InsideHealthPolicy.com’s Inside CMS exclusive news on the most powerful agency in health care Vol. 17, No. 52 - December 25, 2014 CMS: 257,000 Doctors Express Scripts Gets Discount On AbbVie’s Will See Meaningful Use Hep C Drug Viekira Park Penalties In 2015 Express Scripts will only include AbbVie’s hepatitis C drug Viekira Pak About 257,000 physicians will face penalties for not meeting requirements showing the meaningful use of electronic health records in 2015, CMS announced Wednesday (Dec. 17), and thousands will see even steeper penalties for missing eprescribing requirements as well. While some following the issue said that a surprisingly large number of physicians are being hit with penalties next year, a health technology lobbyist said those numbers will likely be just as high — if not higher — in 2016. CMS on a press call said that doctors who didn’t meet the Medicare meaningful use requirements will be sent a notification letter, and the 1 percent cut will go into effect in January. The 28,000 physicians who did not meet e-prescribing or meaningful use program requirements will see a 2 percent cut. About 200 hospitals were subject to a meaningful use penalty as well for 2015, and they started seeing penalties in October, a CMS official said. “This disturbingly high number of eligible professionals subject to the 2015 penalties is further continued on page 10 on its National Preferred Pharmacy formulary in exchange for a “significant” discount on the drug, an Express Scripts spokesman said, and there will be no restrictions to access for the 25 million people on that formulary. Biotech analysts for J.P. Morgan believe the deal marks the beginning of pharmacy benefit managers using exclusionary formularies to cut drug prices. Since Gilead Sciences priced Sovaldi at $84,000 for a 12-week course a continued on page 14 Court Tosses AHA Lawsuit; Says Congress, HHS Should Fix Backlogs The federal DC District Court dismissed the American Hospital Association’s lawsuit to compel HHS to turn around Medicare appeals decisions on time — within 90 days at the third level of appeals — and ruled that Congress and HHS should solve the problem, not the courts. The AHA said it plans to appeal the dismissal. US District Court Judge James Boasberg said he sympathizes with the hospitals but it’s not his place to intervene. continued on page 16 Patient Group Challenges Dialysis Star Rating Program With Data Quality Act Dialysis patients are challenging CMS’ dialysis star ratings program, using a law called the Data Quality Act, on the grounds the ratings program confuses patients, disadvantages facilities in states with sicker residents and was created without public input. The day after delivering the complaint, Dialysis Patient Citizens learned that CMS had begun testing consumers’ understanding of the ratings program even though the agency insisted for nearly four months that consumer testing wasn’t necessary, according to EDITOR’S NOTE In observance of the holidays, Inside CMS will not be published on Jan. 1. Your next issue will be published Jan. 8, 2015. continued on page 18 CMS Adds 68,000 Records To Open Payments Database CMS added about 68,000 payment records to the Sunshine Act and Affordable Care Act’s Open Payments database on Friday (Dec. 19). The Open Payments database details financial relationships among certain providers and drug and device manufacturers and group purchasing organizations. The additional records include updates to payments that were disputed by doctors and teaching hospitals at the end of the review period (Sept. 11) so there wasn’t enough time to review them before the Open Payments database was published at the end of September. CMS says the added payments are worth more than $200 million. The sunshine and health reform laws require drug and device manufacturers and GPOs to report payments to teaching hospitals and physicians. If providers disagree with reported payments, providers must work with the manufacturers or GPOs outside of the Open Payments system to resolve the dispute. CMS originally said unresolved disputes would be still be published but marked as under dispute when the database was released. That did not sit well with either providers or drug and device makers so the agency later decided to put the disputed payments on “pathway to publication,” rather than make those records public. The agency said records under dispute would be made public once doctors and teaching hospitals had a chance to rereview them and dispute them again. CMS says other records added to the system on Friday include those attested to on the last day of the data submission period for 2013 (July 7). Those records were “inadvertently excluded from publication,” CMS says, although they were included in the 45-day review and dispute process. Last summer, providers noticed that the database incorrectly attributed payments to some providers with similar names. CMS responded by de-identifying 40 percent of provider payments. By the end of June, CMS plans to link those payments to providers that received them. CMS also