Monthly Archives: October 2015

Federal Funding Towards Preventative Care

Planned Parenthood Foundation provides easily accessible and affordable birth control, preventive health care measures, including breast and cervical cancer screenings, and medically safe and legal abortions resulting in vast improvements to the health of millions of women and children. The controversies surrounding Planned Parenthood does not negate the evidence that women, men, children, and families have reaped great benefits to their health since the Supreme Court’s decision in Roe v. Wade.

The Center for Medical Progress, an anti-abortion group based in California, released eight videos alleging Planned Parenthood violated federal law; first, selling fetal organs and tissues and, second, manipulating abortion procedures to procure intact fetuses. This conservative, anti-abortion group hired actors to go undercover as pro-choice, record and interview Dr. Deborah Nucatola, Senior Director of Medical Services at Planned Parenthood Foundation. David Daleiden led this manipulative deceitful attack as another attempt to terminate the foundation’s federal funding.

The Partial-Birth Abortion Ban Act of 2003 prohibits partial-birth abortions procured by intact dilation and extraction, (“intact D&E”). Under this law, 18 U.S.C. §1531,”Any physician who, in or affecting interstate or foreign commerce, knowingly performs a partial-birth abortion and thereby kills a human fetus shall be fined under this title or imprisoned not more than 2 years, or both.” In the Supreme Court decision of Gonzales v. Carhart, Justice Kennedy wrote the majority opinion upholding the Partial-Ban Abortion Act solely when the physician intends to perform an intact D&E, not the more common partial-birth abortion.

Differences exist between the more common partial-birth procedure known as dilation and evacuation and the illegal intact dilation and extraction method. The former first ensures fetal death has occurred before beginning the surgical abortion procedure. Whereas, the latter, “the person performing the abortion deliberately and intentionally vaginally delivers a living fetus until, in the case of a head-first presentation, the entire fetal head is outside the body of the mother, or, in the case of breech presentation, any part of the fetal trunk past the navel is outside the body of the mother.”

Congress’s intention behind the Act is that no partial-birth abortion exists that is medically necessary and consequently cannot put the safety of a mother first. However, the Supreme Court in Gonzales v. Carhart, only upheld the Partial-Ban Act solely to intact dilation and extraction and, furthermore, left open the possibility of an as-applied challenge if rendered medically necessary.

The paramount goal of an abortion is safety and care for the mother and her health. Mr. Daleiden alleges that Planned Parenthood is performing illegal partial-birth abortions. In one of the videos, Dr. Nucatola explains their success in receiving fetal organ tissue because the doctors perform abortions by using ultrasounds to ascertain the best location to grab the fetus with forceps. Any diversion of an abortion procedure for the purpose of gaining organ research is extremely unethical and it would defeat the primary purpose of the foundation providing safe, legal abortions.

Mr. Daleiden also alleges, “Planned Parenthood’s criminal conspiracy to make money off of aborted baby parts.” It is against federal law to sell fetal tissue. The foundation claims it makes no profit, but rather, the actual costs, including the cost to transport tissue to research centers, are reimbursed, which is standard across the medical field. Dawn Lagues, Planned Parenthood Executive Vice President, stated, “this was always about one thing – honoring the desire of women to contribute to lifesaving research. It was never about money.” Participating in this not-for-profit research is a voluntary and legal way to contribute towards creating successful vaccinations for diseases including Parkinson’s, polio, rubella, and chicken pox.

Irrespective of Planned Parenthood’s letter to Congress that proves the videos are heavily edited and inaccurate, the foundation announced they no longer will accept legal reimbursements from research in hopes to end another political anti-abortion attack.

Federal funding is imperative to Planned Parenthood providing women access to preventive care, life-saving screenings, and family planning services. While Federal funding is prohibited from paying for any abortions, these anti-abortion attacks on such an honorable and respected foundation will have devastating impacts. Restricting woman’s right to access medically safe, legal abortions and accessible preventive health screenings jeopardizes the health of women, their families, and our nation.

