Congress has adjourned until after the midterm elections. The folks are out trolling for votes. The Affordable Care Act is still on the books and government sponsored healthcare, aka Medicare for All is the new feel-good campaign slogan. There have been some wins for price transparency but some folks in DC are pushing government control of our medical care.
To help separate fact from fiction, AAPS is reaching out to candidates, voters, and the media with a series of questions and analysis that needs to be considered as leaders are selected in coming weeks. Click here to learn more about this initiative.
Learn more about what Congress has been doing on the health policy front, ahead of November 6, in this edition of Legislative Update by Marilyn Singleton, MD, JD:
Bills Signed by the President
On October 10, 2018, the President signed two bills designed to increased transparency of prices of pharmaceuticals.
The Know the Lowest Price Drug Act of 2018, S. 2553 was introduced March 14, 2018 by Sen. Debbie Stabenow (D-MI) and referred to the Senate Finance Committee. The bill has 9 cosponsors: John Barrasso, MD (R-WY), Bill Cassidy, MD (R-LA), Susan Collins (R-ME), Claire McCaskill (D-MO), Ron Wyden (D-OR), Sherrod Brown (D-OH), Rand Paul, MD (R-KY), Donnelly (D-IN). Rob Portman (R-OH). This bill has an effective date of January 1, 2020 and prohibits health plans and pharmacy benefit managers from restricting pharmacies from informing individuals regarding the prices for certain drugs and biologicals prescribed in connection with Medicare Part D.
The Patient Right to Know Drug Prices Act, S. 2554, was introduced by Sen. Susan Collins (R-ME) on March 14, 2018 and referred to the Senate Health, Education, Labor, and Pensions Committee. The bill has 6 cosponsors: John Barrasso, MD (R-WY), Bill Cassidy, MD (R-LA), Claire McCaskill (D-MO), Tina Smith (D-MN), Debbie Stabenow (D-MI), Joe Donnelly (D-IN). This bill takes effect immediately and applies to group and individual plans. It prohibits a health-benefits plan or pharmacy-benefits manager from restricting a pharmacy from informing an enrollee of any difference between the price of a drug or biological under the plan and the price of the drug or biological without health-insurance coverage.
Opiate Bill on the President’s Desk
H.R. 6 combines many of the 60 bills related to the opiate problem. includes Medicaid, Medicare, and public health reforms to combat the opioid crisis by advancing treatment and recovery initiatives, improving prevention, protecting communities, and bolstering efforts to combat illicit synthetic drugs like fentanyl.
Major provisions include (Republican policy committee summary):
- Require state Medicaid programs to not terminate a juvenile’s medical assistance eligibility because the juvenile is incarcerated. A state may suspend coverage while the juvenile is an inmate, but must restore coverage upon release without requiring a new application unless the individual no longer meets the eligibility requirements for medical assistance (H.R. 1925)
- Enable former foster youth who are in care by their 18th birthday and previously enrolled in Medicaid to receive health care until the age of 26 if they move out of state (H.R. 4998)
- Require the Centers for Medicare and Medicaid Services (CMS) to carry out a demonstration project to provide an enhanced federal matching rate for state Medicaid expenditures related to the expansion of substance-use treatment and recovery services targeting provider capacity (H.R. 5477)
- Require all state Medicaid programs to have a beneficiary assignment program that identifies Medicaid beneficiaries at-risk for substance use disorder (SUD) and assigns them to a pharmaceutical home program, which must set reasonable limits on the number of prescribers and dispensers that beneficiaries may utilize (H.R. 5808)
- Require state Medicaid programs to have safety edits in place for opioid refills, monitor concurrent prescribing of opioids and certain other drugs, and monitor antipsychotic prescribing for children (H.R. 5799)
- Require CMS to issue guidance on Neonatal Abstinence Syndrome (NAS) treatment options under Medicaid and require a study by the nonpartisan Government Accountability Office (GAO) on coverage gaps for pregnant women with SUD (H.R. 5789)
- Provide additional incentives for Medicaid health homes for patients with substance use disorder (H.R. 5810)
- Instruct CMS to evaluate the utilization of telehealth services in treating SUD (H.R. 5603)
- Creates a pass-through payment extension under Medicare to encourage the development of clinically superior nonopioid drugs (H.R. 5809)
- Add a review of current opioid prescriptions and, as appropriate, a screening for opioid use disorder (OUD) as part of the Welcome to Medicare initial examination (H.R. 5798)
- Incentivize post-surgical injections as a pain treatment alternative to opioids by reversing a reimbursement cut for these treatments in the Ambulatory Service Center setting, as well as collect data on a subset of codes related to these treatments (H.R. 5804)
- Require e-prescribing, with exceptions, for coverage of prescription drugs that are controlled substances under the Medicare Part D program (H.R. 3528)
- Require prescription drug plan sponsors under the Medicare program establish drug management programs for at-risk beneficiaries (H.R. 5675)
- Provide access to Medication-Assisted Treatment (MAT) in Medicare through bundled payments made to Opioid Treatment Programs for holistic service (Section 2 of H.R. 5776)
- Direct the Food and Drug Administration (FDA) to issue or update guidance on ways existing pathways can be used to bring novel non-addictive treatments for pain and addiction to patients. Several approaches have proven successful in speeding the availability of treatments for serious conditions through the FDA (H.R. 5806)
- Authorize grants to state and local agencies for the establishment or operation of public health laboratories to detect fentanyl, its analogues, and other synthetic opioids (H.R. 5580)
- Enable clinical nurse specialists, certified nurse midwives, and certified registered nurse anesthetists to prescribe buprenorphine; and make the buprenorphine prescribing authority for physician assistants and nurse practitioners permanent.
