Pharmacy Benefit Managers (PBMs) Under Fire in Washington

For years lawmakers have aimed criticism at pharmaceutical companies for the increasing costs of medications in the United States. However, the cost of prescriptions lies in the lap of three of the largest pharmacy benefit managers (PBMs), OptumRx, Caremark, and Express Scripts. These PBMs also happen to be owned by large health organizations including CVS Health, UnitedHealth Group, and Cigna.

A bipartisan effort from Congress has proposed that PBMs reimburse pharmacies that serve Medicaid patients based on an authorized price list and not the current standards PBMs currently use. The Congressional Budget Office (CBO) expects $1 billion in savings over the next 10 years with these new regulations. However, PBMs have been skilled in finding ways around regulations over the past several years and the negotiations they have with manufacturers and insurers are proprietary, leaving lawmakers looking at antitrust laws to help level the playing field.

Source: Kaiser Family Foundation

Privacy and Security Complaints Prompt Creation of New Divisions at HHS

An increase in complaints about health information privacy and security has caused the Department of Health and Human Services (HHS) to create a new office through the Office for Civil Rights (OCR), which also oversees HIPAA and the Health Information Technology for Economic Clinical Health Act. There will be three new divisions within the OCR that will focus on Enforcement, Policy, and Strategic Planning. The caseload for complaints has risen 69% since 2017. The former Health Information Privacy (HIP) division will now be known as the Health Information Privacy, Data, and Cybersecurity (HIPDC) division.

The HIPDC will help provide a more collaborative approach to managing cases between policy, enforcement, and investigations. A focus on data analytics and coordinating data collection across HHS will also be a part of this renewed effort.

Source: JDSupra.com

Telehealth Prescriptions for Controlled Substances Extended

The Covid-19 public health emergency allowed healthcare providers to prescribe controlled substances through telehealth appointments. Providers and patients who utilize telehealth were concerned that as the emergency order expired this month, patients would be left with a gap in their healthcare, especially those in treatment for opioid use.

Patient and provider relationships set up through telehealth before November 11, 2023, will be allowed under more flexible rules, to continue care through November 11, 2024. Healthcare providers have applauded the extension which they say will prevent barriers to care. Stricter rules for prescribing controlled substances were enacted in 2008 to prevent patients from receiving a prescription without an in-person visit. The DEA is still reviewing processes for the future, but for now, those utilizing telehealth for prescriptions will be able to continue care.

Source: Fierce Healthcare

FDA Encourages Regulation of Chat GPT Models for Healthcare

Artificial intelligence is changing many industries, healthcare included. The Commissioner of the Food and Drug Administration (FDA), Robert Califf, is warning leaders that regulation of AI is essential before its use crosses into areas that are murky for patients and privacy.

Califf is the former head of medical strategy at Alphabet (Google’s parent company) and while he has concerns about AI use, he sees great potential as well. AI has the potential to create efficiencies in healthcare, especially as it relates to data analysis for clinical trials.

Source: Healthcare Dive

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