Health Issues
The partial shutdown impacted the ability of key regulatory agencies, DOL, HHS and Treasury/IRS
to move forward on reviewing comment letters pertaining to the proposed HRA Excepted Benefits Rule and decide whether to extend Limited Wraparound Plans. Discussions were held to understand the status of the comments received and when decisions might be made.
Rep. David Joyce introduced H.R.383, a bill called, the Continuing Coverage for Preexisting Conditions Act of 2019, on January 9. The bill would amend the Patient Protection and Affordable Care Act to ensure that preexisting condition exclusions with respect to enrollment in health insurance coverage and group health plans continue to be prohibited.
Rep. Joe Courtney (D-CT) introduced a bill on January 24 to repeal the Cadillac tax, the Affordable Care Act's forty percent tax on high-cost health plans. H.R. 748, entitled the Middle Class Health Benefits Tax Repeal Act would amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage.
A bill, S.61, the Safe and Affordable Drugs from Canada Act of 2019, sponsored by Senator Chuck Grassley (R-IA), was introduced on January 9. The bill would amend the Federal Food, Drug, and Cosmetic Act to allow for the personal importation of safe and affordable drugs from approved pharmacies in Canada.
S. 489, a bill to establish a State public option through Medicaid to provide Americans with the choice of a high-quality, low-cost health insurance plan, was introduced on February 14 by Senator Brian Schatz (D-HI). A companion bill has been introduced in the House, which is H.R. 1277. Rep. Marcia Fudge (D-OH) is a cosponsor.
S.692, a bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on medical devices, was introduced by Senator Pat Toomey (R-PA) on March 7.
S.684, a bill to amend the Internal Revenue Code of 1986 to repeal the excise tax on high cost employer-sponsored health coverage, the Cadillac Tax was introduced on March 6 by Senator Martin Heinrich (D-NM).
H.R. 1398, a bipartisan bill to delay the re-imposition of the annual fee on health insurance providers, aka the Health Insurance Tax (HIT) until after 2021 was introduced on February 27. The bill was introduced by Rep. Ami Bera (D-CA). Rep. Steve Stivers (R-OH) introduced H.R. 1366, the Responsible Additions and Increases to Sustain Employee Health Benefits Act, RAISE Act to put flexibility back in Flexible Spending Accounts and to help families pay for out of pocket health care costs.
On February 5, H.R. 965, the CREATES Act, was reintroduced in Congress by Rep. David Cicilline (D-RI). The bill would promote competition in the market for drugs and biological products by facilitating the timely entry of lower-cost generic and biosimilar versions of those drugs and biological products.
Senator Rob Portman (R-OH) introduced the Biologic Patent Transparency Act. The bill would require companies to publicly disclose the web of patents that protect their biologics, making it easier for competitors to evaluate and plan for the development of generic versions of these drugs.
S.516, the Prescription Drug Monitoring Act of 2019, was introduced by Senator Amy Klobuchar (D-MN) on February 14. The bill would require the use of prescription drug monitoring programs.
Another Senate bill, S.475, the RxCAP Act of 2019, was introduced by Senator Ron Wyden (D-OR) on February 13. The bill would amend title XVIII of the Social Security Act to prevent catastrophic out-of-pocket spending on prescription drugs for seniors and individuals with disabilities.
Senator Sherrod Brown introduced S. 378, the Stop Price Gouging Act. The bill would penalize pharmaceutical companies that engage in price gouging without cause, leading to price spikes for patients who rely on medication to treat illnesses. H.R. 1091 is the companion House bill, which has been cosponsored by Rep. Marcy Kaptur (D-OH).
On February 7, Senator Sherrod Brown introduced legislation to address prescription drug affordability. The bill, S. 377, entitled, "The Medicare Negotiation and Competitive Licensing Act," would authorize the Secretary of Health and Human Services to negotiate drug prices and if a drug company refuses to negotiate in good faith, the secretary would be enabled to issue a competitive, compulsory license to another company that is willing and able to produce the medication as a generic.
On February 13, Senator Ron Wyden (D-OR) introduced S.476, a bill for Creating Transparency to Have Drug Rebates Unlocked (C-THRU) Act of 2019. Senator Sherrod Brown is one of the cosponsors. The bill would amend titles XI and XVIII of the Social Security Act to provide greater transparency of discounts provided by drug manufacturers.
At the end of January 2019, the Health and Human Services Department issued a proposed rule, Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. The proposed rule has been interpreted to eliminate safe harbor protection for rebates paid by drug manufacturers to pharmacy benefit managers (PBMs), Medicare Part D plans and Medicaid managed care plans; create a new safe harbor for drug discounts offered to patients at the point of sale, and
create a new safe harbor for PBM fees charged to drug manufacturers.
LobbyistsCAROL NOLAN DRAKE
Covered position (CAROL NOLAN DRAKE): Federal Liaison
TargetedSENATE · HOUSE OF REPRESENTATIVES · Health & Human Services, Dept of (HHS) · Labor, Dept of (DOL) · Treasury, Dept of · Centers For Medicare and Medicaid Services (CMS) · Internal Revenue Service (IRS)