Washington Healthcare Update - April 2023 #2

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This Week in Washington: CMS Releases Annual Payment Rules for Skilled Nursing Facilities, Hospice and Other Segments of Medicare

Congress

House

  • House Energy and Commerce Chair Questions SAMHSA on COVID-19 Spending and Action on Mental Illness

Senate

  • Senate Committee Chairmen Urge HHS to Allow Continued Medicare Coverage of COVID-19 At-Home Tests
  • Drug Price Transparency in Medicaid Act of 2023 Introduced

Administration

  • FDA Withdraws Approval of Makena
  • FDA Releases Draft Guidance Regarding Patient-Focused Drug Development
  • FDA Releases Draft Guidance Regarding Pharmaceutical Product Manufacturing Interruptions
  • FDA Adds Quinacrine Hydrochloride (HCL) to 503B Bulks List
  • FDA Grants Gohibic COVID-19 Treatment EUA
  • FDA Requests Information on Opioid Analgesics In-Home Disposal Systems
  • FDA Announces Opioid Analgesics Outpatient Mail-back Envelopes Requirement
  • NIH Releases National Cancer Plan

Proposed Rules

  • CMS Proposed Rule Updates Inpatient Psychiatric Facility (IPF) PPS Rates
  • CMS Proposed Rule Updates Skilled Nursing Facility PPS Rates
  • CMS Proposed Rule Updates Inpatient Rehabilitation Facility PPS Rates
  • CMS Releases Hospice Index, Payment Rate and Aggregate Cap Proposed Rule
  • FDA Proposes New Tobacco Product Manufacturing Practices Requirements
  • CMS Proposed Rule Revises Medicare DSH Section 1115 Waiver Calculation
  • CMS Proposes Rule to Clarify Changes to DSH Payment Calculations
  • ACF Proposes Rule to Revise Foster Family Home Definition
  • CMS Proposes Rule to Increase Nursing Home Transparency

Final Rules

  • CMS Finalizes Changes to Medicare Advantage, Part D, Cost Plan, and PACE Regulations
  • CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies
  • FDA Issues Final Rule Regarding Mammography Quality Standards
  • CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)
  • FDA Delays Tobacco Product Required Warning Final Rule Effective Date
  • CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

Reports

  • GAO Releases Report Regarding Coast Guard Healthcare

CBO Cost Estimates

  • CBO Releases Cost Estimate for H.R. 187, Default Prevention Act
  • CBO Releases Cost Estimate for S.113, Prescription Pricing for the People Act

House and Senate on Recess

House

House Energy and Commerce Chair Questions SAMHSA on COVID-19 Spending and Action on Mental Illness

On April 5, House Energy and Commerce Chairman Cathy McMorris Rodgers (R-WA), joined by Reps. Guthrie (R-KY) and Griffith (R-VA), sent a letter to the Substance Abuse and Mental Health Services Administration (SAMHSA) Administrator Dr. Miriam Delphin-Rittmon. The letter asked for information concerning:

  • SAMHSA’s supplemental COVID-19 funds and how they were used;
  • A 2021 outage of the 9-8-8 suicide hotline; and
  • The new Office of Recovery and how it will support mental illness treatment efforts.

For more information, click here.

Senate

Senate Committee Chairmen Urge HHS to Allow Continued Medicare Coverage of COVID-19 At-Home Tests

On April 4, Senate Finance Committee Chairman Ron Wyden (D-OR) and Senate Special Committee on Aging Chairman Bob Casey (D-PA) led 16 senators in sending a letter to Department of Health and Human Services (HHS) Secretary Xavier Becerra, urging HHS to continue allowing Medicare to cover the costs of rapid, at-home COVID-19 tests following the COVID-19 public health emergency (PHE) unwinding on May 11. The senators are concerned about the impact the loss of Medicare coverage for COVID-19 at-home tests would have on vulnerable populations such as seniors and people with disabilities.

The other senators who signed the letter include Democratic senators Blumenthal (CT), Warren (MA), Merkley (OR), Duckworth (IL), Reed (RI), Stabenow (MI), Whitehouse (RI), Cardin (MD), Menendez (NJ), Brown (OH), Smith (MN), Kaine (VA), Kelly (AZ) and Warner (VA). Sens. Sinema (I-AZ) and King (I-ME) also signed.

