This Week: CHIP legislation moves forward in House and Senate; budget resolutions move; hearing on drug prices to come; Administration rolls back birth control coverage

1. Congress

House

House Energy and Commerce Subcommittee on Health Considers “Right to Try Legislation”

On Oct. 3, the House Energy and Commerce Subcommittee on Health held a hearing during which FDA Commissioner Scott Gottlieb asked the committee to change the Right to Try legislation passed by the Senate by reducing the patient population covered, restricting promotion and commercialization of experimental drugs, and protecting the FDA from federal tort liability. Energy and Commerce Chairman Greg Walden (R-OR) noted there is not much interest in the Senate to revisit the Senate-passed legislation, which makes it difficult for the House to change it. Right to Try prevents the FDA from restricting experimental drugs that have completed phase I clinical trials from being produced, manufactured, distributed, prescribed or dispensed. The Senate bill includes changes to the original language by scaling back a national liability shield for pharmaceutical companies, preempting state laws and among other modifications.

Energy and Commerce Ranking Member Frank Pallone (D-NJ) stated the bill has potential to be harmful to the FDA’s protection of patients and focus should be centered on the FDA’s compassionate use program. Gottlieb also pointed to the FDA’s improvements to access the expanded use program.

To view the hearing and press release, click here.

House Energy and Commerce Committee Moves CHIP Legislation

On Oct. 4, the House Energy and Commerce Committee passed CHIP legislation on a party line vote, 28-23, to extend funding for five years. The bill is similar to the Senate Finance version to continue funding through 2022. The bill would reduce the ACA’s 23 percent increase in federal matching grants in two years and edits the law’s “maintenance of effort” requirement. It also was amended to aid the USVI with Medicaid funds, in addition to providing $1 billion for Puerto Rico.

Although Democrats object, the House GOP has proposed pay-fors for CHIP legislation by increasing means-testing in Medicare for wealthy seniors, allowing states to remove lottery winners from Medicaid and changing Medicaid’s third-party liability policy.

To view the bill, click here.

Energy and Commerce Committee Reports Eight Bills

On Oct. 4, the Energy and Commerce Committee reported out eight bills:

  • H.R. 3922, the Community Health and Medical Professionals Improve Our Nation (CHAMPION) Act, authored by Chairman Walden. This legislation would extend funding for Community Health Centers, the Special Diabetes Programs, the National Health Service Corps, Teaching Health Center Graduate Medical Education, Family-to-Family Health Information Centers, the Youth Empowerment Program and Personal Responsibility Education. H.R. 3922 passed by a party line vote of 28-23. Democrats were concerned with how the bill would be funded.
  • H.R. 1148, the Furthering Access to Stroke Telemedicine Act of 2017, authored by Rep. Morgan Griffith (R-VA) and Rep. Joyce Beatty (D-OH). This legislation would expand the ability of patients presenting at hospitals or at mobile stroke units to receive a Medicare-reimbursed neurological consult via telemedicine. H.R. 1148 passed by voice vote.
  • H.R. 2465, the Steve Gleason Enduring Voices Act of 2017, authored by House Republican Conference Chair Rep. Cathy McMorris Rogers (R-WA), House Majority Whip Rep. Steve Scalise (R-LA) and Rep. John Larson (D-CT). This legislation would make coverage of speech-generating devices under “routinely purchased durable medical equipment” permanent under the Medicare program. H.R. 2465 passed by voice vote.
  • H.R. 2557, the Prostate Cancer Misdiagnosis Elimination Act of 2017, authored by Rep. Larry Bucshon (R-IN) and Rep. Bobby Rush (D-IL). This legislation would provide for coverage of DNA Specimen Provenance Assay (DSPA) testing for prostate cancer. H.R. 2557 passed by voice vote.
  • H.R. 3120, to reduce the volume of future electronic health record-related significant hardship requests, authored by Chairman Burgess and Rep. Debbie Dingell (D-MI). This legislation would amend the Health Information Technology for Economic and Clinical Health (HITECH) Act to remove the mandate that meaningful use standards become more stringent over time and allows the Department of Health and Human Services (HHS) to be more deliberative in such evaluations. H.R. 3120 passed by voice vote.
  • H.R. 3245, the Medicare Civil and Criminal Penalties Act, authored by Rep. Gus Bilirakis (R-FL) and Rep. Kathy Castor (D-FL). This legislation would update both penalties within the Medicare program, many of which have not been updated in 20 years. H.R. 3245 passed by voice vote.
  • H.R. 3263, to extend the Medicare Independence at Home Medical Practice Demonstration Program, authored by Chairman Burgess and Rep. Dingell. This legislation would extend the Independence at Home Medical Practice Demonstration Program (IAH), which provides for two additional years, a home-based primary care benefit to high-need Medicare beneficiaries with multiple chronic conditions, ideally allowing them to avoid unnecessary hospitalizations, ER visits and nursing home use..H.R. 3263 passed by voice vote.
  • H.R. 3271, the Protecting Access to Diabetes Supplies Act of 2017, authored by Rep. Diana DeGette (D-CO) and Rep. Susan Brooks (R-IN). This legislation would address several issues beneficiaries have reported facing under the competitive bidding program regarding Diabetes Test Strips (DTS). Among those issues are providing enhanced reporting that will aid Congress and CMS in ensuring beneficiaries are receiving the diabetic testing supplies they need to manage their condition. H.R. 3271 passed by voice vote.

