Ally Lopshire

Association of Clinical Urologists (AACU)

 provide updates on legislative processes and issues affecting urologists. We welcome your comments and suggestions. Contact the AACU government affairs office at 847-517-1050 or 

	Congress ended 2017 with its first big legislative win for the Trump administration: passing a sweeping tax bill that promises the biggest reform to the U.S. tax program in over 30 years. But despite Republican claims that the tax cuts will pay for themselves, numerous nonpartisan analyses estimate that the bill will add billions, if not trillions, to the national debt over the next 15 years, leaving many to worry that cuts to federal programs like Medicare and Social Security are inevitable.

	Adding to these fears are recent statements by House Speaker Paul Ryan (R-WI), who specifically called out Medicare as being the "biggest entitlement that's got to have reform.” Unfortunately, Speaker Ryan and other GOP lawmakers have given virtually no details on what “Medicare reform” on the horizon might look like, leaving the health care community to speculate on the details, particularly with respect to potential payment cuts for physicians.

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	When President Trump signed the tax bill into law in December 2017, he effectively reduced the potential revenue to the federal government by almost $1.5 trillion, according to the nonpartisan Joint Committee on Taxation. GOP lawmakers have continually claimed that the tax bill will “pay for itself,” but the reality is unless it generates a substantial amount of economic growth to offset the decrease in revenue, the new law will likely add to the national debt.

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	A fiscal impact that large would have normally triggered the Pay-As-You-Go Act of 2010, which requires cuts to Medicare and other programs if a new law increases the deficit. Fortunately, both the Senate and the House passed a continuing resolution on Dec. 21 to prevent the automatic cuts to Medicare as a result of the tax bill, which was estimated to be around $25 billion.

	But the threat to Medicare still looms. Speaker Ryan has made it clear that he plans to push entitlement reform in 2018, especially in the health care space: “Frankly,” he said, “it's the health care entitlements that are the big drivers of our debt, so we spend more time on the health care entitlements-because that's really where the problem lies, fiscally speaking.”

Next: What reform could mean for urologists

	Despite being outspoken on his intentions to focus on entitlement reform in 2018, Speaker Ryan has yet to give any indication of what that might look like in the Medicare program. However, recent changes and existing efforts provide a glimpse into what reform could mean for providers in the coming year.

	One example is the recent push by the Centers for Medicare & Medicaid Services to develop and examine new and “innovative” payment models to reduce costs and improve quality of care while also rolling back mandatory participation in certain programs. This effort was made clear with the agency’s decision to eliminate two mandatory bundled payment models-under which multiple providers are reimbursed with a single lump-sum payment for a complete episode of care-and reduce participation in a third. CMS plans to replace these models with new voluntary payment bundles soon, which will have a renewed focus on voluntary, not mandatory, participation and fewer regulations in an effort to decrease the regulatory burden on physicians.

	In all, the ongoing efforts of CMS to discover and test new payment models that seek to reduce costs while maintaining quality care for patients indicates the agency’s desire to find ways to restructure how physicians are reimbursed for services under Medicare.

	CMS also recently indicated that it will begin taking a more proactive, targeted approach to auditing and recovering fraudulent and erroneous Medicare payments to providers by expanding the Targeted Probe and Educate program it began 3 years ago. This likely means that physicians will see an increase in Medicare audits as their billing practices come under more scrutiny.

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	CMS also announced in November the 2018 premiums, deductibles, and coinsurance amounts for Medicare Parts A and B, which indicated that some beneficiaries will see increases in their cost-sharing obligations under the program.

	But perhaps the biggest Medicare reform concern for urologists is the potential for provider reimbursements cuts, a threat that has continued to loom over the health care community for some time. If recent events are any indication, this threat is moving closer to becoming reality, perhaps best evidenced by the massive cuts to the payment rate for certain Medicare Part B drugs purchased by many hospitals through the 340B Drug Pricing Program. These cuts reduced the amount hospitals participating in the program are reimbursed from a rate of the drug's average sales price plus 6% to 22.5% less than the average sales price, constituting a 28.5% reduction in reimbursement payments for drugs purchased under the 340B program.

	What’s worse, despite widespread efforts to repeal by the AACU and numerous other advocates in the health care field, the threat of the Independent Payment Advisory Board (IPAB) still exists. If triggered, IPAB would likely make significant cuts to Medicare payments for physicians and ultimately have a devastating effect on patient access to care.

	Congress has failed to pass a bill repealing IPAB, despite widespread bipartisan support in both the House and Senate, and while IPAB managed to avert being triggered this year, the July Medicare trustees' determination report predicted that its triggering is likely as early as 2021. The continued threat of IPAB combined with the new threat to additional payment cuts as part of Medicare reform in the coming year is quite ominous for the urology community.