For more information, click here.

Drug Price Transparency in Medicaid Act of 2023 Introduced

On April 4, Sens. Marshall (R-KS) and Welch (D-VT) introduced the Drug Price Transparency in Medicaid Act of 2023. The bill would prohibit pharmacy benefit managers (PBMs) from using spread pricing. Spread pricing refers to a technique used by PBMs whereby PBMs charge Medicaid more than they pay pharmacies for a particular drug. The bill would also require Medicaid payments made to PBMs to go directly through pharmacies, and would require pharmacies participating in state Medicaid programs to report National Average Drug Acquisition Costs (NADAC), to ensure prescription drug price transparency. A companion bill was introduced by Reps. Carter (R-GA) and Gonzalez (D-TX) in the House.

For more information, click here.

Administration

FDA Withdraws Approval of Makena

On April 6, the Food and Drug Administration (FDA) withdrew the approval for Makena, a drug manufactured by Covis Pharma that is used to reduce the risk of preterm birth in women who have a history of spontaneous preterm birth. The drug had been granted accelerated approval in 2011, after the FDA reviewed intermediate clinical endpoint data and determined that the drug would likely have clinical benefits. The FDA had requested Covis Pharma to submit a post marketing confirmatory study but the study that was submitted did not show Makena having any verifiable clinical benefits.

For more information, click here.

FDA Releases Draft Guidance Regarding Patient-Focused Drug Development

On April 5, the Food and Drug Administration (FDA) released a draft guidance regarding patient-focused drug development. The draft guidance is the fourth guidance the FDA has issued on this topic and intends to keep patients, caregivers, researchers and medical product developers informed on how they can collect and submit patient experience data to be considered during the drug development and regulatory decision-making process. The draft guidance also outlines how stakeholders can improve their collection, identification and validation of clinical trial data.

For more information, click here.

FDA Releases Draft Guidance Regarding Pharmaceutical Product Manufacturing Interruptions

On April 5, the Food and Drug Administration (FDA) released a draft guidance for industry regarding the interruption and discontinuance of pharmaceutical product manufacturing. The draft guidance is intended to inform drug and biological product manufacturers on the steps they should take if they face an interruption in the manufacture of their products. The FDA is concerned about delays and shortage in the drug and biological product supply chains and is urging manufacturers to keep the FDA informed on any disruptions they face.

For more information, click here.

FDA Adds Quinacrine Hydrochloride (HCL) to 503B Bulks List

On April 5, the Food and Drug Administration (FDA) released a notice announcing that it had added quinacrine hydrochloride (HCL) to the 503B Bulks List. The 503B Bulks List outlines bulk drug substances that have been identified by the FDA as having significant clinical need. Outsourcing facilities that compound drug products using 503B Bulk List substances can qualify for certain Federal Food, Drug, and Cosmetic (FD&C) Act exemptions. The FDA notice also lists 10 bulk drug substances that the FDA chose not to include on the 503B Bulk List at this time.

For more information, click here.

FDA Grants Gohibic COVID-19 Treatment EUA

On April 4, the Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Gohibic, a vilobelimab injection used for the treatment of COVID-19. Gohibic is intended to be used in adults who were hospitalized for COVID-19 and receiving invasive mechanical ventilation or artificial life support in the previous 48 hours. The FDA decided to grant the EUA after reviewing clinical trial data that showed Gohibic lowering the risk of death among patients by day 28 and day 60 of treatment.

For more information, click here.

FDA Requests Information on Opioid Analgesics In-Home Disposal Systems

On April 3, the Food and Drug Administration (FDA) released a notice requesting information on in-home disposal systems for opioid analgesics. The FDA is seeking public feedback on whether in-home opioid analgesic disposal systems could feasibly help mitigate the risk of opioid nonmedical use or overdose if the FDA were to require drug manufacturers to make in-home disposal systems available to patients under a risk evaluation and mitigation strategy (REMS). Public feedback and comments will be discussed at the “Defining and Evaluating In-Home Disposal Systems for Opioid Analgesics” public workshop held by the National Academies of Sciences, Engineering and Medicine’s (NASEM’s) Forum on Drug Discovery, Development, and Translation on June 26 and 27. Public comments will be accepted until Aug. 28.