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D.C. District Court Limits Discounts to Orphan Drugs

On October 14, 2015, Judge Rudolph Contreras of the District Court for the District Court of Columbia sided with drugmakers in a decision that narrowed the scope of 340B, a popular but controversial drug discount program. The decision effectively bars children’s hospitals, cancer hospitals, and rural hospitals from obtaining 340B discounts for so-called “orphan” drugs like Prozac.

The plaintiffs in the case, Pharmaceutical Research and Manufacturers of America (“PhRMA”), is a lobbying group comprised of 48 of the nation’s pharmaceutical heavyweights, including Novartis and Pfizer. PhRMA challenged an HHS Interpretive Rule, which would have expanded the scope of the drug discount program. PhRMA argued that the agency’s Interpretive Rule contravenes the plain language of 340B. Judge Contreras agreed.

Background to 340B and the Disputed Interpretive Rule

At the heart of this dispute are high-demand “orphan” drugs like Prozac. Orphan drugs are drugs developed to treat a rare disease or condition; the rare disease or condition is the “orphan” use. But, by and large, orphan drugs are more well-known for their non-orphan uses. In the case of Prozac, the drug’s designated orphan use is autism and certain types of body dysmorphic disorders. Yet most patients and providers use Prozac as a treatment for depression.

When the Affordable Care Act was passed, Congress significantly expanded the types of covered entities that would be eligible for 340B program discounts. The ACA added children’s hospitals, freestanding cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals to the 340B drug pricing program. The newly covered entities, however, are excluded from certain types of 340B program discounts.

Under 340B(e), newly covered entities do not have access to discounts for a “drug designated . . . for a rare disease or condition.” Pharmaceutical companies and providers disagreed over the scope of 340B(e). Pharmaceutical companies argued for a broader interpretation and insisted that the provision refers to all types orphan drugs.

To clarify the confusion, HHS issued an interpretive rule on July 23, 2014. Under the Interpretive Rule, drugmakers must offer orphan drugs at a discount to newly-covered entities when the covered entity purchases the drug for a non-orphan use. In the Prozac example, that means a covered entity like a rural hospital could get a discount on Prozac when purchasing the drug for depression (a non-orphan use), but not for autism (the designated orphan use). Drugmakers that fail to comply and refuse to offer the discount price must provide a refund to the covered entity for the overcharge.

D.C. District Court Applies Chevron Test, Vacates HHS Ruling

The court vacated HHS’s Interpretive Ruling, finding that it failed the Chevron test. Under the first prong of the Chevron test, the question is whether Congress has directly spoken on the precise question at issue. If so, the agency must follow the intent of Congress as clearly expressed in the statute. If the congressional intent is unclear, the court proceeds to the second step of the Chevron analysis to determine whether the agency’s ruling is “based on a permissible construction of the statute.”

In this case, Judge Contreras concluded Congress’s intent was clearly expressed in 340B(e) and its related statutory provisions, and that the second part of the Chevron analysis was unnecessary.

The court held in favor of the pharmaceutical company and rejected HHS’s Interpretive Rule.

After concluding that the Interpretive Rule failed the first prong of the Chevron analysis, the Court vacated the Interpretive Rule as “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” In effect, the D.C. District Court’s decision signals a victory for pharmaceutical companies who now do not have to provide orphan drugs at a discount for newly-covered entities like children’s hospitals and rural hospitals.

Experts Foresee Legal Attacks on Other Parts of Drug Discount Program

HHS can still appeal. In the meantime, legal experts weighed in on Law360 and predicted that the decision could encourage drugmakers to lodge additional lawsuits on other parts of the 340B program. In particular, the pharmaceutical industry has railed against the “mega-guidance” that HHS released in August 2015 for the drug pricing program. The omnibus guidance is still in the note and comment process, with the current 60-day comment period ending on October 27, 2015.