said Friday that the Open Payments system will be unavailable for much of January while the agency upgrades the system. During that time, the databases will still be available and physicians and teaching hospitals will still be able to register through the separate portal system, but some aspects of registration, data submission and review and dispute functions will not be accessible. — Michelle M. Stein MedPAC Drafts Recommendation For Primary-Care Pay; Urges SGR Repeal The Medicare Payment Advisory Commission (MedPAC) plans to recommend a budget-neutral per-beneficiary permonth payment to primary care physicians, instead of continuing the expiring primary care pay bump, and commissioners plan to reiterate their call for repealing the Sustainable Growth Rate (SGR), which would cut doctors pay by 24 percent if it isn’t patched or repealed by the end of March. Commissioners said Thursday (Dec. 18) the $31 per-beneficiary permonth payment to primary care physicians is needed to address what they see as pay disparity between primary care doctors and specialists to help stave-off what could become a shortage of primary care physicians for beneficiaries. MedPAC Chair Glenn Hackbarth said the panel would vote on the per-beneficiary per-month recommendation — which had the support of the full commission — at its January meeting, but would put the SGR recommendation through Hot Documents Now Available on InsideHealthPolicy.com The following new documents are available on InsideHealthPolicy.com, our new online health news service. Subscribers to InsideHealthPolicy.com also have access to hundreds of other health-related documents, daily news updates, and a searchable archive of back issues. Ellmers Urges CMS To Shorten Meaningful Use Reporting Period In 2015 AMA ‘Appalled’ That Half Of Doctors To Pay Meaningful Use Penalties FY 2015 Results Of HAC Reduction, Value-Based Purchasing Programs CMS Reports October Enrollment Numbers For CHIP/Medicaid Advocates For Children Tell Congressional Medicaid Advisers Kids Should Not Be Moved To Exchange Plans Without Equivalent Medicaid Benefits CMS Releases 2016 Draft Letter To FFE Issuers Obama Administration Publishes Proposed Rule On Excepted Benefits SCOTUS Sets March 4 Oral Arguments For King v. Burwell CMS Issues Proposed Rule To Strengthen QHP Summary Of Benefits And Coverage Not an online subscriber? Inside CMS subscribers can get a free, two-week trial to InsideHealthPolicy.com by calling 1-800-424-9068 or signing up at http://www.insidehealthpolicy.com/health_signup.asp. 2 INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 without a vote because it is the same as in the past. All of the panel’s commissioners supported resending Congress its SGR recommendation without a vote, and they said they support voting on the draft recommendation for the per-beneficiary payment to primary care providers at the January meeting. In order to keep the per-beneficiary payment budget neutral, commissioners decided that payment cuts would not affect evaluation and management services (E&M) provided by specialists. Had the panel decided to include those services in the payment reductions — exempting only E&M furnished by primary care providers the cuts — 90 percent of the physicians fee schedule would have been cut by 1.1 percent. Instead, the commission plans to recommend a 1.4 percent payment reduction for all non-E&M and non-eligible E&M services, which represent about 75 percent of the physicians fee schedule. A representative of the American Academy of Neurology and the Cognitive Specialty Coalition asked the commission to rethink its policy and include specialists who exceed the 60 percent E&M threshold in the per-beneficiary payment. Mike Amery, a lobbyist for the American Academy of Neurology, argued that these specialists coordinate care for many of their patients and use the same E&M billing codes as primary care physicians, noting that there are no distinct billing codes for primary care services. He said MedPAC has been provided with data that shows the specialty groups he represents face similar problems of lower pay and recruitment as primary care physicians. “These policies simply pick winners and losers based on specialty designation not on care being provided to patients,” Amery said during the public comment period of the MedPAC meeting. “This shouldn’t be about primary care versus everybody else. It should be about patients who need the time to talk with their appropriate physicians, discuss medications, manage symptoms regardless if that physician is in family medicine or neurology, a general internist or an endocrinologist.” At the panel’s November meeting, some commissioners questioned whether other specialties that find themselves above the 60 percent E&M threshold should be included in the per-beneficiary payment, but they decided instead to not cut E&M provided by specialists. MedPAC has long contended that primary care physicians have been underpaid in relation to specialists. At Thursday’s meeting, commissioners worried that in the near future the country could be facing a