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Today’s topic is the The Federal NOPAIN Act.

The Federal “Non-Opioids Prevent Addiction In the Nation Act” (or, the “NOPAIN Act”), Senate bill S.586, was signed into law in December 2022. It takes effect this coming January as part of the Centers for Medicare and Medicaid Services 2025 OPPS proposed rule.

The NOPAIN Act directs CMS to reimburse hospital and surgical centers separately for non-opioid, post-surgical pain control, in hopes of reducing or replacing opioid consumption. By separating, or “unbundling,” payment for non-opioid pain control, hospitals and surgical centers may receive additional reimbursement for non-opioid alternatives, encouraging the use of substitute means of pain control. This helps to ensure that non-opioid options are more widely available to individuals as a post-surgical treatment option.

You can download the full Executive Briefing at: https://tkgpact.com/executive-briefings/

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The High-Value Pharmacy Enterprise Framework.

The High-Value Pharmacy Enterprise Framework is a collection of evidence-based and expert recommended best practices designed to enhance health system pharmacy operations by ensuring safe, effective, and patient-centered medication management throughout the health-system pharmacy enterprise. It is gaining in popularity due to the many patient safety, operational, and cost efficiencies it brings to health systems that embrace the model.

The HVPE framework is built around 8 Domains of essential pharmacy practice elements that are established best practices for health-system pharmacies. The framework contains a total of 94 operational statements and 336 performance measures within these 8 domains.

You can download the full Executive Briefing at: https://tkgpact.com/executive-briefings/

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Introduction to Targeted Therapies: Monoclonal Antibodies

Targeted Therapy is the foundation of Precision Medicine. Targeted therapy is a type of personalized treatment that targets specific proteins that control how cells grow, divide, and spread.

Antibodies are produced naturally by our body and help the immune system recognize cells that cause disease, such as bacteria and viruses, and mark them for destruction. Antibodies can be engineered in the laboratory to find and attach themselves to specific targets, called antigens, found on cancer cells. They are made to recognize and bind only to a very specific antigen target.

This week's episode highlights three important terms you may be hearing: Antibody-Drug Conjugates, Monoclonal Antibodies, and Bispecific Antibodies.

You can download the full Executive Briefing at: https://tkgpact.com/executive-briefings/

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All 50 states now allow pharmacists and physicians to enter into Collaborative Practice Agreements (CPAs) in which one or more pharmacists establish a formal relationship with a prescriber, in which the prescriber can delegate specific tasks to a pharmacist under negotiated conditions, which would not otherwise be permitted under the pharmacist’s normal scope of practice

Although state laws vary, generally, CPAs allow prescribers to delegate specific patient care tasks to pharmacists. The pharmacist’s scope of practice under a CPA is generally defined by established protocols that are condition or disease specific. For example, under a CPA, pharmacists many be empowered to perform patient assessments, order laboratory tests, prescribe drugs, counsel patients, and make referrals for related care. They may also be permitted to select, initiate, monitor, continue, discontinue, adjust, and refill therapy regimens.

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When a physician prescribes an expensive specialty medication for a patient, the traditional distribution process was for the provider to purchase the medication, administer it to the patient, and then bill the insurance company for the drug. This “buy-and-bill” process has been utilized for many years.

In recent years, and to help control costs, third-party payers have mandated that the medications come from their own pharmacies where they have more control over the acquisition price of the drugs. This is especially prevalent for expensive, specialty pharmaceuticals.

Various alternatives of this approach have been referred to as “bagging”. In this episode, we define the different types of "bagging" that you may be hearing about.

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Laboratory Benefit Managers have emerged over the past decade to fill the need to manage complex and expensive laboratory testing for payers. They have become the new Precision Medicine Gatekeepers.

Results from over 14 billion diagnostic tests are estimated to influence 70% of today’s clinical decisions. It’s estimated that there is both overutilization of testing in approximately 20% of cases, and underutilization of testing in approximately 45% of cases. Laboratory Benefit Managers have improved Next Generation Sequencing test payment turnaround times, but also have increased denial rates.

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The term therapeutic inertia describes the failure of health care providers to initiate or intensify therapy when it is clearly indicated by established guidelines. The term has largely been applied to the management of blood pressure, blood sugar, and cholesterol, by primary care physicians who recognize the need for their patients to control these conditions but fail to act sufficiently to achieve the guideline recommended therapeutic targets. Despite clearly articulated, evidence-based, clinical guidelines, some physicians fail to translate this knowledge into practice. We believe that therapeutic inertia plays a significant role in delaying the adoption of many new treatments.

Most practitioners function within a “personal comfort zone” of prescribing behavior, being reluctant to take unnecessary risks with new drugs. There is a natural “learning curve,” where clinicians need to learn the side effect profiles and characteristics of new drugs, as well as to be assured that the drugs perform as promised.

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Since 2016, 13 states have passed Drug Price Transparency Laws focused on enabling state policymakers to understand opaque drug pricing and payment systems to formulate policy solutions to high prices, while also creating the data infrastructure to realize those policy solutions.

Most of these state programs require reporting from manufacturers when they increase the Wholesale Acquisition Cost (WAC) of a drug above a certain threshold or if they introduce a drug with a high launch price.

Since 2020, 8 states have enacted Prescription Drug Affordability Boards often referred to as P-DABs, entities with the authority to review high cost drugs and in some states set an upper payment limit to ensure no one pays more than that amount in the state.

You can download the full Executive Briefing at: https://tkgpact.com/executive-briefings/

Or, feel free to email us at Insights@thekinetixgroup.com