Lawyers speculate that this decision leaves the omnibus guidance vulnerable to legal attack. Based on this decision, pharmaceutical companies can challenge the mega-guidance in court as soon as it is finalized, before HHS even attempts any type of enforcement. As Kristi Kung of Pillsbury Winthrop Shaw Pittman stated, “The court here found that the agency didn’t actually have to take an enforcement action against a manufacturer for there to be [a lawsuit].”

Reactions from Providers Underscore Deep Disappointment, Concern Over Access

The District Court decision struck a deep nerve among hospitals and providers. Immediately after the decision was released, the American Hospital Association (AHA) released a statement expressing its deep disappointment.

“This decision comes at a steep cost for the vulnerable patients cared for by rural and cancer hospitals,” AHA stated. “[The decision] will reduce access to critical services and treatments for some of the most vulnerable patients in society. Sadly, the biggest beneficiary of this ruling is the pharmaceutical industry – it does nothing to help either patients or taxpayers.”

The American Society of Health System-Pharmacists (ASPH) similarly stepped out in opposition of the decision. In its own statement, ASPH pointed out the adverse effects of the decision on access to care. According to ASPH, “this ruling will limit access to critical medications for the sickest patients in our healthcare system. . . . Without access to these discounts, participating hospitals may not be able to absorb the cost of providing care to patients who otherwise would not be able to afford it.”

In an interview with Modern Healthcare, the National Rural Health Association agreed, adding that the decision might cause rural hospitals to pass some orphan drug costs onto patients and could lead to some hospitals not stocking certain medications.

The overwhelming reaction against the decision is clear: the D.C. District Court decision creates public policy implications which cut off access to affordable care. By rejecting HHS’s orphan drug discount rule, this decision strongly disadvantages the same patients from underserved areas which the Affordable Care Act meant to assist.

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Balancing a 5,455% Drug Price Increase with Innovation

By: Nawa Arsala

In a widely-criticized and controversial move, Martin Shkreli of Turing Pharmaceuticals increased the price of the drug Daraprim from $13.50 a tablet to $750. That is 5,455% more expensive than it was only two months ago. The seemingly overnight price increase has caused waves in the political arena, the pharmaceutical industry, and the financial market.

Daraprim is approved by the Food and Drug Administration to help prevent malaria and treat toxoplasmosis, an infection caused by a parasite. It is also used to prevent other kinds of infections, at the discretion of doctors. Although these uses are not explicitly included in Daraprim’s approved labeling by the FDA, doctors are able to prescribe as they see fit, which is known as off-label usage. Courts have deemed that off-label usage by doctors is permissible, and constitutes the practice of medicine. Some of these off-label uses include treating opportunistic infections of HIV. Moreover, Daraprim is also used on cancer patients on chemotherapy, whose immune systems are weakened and get infections. This can explain the outcry from patient advocates, claiming that Turing has raised the prices of a “cancer drug” or a “HIV drug.”

Martin Shkerli, CEO of Turing, has had a rocky and controversial history in the pharmaceutical industry. He began vilifying certain small drugmakers online, while simultaneously selling their stock short. This means that he’d profit if share prices fell. Many in the industry found this behavior as sneaky. In 2011, Shkreli founded the biotech firm Retrophin, which focused on medicines for rare, life-threatening diseases, and orphan drugs. Eventually, Shkreli was publically ousted and sued for arranging a series of backdoor deals using company cash and stock. Shkerli has since countersued demanding that Retrophin pay Shkreli more than $70 million reflecting company stock he’s owed and damage to his image as a businessman. 