shortage of primary care physicians who treat Medicare beneficiaries as baby boomers swell the Medicare ranks and baby-boomer age doctors retire. “My concern is having an inadequate payment policy today means we have an irreversible problem five or six or seven years from when physicians or other practitioners choose not to go into primary care,” Commissioner Craig Samitt said. “For me it underscores the urgency of repeal [of the SGR] and a rebalancing between primary care and specialties today. I think we’re not dealing with accessibility issues today, I think we’re dealing with accessibility issues in the more distant future that we should be concerned about.” Hackbarth said that point should be emphasized in the panel’s report to Congress, noting the balance between supply and demand for primary care is “pretty tight.” “With a big influx of beneficiaries; new patients coming in as a result of ACA; and a big cohort of baby boom clinicians retiring that tenuous balance could be thrown out of whack,” Hackbarth said. Many stakeholders hoped that Congress would repeal the SGR during the lame-duck session based on a bipartisan deal it failed to pass last March, opting for one-year freeze of the cuts. MedPAC staff noted that the Congressional Budget Office (CBO) recently issued numbers slightly lowering the cost of a repeal. — Todd Allen Wilson Cindy Mann To Step Down As Medicaid Chief In January CMS Medicaid Chief Cindy Mann will leave the agency in late January after serving as the head of CMS’ Medicaid and Children’s Health Insurance Program for five years, the agency announced Friday (Dec. 19). Deputy Director of the Center for Medicaid and CHIP Services Vikki Wachino will serve as acting director until the agency finds a permanent replacement, CMS Administrator Marilyn Tavenner wrote in an email to CMS staff. “In the five years that Cindy has led CMCS, she has overseen the implementation of the biggest improvements to the Medicaid program since its inception,” Tavenner said. The Affordable Care Act’s Medicaid expansion got its start under Mann’s watch. Medicaid and CHIP now have more than 68 million beneficiaries, and 27 states have expanded Medicaid. More states are expected to expand their programs eventually. Mann also led the development and implementation of policies to simplify Medicaid enrollment. Under the ACA, states are required to use a single, streamlined process for all insurance affordability programs that can be accessed by phone, online, by mail, in-person or by fax. Asset tests and in-person interviews were also removed as states moved to a “no-wrong-door” enrollment system. Tavenner praised Mann’s work on long-term services and supports and helping those with disabilities and chronic conditions stay in the community. She noted Mann’s work on the Innovation Accelerator Program, as well. “She has been an open and trustworthy partner to state leaders on the front lines of administering these programs. She has also been a passionate advocate for beneficiaries, a stalwart steward of taxpayer funds, and an inspiring and tireless leader for staff in CMCS and throughout the agency,” Tavenner says. — Michelle M. Stein INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 3 Home Health Tried To Persuade MedPAC To Delay Rebasing Conclusions The home health industry said it’s too soon for Medicare payment advisers to determine whether home health pay cuts impede seniors from getting good care, even though the Medicare Payment Advisory Commission must report to Congress by year’s end on the impact of rebasing on beneficiary access and quality of care. MedPAC Chair Glenn Hackbarth said Thursday (Dec. 18) that commissioners already sent the report to Congress and a commission spokesperson said the report will be public next week. The Affordable Care Act requires CMS to rebase pay for home health services, starting this year, and it requires MedPAC to report on the impact of those pay cuts by the end of the year. MedPAC discussed preliminary findings at an April meeting and went over findings again in September. One of industry’s complaints is that MedPAC is relying on data collected before pay was rebased. Rebasing started this year, and the data that MedPAC reviewed runs only through 2012. “MedPAC is charged by the ACA with assessing the impact of home health rebasing cuts, but this analysis does not include data from any year in which the cuts are in effect, ” according to an Oct. 30 letter to MedPAC from trade groups representing for-profit and nonprofit home health agencies, and the Council of State Home Care Associations. CMS also stated in this year’s final home health pay rule that it’s too early to determine the impact of home health rebased pay. “[S]ufficient claims data for CY 2014 is not available for analysis. We plan to provide an update on our monitoring efforts once sufficient CY 2014 claims data become available,” the final rule states. MedPAC staff acknowledged to commissioners during this week’s meeting that the report is due before data from the first year of rebasing is available. Instead, they