For more information, click here.

FDA Announces Opioid Analgesics Outpatient Mail-back Envelopes Requirement

On April 3, the Food and Drug Administration (FDA) announced that it would require manufacturers of opioid analgesics to offer prepaid mail-back envelopes to outpatient pharmacies and other facilities that dispense their products, to provide patients with an additional method of disposing of their unused opioid medications. Manufacturers will also be required to develop education materials to inform patients on how they can safely dispose of their opioid analgesics. The FDA has given all outpatient-setting opioid analgesics manufacturers 180 days to submit a modified Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) reflecting these requirements.

For more information, click here.

NIH Releases National Cancer Plan

On April 3, the National Institutes of Health (NIH) released a National Cancer Plan. The plan provides a framework for federal agencies and the private sector and explains how they can work together to prevent and reduce cancer deaths. The plan outlines eight strategic goals that the Department of Health and Human Services (HHS) and cancer community representatives have identified as being necessary for reducing the cancer death rate. The goals are:

  • Prevent Cancer;
  • Detect Cancers Early;
  • Develop Effective Treatments;
  • Eliminate Inequities;
  • Deliver Optimal Care;
  • Engage Every Person;
  • Maximize Data Utility; and
  • Optimize the Workforce.

For more information, click here.

Proposed Rules

CMS Proposed Rule Updates Inpatient Psychiatric Facility (IPF) PPS Rates

On April 4, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Inpatient Psychiatric Facility (IPF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the IPF Quality Reporting Program (QRP), for fiscal year (FY) 2024. The proposed rule would:

  • Result in a 1.9 percent (approximately $55 million) payment increase for IPFs in FY 2024, based on a 3.0 percent increase in the IPF PPS payment rate;
  • Adopt a 2021-based IPF market basket;
  • Update and increase the labor-related share (LRS) to 78.5 percent;
  • Make it easier for hospitals to open new IPF units, by allowing them to open new units at any time during the cost reporting period, so long as they notify their CMS Regional Office and Medicare Administrative Contractor within 30 days; and
  • Make changes to the IPF QRP measures.

Public comments will be accepted until June 5, 2023. For more information, click here.

CMS Proposed Rule Updates Skilled Nursing Facility PPS Rates

On April 4, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Skilled Nursing Facility (SNF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the SNF Quality Reporting Program (QRP) and SNF Value-Based Purchasing (VBP) Program, for fiscal year (FY) 2024. The proposed rule would:

  • Result in a 3.7 percent (approximately $1.2 billion) Medicare Part A payment increase for SNFs in FY 2024, based on a 2.7 percent market basket update; a 3.6 percent increase in the market basket forecast error adjustment; a 0.2 percent decrease in the productivity adjustment; and a 2.3 percent decrease in the FY 2024 SNF PPS rates; and
  • Make multiple changes to the SNF QRP measures.

Public comments will be accepted until June 5, 2023. For more information, click here.

CMS Proposed Rule Updates Inpatient Rehabilitation Facility PPS Rates

On April 3, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would update the Inpatient Rehabilitation Facility (IRF) Prospective Payment System’s (PPS) Medicare payment policies and rates, as well as the IRF Quality Reporting Program (QRP), for fiscal year (FY) 2024. The proposed rule would:

  • Result in a 3.0 percent payment increase for IRFs, based on the proposed market basket update of 3.2 percent minus the 0.2 percentage point productivity adjustment;
  • Increase IRF outlier payments by 0.7 percent;
  • Make it easier for hospitals to open IRF units by allowing them to immediately start billing under the IRS PPS at any time during the cost reporting period, so long as they notify the CMS Regional Office and Medicare Administrative Contractor in writing within 30 days; and
  • Make changes to the IRF QRP measures.

Public comments will be accepted until June 2, 2023. For more information, click here.

