{"id":926,"date":"2019-04-17T13:19:01","date_gmt":"2019-04-17T17:19:01","guid":{"rendered":"https:\/\/sites.bu.edu\/dome\/?p=926"},"modified":"2019-04-20T11:16:48","modified_gmt":"2019-04-20T15:16:48","slug":"curbing-medicare-drug-costs","status":"publish","type":"post","link":"https:\/\/sites.bu.edu\/dome\/2019\/04\/17\/curbing-medicare-drug-costs\/","title":{"rendered":"Curbing Medicare Drug Costs"},"content":{"rendered":"<p>Prescription drug spend in the U.S. is the highest in the world. Americans pay <a href=\"https:\/\/www.commonwealthfund.org\/publications\/issue-briefs\/2017\/oct\/paying-prescription-drugs-around-world-why-us-outlier\">up to three times the amount per capita of other countries<\/a>. This is problematic for our growing <a href=\"https:\/\/www.kff.org\/medicare\/issue-brief\/how-many-seniors-live-in-poverty\/\">aging population<\/a> since their income becomes limited. While Medicare covers prescription drug costs, there are policy gaps that make it unaffordable. One major barrier to price controls is <a href=\"https:\/\/legcounsel.house.gov\/Comps\/Social%20Security%20Act-TITLE%20XVIII(Health%20Insurance%20for%20The%20Aged%20and%20Disabled).pdf\">part D of title XVIII of the Social Security Act<\/a>, in which <a href=\"https:\/\/www.healthcarefinancenews.com\/news\/most-americans-disapprove-how-trump-congress-addressing-prescription-drug-costs-poll-shows\">explicitly prohibits the federal government \u201cfrom negotiating directly with pharmaceutical companies to lower drug prices<\/a>\u201d. President Donald Trump proposed several policies to reduce the cost burden of prescription drugs on consumers through free-market competition approach, focusing mainly on cost transparency and promoting use of <a href=\"https:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/HowDrugsareDevelopedandApproved\/ApprovalApplications\/TherapeuticBiologicApplications\/Biosimilars\/ucm580419.htm\">biosimilar or generic drugs<\/a>. The policies are praised as a <a href=\"https:\/\/thehill.com\/opinion\/healthcare\/401404-new-medicare-drug-pricing-rule-a-small-step-in-the-right-direction\">\u201csmall step in the right direction<\/a>\u201d. Yet, many Americans are <a href=\"http:\/\/www.norc.org\/Research\/Projects\/Pages\/what-should-be-done-about-the-high-cost-of-prescription-drugs.aspx\">dissatisfied<\/a> since the proposals do not include direct Medicare negotiations with drug manufacturers. Pharmaceuticals argue that price controls would strain their investments in research and development (R&amp;D) of new drugs. After taking a closer look, that is not fully the case. Greater price control measures can be taken, but there must be political will to support it. For now, the President\u2019s policies are a small victory for seniors across America.<\/p>\n<p><u>Medicare Coverage Today<\/u><\/p>\n<p><a href=\"https:\/\/www.medicare.gov\/index.php\/drug-coverage-part-d\/how-to-get-drug-coverage\">Prescription drugs are covered under Medicare Part A, B, and C plans<\/a>, but to a limited capacity. Part A is hospital insurance, part B is traditional medical insurance, and part C (Medicare Advantage) is like a <a href=\"https:\/\/www.ehealthinsurance.com\/health-plans\/hmo\">health maintenance organization (HMO)<\/a> or <a href=\"https:\/\/www.ehealthinsurance.com\/health-plans\/ppo\">preferred provider organization (PPO)<\/a> plan type. Only drugs administered within these respective settings are covered. Because of these limitations, the <a href=\"https:\/\/www.congress.gov\/bill\/108th-congress\/house-bill\/1\">Medicare Modernization Act of 2003<\/a> was enacted, creating Medicare part D drug benefit.<\/p>\n<p>Part D is an \u201coptional\u201d supplemental insurance that can be purchased with any of the other Medicare plans. It, however, is severely flawed. First, <a href=\"https:\/\/economix.blogs.nytimes.com\/2013\/11\/19\/medicare-part-d-republican-budget-busting\/\">Congress did not commit any financing for part D<\/a>, leaving costs falling on the recipient. Second, and most notoriously, is the \u201cdonut hole\u201d coverage gap between initial enrollment and a \u201ccatastrophic coverage threshold\u201d. The entry-point coverage limit is currently $3,750. Once this amount is reached, the patient is then responsible for fully paying for their medication until the maximum amount of the out-of-pocket (OOP) costs have been paid, or the annual time period lapsed. The OOP threshold now is <a href=\"https:\/\/www.kff.org\/medicare\/fact-sheet\/an-overview-of-the-medicare-part-d-prescription-drug-benefit\/\">$5,100<\/a>, unaffordable for many seniors that suffer multiple chronic conditions.