	The AACU is committed to advancing and advocating for the interests of urologists across the country, and will continue to actively engage with lawmakers in 2018 to ensure any attempt at Medicare reform will not harm the urology community.

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"Perhaps the biggest Medicare reform concern for urologists is the potential for provider reimbursements cuts, a threat that has continued to loom over the health care community for some time," writes the AACU's Ally Lopshire.

Tax law may threaten Medicare, provider pay

Based on a partnership with Urology Times, articles from the 

merican Association of Clinical Urologists (AACU)

	After storming onto the scene following a few highly publicized controversies, the cost of prescription drugs continues to be at the forefront of the health care debate in America, and for good reason. List prices for drugs in the U.S. are on the rise, and, as the health care system gets more complex and convoluted, even those with insurance are being forced to pay more out of pocket for their prescriptions. It is therefore hardly surprising that according to a recent poll, 77% of Americans believe the cost of prescription drugs is unreasonable, and 74% think Americans pay higher prices for their drugs than people in Canada, Mexico, and Western Europe.

	In the face of mounting pressure to take definitive action to keep the costs of prescriptions down, an increasing number of legislators are addressing drug costs in a variety of ways.

	One method that is gaining traction in Washington is drug importation. Sen. Bernie Sanders (I-VT) recently introduced a bill to permit drugs to be imported first from Canada and then from other developed countries after 2 years. The proposed legislation has become somewhat popular among Democrats in Congress. On its surface, it appears to be an appealing idea: drugs are cheaper abroad due to price controls and other mechanisms, and bringing in those cheaper drugs gives Americans lower cost alternatives to U.S.-manufactured medications. But as alluring as it may seem at first glance, drug importation in reality is as dangerous as it is ineffective.

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	The closed distribution system for prescription drugs in America allows the FDA to monitor virtually every aspect of the supply chain, all the way from manufacturing to distribution, in order to ensure that patients receive safe, effective, and quality medications. This closed system is critical to protecting patients from unsafe, substandard, adulterated, and counterfeit medications and has made the U.S. drug market the most trusted and secure in the world. The importation plan established under the proposed legislation would undermine the fundamental integrity of this closed system, compromising the many safety protections it affords.

	To its credit, the bill does attempt to address these safety concerns by requiring all foreign exporters to be certified and by prohibiting importation of drugs not manufactured at FDA-inspected facilities. But despite claims that importation under this plan would be adequately monitored to assure drug quality and safety, these provisions are simply insufficient to prevent adulterated, contaminated, or counterfeit drugs from infiltrating the U.S. supply chain and could put patients at risk for potentially serious harm.

Next: "Unfortunately, this risk is far from imaginary"

	Unfortunately, this risk is far from imaginary, particularly within the urology space. Sildenafil citrate (Viagra) and other erectile dysfunction drugs are believed to be among the world’s most counterfeited, as more men are turning to the Internet to obtain these pills. While it is hard to accurately measure just how many counterfeit ED drugs are available and how many actually make their way into the U.S., the numerous counterfeit examples on record paint a rather grim picture.

	Just a few months ago, two men were sent to federal prison after being convicted of introducing adulterated and misbranded prescription drugs into the U.S. commerce system. Each admitted to trafficking more than 10,000 counterfeit sildenafil and tadalafil (Cialis) pills, importing them from China and selling them to individuals for further distribution to unsuspecting customers. The counterfeit drugs contained less than or none of the active ingredients listed on the label, even though they looked authentic.

	Many proponents believe that drugs imported from reputable countries with relatively high regulatory standards, such as Canada, are safe, but this belief is dangerously misguided. Countries with relatively safe markets still do not impose the same level of protection afforded under the U.S. regulatory system, but even if they did, there is no guarantee that drugs imported from those countries actually meet those standards. Most foreign governments impose a lesser standard of regulation on products intended for export and do not regulate the transshipment of products through their territory.

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	Thus, these countries generally lack the ability to ensure that drugs exported to the U.S. are safe. In fact, the Canadian health agency, Health Canada, has expressly stated that while it regulates medications manufactured for its citizens, it is not responsible for the safety and quality of drugs imported into the U.S.

	But even if foreign governments could guarantee the safety and quality of the drugs they export, importation would create an opening in our currently closed distribution system that would allow adulterated and counterfeit drugs to penetrate the U.S. market. This is not an insignificant problem by any means: the number of counterfeit drugs both globally and in the U.S. has continued to rise over the past decade, due in large part to the proliferation of online pharmacies. Men who try to buy ED drugs online will almost certainly receive a drug that contains, at best, a lower dose of the active ingredient-and at worst, none at all-mixed in with other unknown materials that can range from brick dust to paint to potentially poisonous chemicals.

