After returning from their month long summer recess for a few weeks of work on the Hill, Congress has left DC again for a 2-week “district work period” and won’t be back until mid-October. None-the-less, and notwithstanding other diversions focused on the White House, health policy bills continue to advance, at varying speeds, through the chambers.
It is anyone’s guess right now which ones will gain enough momentum to reach the President’s desk, but Marilyn Singleton, MD, JD gives an overview of pending legislation with the potential to impact patients and physicians, in this edition of her Legislative Update.
Pre-Authorization
On June 5, 2019, H.R. 3107, the Improving Seniors’ Timely Access to Care Act of 2019 was introduced by Rep. Susan DelBene (D-WA) and referred to the House Energy and Commerce and Ways and Means Committees.The bill provides that a Medicare Advantage plan may not impose any additional prior authorization requirement with respect to any surgical procedure or otherwise invasive procedure (as defined by the Secretary), and any item furnished as part of such surgical or invasive procedure, if such procedure (or item) is furnished during the peri-operative period of a procedure for which— (A) prior authorization was received from such plan before such surgical or otherwise invasive procedure (or item furnished as part of such surgical or otherwise invasive procedure) was furnished; or (B) prior authorization was not required by such plan
Full text: https://www.govtrack.us/congress/bills/116/hr3107/text.
Pre-Existing Conditions
On August 2, 2019 H.R. 4159, the Maintaining Protections for Patients with Preexisting Conditions Act of 2019 as introduced by Rep. Denver Riggleman (R-VA) and referred to the House Energy and Commerce and Education and Labor Committees. The bill mandates guaranteed issue of individual and employer health insurance. Any health insurance issuer that offers health insurance coverage in the individual or group market in a State must accept every employer and individual in the State that applies for such coverage. In the case of a health insurance issuer with a network plan, the issuer may (A) limit the employers that may apply for such coverage to those with eligible individuals who live, work, or reside in the service area for such network plan; and (B) within the service area of such plan, deny such coverage to such employers and individuals if the issuer has demonstrated, if required, to the applicable State authority that (i) it will not have the capacity to deliver services adequately to enrollees of any additional groups or any additional individuals because of its obligations to existing group contract holders and enrollees; and (ii) it is applying this paragraph uniformly to all employers and individuals without regard health status or past claims.
The bill also provides that premium rates may only vary by (i) whether such plan or coverage covers an individual or family; (ii) rating area, as established in accordance with paragraph (2); (iii) age, except that such rate shall not vary by more than 3 to 1 for adults; and (iv) tobacco use, except that such rate shall not vary by more than 1.5 to 1; and
A health insurance issuer offering group or individual health insurance coverage may not establish rules for eligibility of any individual to enroll under the terms of the plan or coverage based on any of the following health status-related factors in relation to the individual or a dependent of the individual: (1) Health status; (2) Medical condition (including both physical and mental illnesses); (3) Claims experience; (4) Receipt of health care; (5) Medical history; (6) Genetic information; (7) Evidence of insurability (including conditions arising out of acts of domestic violence); (8) Disability.
A group health plan and a health insurance issuer offering group or individual health insurance coverage may not impose any preexisting condition exclusion with respect to such plan or coverage.
Full text: https://www.govtrack.us/congress/bills/116/hr4159/text.
Health Savings Accounts and Tax-Related Bills
Multiple bills were introduced in the 2019-2020 session and have gotten nowhere in the Democratic controlled Congress. Despite actuarial data that shows that individuals with modest incomes can save up to $300, 000 in HSA and they are not just for “the rich”, the party line was that they will hurt the poor by stealing tax dollars from the general fund. Here are some bills since our last legislative update.
On March 6, 2019 S. 680, the Personal Health Investment Today Act of 2019 (PHIT Act) was introduced by Sen. John Thune (R-SD) and referred to the Senate Finance Committee. The bill allows a medical care tax deduction for up to $1,000 ($2,000 for a joint return or a head of household) of qualified sports and fitness expenses per year. The bill defines “qualified sports and fitness expenses” as amounts paid exclusively for the sole purpose of participating in a physical activity, including (1) fitness facility memberships, (2) physical exercise or activity programs, and (3) equipment for a physical exercise or activity program.
