Heads up: this issue is from February 26, 2025. Because it covers time-sensitive coding and regulatory topics, some details may have changed since. See the latest issues for current guidance.
CMS posted an updated list of billing and payment codes (PDF) for orphan drugs that qualify for a 26% increased applicable percentage in terms of WASTE TRACKING for calendar quarters in 2023. For most other drugs, the percentage for fines is 10%. To qualify, a drug must meet all 3 of the following requirements: (1) Designated as an orphan drug under section 526 of the Federal Food, Drug, and Cosmetic Act; (2) Approved by the FDA exclusively for indications within the designated rare disease or condition; and, (3) Furnished to fewer than 100 unique beneficiaries per calendar year...Fierce Healthcare reporting-- federal judge sided with the Federal Trade Commission (FTC) in a case against the nation’s three largest pharmacy benefit managers (PBMs), declining to halt the lawsuit. The case is now expected to move forward following the Feb. 19 court ruling. The FTC announced last September that it was suing the “big three” PBMs, alleging they colluded to raise the price of insulin through “discounts” that pass additional costs to patients. The companies being sued include Caremark, Express Scripts, and Optum RX—owned by CVS Health, Cigna, and UnitedHealth Group, respectively. Allegations of price-fixing and collusion were also levied against the group purchasing organizations (GPOs) for each PBM, all of which fall under the same parent companies. The FTC alleged that this vertical integration allows the drug distributors to rig the “pharmaceutical supply chain competition” in their favor, forcing patients to pay more for life-saving medication...On February 18, 2025, the First Circuit adopted the "but-for" causation standard as a threshold for proving a False Claims Act (FCA) claim based on an Anti-Kickback Statute (AKS) violation in the case of United States v. Regeneron Pharmaceuticals Inc. This decision aligns the First Circuit with the Sixth and Eighth Circuits, holding that FCA liability requires that a kickback be the but-for cause of a claim. The reason this is BIG News is that it makes it harder to prosecute False Claims based on the Anti-Kickback Statute. Why? "But for" requires only a “causal link” between the alleged kickback and subsequent claim (s). In the Regeneron case, the government thought a Copay program caused false claims. But, the government does not pay the copays, so this could not have produced false claims. This case may go to the Supremes, but for (!!) now, cases must consider this causal link...The Class action lawsuit against UnitedHealth's AI claim denials will advance, although parts have been dropped. The plaintiffs have accused the insurer of using artificial intelligence algorithms to deny claims illegally. A federal judge has dismissed five out of seven counts in a class action lawsuit against UnitedHealth Group but will allow it to continue, with the suit claiming that UHG, UnitedHealthcare and naviHealth denied claims by using an artificial intelligence program instead of medical professionals in Medicare Advantage plans. The plaintiffs are members who were denied benefit coverage. They claim in the lawsuit that the use of AI to evaluate claims for post-acute care resulted in denials, which in turn led to worsening health for the patients and in some cases resulted in death. They said the AI program developed by UnitedHealth subsidiary naviHealth, NH Predict, would sometimes supersede physician judgment and has a 90% error rate, meaning nine of 10 appealed denials were ultimately reversed. The plaintiffs also allege that UnitedHealthcare breached its insurance contract, which stipulated that it would cover medically necessary healthcare services and that coverage decisions be made by clinical staff. and the claims would have been billed anyway...CMS announces 50 new ICD-10-PCS codes (PDF), effective April 1, 2025. The April 1, 2025, procedure code update files are now available. Use these codes for discharges occurring from April 1, 2025 – September 30, 2025, and for patient encounters occurring from April 1, 2025 -September 30, 2025. CDC announces no new ICD-10-CM codes effective April 1, 2025. The April 1, 2025, diagnosis code update files, which address revisions and typographical errors, are now available. Use these files for discharges occurring from April 1, 2025, to September 30, 2025, and for patient encounters occurring from April 1, 2025, to September 30, 2025...Two months after delaying the expiration of COVID-era telehealth prescribing rules, the Drug Enforcement Administration (DEA) has released a regulatory framework to keep these rules in place permanently. During the COVID-19 pandemic, flexibilities were introduced to allow providers to prescribe controlled substances such as Adderall, benzodiazepines, sleep medications, and certain painkillers via telehealth visits. Prior to COVID, prescribing controlled substances required an in-person visit, along with additional limitations. The new rule authorizes the prescription of controlled substances classified up to Schedule II without the need for an in-person visit. The DEA is also adding buprenorphine to the list of approved substances, a drug that is gaining popularity as a less addictive alternative to opioids. It is also used to treat opioid addiction. The framework was published in the Federal Register on Jan. 17 and will become effective 30 days later...Claims adjudication costs healthcare providers more than $25.7 billion, according to a new national survey of hospitals, health systems and post-acute care providers conducted by Premier, Inc. This figure represents a 23 percent increase over the $19.7 billion in costs reported in the previous year. Claims move into the adjudication process after payers issue an initial denial on the submission. While denial rates remained consistent at nearly 15 percent, according to survey data, they ranged as high as 49 percent in certain instances. In addition, the administrative costs associated with fighting them increased dramatically – from $43.84 per claim in 2022 to $57.23 in 2023. Additional costs primarily resulted from added labor, responsible for 90 percent of claims processing expenses incurred by providers...The U.S. Department of Justice (DOJ) is investigating potential illegal activity at UnitedHealth Group, related to the insurer’s billing practices (again), according to a report published Friday by the Wall Street Journal.Per the outlet, UnitedHealth is being probed for upcoding Medicare Advantage claims. Specifically, the DOJ is looking into whether the insurer is responsible for billing the Centers for Medicare & Medicaid Services (CMS) for patient diagnoses not applicable to the actual care (color me shocked) in an effort to boost monthly payments ("PMPM") received through the program. The Wall Street Journal cites sources familiar with the case for its coverage. According to reporters, the DOJ has spoken with providers about the alleged upcoding, which could have led to the insurer pocketing billions of extra reimbursement dollars. The Wall Street Journal also reported that the Department of Health and Human Services Office of Inspector General (OIG) is supporting the DOJ investigation. However, neither agency has released a statement. UnitedHealth quickly responded, issuing its own statement Friday morning, calling the claims made by the Wall Street Journal "misinformation" and adding that the outlet has a history of misleading the public about the Medicare Advantage program...According to Drug Channels, for 2025, 40% of the plans in 39 states have copay accumulators—although you may not be able to figure it out. That is because plans mostly do not list the accumulators on web sites, according to a report by the AIDS Institute.