built a model based on data from 2001-2012 and used it to make projections. The commission’s long-held position is that Medicare overpays for home health services and past efforts to cut profit margins mostly haven’t worked. In 11 of 12 years, Medicare cut pay rates for home health services, but the reduction was large enough to lower the base rate in only three of those years, and in even those years, an increase in case mix helped offset those cuts — CMS multiplies the base rate by the case-mix value to compute payment. In years that the base rate increased, the rise in case mix compounded growth in average pay per episode, according to MedPAC research. Thus, MedPAC researchers told commissioners that they don’t anticipate the rebasing of pay rates this year to significantly hurt patient access or the quality of care. However, industry points out that CMS estimated 40 percent of home health agencies would have negative profit margins by 2017 under rebasing. Industry says if that many home health agencies are losing money, rebasing hurts seniors’ access to home health providers. MedPAC on Thursday projected that the home health industry would have projected profit margins of about 10.3 percent in 2015, but industry disagrees with MedPAC’s assertions of high profit margins. The Partnership for Quality Home Healthcare asked Avalere Health to review the financial documents filed with the Securities and Exchange Commission of the four biggest publicly traded home health companies, and it found that in 2013, their average profit margin was 1.3 percent. That margin combines all payers, but Medicare accounts for about 80 percent of their reimbursement. The industry letter states that MedPAC grossly underestimated the cost of rebasing by not factoring in market basket increases. Also, the commission doesn’t account for costs such as taxes and telehealth technology.—John Wilkerson AMA: Meaningful Use Program Is Failing Physicians The American Medical Association says the number of physicians subject to meaningful use penalties in 2015 — about 257,000 physicians — is disheartening and the program is failing doctors. Both the AMA and the American Hospital Association, which says it can’t succeed in meaningful use without physician partners, say that CMS needs to address provider concerns with the meaningful use program. “The American Medical Association (AMA) is appalled by news from the Centers for Medicare and Medicaid Services (CMS) today that more than 50 percent of eligible professionals will face penalties under the Meaningful Use program in 2015, a number that is even worse than we anticipated,” AMA President Elect Steven Stack says in a statement. CMS Wednesday (Dec. 17) said about 257,000 physicians will be hit with penalties in 2015 for not showing socalled meaningful use of electronic health records, and about 28,000 will be see even bigger penalties for also not meeting e-prescribing requirements. The AMA in a statement also notes that CMS has said only half of eligible physicians participated in the Physician Quality Reporting System in 2013, which means that many doctors will see penalties from that program in 2015, as well. Providers will be hit by penalties for not showing meaningful use of electronic health records for the first time in 2015. CMS usually has a two-year look-back period, and will be looking at whether an eligible physician attested to meaningful use in 2013. CMS also allowed those physicians showing meaningful use for the first time in 2014 to avoid 2015 penalties by attesting before Oct. 1 of this year. But the AMA says that while the meaningful use program was meant to increase doctors’ use of technology to 4 INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 improve care and help increase efficiency, “[u]nfortunately, the strict set of one-size-fits-all requirements is failing physicians and their patients.” “They are hindering participation in the program, forcing physicians to purchase expensive electronic health records with poor usability that disrupts workflow, creates significant frustrations and interferes with patient care, and imposes an administrative burden,” Stack says. With the “dismal” number of physicians meeting meaningful use, the AMA says it’s time for CMS to make changes to improve the program, and points to the group’s meaningful use blueprint for examples of how that could be done. The AMA’s blueprint, released in October, calls for CMS to ease compliance thresholds; get rid of the list of the meaningful use program’s core requirements; align the PQRS and meaningful use programs; compile standards for sharing and transmitting data between EHRs and clinical data registries; ease restrictions on who can input doctors’ orders; and streamline meaningful use vender certification. The blueprint also calls for adding exemptions to meaningful use for those close to retirement, and a CMS official Wednesday said that some doctors close to retirement don’t want to switch to electronic records. The blueprint also calls for more opportunities for hardship exemptions. CMS said 43,000 