Full text: https://www.govtrack.us/congress/bills/116/s680/text.
On April 9, 2019, HR 2177, the Faith in Health Savings Accounts Act of 2019 was introduced by Rep. Mike Kelly (R-PA) and referred to the House Ways and Means Committee. This bill modifies the requirements for health savings accounts (HSAs) to treat membership in a tax-exempt health care sharing ministry as coverage under a high deductible health plan for purposes of the tax deduction for contributions to an HSA.
Full text: https://www.govtrack.us/congress/bills/116/hr2177/text.
On June 27, 2019, H.R. 3565, the Veterans Health Savings Account Act was introduced by Paul Gosar (R-AZ) and referred to the House Ways and Means Committee. This bill allows veterans who receive hospital care or medical services under any law administered by the Department of Veterans Affairs to remain eligible to participate in or contribute to a health savings account.
Full text: https://www.govtrack.us/congress/bills/116/hr3565/text.
On June 28, 2019, H.R. 3594, the Healthcare Freedom Act of 2019 was introduced by Rep. Chip Roy (R-TX) and referred to the House Ways and Means Committee. This bill wouldexpand the availability of health savings accounts. It renames such accounts as “health freedom accounts” and allows all individuals to receive increased tax deductions for contributions to such accounts. The term “qualified medical expenses” is expanded to include costs associated with direct primary care, health care sharing ministries, and medical cost sharing organizations. The bill also excludes employer contributions to health freedom accounts from employee gross income for income tax purposes.
Full text: https://www.govtrack.us/congress/bills/116/hr3594/text.
On July 11, 2019, H.R. 3708, the Primary Care Enhancement Act of 2019 was was introduced by Rep. Earl Blumenauer (D-OR) and referred to the House Ways and Means Committee. This bill reintroduces flawed language that was swapped in last session to replace the original simple bill intended to grant patients with Health Savings Accounts the option of joining a Direct Primary Care practice. For an analysis of the problems with the bill click here.
Full text: https://www.congress.gov/bill/116th-congress/house-bill/3708/text
On July 11, 2019 H.R. 3709, the Chronic Disease Management Act of 2019 was introduced by Rep. Earl Blumenauer (D-OR) and referred to the House Ways and Means Committee. The amends the Internal Revenue Code, with respect to health savings accounts (HSAs), to allow the high deductible health plans required for an HSA to provide care for chronic conditions with no deductible. Its sister bill, S. 1948 in the Senate was introduced by Sen John Thune (R-SD).
Full text: https://www.govtrack.us/congress/bills/116/hr3709/text
Full text (Senate): https://www.govtrack.us/congress/bills/116/s1948/text.
On July 17, 2019, H.R. 748, the Middle Class Health Benefits Tax Repeal Act of 2019 which was introduced by Joe Courtney (D-CT) passed the House 419 to 6. This bill repeals the excise tax on employer-sponsored health care coverage for which there is an excess benefit (high-cost plans/40% “Cadillac tax” provision). The repeal applies to taxable years beginning after December 31, 2019.
Full text: https://www.govtrack.us/congress/bills/116/hr748/text.
On July 17, 2019 H.R. 3796, the Health Savings Act for Seniors was introduced by Rep. Ami Bera (D-CA) and referred to the House Ways and Means Committee. — Introduced. This bill permits a Medicare beneficiary to participate in and contribute to health savings accounts.
Full text: https://www.govtrack.us/congress/bills/116/s2252/text.
On July 23, 2019, H.R. 3880, the Tax Fairness for the Self-Employed Act of 2019 was introduced by Rep. Antonio Delgado (D-NY) and referred to the House Ways and Means Committee. The bill would allow the tax deduction for health insurance costs in determining net earnings from self-employment.
Full text: https://www.govtrack.us/congress/bills/116/hr3880/text
On July 30, 2019 H.R. 4130, the Keeping HSAs Accessible Act of 2019 was introduced by Rep. Kenny Marchant (R-TX) and referred to the House Ways and Means Committee. This bill would amend the Internal Revenue Code to eliminate the ceiling on the sum of the annual deductible and out-of-pocket expenses required under a high deductible health plan (i.e., $5,000 for self-only coverage and twice that amount for family coverage), for purposes of health saving account eligibility.
