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This Week in Washington: The House and Senate are back in session.
Final Regulations/Guidance
- FDA Issues Ban on Flavored Vaping Products
- CMS: Hospital Price Transparency Requirements: CY 2020 Hospital Outpatient Prospective Payment System (OPPS) Policy Changes
Proposed Regulations/Guidance
- CMS and HRSA: Two Proposed Rules for Organ Procurement Organizations (OPOs)
- CMS: Transparency in Coverage Proposed Rule
- CMS Releases Kidney Care Choices Model Request for Application
- CMS: Proposed Radiation Oncology (RO) Model
- FDA and HHS: Proposed Rule on Canadian Drug Importation Plan
- FDA: Draft Guidance on Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff
Courts
House Committee on Energy and Commerce: “Legislation to Improve Americans’ Health Care Coverage and Outcomes”
The Subcommittee on Health of the Committee on Energy and Commerce will hold a legislative hearing on the following bills:
- H.R. 1379, the “Ensuring Lasting Smiles Act”
- H.R. 2271, the “Scarlett’s Sunshine on Sudden Unexpected Death Act”
- H.R. 2468, the “School-Based Allergies and Asthma Management Program Act”
- H.R. 2477, the “Beneficiary Enrollment Notification and Eligibility Simplification Act of 2019” or the “BENES Act of 2019”
- H.R. 3935, the “Protecting Patients Transportation to Care Act”
- H.R. 4801, the “Healthy Start Reauthorization Act of 2019”
- H.R. 5534, the “Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act”
Find hearing updates as they become available here.
Final Regulations/Guidance
FDA Issues Ban on Flavored Vaping Products
On Jan. 2, the Food and Drug Administration (FDA) released guidance that bans flavored vaping products containing sweet and fruity flavors, yet allows menthol pods and a range of vape liquids to remain on the market. FDA’s guidance does not permanently ban flavored or cartridge-based e-cigarettes. It also adds that manufacturers will have 30 days to take the flavored vaping products off the shelves, and open-tank systems can be sold so long as companies go to lengths to prevent children from using the products. Each manufacturer will have to submit products for review by May 2020.
Find the guidance here.
CMS: Hospital Price Transparency Requirements: CY 2020 Hospital Outpatient Prospective Payment System (OPPS) Policy Changes
On Nov. 15, the Centers for Medicare and Medicaid Services (CMS) finalized policies that follow directives in President Trump’s executive order entitled “Improving Price and Quality Transparency in American Healthcare to Put Patients First.” The rule requires facilities to disclose currently confidential rates they have negotiated with insurers, what the hospital is willing to accept from a patient and the minimum and maximum negotiated charges. The requirement would apply for all items and services and be available online in a single data file.
Hospitals will have to post that information online for 300 common services in an easily understandable format. CMS will specify 70 of these services, and the rest can be chosen by the hospitals. Hospitals that do not comply could face fines of up to $300 per day.
Find the final rule here.
In response to comments, CMS is extending the effective date to Jan. 1, 2021, to ensure hospital compliance with these regulations.
Proposed Regulations/Guidance
CMS and HRSA: Two Proposed Rules for Organ Procurement Organizations (OPOs)
On Dec. 17, two rules were proposed related to organ procurement organizations (OPOs), specifically on performance standards and the promotion of donations from living donors.
The first rule, by the Centers for Medicare and Medicaid Services (CMS), holds OPOs accountable for meeting specific performance metrics. The rule uses federal death records, which show the entire pool of potential organ donors, to calculate an OPO’s donation and transplantation rates. In addition, the proposed rule would require all OPOs to meet the donation and transplantation rates of the current top 25 percent of OPOs. CMS will be able to rank the OPOs based on their performance and make that data public, assessing them annually through a re-certification cycle.
Find the CMS rule here.
Public comments are due by Feb. 21, 2020.
The second rule, by the Health Resources and Services Administration (HRSA), attempts to eliminate financial burden on living donors. The proposed rule would allow insurers to reimburse living donors for lost wages, as well as any child care or elder care expenses they incurred during their hospitalizations for or recoveries from the donation.
Find the HRSA rule here.
Public comments are due by Feb. 18, 2020.
CMS: Transparency in Coverage Proposed Rule
On Nov. 15, the Centers for Medicare and Medicaid Services (CMS) proposed a rule with the Department of Labor and the Department of the Treasury to implement President Trump’s executive order on Improving Price and Quality Transparency in health care.
The rule proposes to make each non-grandfathered group health plan or health insurance issuer offering non-grandfathered health insurance coverage in the individual and group markets be required to make available to participants, beneficiaries and enrollees (or their authorized representative) personalized out-of-pocket cost information for all covered health care items and services through an internet-based self-service tool and in paper form upon request. The same plans would be required to make available to the public the in-network negotiated rates with their network providers and historical payments of allowed amounts to out-of-network providers through standardized, regularly updated machine-readable files. This would provide opportunities for innovation to drive price comparison and consumerism in the health care market.
