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Coming Week’s Highlights: House and Senate hold hearings on drug prices, Senate Committee to discuss preventable diseases and the debate on vaccinations.
Congress
Hearings
- House Committee on Energy and Commerce: “Confronting a Growing Public Health Threat: Measles Outbreaks in the U.S.”
- Senate Finance Committee: “Drug Pricing in America: A Prescription for Change, Part II”
House
Senate
Administration
- HHS, Treasury and Labor Departments Request Feedback on ACA Grandfathered Plans
- CMS Upcoming Rule: Revision of Requirements for Long-Term Care Facilities: Arbitration Agreements
- FDA, CMS, CDC Create Task Force to Foster Emergency Diagnostics Development
Regulations
- FDA: Quality Considerations for Continuous Manufacturing
- FDA: Competitive Generic Therapies Draft Guidance
- CMS Updates Overall Hospital Star Ratings, Asks for Feedback
- CMS: Coverage with Evidence Development for Chimeric Antigen Receptor (CAR) T-cell Therapy
- ONC/CMS: Interoperability; Exceptions to Information Blocking
- HHS Proposal Calls for Reforming Drug-Rebate System
Reports
Upcoming Hearings
Tuesday, March 5, 2019
Senate Committee on Health, Education, Labor and Pensions (HELP): “Vaccines Save Lives: What is Driving Preventable Disease Outbreaks?”
The Senate Committee on Health, Education, Labor and Pensions (HELP) will hold a hearing on the outbreak of preventable diseases and the debate on vaccinations. Find a link to witness testimonies, member statements and the hearing live feed here.
Wednesday, March 6, 2019
House Committee on Energy and Commerce: “Strengthening Our Health Care System: Legislation to Lower Consumer Costs and Expand Access”
The House Committee on Energy and Commerce will hold a hearing on lowering consumer costs and expanding access to health care. Find a link to witness testimonies, member statements and the hearing live feed here.
Senate Finance Committee: “Not Forgotten: Protecting Americans from Abuse and Neglect in Nursing Homes”
The Senate Committee on Finance will hold a hearing on the issue of abuse and neglect in nursing homes. Find a link to witness testimonies, member statements and the hearing live feed here. Chairman Grassley has a long history in performing oversight of nursing homes from his days as a member of the Senate Special Committee on Aging and as a member of the Senate Finance Committee. Sen. Wyden, when he was a member of the House, led nursing home reform efforts and as a member of the Senate has been part of other oversight activities related to long-term care.
Senate Committee on Aging: “The Complex Web of Prescription Drug Prices, Part I: Patients Struggling with Rising Costs”
The Senate Committee on Aging will hold the first part of a hearing series on rising costs of prescription drug prices. The second part of the series is being held this week. Find a link to witness testimonies, member statements and the hearing live feed here.
Thursday, March 7, 2019
House Ways and Means Committee, Subcommittee on Health: “Promoting Competition to Lower Medicare Drug Prices”
The House Ways and Means Subcommittee on Health will hold a hearing on lowering Medicare drug prices by promoting competition among manufacturers. Find a link to witness testimonies, member statements and the hearing live feed here.
House Committee on the Judiciary: “Diagnosing the Problem: Exploring the Effects of Consolidation and Anticompetitive Conduct in Health Care Markets”
The House Committee on the Judiciary will hold a hearing on the issue of anticompetitive conduct affecting health care markets. Find a link to witness testimonies, member statements and the hearing live feed here.
Senate Committee on Aging: “The Complex Web of Prescription Drug Prices, Part II: Untangling the Web and Paths Forward”
The Senate Committee on Aging will hold the second part of this week’s hearing series on rising costs of prescription drug prices, highlighting possible solutions going forward. Find a link to witness testimonies, member statements and the hearing live feed here.
Upcoming Events
March 7-8, 2019: Medicare Payment Advisory Commission (MedPAC) Public Meeting
Find the meeting agenda and more details as they become available here.
March 7-8, 2019: Medicaid and CHIP Payment and Access Commission (MACPAC) Public Meeting
Find the meeting agenda and more details as they become available here.
Congress
Hearings
House Committee on Energy and Commerce: “Confronting a Growing Public Health Threat: Measles Outbreaks in the U.S.”
Wednesday, Feb. 27, 2019: The House Energy and Commerce Committee’s Oversight and Investigations Subcommittee held hearing on the current measles outbreak and response efforts. This hearing focused on the need to combat information that discourages individuals from vaccinating their children. Find a link to witness testimonies, member statements and the hearing live feed here.