Full text: https://www.govtrack.us/congress/bills/116/hr4130/text.
On August 1, 2019 S. 2440, the Qualified Health Savings Account Distribution Act of 2019 was introduced by Sen. Ben Sasse (R-NE) and referred to the Senate Finance Committee. The bill would amend the Internal Revenue Code of 1986 to expand permissible distributions from an employee’s health flexible spending account or health reimbursement arrangement to their health savings account.
Full text: https://www.govtrack.us/congress/bills/116/s2440/text.
On August 1, 2019 S. 2441, the Health Savings Account Expansion Act of 2019 was introduced by Sen. Ben Sasse (R-NE) and referred to the Senate Finance Committee. The bill would amend the Internal Revenue Code of 1986 to allow individuals who are not enrolled in a high deductible health plan to have access to health savings accounts.
Full text: https://www.govtrack.us/congress/bills/116/s2441/text.
On August 1, 2019 S. 2414 was introduced by Sen. Rob Portman (R-OH) and referred to the Senate Finance Committee. This bill amends the Internal Revenue Code to extend for five years the tax credit for health insurance coverage.
Full text: https://www.govtrack.us/congress/bills/116/s2414/text.
Drug Pricing
The Senate Finance Committee and Speaker Pelosi have recently introduced dueling bills intended to lower drug prices by imposing price controls on brand name prescription drugs.
On September 25, 2019, S. 2543, the Prescription Drug Pricing Reduction Act of 2019 was introduced by Senate Finance Chairman, Sen. Charles Grassley. This 231 page bill contains caps on payment above inflation for branded medications obtained through Part B and Part D as well as a wide range of additional reforms. For a summary of sections click here.
On September 19, 2019, H.R. 3, the Lower Prescription Drug Costs Now Act of 2019 was introduced by House Energy and Commerce Chairman Rep. Frank Pallone on behalf of Speaker Pelosi. The main feature of this 101-page bill is to cap prices for drugs without competition from at least one generic or biosimilar. Unlike the Senate bill, the cap would apply to drugs system-wide, not just in Part D and Part B and it would be tied to an index of international prices. For the Democrat’s summary of the bill click here.
Full Text: https://www.congress.gov/116/bills/hr3/BILLS-116hr3ih.pdf
On May 9, 2019, S. 1384, the Prescription Drug Rebate Reform Act of 2019 was introduced by Sen. Mitt Romney (R-UT) and referred to the Senate Health, Education, Labor, and Pensions Committee. The bill provides that an insurer must base its copay on the net price, not the list price of a prescription drug.
Full text: https://www.govtrack.us/congress/bills/116/s1384/text.
On June 18, 2019 H.R. 3327, the Drug Price Transparency for Medicare Patients Act of 2019 was introduced by Rep. Francis Rooney (R-FL) and referred to the House Energy and Commerce and Ways and Means Committees. This bill provides statutory authority for the Centers for Medicare & Medicaid Services rule titled “Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency,” published on May 10, 2019. The rule requires direct-to-consumer television advertisements for covered drugs and biologics under Medicare and Medicaid to include the list price of a 30-day supply or for a typical course of treatment, if the list price is at least $35 per month.
Full text: https://www.govtrack.us/congress/bills/116/hr3327/text.
On July 10, 2019, S. 2081, the Stop Drug Companies from Overcharging Seniors in Medicare Part B Act of 2019 was introduced by Sen. Gary Peters (D-MI) and referred to the Senate Finance Committee. The bill would require drug manufacturers to provide rebates for drugs furnished under Medicare part B for which the growth in average sales price has exceeded inflation.
Full text: https://www.govtrack.us/congress/bills/116/s2081/text.
On July 24, 2019 S. 2252, the Empowering States to Address Drug Costs Act was introduced by Chris Van Hollen (D-MD) and referred to the Senate Finance Committee. The bill would expand the permitted uses of drug price information disclosed to States under the Medicaid drug rebate program to assist in price setting.
