Marilyn Singleton, MD, JD compiles and analyzes recently-introduced healthcare-related legislation.
Yet Another Bill to Repeal the ACA
On March 3, 2015, S. 647, the Health Care Choice Act of 2015 was introduced by Sen. Ted Cruz (R-TX) and referred to the Senate Finance Committee. The sister House bill, H.R. 543 was introduced by Marsha Blackburn (R-TN) and referred to the House Education and Workforce, Energy and Commerce Health, and Ways and Means Committees.
This bill repeals the health insurance and health coverage expansion requirements of the Patient Protection and Affordable Care Act and related requirements of the Health Care and Education Reconciliation Act of 2010. Restores provisions of law amended or repealed by such provisions. The bill also sets rules for issuing insurance across state lines, keeping the regulation within the states’ hands.
Full text Senate Bill: https://www.govtrack.us/congress/bills/114/s647/text.
Full text House bill: https://www.govtrack.us/congress/bills/114/hr543/text.
Another Tweak to the ACA
On April 13, 2015, H.R. 1752 was introduced by Rep. Mike Kelly (R-PA) and referred to the House Ways and Means Committee. The bill would amend the Internal Revenue Code to allow members of health care sharing ministries eligible to establish Health Savings Accounts (HSAs), i.e., such insurance would be treated as coverage under a high deductible health plan.
Full text: https://www.govtrack.us/congress/bills/114/hr1752/text.
More Expansions to Medicare Coverage
On March 19, 2015, H.R. 1516, the Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015 was introduced by Rep. James Sensenbrenner (R-WI) and referred to the House Energy and Commerce and Ways and Means Committees. The sister Senate bill was introduced by Sen. Thad Cochran (R-MS) on April 20, 2015 and referred to the Senate Finance Committee.
The bill provides for a new separate benefit category with unique coding, coverage, and payment rules for persons with conditions such as Cerebral Palsy, Muscular Dystrophy, Multiple Sclerosis, Spinal Cord Injury, Amyotrophic Lateral Sclerosis, and Spina Bifida who require specialized wheelchairs and the like. These items would be exempt from the Durable Medical Equipment (DME) competitive bidding process.
Full text: https://www.govtrack.us/congress/bills/114/hr1516/text.
On March 18, 2015, S. 776, the Medication Therapy Management Empowerment Act of 2015 was introduced by Sen. Pat Roberts (R-KS) and referred to the Senate Finance Committee. This bill modifies the program where pharmacists can be paid for management of medications for beneficiaries who have multiple chronic diseases (such as diabetes, asthma, hypertension, hyperlipidemia, and congestive heart failure) or are taking multiple covered part D drugs. The bill simply adds having a single chronic disease of cardiovascular disease, chronic obstructive pulmonary disease, hyperlipidemia, or diabetes to the list of qualifying beneficiaries.
Full text: https://www.govtrack.us/congress/bills/114/s776/text.
On March 24, 2015, H.R. 1559, the Health Outcomes, Planning, and Education (HOPE) for Alzheimer’s Act of 2015 was introduced by Rep. Christopher Smith (R-NJ) and referred to the House Energy and Commerce and Ways and Means Committees. The sister bill, S. 857, was introduced by Sen. Debbie Stabenow (D-MI) on March 25 and referred to the Senate Finance Committee. The bill would provide Medicare coverage of comprehensive Alzheimer’s disease (and other related dementias) care planning services.
Full text House bill: https://www.govtrack.us/congress/bills/114/hr1559/text
State Bills Introduced Mandating Transparency of Certain Drug Prices
The real question is what will be done with the information. Two states plan to use the information to cap prices.
California
On February 23, 2015, AB 463, the Pharmaceutical Cost Transparency Act of 2015 was introduced in the California assembly. The bill would require each manufacturer of a prescription drug that costs “$10,000 or more annually or per course of treatment” to file a yearly report outlining the costs for every such drug.
The report would have to include :
(1) Total costs (including predecessors’ costs) for the production of the drug, including the total R&D costs;
(2) Total costs of clinical trials and other regulatory costs;
(3) Total costs for materials, manufacturing, and administration attributable to the drug;
(4) Total costs paid by any entity other than the manufacturer or predecessor for research and development, including any amount from federal, state, or other governmental programs, or any form of subsidies, grants, or other support.
(5) Any other costs to acquire the drug, including costs for the purchase of patents, licensing, or acquisition of any corporate entity owning any rights to the drug while in development.
(6) The total marketing and advertising costs for the promotion of the drug directly to consumers.
Full text: http://leginfo.legislature.ca.gov/faces/billNavClient.xhtml?bill_id=201520160AB463.
Oregon
On March 11, 2015, House Bill 3486 was introduced to the Oregon House of Representatives. The bill would require pharmaceutical manufacturers who distribute the drug in Oregon to file a report with the Oregon Health Authority on costs in the previous year associated with prescription drugs that cost $10,000 or more per year or per course of treatment.
