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Jul 1, 2019

Washington Healthcare Update

This week in Washington: Congress is in recess for the July 4th holiday. 

Upcoming Hearings/Markups

Congress

Hearings/Markups

House

Senate

Administration

Final Rules/Guidance

Proposed Regulations/Guidance

Courts


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.

Congress

Hearings/Markups

House Committee on Energy and Commerce: “Reauthorizing Vital Health Programs for American Families"

Tuesday, June 25, 2019 - The Health Subcommittee of the Committee on Energy and Commerce held a legislative hearing on health care bills that reauthorize a variety of health programs for Americans:

  • H.R. 776, the “Emergency Medical Services for Children Program Reauthorization Act of 2019” reauthorizes the Emergency Medical Services for Children Program at $22.334 million each year through 2024.
  • H.R. 1058, the “Autism CARES Act of 2019” reauthorizes funding for programs at the National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC) and Health Resources and Services Administration (HRSA) through 2024.
  • H.R. 2035, the “Lifespan Respite Care Reauthorization Act of 2019” reauthorizes the Lifespan Respite Care Program at $20 million in fiscal year (FY) 2020 and increases the funding level by $10 million each year thereafter through FY 2024. It would also add new reporting requirements for program grantees.
  • H.R. 2507, the “Newborn Screening Saves Lives Reauthorization Act of 2019” reauthorizes newborn screening programs for five years. The bill includes reforms to ensure that the activities of the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) are transparent, including requiring the creation of a publicly accessible website that details the uniform screening panel nomination process. The bill also requires the Centers for Disease Control and Prevention (CDC) to standardize data collection and reporting to track and monitor newborn screening in real time. Additionally, the bill orders a study on the modernization of newborn screening. The bill authorizes appropriations of $60.65 million per year through 2024.

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

House Ways and Means Committee: “Markup of Health Legislation”

Wednesday, June 26, 2019 - The House Ways & Means Committee held a markup and advanced five Medicare-related bills, including legislation to expand coverage of telehealth services for mental health treatment, eliminate beneficiary cost sharing for chronic care management services and add 1,000 new residency slots under the Graduate Medical Education (GME) program.

  • H.R. 3414, the Opioid Workforce Act: Funds 1,000 new residency positions in the areas of addiction medicine and psychiatry, under the GME program, over the next six years.
  • H.R. 3417, the BETTER Act: Includes various Medicare proposals, and one provision expands Medicare’s coverage of telehealth services for mental health treatment by eliminating restrictions on originating sites so that beneficiaries can receive the services in their homes. The package also extends funding for the National Quality Forum and State Health Insurance Programs before funding expires; provides more outreach and education to people before they become eligible for Medicare; and fixes a technical issue in existing law that, according to committee members, prevents some rural and community hospitals from establishing GME programs.
  • H.R. 3436, the Improving Chronic Care Management Act: Eliminates the coinsurance paid by beneficiaries receiving chronic care management services. That benefit was created in 2015 and provides care coordination to people with two or more chronic conditions.
  • H.R. 3439, the Protecting Patient Access to Information for Effective and Necessary Treatment Act: Extends funding for the Patient-Centered Outcomes Research Trust Fund through fiscal 2026. The committee rejected two Republican amendments: one seeking to convert PCORI’s funding mechanism from mandatory spending to discretionary spending, and another seeking to repeal the Affordable Care Act’s tax on health insurers.
  • H.R. 3429, the HEARTS and Rural Relief Act: Allows veterans to retain coverage under TRICARE, the veterans’ health coverage program, without having to pay Medicare premiums. It also adds an ambulatory surgical center representative to the advisory panel on hospital outpatient payment, exempts accessories for certain wheelchairs from the competitive bidding program and codifies a delay in CMS’ direct supervision rule for critical access hospitals for two years.

Find markup updates here.

Senate Committee on Health, Education, Labor and Pensions (HELP):“Executive Session/Markup of S. 1199, S. 1173, S. 1895”

Wednesday, June 26, 2019 - The Senate Committee on Health, Education, Labor and Pensions (HELP) held a markup and passed the following to the Senate floor:

  • S. 1199, Poison Center Network Enhancement Act of 2019
  • S. 1173, Emergency Medical Services for Children Reauthorization Act of 2019
  • S. 1895, Lower Health Care Costs Act

Why this is important:

The first two bills, S. 1199 and S. 1173, passed by voice vote and were reported favorably as amended (unanimous consent to a manager’s amendment).