<\/p>\n<p>Additionally, the plan disincentivizes patients from purchasing brand name drugs by increasing patient coinsurance payments. Provisions of the Affordable Care Act attempted to close this gap by 2020 by <a href=\"https:\/\/www.pbs.org\/newshour\/economy\/making-sense\/president-trump-signed-these-medicare-changes-into-law-heres-what-to-watch-for\">limiting patient payments to 25% of the gap<\/a>. Under the Trump Administration, the <a href=\"https:\/\/www.congress.gov\/bill\/115th-congress\/house-bill\/1892\">Bipartisan Budget Act of 2018<\/a> advanced that date to 2019. Another caveat to Part D is that it is not really \u201coptional\u201d. If an individual fails to sign up once qualified and decides to enroll later, they will pay penalty fees for as long as they are on part D, with the exception of a few circumstances, such as having drug coverage from an employer.<\/p>\n<p><u>The President\u2019s Policies<\/u><\/p>\n<p>To mitigate the Medicare drug coverage issues, the Trump Administration released his \u201c<a href=\"https:\/\/www.hhs.gov\/sites\/default\/files\/AmericanPatientsFirst.pdf\">blueprint<\/a>\u201d rules and policies, supplemental to the Bipartisan Budget Act. Provisions that went into effect include:<\/p>\n<ul>\n<li>\u201c<a href=\"https:\/\/thehill.com\/opinion\/healthcare\/401404-new-medicare-drug-pricing-rule-a-small-step-in-the-right-direction\">Step therapy<\/a>\u201d rule within the Medicare Advantage plans- clinicians are to prescribe cheaper drugs and monitor patient progress closely. If the drug is found to be ineffective, then a clinician can prescribe the next expensive drug. Clinicians in the Advantage plan get commission for the drugs they provide. The rationale is to curb physicians from \u201cgaming\u201d for greater profits. This rule is now in effect.<\/li>\n<li>Taking harder action, the President recently signed <a href=\"https:\/\/www.nytimes.com\/2018\/10\/10\/us\/politics\/trump-health-insurance-drug-costs.html\">legislation to ban \u201cgag clauses\u201d<\/a> that prevented pharmacists from disclosing the best drug prices with customers. This is helpful for those who may be in the coverage gap of part D and would have to pay full price of the drug.<\/li>\n<\/ul>\n<p>Other policies proposed and will likely be revisited for the upcoming session include:<\/p>\n<ul>\n<li>Limiting doctor\u2019s offices to charge consumer price index (CPI) of drugs administered in their office.<\/li>\n<li>Shifting drugs from part B to D to promote greater market competition among drug makers to lower prices.<\/li>\n<li>Allowing drug rebates to go to the consumer rather than the healthcare provider or health plan.<\/li>\n<li>Promoting the use of biosimilars and generic biotechnology drugs.<\/li>\n<li>Closing loopholes, such as the 180-day exclusivity that allow brand-name drug companies to \u201cgame\u201d Food and Drug Administration (FDA) rules in ways that hinder generic competition.<\/li>\n<li>Requiring drug manufacturers to disclose list prices in their advertisements.<\/li>\n<\/ul>\n<p>These policies are a great step towards drug price controls. Yet, many argue that true price controls could only be achieved by allowing Medicare to directly negotiate drug prices. Perhaps that may be the case, as demonstrated by many other rich democracies. Pharmaceuticals, however, dispute this on the grounds that it would limit R&amp;D investments.