This week in Washington: Congress is back in session.

Upcoming Hearings/Markups

Congress

Hearings/Markups

• Senate Committee on Aging: “Redefining Reality: How the Special Diabetes Program is Changing the Lives of Americans with Type 1 Diabetes”
• House Committee on Oversight and Reform: “The Trump Administration’s Attack on the ACA: Reversal in Court Case Threatens Health Care for Millions of Americans”
• House Committee on Energy and Commerce: Markup of Health Care Legislation
• House Committee on Oversight and Reform: “Identifying, Preventing, and Treating Childhood Trauma: A Pervasive Public Health Issue that Needs Greater Federal Attention”

House

• Cadillac Tax Repeal to Be Considered

Senate

• FDA Has Not Responded to Warren, Murray Letter on Progressive Approval Device Path
• Bipartisan Bill Introduced on Development of FDA-Approved Cannabis Drugs

Administration

• U.S., EU Fully Implement Pharmaceutical Mutual Recognition Agreement
• President Trump Signs Executive Order on Advancing American Kidney Health
• HHS Announces Summit to Begin New Quality Roadmap
• FDA Enforces Priority Review for Generic Overdose Reversal Drugs
• CMS Will Up Oversight of Hospices After OIG Finds Deficiencies
• CMS Asks for Feedback to Reduce Regulatory Burdens

Proposed Regulations/Guidance

• CMS: CY 2020 and 2021 New Home Infusion Therapy Benefit, Payment and Policy Changes for Home Health Agencies
• CMS: Monitoring of Medicaid Beneficiary Access for Patients While Relieving Administrative Burden for States
• CMS: Proposed Radiation Oncology (RO) Model
• FDA: Treatment for Heart Failure — Endpoints for Drug Development
• FDA: Biologics License Applications and Master Files
• FDA Considering New Incentives for Safer Pain, Addiction Therapies

Other

• FCC Advances $100 Million Telehealth Pilot Proposal

Courts

• Home Care Providers Group Files Suit to Test Janus v. FSCME Ruling
• Federal Court Stops Trump Administration DTC Advertisement Rule

Upcoming Hearings/Markups

Tuesday, July 16, 2019

House Committee on Energy and Commerce: “Oversight of Federal Efforts to Combat the Spread of Illicit Fentanyl”

The House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations of the Committee will hold a hearing on the federal oversight of fentanyl, a synthetic opioid that is 80-100 times stronger than morphine, with a high risk for addiction and dependence.

Find witness testimonies and hearing updates as they become available here.

Thursday, July 18, 2019

House Committee on the Judiciary: “Counterfeits and Cluttering: Emerging Threats to the Integrity of the Trademark System and the Impact on American Consumers and Businesses”

The House Committee on the Judiciary, Subcommittee on Courts, Intellectual Property, and the Internet, will hold a hearing on threats to the U.S. trademark system.

Find witness testimonies and hearing updates as they become available here.

Tuesday, July 23, 2019

Senate Committee on the Judiciary: “Oversight of the Enforcement of the Antitrust Laws”

The Senate Committee on the Judiciary’s Subcommittee on Antitrust, Competition Policy, and Consumer Rights will hold another hearing related to antitrust laws, seeking suggestions on oversight and enforcement at the federal level.

Find witness testimonies and hearing updates as they become available here.

Congress

Hearings/Markups

Senate Committee on Aging: “Redefining Reality: How the Special Diabetes Program is Changing the Lives of Americans with Type 1 Diabetes”

Wednesday, July 10, 2019: The Senate Committee on Aging held a hearing on the realities of Type 1 diabetes, in light of rising insulin costs and the possible loss of funding for Type 1 diabetes research.

Why this is important: The panel of witnesses asked the committee to renew the Special Diabetes Program at the National Institutes of Health (NIH). Failure to renew by the end of September would mean $150 million in lost funding for Type 1 diabetes research.

Find witness testimonies and hearing updates here.

House Committee on Oversight and Reform: “The Trump Administration’s Attack on the ACA: Reversal in Court Case Threatens Health Care for Millions of Americans”

Wednesday, July 10, 2019: The House Committee on Oversight and Reform held a hearing on the Texas v. Azar (U.S.) case, which threatens to dismantle the Affordable Care Act (ACA) if upheld.

Find witness testimonies and hearing updates here.

Why this is important: The hearing came a day after a federal appeals court heard oral arguments in Texas v. Azar, during which the two judges expressed skepticism that the ACA’s individual mandate is constitutional without a penalty. Republican members of the committee spent the hearing criticizing the ACA, as well as any plans for Medicare for All.

