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www.kslaw.comPharmaceutical Government Pricing and Compliance
King & Spalding’s
healthcare, life
sciences, and food
and beverage
practices are all
recognized as
leading national
practices by
Chambers USA.
Pharmaceutical Government
Pricing and Compliance
King & Spalding has a nationally recognized practice in the highly specialized
field of pharmaceutical and biopharmaceutical government price calculation
and reporting. Our intimate knowledge of, and extensive experience with,
federal and state pharmaceutical pricing regimes allow us to assist with every
type of government price calculation and report, including day-to-day
counseling, managed markets and government contracting, pricing risk
assessment and review, strategic planning, merger integration, internal
investigations, legislative and regulatory initiatives, civil litigation and defense
in government investigations. Our attorneys are recognized as thought
leaders in the field, frequently speak at pricing conferences and symposia,
and continuously update the pharmaceutical and biotechnology industries on
legislative, regulatory and subregulatory change.
We counsel dozens of pharmaceutical and biotechnology manufacturers with
respect to their rights and obligations under Medicaid, Medicare Parts B and
D, the Federal Supply Schedule Program, the 340B Drug Pricing Program,
the TRICARE Retail Pharmacy Program, state-specific pricing and
supplemental rebate regimes, and related programs. This broad industry
experience allows us to counsel manufacturers not only with regard to the
letter of the law, but also about the state of the industry and each client’s
place along the continuum of compliance.
King & Spalding’s price reporting team is fully integrated into the Firm’s life
sciences practice, allowing us to bring 360º service to our pharma and biotech
clients. The firm currently represents more than 75 pharmaceutical and
biotechnology manufacturers, including eight of the top 10 innovator
manufacturers in the world. Our lawyers work together across all practice
groups—one area of expertise informing another—to provide our clients with
cost-effective, informed and strategic counsel based on thorough knowledge of
the pharmaceutical and biotechnology industries and governing laws. We also
work closely with our coverage, coding and reimbursement experts to ensure
that product launches and pricing changes are implemented in a coordinated
way to maximize market and reimbursement benefits while navigating price
reporting and rebate impacts. This coordination is essential to helping our
clients identify and consider future risks and preserve strategic options across
the full spectrum of their business activities.
220320151123715383In some jurisdictions, this may be considered “Attorney Advertising.”
Contacts
John Shakow
+1 202 626 5523
jshakow@kslaw.com
David Farber
+1 202 626 2941
dfarber@kslaw.com
Preeya Pinto
+1 202 626 5547
ppinto@kslaw.com
Liz Lindquist
+1 202 626 5585
elindquist@kslaw.com
Anne Allen
+1 212 556 2284
aallen@kslaw.com
Representative Experience
•	Creatively assist clients in resolving commercial and organizational challenges
while maintaining the integrity of their price reporting compliance efforts.
•	Manage comprehensive assessments and audits of pharmaceutical
manufacturers government price reporting and calculation practices involving
all price types and pricing issues.
•	Analyze commercial contracting and discounting arrangements to determine
their impact on drug price reporting obligations and any potential fraud and
abuse enforcement risk posed by such arrangements.
•	Provide informed expertise regarding coming to market and portfolio
management, bona fide service fee analysis, complex bundling identification and
allocation, class of trade assignment and inclusion/exclusion determinations, all
aspects of 340B compliance and other complex regulatory requirements related
to pricing and price reporting.
•	Recalculate and reconcile historic pharmaceutical pricing, including coordination
with and among affected government programs.
•	Assist in the development and implementation of government price calculation
and reporting policies, procedures, systems and methodologies, including the
development of prudent and defensible reasonable assumptions.
•	Counsel clients in all aspects of Department of Veterans Affairs Federal Supply
Schedule Program contracting and contract compliance.
•	Support clients in interactions with the Centers for Medicare & Medicaid
Services, the Health Resources and Services Administration, the Department
of Health and Human Services Office of Inspector General, the Department
of Veterans Affairs Federal Supply Schedule Service and Office of Inspector
General, and the Department of Justice.
•	Aid in implementation of new statutory and regulatory requirements, including
the preparation of comments to proposed rules and the creation or review of
related policies and procedures.
•	Provide litigation and investigation experience in the pharmaceutical pricing
area, including:
•	Authored PhRMA amicus briefs in the Santa Clara Supreme Court
340B case.
•	Counseled drug manufacturers before the House Energy & Commerce and
Senate Finance committees in drug pricing investigations and inquiries.
•	Represented a major pharmaceutical manufacturer in the nationwide
AWP litigation.
•	Represented several manufacturers in the Streck service fee litigation.
•	Assist manufacturers in navigating the Medicare Part D Coverage Gap
Discount Program, NADAC and the AAC methodologies currently being
adopted by state Medicaid programs.
•	Provide legislative and regulatory advocacy and influence on government price
calculation and reporting issues.
