This week in Washington: Senate to hold hearings on the enforcement of antitrust laws and elder justice, while the House plans to hold a member day hearing and examine the Social Security 2100 Act.

Upcoming Hearings/Markups

Congress

Hearings/Markups

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

House

• Bipartisan Medical Marijuana Research Bill Reintroduced
• House Passes Cadillac Tax Repeal
• House Republicans Ask FDA to Expand Parallel Track Pathway

Senate

• CBO Score: Lower Health Care Costs Act Could Save $7.6 Billion by 2029
• Lower Health Care Costs Act Fails to Pass by Unanimous Consent

Administration

• HHS Announces Summit to Begin New Quality Roadmap
• CMS Asks for Feedback to Reduce Regulatory Burdens

Final Rules/Guidance

• IRS Issues Guidance Related to President Trump’s Transparency Executive Order
• CMS Rolls Back Ban on Binding Arbitration for Nursing Home Residents

Proposed Regulations/Guidance

• CMS: Proposed Radiation Oncology (RO) Model
• FDA: Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process
• FDA: Using the Inactive Ingredient Database
• 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

Courts

• Judge Permits Short-Term Health Plans
• DOJ: Insurers Not Financially Damaged by Ending CSRs

Reports

• GAO: VA Mental Health – VHA Improved Certain Prescribing Practices, but Needs to Strengthen Treatment Plan Oversight
• GAO: Medicare – Limited Information Exists on the Effects of Synchronizing Medication Refills

Upcoming Hearings/Markups

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.

Senate Committee on Finance: “Promoting Elder Justice: A Call for Reform”
The Senate Committee on Finance will hold a hearing examining elder abuse by health care providers. Find witness testimonies and hearing updates as they become available here.

Thursday, July 25, 2019

House Ways and Means Committee: “Legislative Hearing on the Social Security 2100 Act”
The House Ways and Means Committee will hold a hearing examining H.R. 860, the Social Security 2100 Act, introduced by Rep. John Larson (D-CT). Find the legislation here. Find witness testimonies and hearing updates as they become available here.

House Committee on Energy and Commerce: “Member Day Hearing”
The House Committee on Energy and Commerce will hold a “Member Day” hearing, which will be focused on issues within the committee’s jurisdiction and will highlight specific legislation or issues of importance. There will likely be health-related legislation mentioned. Find hearing updates as they become available here.

Congress

Hearings/Markups

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

Tuesday, July 16, 2019: 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.

Why this is important: Members acknowledge that the Food and Drug Administration (FDA), Customs and Border Protection (CBP), Drug Enforcement Administration, the Department of Homeland Security and the U.S. Postal Service have worked to address the spread of illicit fentanyl. Yet, they told the agency witnesses that a lack of data sharing among the agencies is a challenge in properly doing so.

House Committee on Energy and Commerce: Full Committee Markup

Wednesday, July 17, 2019: The House Committee on Energy and Commerce held a committee markup on 26 total bills, 12 of which were health care–related legislation. All 12 were favorably reported, as amended, to the House floor. Most notably, Chairman Frank Pallone (D-NJ) offered an amendment in the nature of a substitute, to add H.R. 3631, the “Territories Health Care Improvement Act” and H.R. 3630, the “No Surprises Act” into the package H.R. 2328, the “Reauthorizing and Extending America’s Community Health Act” or the “REACH Act.”

To address concerns on the benchmark pricing provision in H.R 3630, a bill to address “surprise bills,” Reps. Ruiz (D-CA) and Bucshon (R-IN) introduced an amendment that allows providers and insurers to appeal to a neutral arbiter in cases where the billed charges exceed $1,250. The arbiter will have final say over payment. The amendment was passed by voice vote.

Other legislation from the markup that was favorably reported includes:

• H.R. 2211, the “Stop Tip-Overs of Unstable, Risky Dressers on Youth Act” or the “STURDY Act”
• H.R. 3172, the “Safe Sleep for Babies Act of 2019”
• H.R. 3170, the “Safe Cribs Act of 2019”
• H.R. 2781, the “Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act of 2019” or the “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 Act of 2019” or the “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 “More Efficient Tools to Realize Information for Consumers Act’’ or the “METRIC Act”
• H.R. 2328, the “Reauthorizing and Extending America’s Community Health Act” or the “REACH Act”

Find details of the markup, with amendments and vote tallies, here.

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”

Thursday, July 18, 2019: 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.