Full text: https://www.govtrack.us/congress/bills/116/s2252/text.
Insulin
On July 11, 2019 S. 2103, the Affordable Insulin Approvals Now Act was introduced by Sen. Richard Durbin (D-IL) and referred to the Senate Health, Education, Labor, and Pensions Committee. The bill provides that the FDA will speed up the approval of pending biologics.
On July 22, 2019 S. 2199 the Insulin Price Reduction Act of 2019 was introduced by Sen. Jeanne Shaheen (D-NH) and referred to the Senate Finance Committee. The bill provides thata group health plan or a health insurance issuer offering group or individual health insurance coverage must ensure that a contracted pharmacy benefits manager does not, directly or indirectly, receive from a manufacturer of certified insulin a rebate, reduction in price, or other remuneration with respect to such insulin received by an enrollee in the plan or coverage and covered by the plan or coverage. An exception applies if any reduction in price is reflected at the point of sale to the enrollee and the other remuneration is a flat fee-based service fee paid to the pharmacy benefits manger by the manufacturer.
Full text: https://www.govtrack.us/congress/bills/116/s2199/text.
On July 25, 2019, H.R. 4010, the Emergency Access to Insulin Act of 2019 was introduced by Rep. Angie Craig (D-MN) and referred to the House Energy and Commerce and Ways and Means Committees. The bill would mandate grants to the States, Indian tribes and tribal organizations to create programs to assist individuals in obtaining insulin. Various fees would be applied to manufacturers for price spikes.
Full text: https://www.govtrack.us/congress/bills/116/hr4010/text.
Pharmacy Benefits Managers & Transparency
On March 5, 2019 S. 657 was introduced by Sen. Mike Braun (R-IN) and referred to the Senate Health, Education, Labor, and Pensions Committee. The bill provides that a group health plan or a health insurance issuer offering group or individual health insurance coverage must ensure that a contracted pharmacy benefits manager does not, directly or indirectly, receive from a drug manufacturer a rebate, reduction in price, or other remuneration with respect to such prescription drug received by an enrollee in the plan or coverage and covered by the plan or coverage. An exception applies if any reduction in price is reflected at the point of sale to the enrollee and the other remuneration is a flat fee-based service fee paid to the pharmacy benefits manger by the manufacturer.
Full text: https://www.govtrack.us/congress/bills/116/s657/text.
On April 1, 2019, S. 977, the Transparent Drug Pricing Act of 2019 was introduced by Sen. Rick Scott (R-FL) and referred to the Senate Health, Education, Labor, and Pensions Committee. The bill would require pharmacists to disclose to customers, at the point of sale of any prescription drug (i) the customer’s out-of-pocket cost with respect to acquisition of such drug under the health plan in which the customer is enrolled, if applicable; and (ii) the cost to the consumer for acquisition of the drug without using any health plan. the bill also requires that the price of certain drugs or biologics not exceed the lowest retail list price for the drug among Canada, France, the United Kingdom, Japan, or Germany.
Full text: https://www.govtrack.us/congress/bills/116/s977/text.
On May 13, 2019 S. 1437, the Drug-price Transparency in Communications (DTC) Act was introduced by Dick Durbin (D-IL) and referred to the Senate Finance Committee. Direct-to-consumer advertisements for prescription drugs and biologics paid for by the Medicare or Medicaid program must be truthful and non-misleading.
Full text: https://www.govtrack.us/congress/bills/116/s1437/text.
On May 23, 2019 S. 1664, the Prescription Drug Price Reporting Act was introduced by Sen. Rick Scott (R-FL) and referred to the Senate Committee on Health, Education, Labor, and Pensions. bill requires that all prescription drug manufacturers submit certain information for every drug marketed in the United States to the Department of Health and Human Services (HHS). Specifically, manufacturers must provide information about cost, pricing, and rebates. Manufacturers are also required to submit any price changes to a prescription drug at least 30 days in advance. HHS must make this information available through a public database that enables consumers to subscribe to price change notifications for different types of prescriptions drugs.