House Committee on Energy and Commerce: Markup of Health Care Legislation

Thursday, July 11, 2019: The House Committee on Energy and Commerce, Subcommittee on Health held a markup on 10 pieces of health care-related legislation, listed below. All 10 bills were favorably reported to the full committee, with bipartisan support. The subcommittee only had a debate on H.R. 3630, the “No Surprises Act.” While the bill was favorably reported to the full committee without amendment, Republican members raised concerns with the benchmark pricing provision of the bill, urging consideration of arbitration instead. Members anticipate debating amendments on this issue at a full committee markup.

The bills that were considered and favorably reported are:

• H.R. 2781, the “Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness (EMPOWER) for Health Act of 2019”
• H.R. 728, the “Title VIII Nursing Workforce Reauthorization Act of 2019”
• H.R. 1058, the “Autism Collaboration, Accountability, Research, Education, and Support (Autism CARES) Act of 2019”
• H.R. 2507, the “Newborn Screening Saves Lives Reauthorization Act of 2019”
• H.R. 776, the “Emergency Medical Services for Children Program Reauthorization Act of 2019”
• H.R. 2035, the “Lifespan Respite Care Reauthorization Act of 2019”
• H.R. 2296, the “Fair Accountability and Innovative Research Drug Pricing (FAIR Drug Pricing) Act of 2019”
• H.R. 2328, the “Community Health Investment, Modernization, and Excellence Act of 2019”
• H.R. 3631, the “Territories Health Care Improvement Act”
• H.R. 3630, the “No Surprises Act”

Find official markup updates here.

Find a detailed overview of the markup here.

House Committee on Oversight and Reform: “Identifying, Preventing, and Treating Childhood Trauma: A Pervasive Public Health Issue that Needs Greater Federal Attention”

Thursday, July 11, 2019: The House Committee on Oversight and Reform heard directly from trauma survivors, public health experts and government officials to examine the long-term consequences of childhood trauma and the insufficiency of the federal response to this urgent public health issue.

Why this is important: First panel witnesses shared their personal stories of trauma, healing and advocacy. Second panel witnesses were experts who discussed the prevalence of childhood trauma and the limited nature of current federal initiatives to prevent childhood trauma and to treat those who have experienced it.

Find witness testimonies and hearing updates here.

House

Cadillac Tax Repeal to Be Considered

The House is tentatively scheduled to consider H.R. 748, which would repeal the Affordable Care Act’s excise tax, which was designed to penalize employers that provide their workers with expensive benefits. Numerous prior efforts to eliminate what is known as the Cadillac tax have failed in the past because of the need to offset its billions of dollars of potential revenue to the federal government.

Senate

FDA Has Not Responded to Warren, Murray Letter on Progressive Approval Device Path

On June 24, Sens. Elizabeth Warren (D-MA) and Patty Murray (D-WA) wrote a letter to the Food and Drug Administration (FDA) raising concerns with a new device approval pathway proposed in the agency’s fiscal 2020 budget justification. The proposed pathway would allow the FDA to approve devices intended to treat life-threatening illnesses for a limited period based on a demonstration of safety and performance. The senators are concerned that the bill language indicates that the FDA is considering making standards for medical devices more lenient by allowing the marketing of devices that have not met the FDA’s gold standard for safety and effectiveness.

The FDA missed the July 8 response deadline set by the senators.

Read the letter here.

Bipartisan Bill Introduced on Development of FDA-Approved Cannabis Drugs

On June 27, Sens. Dianne Feinstein (D-CA), Chuck Grassley (R-IA) and Brian Schatz (D-HI) introduced a bipartisan bill to encourage scientific and medical research on marijuana and its compounds including cannabidiol (CBD). The Cannabidiol and Marijuana Research Expansion Act (S. 2032) streamlines the application process for researchers interested in marijuana and CBD research, and encourages the development of Food and Drug Administration (FDA)-approved drugs derived from marijuana.

The bill also requires the U.S. Department of Health and Human Services (HHS) to submit a report on the health benefits and risks of marijuana, as well as a report on barriers to cannabis research and how to overcome those obstacles.

Monitor S. 2032 here.

Administration

U.S., EU Fully Implement Pharmaceutical Mutual Recognition Agreement

On July 11, the European Union (EU) announced that the EU and the United States have begun to reduce barriers to trade in pharmaceuticals by fully implementing a mutual recognition agreement. The agreement allows the EU and the U.S. to rely on each other’s drug inspections, rather than duplicating efforts. Together, Europe and the U.S. account for more than 80 percent of global sales of new medicines. The Food and Drug Administration (FDA) completed the capability assessments of the 28 EU competent authorities ahead of the announcement.