- Permit a waivered-practitioner to immediately start treating 100 patients at a time with buprenorphine (skipping the initial 30 patient cap) if the practitioner has board certification in addiction medicine or addiction psychiatry; or if practitioner provides MAT in a qualified practice setting. Medications, such as buprenorphine, in combination with counseling and behavioral therapies, provide a whole-patient approach to the treatment of opioid use disorder (H.R. 3692).”
Bills Passed by the House
On July 24, 2018, H.R. 6138, Ambulatory Surgical Center Payment Transparency Act of 2018 or ASC Payment Transparency Act, sponsored by Devin Nunes (R-CA) passed the House. This bill requires the expert outside advisory panel that reviews the Medicare prospective payment system for hospital outpatient department services to include at least one ambulatory surgical center representative. The bill also requires the Centers for Medicare & Medicaid Services to specify the criteria used to exclude certain procedures from the list of covered surgical procedures that may be performed in an ambulatory surgical center under Medicare.
On September 12, 2018, H.R. 6662, the Empowering Seniors’ Enrollment Decision Act of 2018, sponsored by Rep. Erik Paulsen (R-MN) and Rep. Ron Kind (D-WI). This legislation helps seniors by codifying the Special Enrollment Period offered to Medicare Cost Plan enrollees in regulation. This ensures these seniors will have an adequate amount of time to make a decision on Medicare coverage that is best for them. The legislation clarifies that Medicare Cost Plans have the authority to deem their existing enrollees into a new Medicare Advantage Plan in future plan years. This will minimize disruption for our seniors impacted by the mandatory Cost Plan transition.
On September 12, 2018, H.R. 6690, the Fighting Fraud to Protect Care for Seniors Act of 2018, sponsored by Rep. Peter Roskam (R-IL) and Rep. Earl Blumenauer (D-OR). This bill requires the Centers for Medicare & Medicaid Services (CMS) to establish a pilot program that evaluates the feasibility of using smart card technology to address Medicare fraud. Under the program, smart card technology must be issued free-of-charge to selected Medicare beneficiaries, suppliers, and providers; such technology must support the secure, electronic authentication of beneficiary identity at points of service. In selecting program participants, the CMS must consider the risk of fraud, waste, or abuse among categories of suppliers and providers.
On September 12, 2018, H.R. 6561, the Comprehensive Care for Seniors Act of 2018, sponsored by Rep. Jackie Walorski (R-IN), Rep. Lynn Jenkins (R-KS), Rep. Earl Blumenauer (D-OR), Rep. Ron Kind (D-WI), and Rep. Judy Chu (D-CA), Rep. Gus Bilirakis (R-FL) and Rep. Debbie Dingell (D-MI), Rep. Chris Smith (R-NJ). This bill requires the Centers for Medicare & Medicaid Services (CMS) to issue a final rule based on the provisions of a proposed rule regarding Programs of All-Inclusive Care for the Elderly (PACE) by December 31, 2018. PACE is a program under Medicare and Medicaid that provides in-home and community services for certain individuals as an alternative to nursing home care. The proposed rule updates and revises application, enforcement, and other administrative requirements. The CMS published the proposed rule in August
Government Guidelines and Price Controls
On March 1, 2018, H.R. 5150, the “Protecting Medicare from Excessive Price Increases Act of 2018 was introduced by Rep. Sander Levin (D-MI) and referred to the House Energy and Commerce and Ways and Means Committees. The bill would require drug manufacturers to pay a Medicare part B rebate for certain drugs if the price of such drugs increases faster than inflation.