In the case of Daraprim, Shkerli argues that the price is actually to the benefit of the patients in the long run because innovation is necessary. The Food & Drug Administration also tends to agree, granting market exclusivity to encourage innovation. Shkerli ascertains that only 2,000 people in the United States are prescribed Daraprim every year. Moreover, while many other life-saving drugs must be taken for life, Daraprim only needs to be taken for about six weeks. He believes this drastically reduces the cost for the drug because only one course is needed. Nonetheless, this could explain why there is currently no generic version, as there is not a substantial financial incentive to manufacture Daraprim to produce a drug that only needs one course, and for so few patients.

The pharmaceutical market has long been a hot-button political issue because it is where a free market economy and public health must agree. There is rising criticism over the cost of health care in general, and particularly drugs. With the upcoming presidential elections, many potential candidates are weighing in on Shkerli’s decision. Democratic presidential candidate Hillary Clinton said “price gouging like this in the specialty drug market is outrageous.” Vermont Senator Bernie Sanders took it a step further by sending a letter to Mr. Shkerli, requesting more information about the drug hike. Shkerli has yet to respond to the letter and Sanders believes he is “holding hostage the patients who rely on this lifesaving medication, as well as the hospitals that administer it, by charging unconscionable prices for a drug on which he has a monopoly just because he can.” Public outcry has called for antitrust laws to remedy the price increase. However, under U.S. antitrust law, a unilateral price increase, when done in agreement or not in response to competition, is almost never actionable.

Ultimately, after worldwide criticism, Shkreli promised to lower the price of the drug. To date, that lowered price remains unspecified. Ed Painter, a spokesperson for Turing Pharmaceuticals recently explained that more than half of Daraprim’s sales “continue to participate in federal and state programs such as Medicaid” and a drug discount program, that often lead to costs that are “as low as $1 per bottle.” Nonetheless, almost four weeks after Shkerli made this promise, the price remains the same. It is important to note that Turing is part of a growing trend of price increases in pharmaceuticals that include massive manufacturers such as Pfizer, Merck and Valaent. Shkerli’s latest response to the backlash was “there have been hundreds of companies that have raised [their drug prices] higher, and they’re not rolling back their prices, so why should we?”

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California Governor Signs End of Life Option Act into Law ahead of Deadline

On Monday, October 5th, just a little over the week before the deadline, Governor Jerry Brown signed into California state law the End of Life Option Act.  The act would allow adults suffering from a qualified terminal illness to be prescribed a life-ending drug.  On September 14th, the California Legislature passed the act, but it was unclear which way the governor would go.  The Bill passed forty-four to thirty-five in the Assembly, and twenty-three to fourteen in the Senate.  California is now the fourth state with such a provision alongside Oregon, Washington, and Vermont.

The bill is modeled after the Oregon Death with Dignity Act which provides a number of safeguards to make sure that the bill is not abused by patients or doctors.  The Oregon bill requires a written request that is signed by the patient and witnessed by at least two individuals who attest that the patient is capable, acting voluntarily, and not being coerced.  Both the attending physician and a consulting physician must agree on the diagnosis, prognosis, and capacity of the patient to make an informed decision.  If either physician believes the patient is suffering from a mental disorder or depression, the patient is referred to counseling and cannot receive the prescription until it is determined the patient is not suffering from impaired judgement.  The attending physician must also inform the patient of all of the risks of the prescription and feasible alternatives, which is a common component of informed consent.  Finally, in terms of timing, there has to be fifteen days between an oral request and the prescription being written and forty-eight hours between a written request and a prescription being written.  The California bill has all of these elements as well as a sunset clause, which requires the bill to be renewed after ten years.

The other source of inspiration for the bill was the story of Brittany Maynard, a 29 year-old resident of California who suffered from brain cancer.  She had been given a prognosis of less than six months to live, but since California did not have a law allowing for physician-assisted-end-of-life, she had to establish residency in Oregon to use their law.  Her story caught the attention of the nation, and is credited with re-igniting the conversation of physician-assisted end-of-life options in California and across the country.  Maynard actually spoke to Governor Brown three days before her death, urging him to support the cause.