•	Develop and present timely and appropriately focused price reporting training
to all levels of management and operations.

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PharmaGovPricingCompliance

  • 1. www.kslaw.comPharmaceutical Government Pricing and Compliance King & Spalding’s healthcare, life sciences, and food and beverage practices are all recognized as leading national practices by Chambers USA. Pharmaceutical Government Pricing and Compliance King & Spalding has a nationally recognized practice in the highly specialized field of pharmaceutical and biopharmaceutical government price calculation and reporting. Our intimate knowledge of, and extensive experience with, federal and state pharmaceutical pricing regimes allow us to assist with every type of government price calculation and report, including day-to-day counseling, managed markets and government contracting, pricing risk assessment and review, strategic planning, merger integration, internal investigations, legislative and regulatory initiatives, civil litigation and defense in government investigations. Our attorneys are recognized as thought leaders in the field, frequently speak at pricing conferences and symposia, and continuously update the pharmaceutical and biotechnology industries on legislative, regulatory and subregulatory change. We counsel dozens of pharmaceutical and biotechnology manufacturers with respect to their rights and obligations under Medicaid, Medicare Parts B and D, the Federal Supply Schedule Program, the 340B Drug Pricing Program, the TRICARE Retail Pharmacy Program, state-specific pricing and supplemental rebate regimes, and related programs. This broad industry experience allows us to counsel manufacturers not only with regard to the letter of the law, but also about the state of the industry and each client’s place along the continuum of compliance. King & Spalding’s price reporting team is fully integrated into the Firm’s life sciences practice, allowing us to bring 360º service to our pharma and biotech clients. The firm currently represents more than 75 pharmaceutical and biotechnology manufacturers, including eight of the top 10 innovator manufacturers in the world. Our lawyers work together across all practice groups—one area of expertise informing another—to provide our clients with cost-effective, informed and strategic counsel based on thorough knowledge of the pharmaceutical and biotechnology industries and governing laws. We also work closely with our coverage, coding and reimbursement experts to ensure that product launches and pricing changes are implemented in a coordinated way to maximize market and reimbursement benefits while navigating price reporting and rebate impacts. This coordination is essential to helping our clients identify and consider future risks and preserve strategic options across the full spectrum of their business activities.
  • 2. 220320151123715383In some jurisdictions, this may be considered “Attorney Advertising.” Contacts John Shakow +1 202 626 5523 jshakow@kslaw.com David Farber +1 202 626 2941 dfarber@kslaw.com Preeya Pinto +1 202 626 5547 ppinto@kslaw.com Liz Lindquist +1 202 626 5585 elindquist@kslaw.com Anne Allen +1 212 556 2284 aallen@kslaw.com Representative Experience • Creatively assist clients in resolving commercial and organizational challenges while maintaining the integrity of their price reporting compliance efforts. • Manage comprehensive assessments and audits of pharmaceutical manufacturers government price reporting and calculation practices involving all price types and pricing issues. • Analyze commercial contracting and discounting arrangements to determine their impact on drug price reporting obligations and any potential fraud and abuse enforcement risk posed by such arrangements. • Provide informed expertise regarding coming to market and portfolio management, bona fide service fee analysis, complex bundling identification and allocation, class of trade assignment and inclusion/exclusion determinations, all aspects of 340B compliance and other complex regulatory requirements related to pricing and price reporting. • Recalculate and reconcile historic pharmaceutical pricing, including coordination with and among affected government programs. • Assist in the development and implementation of government price calculation and reporting policies, procedures, systems and methodologies, including the development of prudent and defensible reasonable assumptions. • Counsel clients in all aspects of Department of Veterans Affairs Federal Supply Schedule Program contracting and contract compliance. • Support clients in interactions with the Centers for Medicare & Medicaid Services, the Health Resources and Services Administration, the Department of Health and Human Services Office of Inspector General, the Department of Veterans Affairs Federal Supply Schedule Service and Office of Inspector General, and the Department of Justice. • Aid in implementation of new statutory and regulatory requirements, including the preparation of comments to proposed rules and the creation or review of related policies and procedures. • Provide litigation and investigation experience in the pharmaceutical pricing area, including: • Authored PhRMA amicus briefs in the Santa Clara Supreme Court 340B case. • Counseled drug manufacturers before the House Energy & Commerce and Senate Finance committees in drug pricing investigations and inquiries. • Represented a major pharmaceutical manufacturer in the nationwide AWP litigation. • Represented several manufacturers in the Streck service fee litigation. • Assist manufacturers in navigating the Medicare Part D Coverage Gap Discount Program, NADAC and the AAC methodologies currently being adopted by state Medicaid programs. • Provide legislative and regulatory advocacy and influence on government price calculation and reporting issues. • Develop and present timely and appropriately focused price reporting training to all levels of management and operations.