<a href=\"\/dome\/files\/2019\/02\/Unknown-2.jpeg\"><img loading=\"lazy\" src=\"\/dome\/files\/2019\/02\/Unknown-2.jpeg\" alt=\"\" width=\"299\" height=\"168\" class=\"size-full wp-image-884 alignleft\" \/><\/a><\/p>\n<p>In a recent study, Yu et al. evaluated the \u201c<a href=\"https:\/\/www.healthaffairs.org\/do\/10.1377\/hblog20170307.059036\/full\/\">top 15 drug companies in 2015<\/a>\u201d and found that the inflated prices are not justified by the R&amp;D costs. <a href=\"https:\/\/www.sec.gov\/about\/laws\/secrulesregs.htm\">Securities and Exchange Commission (SEC) laws and regulations<\/a> require all public holding companies to publically disclose their financial statements. Knowing this, I reviewed the 2017 <a href=\"https:\/\/s21.q4cdn.com\/317678438\/files\/doc_financials\/Annual\/2017\/Financial-Report-2017.pdf\">financial report<\/a> of the largest pharmaceutical company in the world, Pfizer. Their R&amp;D costs were $7.7 billion and accounted for 14.7% of their reported revenue of $52.5 billion. After discounting other expenses, their net income was $21.4 billion, allowing them to maintain 40.6% in profits. These figures are not uncommon. According to the International Trade Association, <a href=\"https:\/\/www.trade.gov\/topmarkets\/pdf\/Pharmaceuticals_Executive_Summary.pdf\">15-20%<\/a> of gross revenues is how much U.S. pharmaceutical companies spend on average on R&amp;D (with the exception of the few that price gouged). In other countries, the R&amp;D investments are much less, but drug costs are also lower.<\/p>\n<p>Given these figures, it is of no surprise that advocates for better price controls are not convinced that R&amp;Ds should be the main reason to maintain the inflated drug costs. Cost-effectiveness analysis (CEAs) may help determine the value of the drug, however it would likely, by default, favor biosimilars and generic drugs. In that case, the promotion of these drugs employed by the Federal government serve as a cost-effectiveness measure to some extent. For drugs that treat severe progressive conditions, such as Alzheimer\u2019s disease or multiple sclerosis, it may be difficult to ascertain a value on new treatments since <a href=\"https:\/\/www.cdc.gov\/dhdsp\/evaluation_resources\/economic_evaluation\/docs\/Economic-Evaluation-Part5.pdf\">outcomes<\/a> are unique to a patient\u2019s condition. Moreover, measures involved in formal CEAs are derived from nationally administered quality\/disability-adjusted life-year (Q\/D-ALY) surveys of healthy people, thus not capturing the value of the treatment for those who are ill.<\/p>\n<p>The President\u2019s policies may not be perfect, but it is an experiment worth trying. Prior policies that attempted to \u201cassist\u201d our elderly population have failed, leaving those with chronic conditions and limited incomes <a href=\"https:\/\/www.commonwealthfund.org\/publications\/issue-briefs\/2017\/oct\/paying-prescription-drugs-around-world-why-us-outlier\">forgoing treatment<\/a> due to the high cost. For advocates of government price-fixing, it is important to keep in mind how much will prices be limited to, and it would likely require government to subsidize a portion of R&amp;Ds. It is difficult to imagine that government would be willing to make such an investment if they are barely subsidizing part D costs.<\/p>\n<p><strong>Sarah Zahakos, MPH <\/strong>is working toward a PhD in Health Law, Policy &amp; Management at the Boston University School of Public Health.<br \/>\nAHRQ T32 Research Fellow<br \/>\nTraining in Health Services Research for Vulnerable Populations<br \/>\nGrant # 2T32HS022242<\/p>\n<p>&nbsp;<\/p>\n<p><strong>References<\/strong><\/p>\n<p>\u2022 Bartlett, B. (2013, November 13). Medicare Part D: Republican budget-busting. <em>New York <\/em><em>Times.<\/em> Retrieved from <a href=\"https:\/\/economix.blogs.nytimes.com\/2013\/11\/19\/medicare-part-d-republican-budget-busting\/\">https:\/\/economix.blogs.nytimes.com\/2013\/11\/19\/medicare-part-d-republican-budget-busting\/<\/a><\/p>\n<p>\u2022 Centers for Disease Control and Prevention (2018, November 15). Cost-effectiveness nalysis: Outcomes in natural units. Retrieved from<\/p>\n<p><a href=\"https:\/\/www.cdc.gov\/dhdsp\/evaluation_resources\/economic_evaluation\/docs\/Economic-Evaluation-Part5.pdf\">https:\/\/www.cdc.gov\/dhdsp\/evaluation_resources\/economic_evaluation\/docs\/Economic-Evaluation-Part5.pdf<\/a><\/p>\n<p>Cubanski, J., Koma, W., Damico, A., and Neuman, T. (November 19, 2018). Medicare: ow many seniors live in poverty? <em>Henry J. Kaiser Family Foundation.