physicians applied for the first round of hardship exemptions in 2014, and 13,000 applied for the second round. The American Hospital Association in AHA News also says the wide-spread penalties indicate challenges providers are having with showing meaningful use of electronic health records. “Hospitals cannot be successful without their physician partners. It is time for CMS to address providers’ concerns about the program,” says Chantal Worzala, AHA director of policy. The College of Healthcare Information Management Executives says the fact that roughly half of physicians will receive meaningful use penalties in 2015 validates calls for increased program flexibility, especially around calls for a shorter reporting period in 2015. Stakeholders previously asked CMS for a 90-day reporting period in 2015, rather than a full year, but the agency said no and argued a shorter reporting period would harm the program’s momentum. A group of 30 bipartisan lawmakers led by Reps. Renee Ellmers (R-NC) and Jim Matheson (D-UT) again called on HHS in a Dec. 16 letter to give providers the shorter reporting period in 2015, as few providers have shown they can meet the requirements for the second stage of the program in 2014. “With such extremely low attestation rates, we are unclear why HHS maintains that healthcare providers, hospitals and physicians alike, must perform a full-year EHR reporting period in 2015,” the letter says. — Michelle M. Stein MedPAC Considers Pay Bump For Hospitals, Site-Neutral Oupatient Pay Congressional Medicare advisers said Thursday (Dec. 18) they plan to offer the same recommendations on hospital payments as last year, which includes overall pay increases and some cuts in certain areas. The recommendations would increase hospital pay by 3.25 percent and pay hospitals more for “chronically critically ill” patients, but they also would pay the same for 66 types of services, regardless of whether they’re provided at hospital outpatient departments or physician offices, which would cut pay to hospitals for those ambulatory payment classifications (APC). The American Hospital Association (AHA) asked MedPAC to reconsider its recommendations because the siteneutral payments for 66 APCs, coupled with a projected negative 9 percent profit margin on Medicare patients in 2015, could cause hospitals to cut back services. Medicare Payment Advisory Commission (MedPAC) Chair Glenn Hackbarth said that because last years’ proposal was a multiyear package it made sense to continue the same recommendations. “Last year we recommended a package for hospitals that included the acute care hospital inpatient and outpatient update; a change in outpatient payment rates for specified APCs; a change in LTAC (long term acute care) payment rates; and increase in acute care hospital outlier payments as a package,” Hackbarth said. “My inclination with that package is to do with it as we’ve done with physicians, home health agencies and skilled nursing facilities, which is to rerun that package without a separate vote.” Commissioners agreed to support recommending the package without taking a vote at the panel’s January meeting. As part of the package, MedPAC would recommend paying long-term care hospitals (LTCHs) the same rate as acute care hospitals for patients who are not “chronically critically ill.” Savings from that recommendation would be used for inpatient outlier payments for chronically critically ill patients. The 3.25 percent increase does not factor in sequester cuts of 2 percent. Hackbarth said if the sequester or any other decisions by Congress produce a lower increase than MedPAC’s recommendations, commissioners are “on record as disagreeing with it.” “With specific regard to the sequester, which cuts payments across the board, it has been our view, continues to be our view, that if Congress wishes to save money in the Medicare program, it is better to achieve that through more targeted means. We don’t think that the savings opportunities are spread across Medicare evenly — 2 percent in every INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 5 provider group. We think there are greater opportunities in some areas than others, and that is the best way to achieve Medicare savings consistent with access for Medicare beneficiaries.” MedPAC staff said making 66 ambulatory payment classifications site-neutral between hospital outpatient clinics and physician’s offices would reduce hospital pay by 0.9 percent, but even with that and a projected negative 9 percent margin for Medicare patients, hospitals will still have enough monetary incentive to treat beneficiaries. But an AHA representative who spoke during MedPAC’s public comment section of the meeting asked the panel to reconsider the package before reporting recommendations to Congress. Priya Bathija, senior director of health policy at AHA, said some of CMS’ cost-control initiatives, such as the readmissions program, have cut profits. “The reality is that a negative 9 percent margin does have consequences,” Bathija said. “While the consequences may not be so draconian as to