Why this is important: Since Jan. 1, 2019, the Centers for Disease Control and Prevention (CDC) reported 101 individual measles cases in 10 states. The majority of measles cases have occurred in Clark County, WA, a suburb of Portland, OR, with 53 confirmed measles cases. Of those cases, 47 involved people who were not vaccinated against the disease, and 38 people infected were children between the ages of one and 10.
Senate Finance Committee: “Drug Pricing in America: A Prescription for Change, Part II”
Tuesday, Feb. 26, 2019: The second hearing in a series on drug pricing in the Senate Finance Committee included the testimonies of seven drug company executives. Leaders of pharmaceutical companies refused to testify at a previous hearing. The following seven companies were represented at this hearing:
- AbbVie Inc.
- AstraZeneca
- Bristol-Myers Squibb Co.
- Johnson & Johnson
- Merck & Co., Inc.
- Pfizer
- Sanofi
Find a link to witness testimonies, member statements and the hearing live feed here.
Why this is important: The witnesses agreed that prescription drugs should be more affordable for Americans. However, they were reluctant to promise to cut list prices without other reforms. The executives argued that other factors, such as pharmacy benefit managers (PBMs) that negotiate discounts and insurance coverage, have greater influence on the price consumers pay at the pharmacy counter. They also emphasized drug rebates that do not always reach consumers, payments tied to the value of a drug and more transparency. Chairman Chuck Grassley (R-IA) confirmed that PBM executives will testify next before the committee in the hearing series.
House
Jayapal Introduces “Medicare for All” Bill
On Feb. 27, Rep. Pramila Jayapal (D-WA) introduced a bill to transition the health care system to a single-payer “Medicare for All” program funded by the government, with a transition period of two years. Jayapal’s proposal prohibits private insurance that duplicates what is offered through the government Medicare for All program. It also includes long-term care coverage. The plan sunsets Medicare and Medicaid, transitioning enrollees into the new universal plan. It continues, however, the Veterans Affairs (VA) health system and the Indian Health Services program as they exist now.
Find and monitor H.R.1384 here.
Senate
Capito, Manchin Ask HHS to Align 42 CFR Part 2 with HIPAA
On Feb. 21, West Virginia Sens. Shelley Moore Capito (R) and Joe Manchin (D) sent a letter to the Secretary of the Department of Health and Human Services (HHS), Alex Azar, asking HHS to start working on a rule to align the strict 42 CFR Part 2 substance abuse privacy scheme with the Health Insurance Portability and Accountability Act (HIPAA). The regulation, 42 CFR Part 2, has often been cited as inhibiting the flow of information to providers. During the opioid legislation in the last Congress, an effort was made to address this, but ultimately it was dropped before final passage. HIPPA does not require explicit patient consent each time health records are shared.
Find the “Dear Colleague” letter here.
Administration
HHS, Treasury and Labor Departments Request Feedback on ACA Grandfathered Plans
On Feb. 21, the Department of Health and Human Services (HHS), the Department of the Treasury and the Department of Labor released a request for information (RFI) on feedback from insurers and others on ways the administration could help pre-Affordable Care Act (ACA) group health plans avoid losing “grandfathered” status. The RFI focuses on group coverage since only a small number of individuals remain in grandfathered coverage.
Find the RFI here.
CMS Upcoming Rule: Revision of Requirements for Long-Term Care Facilities: Arbitration Agreements
A final rule from the Centers for Medicare and Medicaid Services (CMS) is expected to clarify that long-term care facilities can require residents or their families to agree, before disputes arise, to settle complaints through arbitration rather than litigation. The rule arrived at the Office of Management and Budget (OMB) for review on Jan. 30, and could end the fight over legal protections for senior citizens in the health care system.
The administration’s proposed rule includes new transparency measures for pre-dispute arbitration agreements, such as requirements for facilities to clearly explain the terms to prospective residents and that those residents acknowledge they understand.
The rule, found here, is still being reviewed at the OMB.
FDA, CMS, CDC Create Task Force to Foster Emergency Diagnostics Development
On Feb. 26, the Food and Drug Administration (FDA) announced a Tri-Agency Task Force for Emergency Diagnostics (TTFED), including the FDA, the Centers for Medicare and Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC). The purpose of the TTFED is to streamline and coordinate the government’s role in making diagnostic tests available during an emergency. The TTFED aims to make the emergency test space more predictable for developers, and to collaborate with international partners during global disease outbreaks.
