravenous injection).” If Purdue’s product is approved, it may spell the end for Zohydro, at least in its current formulation. In a letter to FDA in April of this year, Senators Richard Blumenthal of Connecticut and Patrick Leahy of Vermont called on the FDA to “act swiftly to remove any older, less safe versions” when “safer, abuse-deterrent opioids are approved[.]”
3. At Reuters, Ronnie Cohen reported on a study in the journal Vaccine that found, disappointingly, that “[m]ost doctors do not recommend flu shots to their pregnant patients, who are more likely to develop serious complications if they do get the flu[.]“ Cohen quotes researcher Marie Tarrant: “‘The research is clear that healthcare providers are not providing advice to pregnant women about the importance and benefits of getting vaccinated . . . In addition, they are not making influenza vaccine available to their pregnant clients. . . . By their silence, they are sending a message that influenza vaccine is actually not that important.‘”
4. Elisabeth Rosenthal had another must-read piece in the New York Times last week, this one about the rising prices of generic drugs. She writes: “Digoxin provides a telling case study. There was no drug shortage, according to the Food and Drug Administration, that might explain the increase. There was no new patent or new formulation. Digoxin is not hard to make. What had changed most were the financial rewards of selling an ancient, lifesaving drug and company strategies intended to reap the benefits.“
Filed under: Compliance, Elder Issues, Litigation and Liability, New Jersey, Public Health, Quality Improvement, Whistleblowers
New Jersey has perhaps the most employee-friendly whistleblower law in the nation, and the NJ Supreme Court is one of the most employee-friendly courts. It was, therefore, more than a little surprising to read the court’s most recent Conscientious Employee Protection Act decision, Hitesman v. Bridgeway, Inc.
A quick summary of the law and the facts make it even more surprising.
Law-wise, CEPA protects employees from retaliation for opposing any activity “the employee reasonably believes . . . is incompatible with a clear mandate of public policy concerning the public health.” Further, and seemingly tailor-made for Mr. Hitesman, CEPA also bars retaliation “in the case of an employee who is a licensed or certified health care professional, [for opposing conduct he] reasonably believes constitutes improper quality of patient care.”
As for the facts, plaintiff, a registered nurse who was shift supervisor for the defendant, believed that there was an upswing in respiratory and gastrointestinal infections at the nursing home. He reported his concerns first to management, then to local and state health agencies, and, not getting much of a reaction, went to a local television station. Perhaps needless to say he was fired.
In this kind of scenario, if the whistleblower loses, it’s usually because (1) he can’t prove that he was reasonable in his belief as to a violation of public policy or (2) he can’t prove that the adverse employment action he suffered was causally linked to his protected conduct. But neither was the problem for plaintiff since a jury had found both that Hitesman’s beliefs about improper patient care were “objectively reasonable” and that Hitesman’s reporting his concerns to the government was a “determinative motivating factor” in his discharge.
So why did he lose before the Supreme Court? Apparently, because his attorney never put in evidence that inadequate infection control was a threat to patient health. Really. And in a nursing home at that, which necessarily serves a more vulnerable population. Although it would seemingly have been easy to prove medical standards of care in dealing with potential infection, for example, citing to Center for Disease Control publications, the only evidence put in of the relevant policies was an American Nursing Association Code of Ethics and two internal policies of the nursing home, none of which focused directly on infections.
The court wrote:
[A] pivotal component of a CEPA claim is the plaintiff’s identification of authority in one or more of the categories enumerated in the statute that bears a substantial nexus to his or her claim. . . . [T]he plaintiff must identify the authority that provides a standard against which the conduct of the defendant may be measured.
While CEPA recognizes “a range of standards that may support a claim,” including professional codes, a claim “cannot proceed unless the plaintiff demonstrates a reasonable belief that the defendant’s patient care is ‘improper,’ measured against an authority recognized by CEPA,” which requires plaintiff to “identify a law, rule, regulation, declaratory ruling adopted pursuant to law or professional code of ethics that applies to and governs the employer in its delivery of patient care.”
That plaintiff hadn’t done, or at least so said the majority. The dissent of Justice Albin disagreed on several counts, but one of which was that the plaintiff had testified about the CDC Guidelines on infection control. The majority dismissed this on the ground that “Neither the trial court’s prior references to CDC standards in its summary judgment decision, nor plaintiff’s vague references to CDC-recommended precautions in his testimony” provide the detail of what CEPA requires.
Especially given the court that handed it down, Hitesman is a head-scratcher. Arguably, it’s a sport opinion, whose major impact will be a cautionary tale to attorneys to introduce exhibits citing chapter and verse rather than relying on plaintiff’s testimony and common-sense conclusions. But it’s possible the case may have more significance, signaling to the lower courts that CEPA has been applied too broadly in the past.