Why this is important: This hearing addressed the proliferation of counterfeit products sold in online marketplaces, including fake drugs. The U.S. Patent and Trademark Office’s (USPTO) commissioner for trademarks warned of Chinese filers of fraudulent trademarks. One witness, on behalf of the International Trademark Association (INTA), asked that amendments be made to the Lanham Act to restore the presumption of irreparable harm. The committee is considering next steps.

House

Bipartisan Medical Marijuana Research Bill Reintroduced

On July 18, a bipartisan group of representatives reintroduced a bill that requires the Food and Drug Administration (FDA), in consultation with the National Institute on Drug Abuse (NIDA), to issue guidelines on the production of marijuana. The proposed Medical Marijuana Research Act of 2019 (H.R. 601) amends the Controlled Substances Act (CSA) to establish a new, separate registration process to facilitate research on marijuana for medical purposes.

Reps. Andy Harris (R-MD), Earl Blumenauer (D-OR), Zoe Lofgren (D-CA), Morgan Griffith (R-VA), Debbie Dingell (D-MI) and Rob Bishop (R-UT) reintroduced the bill.

House Passes Cadillac Tax Repeal

On July 17, the House passed, 419-6, a bill to fully repeal the Affordable Care Act’s (ACA) 40 percent tax on high-cost health plans, known as the Cadillac tax. According to the Congressional Budget Office (CBO), repealing the tax will cost the government $196.9 billion over 10 years. Reps. Joe Courtney (D-CT) and Mike Kelly (R-PA) sponsored the bipartisan bill.

House Republicans Ask FDA to Expand Parallel Track Pathway

On July 11, House Republicans sent a letter to the Food and Drug Administration (FDA) arguing that the FDA’s Parallel Track program could be used to provide access to breakthrough drugs while they are still in phase II and phase III of clinical trials. The letter noted that it currently takes about 10 to 12 years and as much as $2.9 billion to bring new treatments to market.

Republican Reps. Mark Walker (NC), Mark Meadows (NC), David Schweikert (AZ), Ted Yoho (FL), Jim Jordan (OH), Ted Budd (NC), Mo Brooks (AL), Steve King (IA), Thomas Massie (KY), Glenn Grothman (WI) and Ralph Norman (SC) signed the letter.

Find the letter here.

Senate

CBO Score: Lower Health Care Costs Act Could Save $7.6 Billion by 2029

On July 16, the Congressional Budget Office (CBO) released the score of the Senate Committee on Health, Education, Labor and Pensions’ (HELP) proposed bill, S.1895, the Lower Health Care Costs Act. The CBO determined that enacting the bill would increase direct spending by about $18.7 billion and increase direct revenues by $26.2 billion, resulting in a net decrease in the deficit of $7.6 billion by 2029.

The CBO states that the section of the bill providing the biosimilar or generic drug manufacturers the right to sue over sample availability and removal of the requirement for biosimilar or generic drug manufacturers to share a risk management system would, on its own, account for more than $3.7 billion in savings over 10 years. This reduction in the deficit would result partly from the ability of generics and biosimilars to reach the market one to two years earlier, on average.

Find the CBO score here.

Lower Health Care Costs Act Fails to Pass by Unanimous Consent

On July 18, the Senate attempted to pass bipartisan legislation reported to the Senate from the Health, Education, Labor and Pensions Committee, which contained provisions to lower drug prices as well as a surprise billing provision. It is believed that those who objected to its passage by UC had concerns about the benchmarking process in the surprise billing section.

Administration

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.

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.

Final Rules/Guidance

IRS Issues Guidance Related to President Trump’s Transparency Executive Order

On July 17, the Internal Revenue Service (IRS) issued guidance listing 14 preventive drugs and services used for common chronic conditions, including insulin, statin and beta-blockers, that now can be covered pre-deductible by health plans linked to health savings accounts (HSAs). The guidance follows President Trump’s June 24 executive order that directed the IRS to explore the possible changes.

Find the IRS guidance here.

CMS Rolls Back Ban on Binding Arbitration for Nursing Home Residents

On July 16, the Centers for Medicare and Medicaid Services rolled back an Obama-era policy on banning binding agreements that forbid nursing home residents from suing the facilities over cases of neglect or abuse.

A final rule from CMS makes clear that long-term care facilities may ask residents or their families to agree—before a dispute arises—to settle complaints through arbitration rather than litigation.

However, in a major change from the original CMS proposal, the final rule won’t let facilities require that residents sign a binding arbitration agreement as a condition of admission to their facility, and this must be stated explicitly in the agreement.

The rule also includes some measures aimed at making arbitration more transparent, such as ensuring the agreement is explained to residents in a manner they can understand. However, the agency declined to include proposals that the policy on binding arbitration be posted in visible areas and agreements be written in plain language.