This proposed rule also solicits comments on:
- Whether group health plans and health insurance issuers should also be required to make available through a standards-based application programming interface (API) the cost-sharing information referenced above that is proposed to be disclosed through the internet-based self-service tool and the machine-readable files.
- How health care quality information can be incorporated into the price transparency proposals included in these proposed rules.
Find the proposed rule here.
CMS Releases Kidney Care Choices Model Request for Application
On Oct. 24, the Center for Medicare and Medicaid Innovation (Innovation Center) announced that the request for applications (RFA) for the Kidney Care Choices (KCC) Model has been posted here.
The deadline to submit an application is Jan. 22, 2020.
The KCC Model is a voluntary model to reduce Medicare expenditures while preserving or enhancing quality of care for beneficiaries with end-stage renal disease (ESRD) and chronic kidney disease (CKD). The KCC Model contains the following four options:
- The CMS Kidney Care First (KCF) option
- The Comprehensive Kidney Care Contracting (CKCC) Graduated option
- The CKCC Professional option
- The CKCC Global option
Stay up to date on the latest Kidney Care Choices Model news and updates rel=”noopener noreferrer” by subscribing to the KCC Model listserv.
CMS: Proposed Radiation Oncology (RO) Model
On July 10, the Centers for Medicare and Medicaid Services (CMS) proposed a Radiation Oncology (RO) Model as a payment model that tests if site-neutral payments, in which providers are paid the same rate no matter the care setting, for a 90-day episode of care, can improve the quality of treatment and save Medicare money. The experiment targets radiation treatment for 17 different types of cancer. Payment will be based on proposed national base rates and trend factors and will be adjusted for geography and the mix of patients the provider treats.
Participants in the model could earn back a share of dollars that are withheld based on the quality of care and patient experience. The model is scheduled to begin in 2020 and end in December 2024.
Find the proposed rule here.
FDA and HHS: Proposed Rule on Canadian Drug Importation Plan
On Dec. 18, the Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) released a draft guidance on the importation of certain prescription drug imports from Canada, leaving out many specialty medications and other therapies for chronic disease that cost patients the most. The FDA seeks request for comment on two importation pathways. One would allow states to submit proposals to the FDA to allow the importation of small molecule brand-name medicines sold at retail pharmacies, typically ones that have rebates attached to them. The draft guidance for industry lets manufacturers import the same versions of FDA-approved drugs they now sell in foreign countries. Under this second pathway, drug manufacturers would use a new National Drug Code (NDC) and sell these drugs in the U.S. at a cheaper price.
Find the proposed rule here.
Find the guidance for industry here—comments are due by March 5, 2020.
FDA: Draft Guidance on Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff
On Nov. 6, the Food and Drug Administration (FDA) released a draft guidance on best practices for drug safety surveillance, made available to the public in compliance with requirements of the 21st Century Cures Act. The draft guidance outlines the FDA’s approach for timely postmarket analyses of drugs and biologics, and includes a high-level overview of tools, methods and signal detection and evaluation activities, using varied data sources, for drug safety surveillance to provide a broader context and a general overview of the overarching effort and commitment in this area.
Find the draft guidance here. Public comments are due by today, Jan. 6, 2020.
Courts
Democratic AGs Ask the U.S. Supreme Court to Take Up Individual Mandate ACA Case This Term
Democratic attorneys general filed a petition Jan. 3 asking the U.S. Supreme Court to review a recent decision by the U.S. Court of Appeals for the 5th Circuit in Texas v. U.S. The decision affirmed a lower court’s ruling that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, yet did not rule on the validity of the rest of the ACA. The appeals court sent the case back to the lower court to review what portions of the ACA could or could not be severed from the individual mandate issue. The lower court had ruled that the entire law failed. Because the 5th District’s decision causes uncertainty that may harm the health of millions of Americans—in addition to doctors, clinics, patients and the health care market—the attorneys general are petitioning the Supreme Court to take up the case and resolve it before the end of the Court’s current term in June.
Filing today’s petition were the attorneys general of California, Colorado, Connecticut, Delaware, Hawaii, Illinois, Iowa, Massachusetts, Michigan, Minnesota (by and through its Department of Commerce), Nevada, New Jersey, New York, North Carolina, Oregon, Rhode Island, Vermont, Virginia, Washington and the District of Columbia, as well as the governor of Kentucky.
If you have any questions, contact the following individuals atMcGuireWoods Consulting:
Stephanie Kennan, Senior Vice President
Mariam Eatedali, Research Associate
Founded in 1998,McGuireWoods Consulting LLC(MWC) is a full-service public affairs firm offering infrastructure andeconomic development, strategic communications & grassroots, and governmentrelations services. McGuireWoods Consulting is a subsidiary of theMcGuireWoods LLPlaw firm and has been named in The National Law Journal’s special annualreport, “The Influence 50,” for the past several years. In the most recentreport, McGuireWoods Consulting was ranked 15th of the 1,900 governmentrelations firms in Washington, D.C.
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