S. 1895 was passed 20-3 and reported favorable as amended to the Senate floor. While the amended final bill chose the benchmarking pricing option as a deterrent to surprise medical billing, the committee passed Sen. Cassidy’s amendment 12-11, requiring insurance companies to post accurate lists of who is in-network, so patients have a better chance of avoiding surprise bills. The committee also passed an amendment from Sens. Baldwin (D-WI) and Braun (R-IN), 16-7, requiring pharmaceutical companies to disclose certain information about a drug, such as the cost of its research and development and advertising funds, if the price of a drug over $100 climbs more than 10 percent in one year or 25 percent over three years.

The package also includes a measure from Sen. Mitch McConnell (R-KY), the majority leader, and Sen. Tim Kaine (D-VA) to raise the smoking age in every state to 21 from 18. The decision to add the majority leader’s bill to S. 1895 could help the package reach the Senate floor this summer.

Find markup updates here.

Senate Committee on the Judiciary: “Executive Business Meeting”

Thursday, June 27, 2019 - The Senate Committee on the Judiciary held a markup and passed the following drug-pricing bills:

  • S. 1227, Prescription Pricing for the People Act of 2019: The bipartisan bill requires the Federal Trade Commission (FTC) to study the role of intermediaries in the drug supply chain and then make recommendations to Congress on fixing the system.
  • S. 440, the Preserving Access to Cost Effective Drugs (PACED) Act: Ranking Member Feinstein (D-CA) argued that the bill was unnecessary due to court precedent and was too far-reaching. The bill prohibits patent holders from using tribal or foreign government sovereign immunity as a defense in proceedings before the U.S. Patent Office, the courts and the International Trade Commission. The bill reinforces last year’s ruling by the U.S. Court of Appeals for the Federal Circuit, which struck down tribal sovereign immunity in patent proceedings. The court expanded on that ruling last week when it determined states also do not have sovereign immunity from patent proceedings. The bill applies to all patents, not just those for pharmaceuticals. 
  • S. 1224, Stop Significant and Time-Wasting Abuse Limiting Legitimate Innovation of New Generics, Stop STALLING Act: The bipartisan bill gives the FTC the authority to deter the use of sham citizen petitions to delay generic or biosimilar competition. 
  • S. 1416, Affordable Prescriptions for Patients Act of 2019: The amended version of the patent bill, by Sens. John Cornyn (R-TX) and Richard Blumenthal (D-CT), is meant to stop the anticompetitive use of patents by codifying definitions of “product hopping” and “patent thicketing” within the FTC Act and empowering the FTC to bring antitrust suits against companies that abuse the patent system.

Find markup updates here.

House

Energy and Commerce Chair Requests Updates on Imported Cosmetics Inspections from FDA

On June 26, House Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) sent a letter to the Food and Drug Administration (FDA) requesting updated information on the inspections of imported cosmetic products. Rep. Pallone’s request follows an announcement from the FDA that it has not conducted any foreign cosmetic inspections in Fiscal Year (FY) 2019 and does not intend to conduct any inspections in FY 2020.

Find the letter here.

Senate

Stabenow, Collins Introduce Bipartisan Bill Focused on Maternal Health Measures for Medicaid, CHIP

On June 25, Sens. Debbie Stabenow (D-MI) and Susan Collins (R-ME) introduced a bipartisan bill that creates maternal and infant health quality measures for Medicaid and the Children’s Health Insurance Program (CHIP) as well as provides funding for regional groups to improve maternal care. The Quality Care for Moms and Babies Act also sets higher care standards in Medicaid and the Children’s Health Insurance Program.

Senate Passes Legislation to Extend Medicaid Funding to Community Behavioral Health Centers

On June 27, the Senate passed legislation to extend by two weeks a program that provides Medicaid funding to about 78 clinics designated “certified community behavioral health centers,” in eight states, and charged with moving mental health and addiction treatment into primary care settings. Sens. Blunt (R-MO) and Stabenow (D-MI) want to eventually expand the effort to every state, if they can overcome cost concerns.

If federal funding dries up, the clinics will remain open but their enhanced federal matching dollars would disappear, resulting in layoffs and diminished services.

Sen. Rand Paul (R-KY) held up a House-passed two-year funding plan last week as part of a broader Medicaid funding bill.