<\/em> Retrieved from <a href=\"https:\/\/www.kff.org\/medicare\/issue-brief\/how-many-seniors-live-in-poverty\/\">https:\/\/www.kff.org\/medicare\/issue-brief\/how-many-seniors-live-in-poverty\/<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>eHealth (2018, November 16). HMO insurance plans. Retrieved from:<\/p>\n<p><a href=\"https:\/\/www.ehealthinsurance.com\/health-plans\/hmo\">https:\/\/www.ehealthinsurance.com\/health-plans\/hmo<\/a><\/p>\n<p>eHealth (2018, November 16). PPO insurance plans. Retrieved from<\/p>\n<p><a href=\"https:\/\/www.ehealthinsurance.com\/health-plans\/ppo\">https:\/\/www.ehealthinsurance.com\/health-plans\/ppo<\/a><\/p>\n<p>Food and Drug Administration (FDA) [2018, November 15]. Biosimilar and interchangeable products. Retrieved from<\/p>\n<p><a href=\"https:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/HowDrugsareDevelopedandApproved\/ApprovalApplications\/TherapeuticBiologicApplications\/Biosimilars\/ucm580419.htm\">https:\/\/www.fda.gov\/Drugs\/DevelopmentApprovalProcess\/HowDrugsareDevelopedandApproved\/ApprovalApplications\/TherapeuticBiologicApplications\/Biosimilars\/ucm580419.htm<\/a><\/p>\n<p>Hederman, Jr., R.S. (2018, August 11). New Medicare drug pricing rule \u2014 a small &#8216;step&#8217; in the right direction. <em>The Hill.<\/em> Retrieved from<\/p>\n<p><a href=\"https:\/\/thehill.com\/opinion\/healthcare\/401404-new-medicare-drug-pricing-rule-a-small-step-in-the-right-direction\">https:\/\/thehill.com\/opinion\/healthcare\/401404-new-medicare-drug-pricing-rule-a-small-step-in-the-right-direction<\/a><\/p>\n<p>H.R.1 &#8211; Medicare Prescription Drug, Improvement, and Modernization Act of 2003.<\/p>\n<p>Retrieved from <a href=\"https:\/\/www.congress.gov\/bill\/108th-congress\/house-bill\/1\">https:\/\/www.congress.gov\/bill\/108th-congress\/house-bill\/1<\/a><\/p>\n<p>International Trade Association (2018, November 15). 2016 top markets report<\/p>\n<p>pharmaceuticals. Retrieved from<\/p>\n<p><a href=\"https:\/\/www.trade.gov\/topmarkets\/pdf\/Pharmaceuticals_Executive_Summary.pdf\">https:\/\/www.trade.gov\/topmarkets\/pdf\/Pharmaceuticals_Executive_Summary.pdf<\/a><\/p>\n<p>Kaiser Family Foundation (2018, October 12). An overview of the Medicare Part D<\/p>\n<p>prescription drug benefit. Retrieved from <a href=\"https:\/\/www.kff.org\/medicare\/fact-sheet\/an-overview-of-the-medicare-part-d-prescription-drug-benefit\/\">https:\/\/www.kff.org\/medicare\/fact-sheet\/an-overview-of-the-medicare-part-d-prescription-drug-benefit\/<\/a><\/p>\n<p>Lagasse, J. (2018, September 13). Most Americans disapprove of how Trump, Congress<\/p>\n<p>are addressing prescription drug costs, poll shows. Retrieved from<\/p>\n<p><a href=\"https:\/\/www.healthcarefinancenews.com\/news\/most-americans-disapprove-how-trump-congress-addressing-prescription-drug-costs-poll-shows\">https:\/\/www.healthcarefinancenews.com\/news\/most-americans-disapprove-how-trump-congress-addressing-prescription-drug-costs-poll-shows<\/a><\/p>\n<p>Medicare.gov (2018, November 15). How to get drug coverage. Retrieved from<\/p>\n<p><a href=\"https:\/\/www.medicare.gov\/index.php\/drug-coverage-part-d\/how-to-get-drug-coverage\">https:\/\/www.medicare.gov\/index.php\/drug-coverage-part-d\/how-to-get-drug-coverage<\/a><\/p>\n<p>Moeller, P. (2018, February 14). President Trump signed these Medicare changes into<\/p>\n<p>law. Here\u2019s what to watch for. <em>PBS.<\/em> Retrieved from<\/p>\n<p><a href=\"https:\/\/www.pbs.org\/newshour\/economy\/making-sense\/president-trump-signed-these-medicare-changes-into-law-heres-what-to-watch-for\">https:\/\/www.pbs.org\/newshour\/economy\/making-sense\/president-trump-signed-these-medicare-changes-into-law-heres-what-to-watch-for<\/a><\/p>\n<p>National Opinion Research Center (NORC) at the University of Chicago (2018, November<\/p>\n<p>15). What should be done about the high cost of prescription drugs? Retrieved from<\/p>\n<p><a href=\"http:\/\/www.norc.org\/Research\/Projects\/Pages\/what-should-be-done-about-the-high-cost-of-prescription-drugs.aspx\">http:\/\/www.norc.org\/Research\/Projects\/Pages\/what-should-be-done-about-the-high-cost-of-prescription-drugs.aspx<\/a><\/p>\n<p>Part D of title XVIII of the Social Security Act. Retrieved from<\/p>\n<p><a href=\"https:\/\/legcounsel.house.gov\/Comps\/Social%20Security%20Act-TITLE%20XVIII(Health%20Insurance%20for%20The%20Aged%20and%20Disabled).pdf\">https:\/\/legcounsel.house.gov\/Comps\/Social%20Security%20Act-TITLE%20XVIII(Health%20Insurance%20for%20The%20Aged%20and%20Disabled).pdf<\/a><\/p>\n<p>Pear, R. (2018, October 10). Trump signs new laws aimed at drug costs and battles<\/p>\n<p>democrats on Medicare. <em>New York Times.