The issue of arbitration has been contentious for years. The Obama tried to end the practice, issuing a rule to ban binding, pre-dispute arbitration agreements in facilities caring for Medicare and Medicaid patients. The American Health Care Association sued to block the rule.

A federal judge issued a temporary injunction. The Trump administration issued a new proposal in June 2017 to reverse the proposed arbitration ban and asked the court to halt the lawsuit.

Proposed Regulations/Guidance

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: Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process

On July 10, the Food and Drug Administration (FDA) released a draft guidance meant to speed up the generic drug approval process. The guidance explains how drug manufacturers should use the United States Pharmacopeia (USP) Pending Monograph Process (USP-PMP) to combine USP’s process for allowing revisions to compendial standards with the FDA’s approved quality and labeling requirements for drug product applications.

Find the draft guidance here.

Public comments must be submitted by Sept. 10, 2019.

FDA: Using the Inactive Ingredient Database

On July 10, the Food and Drug Administration (FDA) released a draft guidance that explains how drug manufacturers can better use the Inactive Ingredient Database (IID) in drug development, including to evaluate the safety of inactive ingredients, also known as excipients. The guidance discusses how the IID is structured; the data regarding excipients in the IID; and how nomenclature, maximum potency levels and units of measure are presented in the IID.

Find the draft guidance here.

Public comments must be submitted by Sept. 10, 2019.

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 Aug. 20, 2019.

Courts

Judge Permits Short-Term Health Plans

On July 19, U.S. District Judge Richard Leon ruled that the Trump administration can expand the sale of short-term health insurance policies that do not meet the standards of the Affordable Care Act (ACA). The federal judge rejected claims that policies sold under a government regulation unlawfully undermine the ACA.

DOJ: Insurers Not Financially Damaged by Ending CSRs

On July 12, the Department of Justice urged the U.S. Court of Appeals for the Federal Circuit to reverse a lower court’s ruling that the government pay billions in cost-sharing reductions (CSRs) Affordable Care Act (ACA) issuers say they are owed for 2017 and 2018, arguing Congress never said issuers could incur damage for nonpayment.

The federal appeals court is expected to schedule oral arguments within the next few weeks on the two separate, but similar, cases, Sanford Health Plan and Montana Health Plan v. USA and Community Health Choice v. USA. The same panel of judges is hearing both suits in order to address all relevant questions in the cases.

Reports

GAO: VA Mental Health – VHA Improved Certain Prescribing Practices, but Needs to Strengthen Treatment Plan Oversight

On July 17, the Government Accountability Office (GAO) released a report after officials from the five selected Department of Veterans Affairs (VA) medical centers (VAMC) spoke with the GAO and reported various factors that contribute to providers’ mental health treatment decisions, including decisions regarding the prescribing of psychotropic medications and the offering of non-pharmacologic therapy.

The GAO found that the VA’s Veterans Health Administration (VHA) has not developed guidance on the expectation to document mental health treatment plans in an easily identifiable way in veterans’ medical records. The VHA has also not monitored whether mental health providers in specialty care document the required consideration of different treatment options, such as psychotropic medications or non-pharmacologic therapy, within mental health treatment plans. However, the GAO did find that the VHA has taken steps to improve veterans’ mental health treatment through the Psychotropic Drug Safety Initiative (PDSI), an initiative focused on the safe and effective prescribing of certain psychotropic medications.

The GAO recommends:

• The Veterans Health Administration disseminate guidance for VISNs and VAMCs that more clearly reflects its expectation that mental health providers in specialty care should record mental health treatment plans within veterans’ medical records in an easily identifiable way.
• The Veterans Health Administration develop and implement an approach for monitoring treatment plans for veterans with mental health conditions to ensure that such plans include documentation that different evidence-based treatment options were considered.

Find the full report here.

GAO: Medicare – Limited Information Exists on the Effects of Synchronizing Medication Refills

On July 15, the Government Accountability Office (GAO) released a report on medication adherence. Congress included a provision in the Bipartisan Budget Act of 2018 for the GAO to review and report on the use of medication synchronization, a process whereby a pharmacist aligns the refill dates of two or more of a patient’s medications to a single day.

The GAO found that no comprehensive national data exist on the extent to which medication synchronization has been used or its potential effects. However, limited information suggests that the use of medication synchronization has increased in recent years and that it may have benefits. Most of the studies that GAO identified found positive effects from medication synchronization, primarily on patients.

Find the full report here.