Full text: https://www.govtrack.us/congress/bills/116/s1664/text.
On May 23, 2019 S. 1688 was introduced by Sen. Mike Enzi (R-WY) and referred to the Senate Health, Education, Labor, and Pensions Committee. The bill would require: (1) health care facilities and practitioners to provide to patients a list of services rendered during the visit to such facility or practitioner upon discharge; and (2) health care facilities and practitioners to send all bills to the patient within 30 business days. No patient may be required to pay a bill for health care services any earlier than 30 business days after receipt of a bill for such services. If a facility or practitioner bills a patient after the 30-business-day period described in subsection such facility or practitioner shall refund the patient for the full amount paid in response to such bill with interest, at a rate determined by the Secretary. The Secretary may impose civil monetary penalties of up to $10,000 a day on any facility or practitioner that submits more than 10 bills outside of the period described in subsection (a)(2), beginning on the date on which such facility or practitioner sends the tenth such bill.
Full text: https://www.govtrack.us/congress/bills/116/s1688/text.
On June 21, 2019, H.R. 3415, the Real-Time Beneficiary Drug Cost Bill was introduced by Rep. Elissa Stotkin (D-MI) and referred to the House Energy and Commerce and Ways and Means Committees. This bill provides statutory authority for certain provisions of the Centers for Medicare & Medicaid Services rule titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses,” published on May 23, 2019. The rule requires, in part, Medicare prescription drug plan sponsors to implement an electronic, real-time benefit tool that is capable of integrating with at least one prescriber’s electronic prescribing system or electronic health record. The tool must provide prescribers with patient-specific, real-time formulary and benefit information, including information regarding cost-sharing, formulary alternatives, and utilization management requirements. The rule takes effect January 1, 2021.
Full text: https://www.govtrack.us/congress/bills/116/hr3415/summary.
On June 21, 2019, H.R. 3408, the Shop Rx Act of 2019 was introduced by Rep. Jody Arrington (R-TX) and referred to the House Energy and Commerce and Ways and Means Committees. This bill provides statutory authority for certain provisions of the Centers for Medicare & Medicaid Services rule titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses,” published on May 23, 2019. The rule requires, in part, Medicare prescription drug plan sponsors to implement an electronic, real-time benefit tool that is capable of integrating with at least one prescriber’s electronic prescribing system or electronic health record. The tool must provide prescribers with patient-specific, real-time formulary and benefit information, including information regarding cost-sharing, formulary alternatives, and utilization management requirements. The rule takes effect January 1, 2021.
Full text: https://www.govtrack.us/congress/bills/116/hr3408/text.
On July 24, 2019 S. 2247, the Phair Relief Act of 2019 was introduced by Sen. John Kennedy (R-LA) and referred to the Senate Finance Committee. The bill provides that HHS must on its website disclose the information on rebates, discounts, and price concessions with respect to pharmacy benefit managers contracted with a health plan. Discounts must be passed through to the plan sponsor.
Full text: https://www.govtrack.us/congress/bills/116/s2247/text.
On June 26, 2019 H.R 3523, the End Price Gouging for Medications Act was introduced by Rep. Peter Welch (D-VT) and referred to the House Committee on Armed Services, House Committee on Energy and Commerce, and 4 other committees. The Senate version, S. 1987 was introduced by Sen. Jeff Merkeley (D-OR). The bill would require HHS to establish a reference price for each prescription drug under subsection (A) by determining the median retail list price for the drug among the reference countries in which the drug is available, if drug pricing information is available for at least three of such countries; or (B) in the case of a drug for which drug pricing information or dosage equivalents are not available for at least three of the reference countries, by determining an appropriate price based on the Secretary’s determination of (i) the added therapeutic effect of the drug; (ii) the value of the drug; (iii) patient access to the drug; (iv) the costs associated with researching and developing the drug; and (v) other factors, as the Secretary determines appropriate.
Full text (House): https://www.govtrack.us/congress/bills/116/hr3523/text. Full text (Senate): https://www.govtrack.us/congress/bills/116/s1987/text.
Note: for information on Surprise Billing legislation see this earlier edition of legislative update.
