The healthcare clinics operate in a world of constant change. Every quarter comes new HCPCS codes for drugs, biologics, and radiopharmaceuticals. Annually in January, CMS often tightens Part B rules under LCD A56124 and each September, the AMA revises the CPT with hundreds of code edits. On top of that, pharmacies juggle vaccine code rollouts every Spring, Summer, and Fall.

To thrive, billing teams must learn fast. They must adapt to the latest technologies. They must train staff. And they must build processes that turn regulatory upheaval into a competitive edge. Hence, to solve this ever-lasting issue, the specialty pharmacy billing services come in who help with creating an accurate billing process to make sure no claim denial occurs. So, before diving into how they help with the billing process, let’s understand the latest pharmacy billing regulations.

What are the Latest Regulations in Specialty Pharmacy?

Medicare Part B Pharmacy Billing (LCD A56124)

Effective January 1, 2025, Medicare enforces two specialty provider codes for Part B pharmacy billing. Code 73 covers only influenza and pneumococcal vaccines and their administration. Code A5 applies to other medical‑benefit drugs but limits scope strictly to pharmacy dispensing under Part B. Specialty pharmacies must enroll NPIs under the correct code in PECOS before claims go live. Failure to do so risks automatic denials and manual reviews.

These changes aim to curb improper billing and ensure accurate program integrity. Pharmacies that were previously billed under general codes now face scrutiny. They must review every NPI specialty designation. Billing teams run enrollment reports weekly. They verify that each dose‑based claim uses the right specialty code. This front‑end work slashes downstream rework and denial rates.

HCPCS Level II Coding Updates for Drugs & Biologicals

CMS updates HCPCS Level II codes four times a year. These cycles matter most to specialty pharmacies that bill high‑cost injectables and biologics. On April 2, 2025, CMS published the Q1 2025 HCPCS Application Summaries and Coding Determinations. This release established permanent codes for new drugs and biologics, including updated descriptors and dosage units for agents like bupivacaine with epinephrine.

Under the OPPS/ASC final rule, Addendum B for January 1, 2025, CMS introduced 50 new HCPCS codes for drugs, biologics, and radiopharmaceuticals. These additions cover novel monoclonal antibodies, enzyme therapies, and gene‑therapy products. Pharmacies must load Addendum B into their billing platforms on Day 1 to capture correct payment rates under OPPS.

The Q2 2025 cycle arrived on April 1, 2025, via a CMS manual transmittal that added 31 more drug and biologic codes while retiring 12 older ones as of March 31, 2025. This wave included cutting‑edge gene‑therapy infusion codes and specialty injectable descriptors. Billing teams schedule an April 1 system refresh. They flag retired codes to prevent post‑March 31 claims.

AMA CPT Code‑Set Updates

In September 2024, the AMA released the CPT 2025 code set, comprising 420 total updates, which are 270 new codes, 112 deletions, and 38 revisions. This overhaul expands laboratory analyses and emerging procedure codes but also touches vaccine and biologic administration entries vital to specialty pharmacy billing. The billing teams highlight pharmacy‑relevant changes first to streamline staff training to make sure no claim gets denied.

Among the new immunization codes, 90593 covers the Chikungunya virus vaccine (recombinant, IM) and takes effect January 1, 2025, following its February 14, 2025, FDA approval. Meanwhile, 90684 for the 21‑valent pneumococcal conjugate vaccine (PCV21) went live on June 17, 2024, and entered the 2025 CPT book for billing purposes.

To stay updated, the billing teams track AMA’s triannual immunization code releases on April 1, July 1, and October 1. These interim updates capture FDA approvals in real time, preventing billing delays for new vaccines or immunoglobulins.

How Specialty Pharmacy Billing Services Combat Regulatory Changes?

Specialty pharmacy billing teams have dedicated experts who convert regulatory turmoil into operational strength. There are several ways in which they help, such as:

• Automated Code Monitoring: They always get updated with the CMS and AMA RSS feeds. They monitor changes to J‑, Q‑, and CPT codes to make sure no claim denial occurs. They mark all effective dates, January 1, April 1, July 1, October 1, to check the latest HCPCS level II codes to make sure no claim denial occurs.
• Helping with Prior Authorization: Prior authorization is a difficult process to manage for the healthcare staff, as they have other important tasks to do. That’s where the specialty pharmacy billing services come in, which provide dedicated experts. These experienced personnel verify patient eligibility, collect important patient documents, and then submit a PA request to make sure no claim denial occurs.
• They are Highly Cost-effective: The in-house billing team incurs a lot of cost. It’s because you need to train them and also buy expensive office space for them. On the contrary, the outsourced experts are previously trained, and they don’t require any separate office space. Hence, it leads to an 80% cost reduction for the clinics.

Healthcare regulations are continuously changing, which is why it’s becoming difficult for the healthcare staff to comply with the updated regulations as they have other important tasks to perform. That is where the specialty pharmacy billing services come into the picture. These experts stay updated with the latest billing and coding regulations. Apart from that, they also provide help with prior authorization to make sure no claim denial occurs. Another reason for choosing them is that they come at 80% less cost compared to the in-house team. Hence, if you want to streamline your billing process, you may consider outsourcing to a third-party expert.