no longer serving Medicare patients it could lead to hospitals discontinuing certain service lines. We’ve seen this especially with the shutting down of hospital psych units. While hospitals will continue to care for Medicare beneficiaries, they may not be able to serve them in all the ways the would be able to if Medicare actually paid its costs.” She also said MedPAC’s analysis of the 66 APCs considered for site-neutral payments was based on 2010 data and a lot has changed since then. Bathija said for calendar years 2014 and 2015 CMS has enacted “sweeping changes to the outpatient PPS that significantly increase packaging and change the structure of many APCs.” She said this could effect how many APCs qualify for site-neutral under MedPAC’s criteria. “We believe this warrants a fresh look at the analysis and recommendations,” Bathija said. — Todd Allen Wilson FDA Gets Third Biosimilar Application As Stakeholders Wait For Guidance Canadian pharmaceutical company Apotex announced Wednesday (Dec. 17) that FDA has accepted the company’s application for pegfiligrastim — a biosimilar version of Amgen’s Neulasta. This is the third biosimilar company to declare that FDA has accepted its application since Sandoz announced the agency’s acceptance of its biosimilar filigrastim application in July. With the third filing of a biosimilar for market in the United States, stakeholders are still waiting for FDA guidance on naming, interchangeability and labeling that the agency has indicated may be coming soon as the clock ticks on the 10-month application review deadline established by the Biosimilar User Fee Act and the 2012 FDA Safety and Innovation Act. Pegfiligrastim is the long-acting form of filigrastim — marketed by Amgen as Neupogen — which boosts white blood cell counts for cancer patients to help them fight off infections and fever, according to a press release issued by Apotex. “We are very pleased to be at the forefront of companies who will introduce high quality biosimilar products into the US marketplace,” Apotex President and CEO Jeremy Desai said. “The benefits for patients, payers and providers from biosimilars will be significant. We are dedicated to playing a leading role in the effort to increase the American public’s access to more affordable versions of these life-saving therapies and generate substantial savings for the US health care system.” An FDA official said earlier this month the agency is working to get out interchangeability and labeling guidance in the near term and Inside Health Policy has reported that the naming guidance has made its way to HHS Secretary Sylvia Burwell for final approval. With the application process underway Apotex will enter into what is known as the “patent dance” with Amgen. Under this process Apotex must provide Amgen with a copy of the application and a description of the manufacturing process within 20 days of the application’s acceptance. Then, within 60 days, Amgen must give Apotex a list of patents the company thinks would be infringed and which of those the company would be willing to license. In the first test case of the “patent dance” process, Amgen filed suit against Sandoz in October charging the biosimilar applicant violated the law’s patent exchange process by not sharing its manufacturing information, and asking a federal court to prevent Sandoz from seeking FDA approval, among other legal requests. Amgen also filed a citizen petition with FDA in early November asking the agency to create a certification process to ensure that companies filing a biosimilar application commit to following statutorily outlined procedures to share application and manufacturing information. Amgen said a new administrative mechanism would prevent companies from circumventing disclosure requirements that the company asserts are mandatory. IHP attempted to ask Apotex how it planned to go forward with the “patent dance” process for its biosimilar application for pegfiligrastim in light of Amgen’s lawsuit against Sandoz, but an Apotex representative said at this point the company cannot publicly share any information other than what was included in its press release. FDA’s Oncologic Drug Advisory Committee is scheduled to hold a public hearing on Sandoz’s filigrastim application Jan. 7, and the agency is expected to finish the application review in March. In August Celltrion was the second company to announce that FDA had accepted its biosimilar application. Celltrion biosimilar infliximab is a copy of Jansen Biotech’s Remicade. Celltrion already markets its infliximab biosimilar under the brand name Remsima in more than 50 countries. — Todd Allen Wilson 6 INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 CMS: Study Reinforces Concerns About Urban Preferred Pharmacy Access CMS officials said Tuesday (Dec. 16) a recent analysis of beneficiaries’ convenient access to lower cost sharing in plans’ preferred pharmacy networks shows that plans in suburban and rural areas generally provide convenient access to lower cost sharing but some aren’t providing convenient access in urban areas. CMS