CMS Releases Hospice Index, Payment Rate and Aggregate Cap Proposed Rule

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would make changes to hospice wage index rates, payment rates and aggregate cap amounts for fiscal year (FY) 2024. The proposed rule intends to inform patients and caregivers on hospice utilization trends, hospice center ownership information and Medicare hospice and non-hospice spending amounts. The proposed rule will:

  • Codify the Hospice Quality Reporting Program (HQRP) data completion threshold policy;
  • Provide an update on future Quality Measures (QM) development and health equity efforts;
  • Provide an update on the Consumer Assessment of Healthcare Providers and Systems, Hospice Survey Mode Experiment; and
  • Require physicians who order or certify hospice services for Medicare beneficiaries to be enrolled in Medicare or validly opted-out.

Public comments will be accepted until May 30, 2023. For more information, click here.

FDA Proposes New Tobacco Product Manufacturing Practices Requirements

On March 8, the Food and Drug Administration (FDA) released a proposed rule that would improve the manufacture, design, packing and storage of tobacco products. The proposed rule seeks to ensure that tobacco products comply with the Federal Food, Drug, and Cosmetic (FD&C) Act. The FDA has noted that it will help minimize and prevent tobacco product contamination, as well as inconsistencies in e-cigarette liquid concentrations and labeling. The proposed rule will also:

  • Establish tobacco product design and development controls;
  • Ensure that tobacco products meet established specifications;
  • Crack down on tobacco products that do not meet specifications;
  • Require manufacturers to take action in cases of product contamination;
  • Require investigations of products that do not meet specifications; and
  • Establish the ability to trace all components, ingredients, additives and materials used by tobacco product manufacturers.

Public comments will be accepted until Sept. 6, 2023. For more information, click here.

CMS Proposed Rule Revises Medicare DSH Section 1115 Waiver Calculation

On Feb. 28, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would change how it defines Medicaid-eligible patients who can be included in Medicare disproportionate share hospital (DSH) payment calculations. CMS is proposing to do this by limiting the types of Medicaid Section 1115 waiver days that can be used by hospitals when calculating their disproportionate patient percentage (DPP) Medicaid fraction. CMS is proposing to allow hospitals to only count Section 1115 waiver days for patients who received a health insurance plan directly from a Section 1115 demonstration, that covers inpatient hospital services or who received, with the help of Section 1115 demonstration premium assistance, a health insurance plan that covers 100 percent of the patient’s premium costs.

Public comments will be accepted until May 1, 2023. For more information, click here.

CMS Proposes Rule to Clarify Changes to DSH Payment Calculations

On Feb. 24, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would clarify changes made to the Medicaid disproportionate share hospital (DSH) payment limit calculation by the Consolidated Appropriations Act of 2021. The proposed rule is intended to give states and hospitals a better understanding of how the limit is calculated. It also outlines technical and administrative changes CMS made recently to the DSH program.

Public comments will be accepted until April 25, 2023. For more information, click here.

ACF Proposes Rule to Revise Foster Family Home Definition

On Feb. 14, the Department of Health and Human Services (HHS) Administration for Children and Families (ACF) released a proposed rule that would revise the current definition of “foster family home” and allow Title IV-E agencies to adopt foster family home licensing and approval standards for foster family homes of individuals related to children by “kin” (blood, marriage or adoption). Title IV-E agencies would also be allowed to adopt licensing and approval standards for individuals related by emotionally significant relationships. The proposed rule would also allow Title IV-E agencies to claim federal financial participation (FFM) for the costs of foster care maintenance payments (FCMP) and would make changes to the requirement that Title IV-E agencies review FCMP amounts to ensure that children placed in “kin” foster homes receive the same FCMP as those in non-kin foster family homes.

Public comments will be accepted until April 17, 2023. For more information, click here.

CMS Proposes Rule to Increase Nursing Home Transparency

On Feb. 15, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that seeks to increase the transparency of nursing home facility information. The proposed rule would require Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities to disclose the following information:

  • Names, titles and period of service for every member of the nursing home facility’s governing body;
  • Names, titles and period of service for the nursing home facility’s officer, director, member, partner, trustee and managing employee;
  • Names, titles and period of service for any additional disclosable parties of the nursing home facility; and
  • A description of the relationship the additional disclosable parties have with the nursing home facility and other disclosable parties.