<\/em> Retrieved from<\/p>\n<p><a href=\"https:\/\/www.nytimes.com\/2018\/10\/10\/us\/politics\/trump-health-insurance-drug-costs.html\">https:\/\/www.nytimes.com\/2018\/10\/10\/us\/politics\/trump-health-insurance-drug-costs.html<\/a><\/p>\n<p>Pearl, R. (2018, September 24). The immorality of prescription drug pricing in America.<\/p>\n<p><em>Forbes.<\/em> Retrieved from<\/p>\n<p><a href=\"https:\/\/www.forbes.com\/sites\/robertpearl\/2018\/09\/24\/nostrum\/#614ba37a4fb1\">https:\/\/www.forbes.com\/sites\/robertpearl\/2018\/09\/24\/nostrum\/#614ba37a4fb1<\/a><\/p>\n<p>Pfizer (2018, November 15). 2017 financial report. Retrieved from<\/p>\n<p><a href=\"https:\/\/s21.q4cdn.com\/317678438\/files\/doc_financials\/Annual\/2017\/Financial-Report-2017.pdf\">https:\/\/s21.q4cdn.com\/317678438\/files\/doc_financials\/Annual\/2017\/Financial-Report-2017.pdf<\/a><\/p>\n<p>Securities and Exchange Commission (2018, November 16). Rules and regulations for<\/p>\n<p>the Securities and Exchange Commission and major securities laws. Retrieved from <a href=\"https:\/\/www.sec.gov\/about\/laws\/secrulesregs.htm\">https:\/\/www.sec.gov\/about\/laws\/secrulesregs.htm<\/a><\/p>\n<p>Sarnak, D.O., Squires, D., &amp; Bishop, S. (2017, October 5). Paying for prescription drugs<\/p>\n<p>around the World: Why is the U.S. an outlier? <em>Commonwealth Fund.<\/em> Retrieved from<\/p>\n<p><a href=\"https:\/\/www.commonwealthfund.org\/publications\/issue-briefs\/2017\/oct\/paying-prescription-drugs-around-world-why-us-outlier\">https:\/\/www.commonwealthfund.org\/publications\/issue-briefs\/2017\/oct\/paying-prescription-drugs-around-world-why-us-outlier<\/a><\/p>\n<p>Trump Administration (2018, May 30). American patients first: The Trump Administration<\/p>\n<p>blueprint to lower drug prices and reduce out-of-pocket costs. Retrieved from <a href=\"https:\/\/www.hhs.gov\/sites\/default\/files\/AmericanPatientsFirst.pdf\">https:\/\/www.hhs.gov\/sites\/default\/files\/AmericanPatientsFirst.pdf<\/a><\/p>\n<p>Yu, N.L., Helms, Z., &amp; Bach, P.B. (2017). R&amp;D costs for pharmaceutical companies do<\/p>\n<p>not explain elevated US drug prices. <em>Health Affairs. <\/em><\/p>\n<p>doi: 10.1377\/hblog20170307.059036<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Prescription drug spend in the U.S. is the highest in the world. Americans pay up to three times the amount per capita of other countries. This is problematic for our growing aging population since their income becomes limited. While Medicare covers prescription drug costs, there are policy gaps that make it unaffordable. One major barrier [&hellip;]<\/p>\n","protected":false},"author":15924,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[10,4],"tags":[242,56,224,250,108,248,246,247,249,58],"_links":{"self":[{"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/posts\/926"}],"collection":[{"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/users\/15924"}],"replies":[{"embeddable":true,"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/comments?post=926"}],"version-history":[{"count":4,"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/posts\/926\/revisions"}],"predecessor-version":[{"id":940,"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/posts\/926\/revisions\/940"}],"wp:attachment":[{"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/media?parent=926"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/categories?post=926"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/sites.bu.edu\/dome\/wp-json\/wp\/v2\/tags?post=926"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}