Life Science Compliance Update

July 15, 2016

Independent Payment Advisory Board (IPAB) What is Happening Now

The Independent Payment Advisory Board (IPAB) is one of the "cost control mechanisms" that can be found within the Affordable Care Act (ACA) and is designed to bring per-capita Medicare spending back in line with statutory benchmarks, if those benchmarks are exceeded. While an IPAB trigger was avoided this year, the IPAB continues to be a reality threatening healthcare stakeholders.

The IPAB is close to the current Medicare Payment Advisory Commission (MedPAC), but there are some stark differences. For one, recommendations made by the IPAB have the force of law unless Congress acts to amend them in ways that also achieve the required savings. Such an automatic implementation has stakeholders on edge: the IPAB is unaccountable to anyone or any entity (including Congress) and could therefore possibly exercise outside authority with significant implications for various industries, including pharmaceutical manufacturers.


Interestingly, since the ACA's enactment in 2010, the current Administration has taken no steps to formalize, or even appoint, the IPAB. The ACA calls for the IPAB to be made up of fifteen members, each appointed by the President for six-year terms, and confirmed by the Senate. The President also selects a Chair, while the Vice Chair is chosen among the members. IPAB members are supposed to be nationally recognized experts in healthcare finance, economics, actuarial science, and health facility management, as well as physicians and other providers from various professional and geographic backgrounds. The Secretary of the Department of Health and Human Services (HHS), the Administrator of the Centers for Medicare and Medicaid Services (CMS), and the Administrator of the Health Resources and Services Administration (HRSA) serve as non-voting members of the board.


Each year, CMS' Office of the Actuary is to issue an annual IPAB determination in which it will compare projected five-year average Medicare per-capital spending growth to the statutory benchmark noted in the ACA. The five-year period considers two years prior, the current year, and two subsequent years. Each determination since 2013 has confirmed actual growth to be below the benchmark level.

The Actuary recently stated that the IPAB has not been triggered for the 2016 determination year. From this year onward, the Medicare savings target for IPAB recommendations to meet (if IPAB is targeted) is the lesser of: 1.5% or the percentage of excess Medicare spending.


If – and when – IPAB is triggered, several statutory deadlines come into play. By September 1, the IPAB is to send the draft proposal to two organizations: to MedPAC for consultation and to HHS for comment. By the following January 15, the proposal is to be sent to Congress and the President, along with an explanation, a legislative proposal, and actuarial cost-saving certification. If IPAB was triggered but does not produce its proposal, HHS has until January 25 to send the proposal to Congress. By April 1, Congressional Committees will have considered the proposal and reported on legislative language suggestions. Congress may amend the proposal if the same savings target is met, or may also vote to block the proposal. On August 15, HHS begins automatically implementing the proposal, with FY proposals taking effect on October 1 and CY proposals, Medicare Advantage proposals, and Part D proposals taking effect January 1.


The ACA seems as though it wants the IPAB to address certain areas, while leaving other areas untouched. For example, prior to 2020, hospitals and hospices that are subject to productivity adjustments under the ACA are excluded. Further, IPAB proposals are not to include raising beneficiary premiums, rationing care, changing Medicare eligibility criteria, or increasing cost sharing.

The IPAB is also limited by statute to only make recommendations on the Medicare program and dual-eligible listed beneficiaries. The IPAB should also give priority to recommendations that extend Medicare solvency, improve healthcare delivery, improve access to evidence-based-services in rural areas, and consider the impacts on provider payments.

Potential Proposals

As with any other uncertainty, stakeholders are trying to bring some certainty to the game by speculating on the areas that are most likely to be touched with it comes to IPAB-driven cuts. Some ideas include: giving HHS the authority to negotiate drug prices in Medicare Part D, implementing a Part B formulary, adopting MedPAC's Part D recommendations on reducing Part D reinsurance and eliminating antidepressant and immunosuppressant drugs' protected class status, and increasing the coding intensity adjustment received by Medicare Advantage plans.

Potential Timelines

In its June 2016 report, the Medicare Trustees projected that the IPAB will be triggered in the 2017 determination year and again in 2022, 2024, and 2025. A 2017 determination year trigger would result in a 2019 implementation year for proposals, barring congressional intervention.


While the trigger has once again been averted, IPAB determinations are an annual process and according to the Medicare Trustees report, it is likely that the threshold will be exceeded next year. It is likely that next spring, stakeholders will once again focus on the IPAB as the CMS actuarial determination and Trustee report approach.

May 14, 2015

Update on the Medical Device Tax Repeal Efforts

Medical Device

The Medical Device Tax, instituted as part of the Affordable Care Act, is a tax of 2.3 percent on the sale price of medical device products. There has been considerable pushback against the tax—with members of Congress from both sides of the aisle arguing that it stifles innovation and costs jobs. While there has been a lot of talk about a repeal, the issue has seemed to stall until recently.  

In late April, the United States Senate Committee on Finance held a hearing entitled “A Fresh Look at the Impact of the Medical Device Tax on Jobs, Innovation and Patients.” In the lead-up to the hearing, Finance Committee Chairman Orrin Hatch (R-UT) stated that the Committee plans to mark up a bill to repeal the tax “soon,” notes Cooley Health Beat.  