Some of the fiercest opposition had come from religious groups and disability rights advocates.  They believed that the safeguards do not do enough to protect vulnerable populations – like the elderly, disabled people, and low-income individuals – from being pressured to avoid life-saving care.  A study in 2007 by the Journal of Medical Ethics actually found vulnerable populations no more likely to use the end-of-life option in the case of Oregon.  They examined the elderly, the disabled, women, the uninsured, people with low educational status, low-income people, and racial/ethnic minorities. The study actually came to the opposite conclusion – the most frequent users of the option were white, highly educated, wealthy, and under 85 years old.

A number of states should have a keen interest in yet another state passing death-with-dignity legislation.  Over the past year, sixteen states and the District of Columbia have introduced bills to their state legislatures for this right.  One such state – Montana – already allows death with dignity via the 2009 Montana Supreme Court ruling in Baxter v. Montana, where the Montana Supreme Court ruled that while there is no right to death-with-dignity, it is also not against the public interest and therefore not illegal. Despite this ruling, legislation that would codify this right has failed as recently as this past year.  The New Mexico Second Judicial District Court also ruled in 2014 that the state statute which makes physician-assisted-suicide a felony is not compatible with their state constitution, but that decision was overturned by the New Mexico Court of Appeals this past August. That case is set to be taken up by the New Mexico Supreme Court, and like all of the states mulling over their own death-with-dignity legislation – another state allowing it could create more momentum for future decisions.

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Health care’s saving grace: Is Telemedicine the real deal or a privacy nightmare?

Health care professionals are constantly developing and brainstorming innovative ways to increase access to healthcare in an affordable way. Is telemedicine the solution to the health care industry’s problems?

The American Telemedicine Association defines telemedicine as the “use of medical information exchanged from one site to another via electronic communications to improve a patient’s clinical health status.” Although telemedicine is considered a recent trend, telemedicine has been utilized for over 40 years and continues to grow in popularity. Today, telemedicine is predicted by many healthcare professionals and public health analysts to drastically cut annual healthcare spending. One report claims that in the coming years, telemedicine will cut annual healthcare spending by $60 billion; $40 billion in eliminating roughly two-thirds of unneeded emergency room visits and $20 billion in by replacing one-third of physician visits. Analysts have also noted that an expansion in Medicare coverage for telemedicine services will further increase annual savings.

Some health care professionals, however, are not sold on telemedicines projected savings. Dr. Jha stated, “You do the telemedicine; it leads to more tests. It leads to more follow-up visits. And, over time, when you look at the data, it turns out that telemedicine overall is not necessarily a big cost saver.” Despite this, the overwhelming message from health care professionals and communication professionals alike is that telemedicine works and will account for unprecedented savings.

Currently, Medicare only covers telemedicine services for rural and medically underserved areas when video conferencing is used. As telemedicine continues to develop public health professionals will keep a watchful eye on the Centers for Medicare and Medicaid Services to see if reimbursement for telemedicine services expands.

Telemedicine seems to be the golden child in healthcare; it cuts costs, increases access to care, and spurs innovation. Despite this, advancements in telemedicine possess major privacy concerns. As telemedicine continues to evolve from its video conference/consultation base to more services are being offered via mobile apps and text messages, how is a patient’s information being managed and protected?

Telemedicine requires developers, consumers, and physicians alike to consider if information from a video consultations will be recorded, or how data collected from a mobile health app will be stored, and whether federal or state privacy law is violated with such practices. The Department of Health and Human Services (HHS) and the Office of the National Coordinator for Health Information Technology (ONC), recognizing the need for guidance in the telehealth arena, provide resources for providers, implementers and consumers to address the many privacy issues related to health and mobile devices. ONC harps on the importance of encryption and being an informed consumer to help decrease privacy violations. Even still, federal, state, and local governments will continue to develop laws and regulations that address the ever-changing privacy landscape in light of continued telehealth innovation.

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