Another bill, H.R. 849, the Protecting Seniors’ Access to Medicare Act of 2017, authored by Rep. Phil Roe (R-TN) and Rep. Raul Ruiz (D-CA), was scheduled to be considered in the markup but was not. This legislation would repeal the Independent Payment Advisory Board (IPAB) created under the Affordable Care Act.

Energy and Commerce Announces Hearing on 340B Drug Discount Program

On Oct. 11, the House Energy & Commerce oversight subcommittee will hold another hearing on the 340B drug program, specifically, on how providers use it. Energy & Commerce Chair Greg Walden (R-OR) and oversight subcommittee Chair Tim Murphy (R-PA) have reached out to 19 providers of 340B to explain the savings received from the program and how they are used. The witnesses for the hearing are:

  • Sue Veer, President and CEO of Carolina Health Cares, Inc.;
  • Mike Gifford, President and CEO of AIDS Resource Center of Wisconsin;
  • Ronald Paulus, President and CEO of Mission Health Systems, Inc.;
  • Charles Reuland, Executive Vice President and COO at Johns Hopkins Hospital; and
  • Shannon Banna, Director of Finance at Northside Hospital, Inc.

Previously, the Health Resources and Services Administration was asked about how 340B providers use savings. The representative from Health Resources and Services Administration stated the agency doesn’t have the authority to oversee that.

To view the hearing page, click here.

House Passes Budget Resolution

On Oct. 5, House Republicans passed a budget resolution that opens the door for tax reform and cuts in entitlement programs. It is considered the most conservative fiscal statement in 20 years. The Senate Budget Committee is working on its own version of the fiscal 2018 budget and it is expected to come to the floor later this month.

The budget resolution is not a law and is not signed by the President. The budget resolution is an outline of the majority party’s fiscal goals. The House-passed resolution shows:

  • A commitment to draft a tax reform plan.
  • A requirement for $203 billion to be cut from entitlement programs over 10 years, including a dramatic plan to overhaul Medicare, developed by Speaker Paul Ryan (R-WI) when he was budget chairman. Also included would be cuts to programs like food stamps, agricultural subsidies and housing assistance.
  • A repeal of the Affordable Care Act’s subsidies, tax increases and Medicaid expansion funding. In its place, they would enact the House-passed replacement package that failed in the Senate this past summer.
  • A goal of creating a budget surplus within a decade.

The differences between the House resolution and what the Senate ultimately passes will have to be worked out in a conference committee.

To view the resolution, click here.

Senate

Senate Finance Committee Acts on CHIP Legislation

On Oct. 4, the Senate Finance Committee reported out of committee S. 1827, the bipartisan funding package for the Children’s Health Insurance Program (CHIP), which expired Sept. 30, for five years and continues the program’s contingency fund. The bill also extends ACA funding by 23 percent for two years and then winds down during the following two years. Sen. Pat Toomey (R-PA) withdrew amendments that prohibit CHIP funds’ being used for unrelated programs. Sen. Cornyn (R-TX) withdrew an amendment repealing Medicare’s Independent Payment Advisory Board. As Congress missed the Sept. 30 deadline to renew funding, 10 states are expected to run out of funding by the end of the year.