Regulations
FDA: Quality Considerations for Continuous Manufacturing
On Feb. 26, the Food and Drug Administration (FDA) released a draft guidance on what factors brand and generic drug manufacturers should consider when setting up and using a continuous manufacturing system to produce their products. The guidance outlines the benefits of continuous manufacturing over traditional batch manufacturing, including the efficiency that comes with continuous manufacturing that could eventually lead to lower drug prices for consumers.
Comment period ends on May 28, 2019; comments can be submitted here.
Find the draft guidance here.
FDA: Competitive Generic Therapies Draft Guidance
On Feb. 19, the Food and Drug Administration (FDA) published a draft guidance on how drug manufacturers can apply for the competitive generic therapy (CGT) pathway, intended for generic versions of drugs that have little-to-no competition in the market. This guidance encourages more generic drug manufacturing and explains how exclusivity would work under the CGT pathway, including exclusivity given to multiple CGT pathway-approved drugs that fit certain criteria.
Comment period ends on April 22, 2019; comments can be submitted here.
Find the draft guidance here.
CMS Updates Overall Hospital Star Ratings, Asks for Feedback
On Feb. 28, the Centers for Medicare and Medicaid Service (CMS) updated the overall hospital star ratings, while announcing that it is looking at possible changes to how ratings are calculated for both the short and long term. Proposed changes help patients make more “like-to-like” comparisons, meaning they could compare similar hospitals. The CMS would accomplish this by placing hospitals into peer groups—meaning small rural hospitals would not be compared to larger, academic hospitals.
Comment period ends on March 29, 2019.
Find the proposed changes and submit comments here.
CMS: Coverage with Evidence Development for Chimeric Antigen Receptor (CAR) T-cell Therapy
On Feb. 15, the Centers for Medicare and Medicaid Services (CMS) proposed Medicare coverage of approved CAR T-cell therapies that use the patient’s immune system to fight cancer. The proposed rule requires Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment. The evidence from these studies and registries allows CMS to identify the patients who benefit from CAR T-cell therapies.
Currently, there is no national Medicare policy for covering CAR T-cell therapy. Local Medicare administrative contractors have discretion over whether to pay for the treatment.
Comment period ends on March 17, 2019; comments can be submitted here.
Find the proposed rule here.
ONC/CMS: Interoperability; Exceptions to Information Blocking
On Feb. 11, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator (ONC) released proposed rules to support secure access, exchange and use of electronic health information. The Interoperability and Patient Access Proposed Rule from CMS outlines opportunities to make patient data more useful and transferable through open, secure, standardized and machine-readable formats while reducing restrictions on health care providers. The ONC rule calls on the health care industry to adopt standardized application programming interfaces (APIs), which will allow individuals to securely and easily access structured electronic health information (EHI) using smartphone applications.
In addition to the policy proposals, CMS released two requests for information (RFIs) to obtain feedback on interoperability and health information technology (health IT) adoption in post-acute care (PAC) settings, and the role of patient matching in interoperability and improved patient care.
Comment period ends on May 3, 2019.
Read the proposed rule and submit comments here.
HHS Proposal Calls for Reforming Drug-Rebate System
Published on Feb. 6, a proposal by the Department of Health and Human Services (HHS) called for a ban on drug rebates, unless shared directly with seniors at the pharmacy counter, significantly lowering out-of-pocket retail drug spending for the minority of seniors on expensive drugs. The proposal would raise premiums for all Medicare beneficiaries. Part of the administration’s plan is set to take effect in a year and an anticipated legal challenge by pharmacy benefit managers (PBMs) could delay implementation.
The proposal cuts rebates tied to a percentage of list price that drug manufacturers pay to Part D plans, Medicaid managed care and PBMs by taking away the long-standing exemption for rebates in anti-kickback law. The administration proposed two new safe harbor protections: one that would allow rebates that are shared with patients at the point of sale and another that would let PBMs charge flat fees for their services.
Comment period ends on April 8, 2019.
Read the proposed rule here.
Reports
GAO: Veterans Health Administration—Greater Focus on Credentialing Needed to Prevent Disqualified Providers from Delivering Patient Care
On Feb. 28, the Government Accountability Office (GAO) released a report on the credentialing process of doctors and health care providers hired by the Veterans Health Administration (VHA). The GAO found that the VHA overlooked or missed disqualifying information in a national database, and did not know that providers with valid licenses were ineligible if they had surrendered a license or had one revoked in another state.
The GAO made seven specific recommendations, including that the VHA ensure facility officials who are responsible for credentialing and hiring receive periodic mandatory training, and periodically review providers who have an adverse action reported in the National Practitioner Data Bank (NPDB). The VHA concurred with GAO’s recommendations.
Find the full report here.
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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