On July 9, 2018, H.R. 5739, the Prescription Drug and Medical Device Price Review Board Act of 2018 was introduced by Rep. Rosa DeLauro (D-CT) and referred to the House Energy and Commerce and Ways and Means Committee. This bill would establish within HHS the Prescription Drug and Medical Device Price Review Board to regulate the prices of certain prescription drugs and medical devices. The bill prohibits “excessive price” of a prescription drug or medical device. The Board shall by regulation prescribe a formula for determining whether the average manufacturer price of such drug or device over an annual quarter is an excessive price.
On July 11, 2018, S. 3194, the Capping Prescription Costs Act of 2018 was introduced by Sen. Elizabeth Warren (D-MA) and referred to the Senate Health, Education, Labor, and Pensions Committee. The bill would amend the Patient Protection and Affordable Care Act cap prescription drug cost-sharing at $250 per month for each enrolled individual, or $500 for each family.
On August 28, 2018, S. 3392, Modernizing Obstetric Medicine Standards Act. of 2018 or the MOMS Act was introduced by Sen. Kirsten Gillibrand (D-NY) with Sen. Cory Booker (D-NJ) and Sen. Kamala Harris (D-CA) as cosponsors) and referred to the Senate Health, Education, Labor, and Pensions Committee. The bill would direct the Health and Human Services Secretary to establish the Alliance for Innovation on Maternal Health program. The program would initiate a “national data-driven maternal safety and quality improvement initiative based on evidence-based best practices to improve maternal safety and outcomes.”
The program would implement standardized best practices, to be known as “maternal safety bundles”, for the purpose of maternal mortality and morbidity prevention. The best practices would address the following topics:
(i) Obstetric hemorrhage.
(ii) Maternal mental, behavioral, and emotional health.
(iii) Maternal venous and thromboembolism.
(iv) Severe hypertension in pregnancy, including preeclampsia.
(v) Obstetric care for women with substance abuse disorder.
(vi) Postpartum care basics for maternal safety.
(vii) Reduction of racial and ethnic disparities in maternity care.
(viii) Safe reduction of primary cesarean birth.
(ix) Severe maternal morbidity review.
(x) Support after a severe maternal morbidity event.
(xi) Ways to empower and listen to women before, during, and after childbirth to ensure better communication between patients and health care providers.
(xii) Other leading causes of maternal mortality and morbidity, including infection or sepsis and cardiomyopathy
Tinkering with the Affordable Care Act
On August 28, 2018, H.R. 4616, the Employer Relief Act of 2018, was introduced by Rep. Devin Nunes (R-CA) and referred to the House Ways and Means Committee. This bill would amend the Internal Revenue Code to suspend the employer mandate for health insurance coverage until January 1, 2019. The bill amends the Patient Protection and Affordable Care Act to delay for one year, until after December 31, 2020, the implementation of the excise tax on high cost employer-sponsored health coverage (commonly referred to as the Cadillac tax).
Medicare Marches On
On September 27, 2018, H.Res. 1096 was introduced by Rep. Glenn Grothman (R-WI) and referred to the House Energy and Commerce and Ways and Means Committees. The resolution expresses the sense of the House of Representatives that
(1) the House of Representatives has a duty to work to maintain and strengthen Medicare for current and future generations of Americans; and
(2) the integrity of Medicare should be preserved by maintaining the current eligibility age of 65.
On September 27, 2018, H.R. 6936, the Bridge to Medicare Act of 2018 was introduced by Rep. Ami Bera (D-CA) and referred to the House Ways and Means Committee. The bill would amend the Internal Revenue Code to allow a deduction for health insurance costs of eligible retirees (no earned income, no Medicare Part A or B).
On July 24, 2018, H.R. 6488, the Seniors Accessing Vouchers Equally Act (SAVE Act) was introduced by Rep. Joe Barton (R-TX) and referred to the House Energy and Commerce and House Ways and Means Committees. The bill would exempt from certain criminal penalties the offering and use of certain pharmaceutical manufacturer coupons to waive or reduce cost-sharing otherwise applied under the Medicare prescription drug benefit.