Public comments will be accepted until April 14, 2023. For more information, click here.

Final Rules

CMS Finalizes Changes to Medicare Advantage, Part D, Cost Plan, and PACE Regulations

On April 5, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will finalize revisions made to the Medicare Advantage (MA), Prescription Drug Benefit and Cost Plan program regulations, as well as the Programs of All-Inclusive Care for the Elderly (PACE) regulations, for calendar year (CY) 2024. The final rule will:

  • Require that MA plans comply with national coverage determinations (NCDs), local coverage determinations (LCDs), and general coverage and benefit conditions included in Traditional Medicare regulations;
  • Require that coordinated care plan prior authorization policies may only be used to confirm the presence of diagnoses or other medical criteria and/or ensure that an item or service is medically necessary;
  • Require coordinated care plans to provide a minimum 90-day transition period to enrollees who are undergoing treatment and switch to a new MA plan;
  • Require all MA plans to establish a Utilization Management Committee and review policies to ensure consistency with Traditional Medicare guidelines;
  • Require that approval of a prior authorization request be valid for as long as medically reasonable and necessary;
  • Prohibit MA plan television ads from using words, imagery or names that may mislead or confuse beneficiaries;
  • Expand access to behavioral healthcare by adding clinical psychologists and licensed clinical social workers to the list of evaluated specialties;
  • Promote equitable care by adding a health equity index to the Star Ratings program and require MA and Part D plans to provide care to underserved populations; and
  • Implement certain provisions of the Inflation Reduction Act (IRA), the Consolidated Appropriations Act (CAA) of 2021 and the Bipartisan Budget Act (BBA) of 2018.

The rule will go into effect on June 5, 2023. For more information, click here.

CMS Finalizes 2024 Medicare Advantage and Part C and D Payment Policies

On March 31, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will finalize the calendar year (CY) 2024 payment policies for the Medicare Advantage (MA) and Medicare Part C and D programs. The final rule implements several changes that were made with regard to the Medicare programs listed above, which are outlined in a Rate Announcement released by CMS. The final rule will:

  • Finalize technical changes and updates made to the MA risk adjustment model, which include transitioning the model to reflect International Classification of Diseases 10 (ICD-10) condition categories and updating the model with recent Medicare data years. CMS intends on phasing in the updated model over the next three years.
  • Finalize changes to the Medicare Part C and D Star Ratings. CMS will provide a list of the eligible disasters for the extreme and uncontrollable circumstances adjustment and of non-substantive updates made to several measure specifications.

CMS’ rate announcement update reflects a 3.32 percent increase in MA payments, equivalent to approximately $13.8 billion. Additionally, the update reflects a 2.28 percent increase in the MA payment effective growth rate, a 1.24 percent decline in star ratings and a 4.4 percent increase in the MA risk score trend.

The rule will go into effect on Jan. 1, 2024. For more information, click here.

FDA Issues Final Rule Regarding Mammography Quality Standards

On March 9, the Food and Drug Administration (FDA) issued a final rule that updates the regulations implemented by the Mammography Quality Standards Act of 1992. The FDA has decided to update the regulations due to advancements made in mammography technology and information. The final rule will:

  • Improve the delivery of mammography services;
  • Strengthen communication of healthcare information;
  • Require mammography facilities to provide patients with additional health information;
  • Ensure the availability of qualified mammography personnel;
  • Bolster medical outcome audits;
  • Modernize technological aspects of mammography services; and
  • Implement enforcement tools to deal with noncompliant facilities.

The rule will go into effect on Sept. 10, 2024. For more information, click here.

CMS Final Rule Adds Items to DMEPOS Order List and Updates Healthcare Common Procedure Coding System (HCPCS)

On Jan. 17, the Centers for Medicare and Medicaid Services (CMS) released a final rule that will update the Healthcare Common Procedure Coding System (HCPCS) codes for required Face-to-Face Encounter and Written Order Prior to Delivery (F2F/WOPD) requirements applicable to Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) orders. The update follows CMS’ decision to add new non-statutorily required DMEPOS items to the F2F/WOPD list. CMS believes the addition of these items will protect Medicare enrollees and further reduce Medicare fraud, waste and abuse.