President Trump Signs Executive Order on Advancing American Kidney Health
On July 10, President Trump signed an executive order directing the Department of Health and Human Services (HHS) to develop policies addressing three goals: reducing the number of patients developing kidney failure; reducing how many Americans get dialysis treatment in dialysis centers, with a focus on at-home care; and making more kidneys available for transplant.

In addition, simultaneously, the Centers for Medicare and Medicaid Services (CMS) announced five proposed new payment models to increase innovation in the delivery of kidney care. The Department of Health and Human Services’s (HHS) “Advancing American Kidney Health” report, released alongside the executive order, included goals to reduce the number of Americans developing end-stage renal disease (ESRD) by 25 percent by 2030; have 80 percent of new ESRD patients in 2025 receive home dialysis or a transplant; and double the number of kidneys available for transplant by 2030.

MWC Senior VP Stephanie Kennan summarized the executive order and CMS’s proposed payment models here.

Find the CMS payment models here.

HHS Announces Summit to Begin New Quality Roadmap

On July 9, the Department of Health and Human Services (HHS) announced a summit of public and health industry leaders to create a roadmap for streamlining HHS’s quality programs. The summit is a result of President Trump’s executive order for more transparency in health care signed in June. Deputy HHS Secretary Eric Hargan and Peter Pronovost, chief clinical transformation officer of University Hospitals, will chair a forum to discuss ways to revamp quality measures in the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), the Agency for Healthcare Research and Quality (AHRQ) and others. The aim of the meeting is better understanding of the health system’s performance as the administration tries to improve these metrics and move toward value-based care.

HHS will accept nominations for participants until Wednesday, July 31, 2019.

Nominations must be submitted via email to DeputySecretary@hhs.gov with the subject line: “Quality Summit Application.”

Find further details on the summit here.

FDA Enforces Priority Review for Generic Overdose Reversal Drugs

On July 8, the Food and Drug Administration (FDA) announced expediting review of all generic drug applications for overdose-reversal drugs, including naloxone nasal spray, injection and auto-injector, and nalmefene injection. The announcement invokes the “Public Health Emergency” factor in the FDA’s Manual of Policies and Procedures (MAPP). The action falls in line with Department of Health and Human Services’s (HHS) public health emergency five-point strategy for curbing the opioid epidemic, which includes targeting availability and distribution of overdose-reversing drugs.

CMS Will Up Oversight of Hospices After OIG Finds Deficiencies

On July 10, the Centers for Medicare and Medicaid Services (CMS) announced it will increase oversight of hospice facilities and work to make hospice quality information more accessible on Hospice Compare. The announcement followed two reports released by the Department of Health and Human Services (HHS) Office of Inspector General (OIG) that found over 80 percent of hospices that provided care for Medicare beneficiaries between 2012 and 2016 had at least one deficiency, including poor care management and inadequate assessment, amid a lack of strict reporting requirements and enforcement tools.

CMS Asks for Feedback to Reduce Regulatory Burdens

On June 6, the Centers for Medicare and Medicaid Services (CMS) announced a request for information (RFI) asking for another round of feedback on ways to cut administrative and regulatory burden through its Patients over Paperwork campaign, an initiative to lower health care costs. The RFI specifically looks for ways to cut down on the burden posed by prior authorization procedures, beneficiary enrollment and beneficiary eligibility determinations, as well as burdens on rural providers and duals.

Comments must be submitted by Aug. 12, 2019.

Find the RFI here.

Proposed Regulations/Guidance

CMS: CY 2020 and 2021 New Home Infusion Therapy Benefit, Payment and Policy Changes for Home Health Agencies

On July 11, the Centers for Medicare and Medicaid Services (CMS) proposed a new rule that includes routine updates to the home health payment rates for calendar year (CY) 2020. This rule will also include: a proposal to modify the payment regulations pertaining to the content of the home health plan of care; a proposal to allow therapist assistants to furnish maintenance therapy; and a proposal related to the split percentage payment approach under the Home Health Prospective Payment System (HH PPS). This rule includes proposals related to the implementation of the permanent home infusion therapy benefit in 2021, as the 21st Century Cures Act requires.