Program backers are eyeing a longer temporary extension to fund the existing effort through the rest of the fiscal year, then come up with a plan to expand it to more states.

Administration

CMS Delays Proposal to Make Medicaid Transportation Benefit Optional

According to the Centers for Medicare and Medicaid Services’ (CMS) regulatory agenda, CMS is postponing a proposed rule that allows states to opt out of providing transportation for beneficiaries to travel to and from nonemergency medical appointments. The proposed rule is now expected to be released in 2021.

Find the regulatory agenda 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

CMS Releases Guidance to Combat Medicaid Eligibility Errors

On June 20, the Centers for Medicare and Medicaid Services (CMS) issued guidance to state Medicaid agencies with necessary assurances that states should make to ensure that program resources are reserved for those who meet eligibility requirements. CMS added that it is developing an assurance program, based on the program readiness checklist included in the guidance, for states that have already expanded. The guidance added that assurance templates can be used by states to attest that they have proper systems and procedures in place to make sure the larger federal match they claim for the expansion population is appropriate.

Find more on the guidance here.

President Trump Signed Executive Order on Health Price Transparency

On June 24, President Trump signed an executive order directing the Department of Health and Human Services (HHS) to develop regulations requiring hospitals to post negotiated rates for shoppable items and services. The order also touched upon increasing access to data, changes in health savings accounts and flexible savings accounts, as well as quality.

MWC Senior VP, Stephanie Kennan outlined the action items from President Trump's executive order, including changes to high-deductible health plans and increased access to data.

Find a timeline of the executive order here.

Proposed Regulations/Guidance

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 on 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.

Find the press release here.

CMS: Fiscal Year (FY) 2020 Medicare Hospital Inpatient Prospective Payment System (IPPS) and Long-Term Acute Care Hospital (LTACH) Prospective Payment System

On April 23, 2019, the Centers for Medicare and Medicaid Services (CMS) proposed to update Medicare payment policies for hospitals under the Inpatient Prospective Payment System (IPPS) and the Long-Term Acute Care Hospital (LTACH) Prospective Payment System (PPS) for fiscal year 2020. The proposals include a raise in pay for low-wage hospitals by cutting pay for high-wage hospitals, as part of the reforms to the hospital wage index, as well as raising the add-on pay for new technology and providing a path for breakthrough devices approved by the Food and Drug Administration (FDA) to access add-on payments. CMS also proposed policy changes to increase significantly Medicare pay to hospitals for administering expensive chimeric antigen receptor T-cell (CAR-T) cancer drugs and make it easier for hospitals to get the maximum possible reimbursement for administering the CAR-T cell therapies.

Find the proposals here.

Courts

U.S. Supreme Court Agrees to Hear ACA Risk Corridor Case

The Supreme Court agreed to consider whether the government had an obligation to pay private health insurers funds meant to offset insurer losses for having sicker patients in the first few years of the ACA exchanges. The “risk corridor” program was a three-year program and has ended; however, insurers argue that they are owed more than $12 billion. The court will hear consolidated cases during the next term which starts in October.

Fifth Circuit Questions Standing of Parties Defending ACA in Texas v. Azar

On June 26, the Fifth Circuit Court of Appeals asked the parties in Texas v. Azar to respond to questions related to whether the Democratic attorneys general and House have standing to intervene in the case anymore, and, if not, what that means for the appeal. With the administration and the plaintiff states now holding the same position against the Affordable Care Act (ACA) in the case, the intervenors are considered to be the only parties currently defending the ACA. To appeal a decision that the primary party, the administration in this case, does not challenge, an intervenor must independently demonstrate standing.

If there is no standing for intervention, there will no longer be a party defending the ACA. However, the Department of Justice (DOJ) has not clearly declared that the full ACA should be invalidated. If there is no case or controversy, then the case is moot, and the court would lack jurisdiction over the appeal. The Fifth Circuit would then decide to vacate the lower court’s decision, or leave that decision in place.


If you have any questions, contact the following individuals at McGuireWoods 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 and economic development, strategic communications & grassroots, and government relations services. McGuireWoods Consulting is a subsidiary of the McGuireWoods LLP law firm and has been named in The National Law Journal's special annual report, "The Influence 50," for the past several years. In the most recent report, McGuireWoods Consulting was ranked 15th of the 1,900 government relations firms in Washington, D.C.

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