The rule will go into effect on April 17, 2023. For more information, click here.

FDA Delays Tobacco Product Required Warning Final Rule Effective Date

On Nov. 25, the Food and Drug Administration (FDA), in compliance with an order issued by the U.S. District Court for the Eastern District of Texas, delayed the effective date of a final rule published on March 18, 2020, titled “Tobacco Products; Required Warnings for Cigarette Packages and Advertisements.” The rule, which was originally supposed to go into effect on June 18, 2021, establishes new cigarette health warnings for cigarette packages and advertisements.

The rule will go into effect on Nov. 6, 2023. For more information, click here.

CMS Issues Correction on Clinical Laboratory Improvement Amendments (CLIA) Final Rule

On Nov. 17, the Centers for Medicare and Medicaid Services (CMS) corrected a technical error that was found in a final rule published in the Federal Register on July 11, 2022. The final rule updates proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to address analytes and newer technologies.

The rule goes into effect July 11, 2024. For more information, click here.

Reports

GAO Releases Report Regarding Coast Guard Healthcare

On April 4, the Government Accountability Office (GAO) released a report on the state of healthcare within the U.S. Coast Guard. The GAO was interested in assessing whether Coast Guard active duty personnel and their dependents have adequate access to Coast Guard healthcare facilities. The GAO analyzed Coast Guard beneficiary access-to-care data and other relevant documents and determined that although most beneficiaries have adequate access to healthcare services, a number of challenges still exist within the Coast Guard healthcare system. These include long distances between certain healthcare facilities and a lack by the Coast Guard in routinely monitoring Defense Health Agency (DHA) and contractor data. The GAO was directed to review the state of the Coast Guard healthcare system by a provision in the William M. Thornberry National Defense Authorization Act of 2021.

For more information, click here.

CBO Cost Estimates

CBO Releases Cost Estimate for H.R. 187, Default Prevention Act

On March 31, the Congressional Budget Office (CBO) released a cost estimate for H.R. 187, the Default Prevention Act. This bill would require the U.S. Treasury to prioritize payment obligations in the event that the total U.S. debt limit ceiling is reached, and would authorize the Treasury to issue debt that would not be subject to standard statutory limits, to pay for Social Security, Medicare, and principal and interest amounts on public debt. The bill would also require the Treasury to report weekly to the House Committee on Ways and Means, regarding transactions and categorical spending. Payments would be prioritized as follows:

  • Social Security, Medicare and public debt obligations;
  • Department of Defense and Department of Veterans Affairs obligations;
  • Obligations of any program not in a designated tier;
  • Federal employee union activity obligations, executive branch travel costs and compensation of the president, vice president and some political appointees; and
  • Compensation of members of Congress.

The CBO stated that the implementation of H.R. 187 would incur higher administrative costs on the Treasury, but admitted that it does not have a basis to estimate the impact the bill would have on spending subject to appropriation.

For more information, click here.

CBO Releases Cost Estimate for S.113, Prescription Pricing for the People Act

On March 31, the Congressional Budget Office (CBO) released a cost estimate for S.113, the Prescription Pricing for the People Act of 2023. The bill would require the Federal Trade Commission (FTC) to evaluate whether anticompetitive practices exist within the pharmaceutical supply chain. The bill would direct the FTC to:

  • Research legal or regulatory barriers that prevent the FTC from enforcing antitrust and consumer protection laws in the pharmaceutical supply chain;
  • Analyze any legal or regulatory hurdles that contribute to the cost of prescription drugs;
  • Identify the methods companies use to weigh the costs and benefits of contracting with intermediaries;
  • Establish new policy and legislative recommendations to deter anticompetitive practices; and
  • Inform Congress about complaints submitted to the FTC regarding anticompetitive practices and report on the commission’s ability to engage in enforcement and prosecution practices against such behavior.

The CBO predicted that the implementation of S.113 will cost $3 million over the next two years. Any spending would be subject to the availability of appropriated funds. The CBO estimated that approximately 12 employees would be needed to complete the work outlined by the bill, and stated that the average cost of an employee would be roughly $213,000.

For more information, click here.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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