Author: WadeEmmert

U.S. Supreme Court Justice Samuel Alito has temporarily stayed until Wednesday a Texas federal court order imposing restrictions on the distribution of the abortion drug mifepristone while they consider a request by the Biden administration to block the restrictions.

Brendan Pierson, writing for Reuters, discusses What Happens Next?

Whether or not the Supreme Court decides to stay Kacsmaryk’s order, it will not decide the merits of the case. Rather, the court will determine whether and how mifepristone can be distributed while the case is pending.

…

Whichever way the Supreme Court rules, it will send the case back to the 5th Circuit, where the FDA will pursue a full appeal of Kacsmaryk’s preliminary injunction. The agency and the anti-abortion groups will both have a chance to file briefs, and the case is scheduled to be argued before a three-judge panel on May 17.

That appeal process could last months. The losing party could petition for rehearing with all judges of the 5th Circuit, known as en banc rehearing, and ultimately petition the Supreme Court once again.

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A final resolution could be months or years away. Once it does come, the losing side will again have the chance to appeal to the 5th Circuit and, eventually, the Supreme Court.

Interesting statistics on hospice care, its growth, and fraud from Deborah Abrams Kaplan, writing for Managed Healthcare Executive:

• Hospice care really started to take hold after Medicare started covering it in 1985. With Medicare paying the bills, hospice gained traction over time. Medicare spending on hospice nearly doubled from 2010 to 2020, increasing from $12.9 billion to $22.4 billion, according to the Medicare Payment Advisory Commission (MedPAC), an independent group that advises Congress on Medicare. During that period, the number of organizations that provide hospice care grew by 44%, from 3,498 in 2010 to 5,058 in 2020.
• With the growth in hospice care has come a growth in fraudulent practices. Hospice fraud is rampant and has gotten more sophisticated, especially in four areas: (1) improper admission, (2) improper retention, (3) improper classification, and (4) kickbacks.
• Hospice care in the U.S. was originally provided almost exclusively by nonprofit organizations, but now the providers are predominately for-profit organizations and an increasing number of them are backed by private equity. In 2010, 1,958 of the 3,498 hospices (or about 56%) in the U.S. were run by for-profit companies, according to MedPAC. By 2020, the number of hospices had grown by 44%, to 5,047, and 73% of them were owned by for-profit companies, according to MedPAC.

Violations of the False Claims Act require a requisite state of “knowledge” a claim’s falsity. To violate the statute, one must have “actual knowledge,” “deliberate ignorance” or “reckless disregard of the truth or falsity” of the claim. Any of those broad levels of knowledge is sufficient to support a False Claims Act violation.

But knowledge in retrospect looks different than knowledge prosectively. Is the “usual and customary” price of a drug the price that cash customers pay in cash, or is it the price negotiated by insurance companies or set by Medicare?

This week, the United States Supreme Court will consider the issue in U.S. ex rel. Proctor v. Safeway, Inc.

Nina Totenberg for NPR explains:

The case essentially began in 2006, when Walmart upended the retail pharmacy world by offering large numbers of frequently used drugs at very cheap prices — $4 for a 30-day supply — with automatic refills. That left the rest of the retail pharmacy industry desperately trying to figure out how to compete.

The pharmacies came up with various offers that matched Walmart’s prices for cash customers, but they billed Medicaid and Medicare using far higher prices, not what are alleged to be their usual and customary prices.

Walmart did report its discounted cash prices as usual and customary, but other chains did not. Even as the discounted prices became the majority of their cash sales, other retail pharmacies continued to bill the government at the previous and far higher prices.

For example, between 2008 and 2012, Safeway charged just $10 for almost all of its cash sales for a 90-day supply of a top-selling drug to reduce cholesterol. But it did not report $10 as its usual and customary price. Instead, Safeway told Medicare and Medicaid that its usual and customary price ranged from $81 to $109.

Web tracking technology has been in the news a lot lately. Most websites use such tools to track users as they navigate through a particular site and around the web. Nothing new here. But in doing so, user data gets transferred from one site to another, or actively collected, posing privacy risks for healthcare providers.

A new study, published in Health Affairs, indicates that 99% of hospital websites use third-party tracking code on their sites, creating privacy risks for patients and legal liability for hospitals:

We found that third-party tracking is present on 98.6 percent of hospital websites, including transfers to large technology companies, social media companies, advertising firms, and data brokers. Hospitals in health systems, hospitals with a medical school affiliation, and hospitals serving more urban patient populations all exposed visitors to higher levels of tracking in adjusted analyses. By including third-party tracking code on their websites, hospitals are facilitating the profiling of their patients by third parties. These practices can lead to dignitary harms, which occur when third parties gain access to sensitive health information that a person would not wish to share. These practices may also lead to increased health-related advertising that targets patients, as well as to legal liability for hospitals.

OIG has approved the use of gift cards to incentivize patients to return sample collection kits, provided there are certain safeguards in place:

• Mailing the gift cards only to those patients who return the kits by the deadline specified in the reminder letter.
• Advising patients that they may not use the gift cards on items or services provided by the requestors.
• Limiting patients to one gift card every 36 months, which is consistent with Medicare’s coverage period for the screening test.
• Implementing processes to ensure patients who received a gift card during the 36-month period do not receive another one during that period.
• Refraining from patient-focused promotional activities that advertise the availability of the gift card.
• Prohibiting advertising or marketing the proposed arrangement to healthcare providers who may order the test.
• Excluding tests ordered by healthcare providers through the requestors’ website from the proposed arrangement.

Dee Harleston, Stewart Kameen, Jinnifer Michael, and Danielle Sloane, for Bass Berry & Sims:

The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion 23-03, approving a proposal by the manufacturer of a colorectal cancer screening test and its wholly owned laboratory to provide gift cards to certain patients to encourage them to return the sample collection kits. While limited in scope, this favorable opinion is noteworthy because OIG typically disfavors arrangements under which providers or suppliers distribute gift cards to incentivize patients to obtain federally reimbursable services. Although OIG approved the proposed arrangement at issue in Advisory Opinion 23-03, the agency also pointedly warned entities against structuring arrangements that differ from the facts of the proposed arrangement.

OIG Advisory Opinion 23-03