The annual report would include the following:
(1) Costs paid by the manufacturer for researching and developing the prescription drug;
(2) Costs paid by any predecessor manufacturer for researching and developing the prescription drug;
(3) Costs paid by the manufacturer and any predecessor manufacturer for researching and developing the prescription drug with moneys made available to the manufacturer or predecessor manufacturer through a federal, state or other governmental program or through a subsidy, grant or other form of
monetary support;
(4) Costs paid by the manufacturer or predecessor for clinical trials for the prescription drug;
(5) Costs paid by the manufacturer for manufacturing and distributing the prescription drug;
(6) Costs paid by the manufacturer for acquiring the prescription drug, including costs paid by the manufacturer for purchasing patents for or licensing the prescription drug or costs paid by the manufacturer for acquiring property rights to the prescription drug;
(7) Costs paid by the manufacturer for marketing and advertising the prescription drug to consumers and prescribers (separately itemized); and
(8) Manufacturers would have to report the total profits attributed to the drug and any financial assistance provided to patients through patient prescription assistance programs.
Full text: https://olis.leg.state.or.us/liz/2015R1/Downloads/MeasureDocument/HB3486
North Carolina
On March 25, 2015, H839, “An Act to require manufacturers of pharmaceutical drugs to report cost and utilization information” was introduced. The bill would require every manufacturer of a drug sold in North Carolina to file an annual report of costs. North Carolina’s bill makes no reference to a dollar cap that the state would impose on pharmaceutical products sold in the state.
The report would include the following:
(1) Total costs derived in the production of the drug;
(2) Average wholesale cost of the drug as filed with the Federal Food and Drug Administration and, for each drug, a five‑year history of average wholesale price;
(3) Total research and development costs paid by the manufacturer in the production of the drug;
(4) Total administrative costs, marketing and advertising costs for the promotion of the drug, and costs associated with direct‑to‑consumer coupons and amount redeemed;
(5) Total profit as represented in total dollars and a percentage of total company profit derived from the sale of the drug;
(6) Total amount of financial assistance the manufacturer has provided through patient prescription assistance programs if such programs are available.
Full text: http://www.ncga.state.nc.us/Sessions/2015/Bills/House/HTML/H839v0.html.
Massachusetts
Massachusetts’ bill ups the mandate ante with setting a maximum price for certain drugs.
On April 15, 2015, Bill S.1048, an “Act to promote transparency and cost control of pharmaceutical drug prices” was introduced. The bill would require the Massachusetts health policy commission develop a list of “critical prescription drugs for which there is a substantial public interest in understanding the development of its pricing.” The health policy commission would “review and consider all data reported to the commission and the center and determine whether the price of the prescription drug is significantly high given: (i) the prescription drug’s medical benefits, (ii) the cost to develop and manufacture the prescription drug, and (iii) the prices charged by the manufacturer in other countries.” “If the commission determines that a prescription drug is significantly high, then the commission may set the maximum allowable price that the manufacturer can charge for that prescription drug that is sold for use in the commonwealth.”
In developing the list, the commission would consider the following:
(1) Cost of the drug to public health care programs;
(2) Current cost of the drug in Massachusetts;
(3) Extent of utilization of the drug within Massachusetts; and
(4) Potential impact of the cost of the drug on Massachusetts achievement of the statewide health care cost growth benchmark.
The manufacturers of such drugs would be required to submit an annual report which includes:
(1) Total cost of production, and approximate cost of production per dose;
(2) Research and development costs of the drug;
(3) Marketing and advertising costs for the drug to consumers and prescribers (separately itemized);
(4) The prices for the drug that are charged to purchasers outside the United States, by country;
(5) Prices charged to typical Massachusetts purchasers, e.g., pharmacies, pharmacy chains, pharmacy wholesalers, or other direct purchasers;
(6) Net typical prices charged to prescription drug benefit managers for distribution in Massachusetts, net of any rebates or other payments from the manufacturer to the pharmacy benefit manager and the pharmacy benefit manager to the manufacturer.
Full text: https://malegislature.gov/Bills/189/Senate/S1048.
Pennsylvania
On April 21, 2015, HB 1042, the “Pharmaceutical Cost Transparency Act” was introduced. The bill would require an annual report from manufacturers of a prescription drug with an average wholesale price of $5,000 or more annually or per course of treatment. Insurers (including the government) would not be required to pay for such drug if the manufacturer fails to submit a report.
The report would contain the following: On or before March 1 of each year, manufacturers would have to file with the Insurance Department the following costs of production of the drug:
(1) The research and development costs paid by the manufacturer and predecessor;
(2) The costs of clinical trials and other regulatory costs paid by the manufacturer and predecessor;
(3) The costs for materials, manufacturing and administration attributable to the drug.
(4) The costs paid by any entity other than the manufacturer or predecessor for research and development;
(5) The other costs to acquire the drug, including costs for the purchase of patents, licensing or acquisition of a corporate entity owning rights to the drug while in development;.
(6) The marketing and advertising costs for the promotion of the drug directly to consumers and prescribers.
Full text: http://www.legis.state.pa.us/cfdocs/Legis/CSM/showMemoPublic.cfm?chamber=H&SPick=20150&cosponId=18101.
