Tag: Department of Health and Human Services

HHS Announces New Payment Models Impacting Nephrology Stakeholders

Posted on July 11, 2019 by - Government Affairs

Blog: HHS Announces New Payment Models Impacting Nephrology Stakeholders

President Trump has signed an Executive Order that directs the Department of Health and Human Services (HHS) to develop new nephrology policies to address reducing the number of patients developing kidney failure, increasing the number of kidneys available for transplant, and reducing the number of dialysis treatment at dialysis centers to encourage more in-home kidney dialysis. These policies will take shape in via five new CMS Center for Medicare and Medicaid Innovation payment models.

According to HHS, “the proposed required End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model would encourage greater use of home dialysis and kidney transplants for Medicare beneficiaries with ESRD in order to preserve or enhance their quality of care while reducing Medicare expenditures, and the Kidney Care First (KCF) and Comprehensive Kidney Care Contracting (CKCC) Models will test new Medicare payment options that aim to improve the quality of care for patients with kidney disease.”

Additionally, CMS announced four optional models:

  • The Kidney Care First (KCF) Model
  • The Comprehensive Kidney Care Contracting (CKCC) Graduated Model
  • CKCC Professional Model
  • The Global Model

These optional payment models are designed to help health care providers reduce the cost and improve the quality of care for patients with late-stage chronic kidney disease and ESRD. These models also aim to delay the need for dialysis and encourage kidney transplantation.

Healthcare and life sciences stakeholders can expect to continue to see policy changes for the foreseeable future so it is better to be prepared ahead of time before they happen. Frier Levitt Government Affairs (FLGA) monitors and forecasts issues of importance for healthcare and life sciences stakeholders, including state and federal legislation and regulation, all presented in a concise, easy to understand and time friendly format. FLGA’s monitoring and forecasting services allow stakeholders to stay educated and engaged on new developments before the trends become mainstream.

With laws and regulations changing all the time, it is imperative for healthcare and life sciences stakeholders and organizations to be proactive instead of reactive. Contact FLGA today to get “in the know” and finally be prepared for the changes ahead.

HHS’ Final Rule Requiring Drug Prices in TV Advertising Presents an Opportunity for Manufacturers

Posted on May 14, 2019 by - Government Affairs

Earlier this month, Health & Human Services (HHS) Secretary Azar announced a final rule from the Centers for Medicare & Medicaid Services (CMS) requiring direct-to-consumer television advertisements for prescription pharmaceuticals covered by Medicare or Medicaid to include the list price – the Wholesale Acquisition Cost – if that price is equal to or greater than $35 for a month’s supply or the usual course of therapy. This policy comes from the American Patients First Blueprint to reduce drug costs.

Lately, the culprit behind higher drug prices has been sharply debated. Some in the manufacturing community point to two issues: better science and rebate pressure. Improved patient outcomes due to scientific advances justifies higher prices, especially since near curative prescription drugs lead to a possible decrease in future healthcare costs. Additionally, manufacturers have rightly been pointing to the pressures by PBMs to increase rebates or face the potential of having certain drugs either removed from the formulary or in the alternative, subjected to increased formulary competition.

While the life sciences industry understands the complexities surrounding drug prices, many state and federal policymakers do not. Hence, there have varied and sometimes disproportionate responses to higher drug prices, which may not solve the problem.

There are many opportunities for manufacturers on the state and federal level to help alleviate policymaker concerns about drug prices, while also helping to provide a grounded response to ensure a stable market that promotes patient access.

Frier Levitt Government Affairs is active on the state and federal level, including both legislative and regulatory developments concerning drug prices. If you are a manufacturer, contact Frier Levitt Government Affairs today for help maximizing your existing resources to get control of the growing drug pricing issue.

What You Need to Know: The HHS “Reforming America’s Healthcare System Through Choice and Competition” Report

Posted on December 14, 2018 by - Government Affairs

Recently, the Department of Health and Human Services (HHS) – in collaboration with the Departments of the Treasury and Labor, the Federal Trade Commission and several offices within the White House – released a report titled “Reforming America’s Healthcare System Through Choice and Competition.”

The report is a product of a directive from Executive Order 13813 titled, “Promoting Healthcare Choice and Competition Across the United States.” The Executive Order directs the administration to facilitate “the development and operation of a healthcare system that provides high-quality care at affordable prices for the American people” by increasing consumer choice and promoting competition in healthcare markets and by removing and revising government regulation.

The report identifies problems with the U.S. healthcare system, as well as four areas of opportunity. It blames issues such as influence of state and federal laws, excessive mandates, and limited insurance coverage options as factors that have increased costs. As a result, four key policy areas – Health Care Workforce and Labor Markets, Health Care Provider Markets, Health Care Insurance Markets, and Consumer-Driven Health Care – have been identified as opportunities to improve healthcare policy.

As seen with the Administration’s “American Patients First” Blueprint, the Administration releases broad policy statements that are refined with either Requests for Information (RFIs) or with specific bills/proposed rules. 2019 looks to be no different, as this report is bound to show up in some regulatory or legislative vehicle.

Healthcare organizations, Health Systems, physician practices, and physicians in general need to stay ahead of trends like this report as they could end up having an impact on their bottom lines. Through the use of federal or state lobbying, assistance with federal or state regulatory comments, bill language verification, the creation of SuperPACs or general business strategy consulting, Frier Levitt Government Affairs, LLC. (FLGA) can help healthcare industry stakeholders realize their long-awaited priorities. Contact FLGA today to discuss options that will best get your voice heard.