The hearing itself is quite interesting. Senator Patrick J. Toomey (R-PA) started things off by holding up various medical devices—including a mechanical heart pump, a spinal implant, and a vagal nerve stimulator for epilepsy—all of which vastly improve patients’ lives but which took millions of dollars in losses to bring to market before ever showing a profit. The device tax only magnifies these losses. Toomey noted that at least one manufacturer, in order to offset the costs of the medical device tax, would be building its next factory outside the U.S. Further, the tax has cost jobs, as a number of speakers testified

Toomey also raised an important point when discussing how the tax works in practice:

My view is that the tax, the Medical Device Tax, is not only onerous on its scale, but it’s bad in its design. It is a tax on sales, not a tax on profits. And so these companies that I alluded to that spent large sums of money making these product and bringing them to market, they were losing money years, even when they started to have sales. The initial sales those years were not enough to be profitable. To impose a tax on those sales prior to there even being a profit, it just adds to the debt load that these companies have to carry. And there is only so much debt that can be financed. This is one of the concerns that I have. The design of this tax is very very unfortunate.

In the House: Protect Medical Innovation Act "prior to Memorial Day recess"

Even more recently, a group of 18 Democrats in the U.S. House of Representatives urged House leaders to pass H.R. 160, the "Protect Medical Innovation Act," that would repeal the device tax. The bill is sponsored by Rep. Erik Paulsen (R-Minn.) and Rep. Ron Kind (D-Wis). 

In a May 1 letter written by Rep. Scott Peters (D-Calif.) and co-signed by 17 other Democrats, the lawmakers said that the medical device tax is blocking new medical technology breakthroughs and ultimately harming patients. Furthermore, the tax is harming the employment outlook of a vibrant sector. “The medical technology industry directly employs over 400,000 Americans,” states the letter. “The industry is primarily comprised of small and medium-sized businesses and American companies representing 38% of the global market.” Importantly, “[o]f the 6,500 medical device manufacturers in the United States, 80% employ fewer than 50 employees," notes Peters. 

The letter was addressed to House Speaker John Boehner (R-Ohio), Minority Leader Nancy Pelosi (D-Calif.), Ways and Means Committee Chairman Paul Ryan (R-Wis.), and Committee Ranking Member Sander Levin (D-Mich.).He urged the House leaders to pass H.R. 160 by the Memorial Day recess. 

The sticking point in getting a medical device repeal has been the lack of a budget offset. Last year, the Joint Committee on Taxation estimated that the tax would raise about $28 billion over the next decade. H.R. 160 doesn’t include a way to offset that expected source of revenue. The White House has indicated that the President would veto a measure that doesn't account for the budget.

May 07, 2015

Over 500 Organizations Urge Congress to Repeal ACA's Independent Payment Advisory Board (IPAB)

  Healthcare reform

In an effort to curtail the rise in Medicare cost, the Affordable Care Act established the Independent Payment Advisory Board (IPAB), which would consist of 15 presidentially appointed members tasked with proposing Medicare cuts if spending growth exceeded certain inflation-based projections. IPAB has been the root of a fair deal of controversy, with opponents criticizing the provision for giving too much power to “15 unelected, unaccountable bureaucrats.” Others have termed the IPAB a “death panel,” given their power over Medicare reimbursements and ability to essentially ration care.

Despite the opposition, IPAB hasn’t been an active issue because Medicare spending has not continued to rise at a high rate over the last few years. In January, Modern Healthcare reported that “[n]ews about the 15-member panel, whose members have yet to be named, quietly reappeared last week when Congress agreed to reduce $10 million in funding for IPAB in the 2014 omnibus spending bill.” The provisions for IPAB come into effect if certain per capita spending surpasses certain targets, and “Medicare spending per enrollee grew just 0.7% in 2012, even slower than the 2.5% growth rate in 2011.”

Indeed, the IPAB seemed to have been lost amidst other healthcare news—including the repeal of SGR and insertion of new quality payment metrics.

However, yesterday, over 500 organizations wrote a letter to Congress to repeal the IPAB provisions of the Affordable Care Act. The organizations wrote that they found IPAB “not only poses a threat to that access but also, once activated, will shift healthcare costs to consumers in the private sector and infringe upon the decisionmaking responsibilities and prerogatives of the Congress.”

The letter to Congress states that an unelected board without adequate oversight or accountability would be taking actions historically reserved for the public’s elected representatives in the U.S. House and Senate.

The letter notes that once in place, IPAB must achieve mandated savings within a one-year time frame. Instead of pursuing long-term reforms to strengthen Medicare, IPAB would be more likely to achieve its targets by cutting payments to healthcare providers, the letter argues

“This would be devastating for patients, affecting access to care and innovative therapies,” the groups wrote, pointing out that the number of physicians unable to accept new Medicare patients due to low reimbursement rates has been increasing. “IPAB-generated payment reductions would only increase the access difficulties faced by too many Medicare beneficiaries. Furthermore, payment reductions to Medicare providers will almost certainly result in a shifting of health costs to employers and consumers in the private sector.”

The letter concludes: “We strongly support bringing greater cost-efficiency to the Medicare program. We also advocate continuing efforts to improve the quality of care delivered to Medicare beneficiaries. The Independent Payment Advisory Board will achieve neither of these objectives and will only weaken, not strengthen, a program critical to the health and well-being of current and future beneficiaries.”

The letter echoes the American Medical Association’s (AMA) concerns with the IPAB. “While some applaud the new advisory board as a mechanism for controlling health care costs outside the influence of political processes and pressures,” AMA states, “others have criticized the scope of its authority and the lack of flexibility in its mandate.” AMA has stated that they “continue[ ] to fight for the elimination of the Independent Payment Advisory Board, which will impose arbitrary across-the-board cuts to physicians and other providers.”

Legislation to repeal the board sponsored by Reps. Phil Roe (R-Tenn.) and Linda Sánchez (D-Calif.) has 222 co-sponsors, including 19 Democrats, reports The Hill


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