Medicare payments under the rule would increase in 2020 by 1.3 percent, or $250 million. Instead of paying for the volume of therapy sessions, CMS will pay providers based on their patients’ clinical characteristics. The new system will be based on a 30-day span of care, half the previous benchmark of 60 days. The rule also includes an 8 percent rate cut within a new home health pay model, which accounts for changes in home health agency behavior expected under the new system.

The proposed rule will be published here, on July 18, 2019.

Find more details in the CMS press release here.

CMS: Monitoring of Medicaid Beneficiary Access for Patients While Relieving Administrative Burden for States

On July 11, the Centers for Medicare and Medicaid Services (CMS) proposed a new rule to rescind 2015 Medicaid requirements on states when monitoring and analyzing certain data on beneficiaries’ access to care. The proposed rule replaces the ongoing access reviews required by current regulations with an outcomes-driven approach to monitoring access across delivery systems, using workgroups and technical expert panels that include state and federal stakeholders.

CMS also issued guidance to states for ongoing statutory responsibilities to ensure appropriate access to care for beneficiaries. The purpose of the rule would be to relieve administrative burden on states, while still holding them accountable for care to beneficiaries.

The proposed rule will be published here, on July 15, 2019.

Find more details in the CMS press release here.

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 next year and end in December 2024.

Find the unpublished, proposed rule here.

FDA: Treatment for Heart Failure — Endpoints for Drug Development

On June 28, the Food and Drug Administration (FDA) released draft guidance seeking to clarify that an effect on symptoms or physical function, without a favorable effect on survival or risk of hospitalization, can be a basis for approving drugs to treat heart failure. The guidance also provides recommendations to sponsors on the need to assess mortality effects of drugs under development to treat heart failure.

Find the draft guidance here. Public comments are due by Aug. 28, 2019.

FDA: Biologics License Applications and Master Files

On June 28, the Food and Drug Administration (FDA) proposed a rule that allows biologic products to continue to include certain information, by reference, in drug master files even after having completed the transition from being regulated as drugs to being licensed as biologics. The goal of the proposal is to avoid disruptions and potential shortages. This includes insulin, which has been historically regulated as a drug and not a biologic. The proposed rule also codifies the FDA’s practice of allowing applications for biologics submitted under the Public Health Service Act (PHSA) to incorporate, by reference, certain information in master files, except for information related to the drug substance, drug substance intermediate or drug product.

Find the FDA press release here.

Find the proposed rule here. Public comments are due on Aug. 27, 2019.

FDA Considering New Incentives for Safer Pain, Addiction Therapies

On June 20, the Food and Drug Administration (FDA) released a draft guidance weighing broader public health effects as it reviews proposed opioids that could be safer pain and addiction therapies, as well as any comparative advantage the proposed product would have over currently approved analgesics. The FDA also announced a public hearing for Sept. 17 to discuss the FDA’s benefit-risk assessment of opioid analgesics, including the manner in which risks of misuse and abuse of these products factor into the benefit-risk assessment.

Find the draft guidance, “Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework,” here.

Public comments are due by August 20, 2019.

Other

FCC Advances $100 Million Telehealth Pilot Proposal

On July 10, the Federal Communications Commission (FCC) unanimously approved a proposal for a $100 million fund to use telehealth to reach low-income Americans, particularly in rural areas. The three-year Connected Care Pilot Program, put forward by Republican commissioner Brendan Carr, would cover up to 85 percent of certain internet connectivity costs for health care organizations participating in the pilot. The FCC is now seeking public comment on the proposal.

Find the “Notice of Proposed Rulemaking” here.

Courts

Home Care Providers Group Files Suit to Test Janus v. FSCME Ruling

On July 11, a group of California home care providers filed a class action lawsuit in federal court seeking to stop the state from withholding union dues from Medicaid payments to providers who no longer want representation. The nonprofit group, Freedom Foundation, is representing the home care providers in the U.S. District Court for the Southern District of California. The case is seen as a test of whether all union membership cards signed prior to the Supreme Court’s 2018 Janus v. AFSCME ruling are invalid. The 2018 ruling barred public-sector unions from collecting mandatory fees from union nonmembers to cover their share of collective bargaining costs.

Federal Court Stops Trump Administration DTC Advertisement Rule

On July 8, the U.S. District Court for the District of Columbia threw out the Trump administration’s rule requiring drug manufacturers to disclose list prices in television advertisements. Judge Amit Mehta found that regulating television ads for prescription drugs is outside the authority of the Centers for Medicare and Medicaid Services (CMS). The rule was set to be enacted on July 9.

Find Judge Mehta’s full opinion here.