Senate HELP Committee Plans Second Hearing on Drug Prices

The Senate’s HELP Committee announced that it will hold a hearing on Oct. 17 that will focus on how the drug delivery system affects the prices patients pay. The session is the second of three that HELP is holding on the various drivers of drug costs.

The witnesses are:

  • Lori M. Reilly, Executive Vice President, Policy, Research & Membership, Pharmaceutical Research and Manufacturers of America, Washington, D.C.
  • Chester “Chip” Davis, Jr., President and Chief Executive Officer chief executive officer, Association for Accessible Medicines, Washington, D.C.
  • Elizabeth A. Gallenagh, Senior Vice President, Government Affairs, and General Counsel, Healthcare Distribution Alliance, Arlington, VA
  • Mark Merritt, President and Chief Executive Officer, Pharmaceutical Care Management Association, Washington, D.C.
  • Thomas E. Menighan, BSPharm, MBA, ScD (Hon.), , Executive Director and Chief Executive Officer, American Pharmacists Association, Washington, D.C.

To view the hearing page, click here.

Senate Budget Committee Approves Budget Resolution

On Oct. 4, the Senate Budget Committee approved a FY 2018 budget plan that would give legislators the leeway to add $1.5 trillion to the deficit over a decade so as to overhaul the tax code. The budget resolution, passed 12-11, is expected to be considered on the Senate floor the week of Oct. 16.

If the Senate passes the measure, a conference committee will work out the differences between the Senate’s plan and the House-passed version.

The Senate’s budget resolution calls for drastic reductions in domestic spending. During the markup, the panel rejected an amendment in a party line vote that would strike instructions in the budget that allow Congress to find $473 billion in savings from Medicare over a decade.

Democrats have made reductions in Medicare their primary complaint with the budget document. Republicans argue that their budget would not cut Medicare but would simply allow Congress to slow the program’s rate of growth.

2. Administration

Administration Rolls Back Contraception Coverage

On Oct. 6, the Administration released new rules that would allow almost any employer to claim a religious or moral objection to the Affordable Care Act’s birth control coverage mandate. The new policy takes effect immediately.

The Affordable Care Act’s requirement to provide FDA-approved contraception at no cost has been opposed by religious groups ever since the mandate went into effect in 2012. The Obama Administration had accepted a recommendation from an independent panel to require plans to cover it at no cost to women with exceptions for houses of worship. The previous administration also tried unsuccessfully to make accommodations for religiously affiliated groups to allow their employees to still receive the coverage from a third party. However, those groups rejected the accommodations and filed lawsuits, leading to two separate Supreme Court challenges, including the Hobby Lobby decision. The Supreme Court last year ordered the Obama administration and religiously affiliated organizations, such as universities and charities, to reach agreement on an accommodation that would let employees of such groups have access to no-cost contraception. They never resolved the issue.

The birth control coverage mandate is broadly supported by the public, polling has found over the years, and about 55 million women have directly benefited from no-cost birth control, according to an Obama administration report released last year.

The Trump administration argues that women have affordable contraceptive options should employers drop coverage, and that several government programs provide free or subsidized contraception for low-income women, including Title X family planning grants.

CMS: Hospice Compare Fact Sheet Now Available

CMS has released a new fact sheet for the Hospice Quality Public Reporting page. The fact sheet has information on Hospice Compare and resources available to providers in reference to quality ratings. The fact sheet also includes approaches on communication with patients and family members.

To view the fact sheet, click here.

CMS Innovation Center New Direction RFI: Submit Comments by Nov. 20

On Sept. 20, the CMS Innovation Center issued a request for information, seeking information on a new methodology to develop patient-centered care and also to experiment with market-driven reforms that empower beneficiaries as consumers, to provide more choice and transparency.

Comments can be submitted by clicking here.

3. Reports

Newborn Health: Federal Action Needed to Address Neonatal Abstinence Syndrome

The rising opioid epidemic has contributed to an increase in the number of babies born with neonatal abstinence syndrome—a withdrawal condition with symptoms including excessive crying and difficulty breathing.

The Department of Health and Human Services identified key recommendations to help guide its efforts to prevent and treat this syndrome—such as providing medical education to health care providers on how to treat these infants. However, GAO found that it is unclear how the department will implement these recommendations, if at all. GAO recommended that HHS develop a plan to implement these recommendations.

To read the report, click here.