	Simply put, the proposed importation plan would allow the already booming counterfeit drug market to flow into the U.S. with virtually no way to adequately monitor and police it. And given that ample evidence suggests that importation itself would likely have a minimal effect on drug costs and patient access to affordable medications, importation is a shortsighted approach to a complex problem that at best promises temporary, minimal cost reductions at the expense of patient safety.

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While drug importation may sound like a good option to reduce drug costs, the potential can of worms it could create isn’t worth it, the AACU’s Ally Lopshire writes.

Drug importation: Shortsighted and ineffective

	Earlier this month, the AACU and AUA held yet another successful annual Urology Joint Advocacy Conference (JAC) in Washington. The conference featured presentations and panels on a host of pertinent urologic and advocacy-related topics, including Independent Payment Advisory Board (IPAB) repeal efforts, U.S. Preventive Services Task Force reform and access to PSA-based screening, MACRA requirements, medical liability reform, and physician burnout.

	A round of highly productive meetings with lawmakers on Capitol Hill capped off the meeting. Two topics of particular relevance were IPAB repeal and medical liability reform, both of which have legislative initiatives currently gaining momentum in Congress.

	During their meeting with lawmakers, urologists called on Congress to permanently repeal the Independent Payment Advisory Board as one of three Urology Joint Advocacy legislative priorities for 2017.

	Created under the Affordable Care Act as a cost control mechanism, IPAB is a 15-member panel of appointed officials who are responsible for reducing Medicare costs should they begin to rapidly rise. More specifically, if Medicare spending in a given year is expected to exceed its target growth rate, IPAB must develop and submit to Congress a proposal recommending cuts to Medicare expenses. Congress can override a submitted proposal by a supermajority, but in doing so, it must provide an alternate plan that would achieve similar cost reductions as the IPAB recommendations. Absent congressional intervention, the IPAB proposal automatically goes into effect.

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	If triggered, IPAB would have unprecedented authority to affect massive change in the health care system despite its minimal amount of congressional oversight. But even putting aside the fundamental legal concerns, an IPAB proposal would likely make significant cuts to Medicare payments for physicians and ultimately have a devastating effect on patient access to care. Because hospitals and hospice services are exempt from IPAB recommendations until 2020-despite the fact that they account for nearly one-third of Medicare spending-IPAB cuts are likely to disproportionately fall on physicians and could in turn greatly limit the ability of urologists to treat Medicare patients.

	Three bills to repeal IPAB were introduced in Congress this year: H.R. 849 (introduced by Reps. Phil Roe, MD (R-TN) and Raul Ruiz, MD (D-CA), S. 251 (Democrat version introduced by Senator Ron Wyden [D-OR]), and S. 260 (Republican version introduced by Sen. John Cornyn [R-TX]).

	During their meetings on Capitol Hill, urologists urged lawmakers to sign on as co-sponsors to the bills, and their efforts seemed to pay off. Since March 7, S. 251 gained one new co-sponsor and S. 260 gained four, while H.R. 849 gained an impressive 41 new co-sponsors. As legislation to repeal IPAB continues to gain momentum, especially in the House, urologists must continue their advocacy efforts and reach out to Congress about this important issue.

Next: Medical liability reform efforts invade D.C.

	Medical liability reform efforts invade D.C.

	Among the speakers at the JAC was Simit Pandya, government relations manager at PIAA, an insurance trade association that represents the medical liability insurance community. After describing the current liability landscape for urologists, Pandya detailed ongoing state and federal reform efforts, noting particularly the progress being made at the federal level.

	Significant tort reform legislation making its way through Congress has renewed efforts to change the medical liability system on a national level. Introduced by Rep. Steve King (R-IA) on Feb. 24, H.R. 1215, or the Protecting Access to Care Act of 2017, would impose a $250,000 cap on non-economic damages and a three-year statute of limitations for medical liability claims. It would also limit attorney contingency fees and implement a fair share rule that allots damages based on each defendant’s percentage of liability.

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	Unlike the federal legislation that has failed in the past, the reforms in this bill apply only to those lawsuits where health care coverage was “provided or subsidized by the federal government, including through a subsidy or tax benefit,” and attempt to afford more flexibility to states.

	Following its recent approval by the House Judiciary Committee, the bill is expected to be considered by the entire House in the next few weeks. Despite this ongoing progress, however, the bill faces significant opposition from plaintiff’s attorneys and those who believe the legislation would trample states’ rights. As such, even if the bill does manage to pass the House, it is likely that, as Pandya predicted, the legislation will ultimately meet its demise in the Senate.

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Author | Ally Lopshire

Articles

Tax law may threaten Medicare, provider pay

Drug importation: Shortsighted and ineffective

JAC 2017: IPAB repeal, liability reform see renewed focus