Category: Around the Web

Press Release for U.S. Attorney’s Office, Northern District of Texas:

Certain amniotic products have been approved by the U.S. Food and Drug Administration for wound care, but not for pain management. (In fact, the FDA has issued repeated consumer alerts warning that biologics like amniotic fluid “have not been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain,” nor for “chronic pain or fatigue.”) Because amniotic products have not been approved to treat pain, Medicare considers amniotic injections administered to treat pain medically unnecessary and does not reimburse for them. They do reimburse for some – but not all – amniotic injections administered to reduce inflammation of damaged tissue, as in a wound.

These types of injections happen all the time under the umbrella of “Regenerative Medicine.” The idea is that the amniotic fluid contains stem cells which can help regenerate cartilage in the joints.

Clearly, the U.S. Attorney’s Office was dubious about the efficacy of the injections. But what got the PA in hot water is the submission of the charges to Medicare for reimbursement.

Charles Honart, for Stevens & Lee:

On July 14, the Federal Trade Commission (“FTC”), as anticipated, announced that it was withdrawing two antitrust policy statements related to enforcement in health care markets:

Statements of Antitrust Enforcement Policy in Health Care (August 1996)
Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program (October 2011)
The FTC’s withdrawal follows the Department of Justice’s (“DOJ”) decision to rescind the same statements in February 2023. (See our previous blog post.)

In withdrawing the policy statements, the FTC stated that it had determined that the withdrawal of the statements is the best course of action for promoting fair competition in health care markets. According to the FTC, much of the statements are outdated and no longer reflect health care market realities, and, given what it describes as the “profound changes” in the market over the last 30 years, the statements no longer serve their intended purpose of providing accurate guidance to market participants

Here’s one for the med mal attorneys. Epic Research issued a report on clinical notes documented in their system.

Researchers evaluated 1.7 billion clinical notes written by 166,318 outpatient providers from May 2020 to April 2023.

They found that the average length across all clinical notes increased 8.1 percent from May 2020 to April 2023. However, even though the average note length increased, the average time spent writing notes decreased by 11.1 percent over this same period.

The researchers also compared each provider’s average note length in 2020 to that same provider’s average note length in 2023. About 40 percent of providers decreased their average note length over the three years.

The research also revealed that almost 90 percent of providers reduced the average time they spent writing each clinical note.

Additionally, 10 percent of providers who decreased their average note lengths the most came from various specialties, including primary care, internal medicine, surgical specialties, dermatology, cardiology, and psychiatry. The researchers noted that this suggests a reduction in note length is achievable in almost any specialty.

Full article by Hannah Nelson, for EHR Intelligence.

Ragini A. Acharya, for HuschBlackwell:

The 36-Month Rule, found at 42 C.F.R. § 424.550(b), provides that where there is a change in majority ownership (“CIMO”) of an HHA by sale (including asset sales, stock transfers, mergers and consolidations) within 36 months after the effective date of the HHA’s initial enrollment in Medicare or within 36 months after the HHA’s most recent CIMO, the provider agreement and Medicare billing privileges do not convey to the new owner. Rather, the prospective owner of the HHA must enroll in the Medicare program as a new HHA and obtain a state survey or accreditation from an approved accreditation organization. Notably, an indirect change of ownership does not trigger the 36-Month Rule.

Will Maddox, for D Magazine:

Mark Cuban Cost Plus Drug Co. CEO Dr. Alex Oshmyansky is always busy disrupting the healthcare system. The latest iteration? Selling medicines directly to hospitals and clinics to address shortages and help providers save on needed medications.

…

The company is focused on manufacturing drugs that are in shortage. The FDA keeps a running list of around 180 medicines in its drug shortage database. When I visited, a few vials of the Cost Plus’ 23.4 percent Sodium Chloride Injection sat on Oshmyansky’s desk. The solution, which was manufactured via the robotic machinery in the factory, is listed in the shortage database and is used to replenish lost water and salt in your body or as an additive to total parenteral nutrition, which allows patients to be given nutrition without accessing the digestive tract.

Victoria Baily, for Revcycle Intellegence:

The agency has said that proposed payment increases for primary care and other direct patient care providers meant that payment cuts must occur in other specialties to achieve budget neutrality. While specialties like internal medicine (1 percent) and family practice (3 percent) would see reimbursement increases, others are facing cuts, including radiation oncology (-2 percent) and emergency medicine (-2 percent).

From Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., posted on National Review:

Texas has joined the growing list of states enacting comprehensive consumer data privacy laws. On June 18, 2023, Governor Abbott (R) signed H.B.4, otherwise known as the Texas Data Privacy and Security Act (“TDPSA”).  The TDPSA is another close cousin of the business-friendly Virginia statute, though Texas takes a different approach with applicability thresholds and gets tougher with regards to high-risk processing activities and consent requirements for using sensitive data. The compliance patchwork continues…

Just a few weeks before the TDPSA became law, the state also tightened the screws on its data breach notification requirements in order to require covered entities to report data breaches to the Texas Attorney General within 30 days (rather than 60 days) of discovering a breach. The amendment to Texas’ data breach notification law (Tex. Bus. & Com. Code Ann. §§ 521.002 and 521.053) takes effect on September 1, 2023 and will also require that reporters of breaches use an electronic form available on the AG’s website.

Zachary S. Taylor and Sarah M. Hall, for Epstein Becker Green:

Of the numerous cases, three specific areas comprised the vast majority of the $2.5 billion in alleged fraud:

Telemedicine Fraud: … 11 defendants were charged for their alleged connection to an $1.9 billion fraudulent scheme in the Southern District of Florida, which involved C-suite executives who were selling DME templates via a software platform in exchange for kickbacks and bribes. These defendants allegedly used telemarketing and advertising to induce elderly and disabled individuals to order unnecessary medical equipment and prescriptions. The defendants allegedly bypassed Medicare requirements of in-person contact by fraudulently generating documentation. Interestingly, this scheme continued after new owners acquired the underlying business. …

Pharmaceutical Fraud: 10 defendants were charged for a $370 million fraud scheme related to drug diversion. One defendant in this case allegedly paid over $5 million in kickbacks in order to get individuals to submit prescriptions to a pharmacy; such drugs were allegedly never dispensed. The defendant received over $100 million from Medicare and Medicaid.

Opioids and Clinical Laboratories: $150 million of the enforcement action’s total loss amount was attributed to the illegal distribution of opioids and clinical laboratory testing fraud.

Beth Mole, for ArsTechnica:

The OTC-approved pill is the Opill (norgestrel), a once-a-day progestrin-only pill manufactured by the Dublin-based company Perrigo. The company said it expects the pill will be available starting in the first quarter of 2024, though its pricing is not yet clear. For optimal efficacy, it needs to be taken consistently every day in the same three-hour window. Opill is estimated to be about 93 percent effective at preventing pregnancy in real-life use, higher than the real-life efficacy of other over-the-counter birth control methods, such as condoms, which are around 87 percent effective.