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Pacira's Exparel Receives Permanent New Product-Specific J-Code
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Pacira BioSciences (PCRX - Free Report) announced that the Centers for Medicare and Medicaid Services (CMS) has issued a permanent product-specific J-code (J0666) for its lead pain-management drug, Exparel (bupivacaine liposome injectable suspension), to facilitate better insurance coverage for the drug. This new J-code will take effect on Jan. 1, 2025, replacing the existing C-code (C9290), which has been in use since 2019.
Please note that J-codes are reimbursement codes used by insurance companies, including Medicare and government payers, for Medicare Part B drugs like Exparel. They help standardize and simplify the billing and payment process. Some insurers also require a J-code for processing payments.
Exparel is Pacira’s flagship pain-management product, which was launched in 2012. The drug is indicated for postsurgical local analgesia in patients aged six years and older. It is also indicated for regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa and femoral nerve block in the adductor canal.
Year to date, shares of Pacira have plunged 52.9% compared with the industry’s 2.6% decline.
Image Source: Zacks Investment Research
The news follows an earlier announcement made by Pacira in July when the CMS proposed the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System rule for 2025. Per this rule, Exparel is among six non-opioid pain treatments, out of which two are specific to ophthalmology, eligible for separate Medicare reimbursement in both ambulatory surgical centers (ASC) and hospital outpatient (HOPD) settings. This policy is set to take effect on Jan. 1, 2025.
The proposed rule is part of the implementation of the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which requires separate CMS payments for qualifying non-opioid drugs and devices in HOPD and ASC settings. Now, with the assignment of the new J-code, patients will also be eligible to receive reimbursement when Exparel is used in the office setting and for office-based surgeries.
Per management, the introduction of a product-specific J-code for Exparel will simplify the reimbursement process while increasing recognition and coverage by commercial payers, who make up a growing share of the drug’s patient base. Combined with upcoming reimbursement from NOPAIN, this change is viewed as crucial in expanding clinician access to Exparel across different care settings and payer types, enhancing the ability to provide long-lasting, non-opioid pain control and facilitating the shift to outpatient procedures.
Exparel – The Primary Growth Driver for PCRX
Exparel is the major contributor to Pacira’s revenues. It has been witnessing strong demand, primarily driven bygrowth within existing accounts, along with increasing acceptance by major hospitals and orthopedic centers, as it continues to be used in orthopedic procedures. It is also ticking the interest among oral and maxillofacial surgeons, fueled by a partnership announced in September 2022 between Pacira and Sevaredent to provide expanded access to Exparel for patients undergoing oral and maxillofacial procedures.
In the first half of 2024, the drug generated revenues worth $269.3 million, representing a year-over-year growth rate of 1.4%.
Pacira is also looking to further expand Exparel’s label to treat younger age groups. During the first quarter of 2024, the company initiated an early-stage pharmacokinetic study of Exparel as a single-dose post-surgical infiltration administration in patients under six years of age.
Subject to the success of this study, Pacira plans to initiate a phase III registration study to support regulatory filings seeking label expansions in the United States and EU. Potential approval will further boost sales by increasing its patient eligibility criteria.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 3%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $1.91 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have soared 41.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from 46 cents to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.67 to $1.14. Year to date, shares of FULC have plunged 45.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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Pacira's Exparel Receives Permanent New Product-Specific J-Code
Pacira BioSciences (PCRX - Free Report) announced that the Centers for Medicare and Medicaid Services (CMS) has issued a permanent product-specific J-code (J0666) for its lead pain-management drug, Exparel (bupivacaine liposome injectable suspension), to facilitate better insurance coverage for the drug. This new J-code will take effect on Jan. 1, 2025, replacing the existing C-code (C9290), which has been in use since 2019.
Please note that J-codes are reimbursement codes used by insurance companies, including Medicare and government payers, for Medicare Part B drugs like Exparel. They help standardize and simplify the billing and payment process. Some insurers also require a J-code for processing payments.
Exparel is Pacira’s flagship pain-management product, which was launched in 2012. The drug is indicated for postsurgical local analgesia in patients aged six years and older. It is also indicated for regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa and femoral nerve block in the adductor canal.
Year to date, shares of Pacira have plunged 52.9% compared with the industry’s 2.6% decline.
Image Source: Zacks Investment Research
The news follows an earlier announcement made by Pacira in July when the CMS proposed the Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System rule for 2025. Per this rule, Exparel is among six non-opioid pain treatments, out of which two are specific to ophthalmology, eligible for separate Medicare reimbursement in both ambulatory surgical centers (ASC) and hospital outpatient (HOPD) settings. This policy is set to take effect on Jan. 1, 2025.
The proposed rule is part of the implementation of the Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act, which requires separate CMS payments for qualifying non-opioid drugs and devices in HOPD and ASC settings. Now, with the assignment of the new J-code, patients will also be eligible to receive reimbursement when Exparel is used in the office setting and for office-based surgeries.
Per management, the introduction of a product-specific J-code for Exparel will simplify the reimbursement process while increasing recognition and coverage by commercial payers, who make up a growing share of the drug’s patient base. Combined with upcoming reimbursement from NOPAIN, this change is viewed as crucial in expanding clinician access to Exparel across different care settings and payer types, enhancing the ability to provide long-lasting, non-opioid pain control and facilitating the shift to outpatient procedures.
Exparel – The Primary Growth Driver for PCRX
Exparel is the major contributor to Pacira’s revenues. It has been witnessing strong demand, primarily driven bygrowth within existing accounts, along with increasing acceptance by major hospitals and orthopedic centers, as it continues to be used in orthopedic procedures. It is also ticking the interest among oral and maxillofacial surgeons, fueled by a partnership announced in September 2022 between Pacira and Sevaredent to provide expanded access to Exparel for patients undergoing oral and maxillofacial procedures.
In the first half of 2024, the drug generated revenues worth $269.3 million, representing a year-over-year growth rate of 1.4%.
Pacira is also looking to further expand Exparel’s label to treat younger age groups. During the first quarter of 2024, the company initiated an early-stage pharmacokinetic study of Exparel as a single-dose post-surgical infiltration administration in patients under six years of age.
Subject to the success of this study, Pacira plans to initiate a phase III registration study to support regulatory filings seeking label expansions in the United States and EU. Potential approval will further boost sales by increasing its patient eligibility criteria.
Pacira BioSciences, Inc. Price and Consensus
Pacira BioSciences, Inc. price-consensus-chart | Pacira BioSciences, Inc. Quote
PCRX’s Zacks Rank and Stocks to Consider
Pacira currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals (ANIP - Free Report) , Krystal Biotech, Inc. (KRYS - Free Report) and Fulcrum Therapeutics (FULC - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 3%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $1.91 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have soared 41.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from 46 cents to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.67 to $1.14. Year to date, shares of FULC have plunged 45.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.