said the results of the study reinforce the agency’s concerns around access to preferred pharmacies, but some following the issue says the study appears incomplete as it looks at the number of plans providing convenient access to lower cost sharing and doesn’t lay out how many beneficiaries are affected when plans don’t provide such lower cost sharing. The study drew praise from community pharmacists, but pharmacy benefit managers raised alarms that CMS may be revisiting its prior plan to impose new pharmacy access requirements that PBMs view as violating the law’s ban on CMS interfering with plans’ price negotiations with pharmacies. A CMS official said the agency is considering future policy options, and though CMS’ next steps haven’t yet been decided further plans will be outlined in a draft Medicare Advantage and Part D call letter. While those plans could come as soon as the 2016 draft call letter, she also said the agency might wait until later years. “While we appreciate the importance of providing lower costs to beneficiaries, these findings reinforce CMS’ concern that plans are offering access to pharmacies with lower cost-sharing in a way that may be misleading to beneficiaries, in violation of CMS requirements,” according to CMS slides presented on a webinar with stakeholders Tuesday. The agency says it plans to provide Medicare Part D and Medicare Advantage plans with information about whether they are meeting the benchmarks CMS used in the study to show convenient access, and hold discussions with those who aren’t. CMS says it will look more closely at plans providing low levels of convenient access to preferred cost sharing in urban, suburban and rural areas and will also continue monitoring complaints and access levels. Though CMS released the results of the study Tuesday and will have another webinar on the study Wednesday (Dec. 17), an agency official said the final report will not be published until after Jan. 1. The agency said in the 2015 Medicare Advantage and Part D Call Letter it was concerned about beneficiaries’ access to preferred pharmacy networks. CMS had earlier planned to open these networks to any pharmacy willing to offer drugs at similar prices to the preferred networks’ terms, but pulled back its proposal, along with other aspects of the controversial Part D rule proposed in January, 2014, and the provision was not included in a final version of the rule. In the 2015 Call Letter, however, CMS said it was still concerned about beneficiaries’ access to the lower costsharing available at preferred pharmacy networks and their understanding of the preferred cost-sharing arrangements. CMS’ study took the standard for convenient access to retail pharmacies, and applied them to preferred pharmacy networks — though the agency noted that there is no current regulation that guides access to preferred pharmacies that offer lower cost sharing. However, an agency official said the standard for convenient access to retail pharmacies provided a reference point for meaningful access. The study said that for urban areas, convenient access meant 90 percent of beneficiaries have access to pharmacies within two miles of where they live, 90 percent of suburban beneficiaries have access within five miles of their homes, and 70 percent of rural beneficiaries have access within 15 miles of their residence. The study looked at Medicareeligible beneficiaries, and the distance between where they live and both in-network and preferred network pharmacies. On average, CMS notes that access to a pharmacy offering preferred cost-sharing in suburban and rural areas goes beyond the convenient access standards CMS applied in the study. But on average, only 79 percent of urban beneficiaries the study looked at had access to a pharmacy offering preferred cost sharing within two miles. CMS said 54 percent of plans did not meet the convenient access standard for preferred pharmacy networks in urban areas, though the overwhelming majority of plans met those standards in suburban and rural areas (87 percent and 95 percent respectively). CMS’ slides say that “urban access is a problem,” and of the plans not meeting the 90 percent standard, 16 percent of those provided convenient access to less than 30 percent of their beneficiaries in urban areas. Some stakeholders on the webinar took issue with CMS’ study, noting that the agency was judging access to pharmacies in preferred pharmacy networks on regulations that don’t apply. But the National Community Pharmacists Association said the preferred networks “have been the proverbial ‘Wild West’ with no consumer safeguards.” NCPA said it appreciates CMS’ conclusion that the findings reinforce the agency’s concerns. But the Pharmaceutical Care Management Association, which represents PBMs, said the study “should raise a new round of questions from policymakers” about CMS’ plans to make changes to plans with preferred cost sharing. Among those are whether the study is “a pretext for new CMS pharmacy access requirements in 2016” and if the agency has the authority to require those without new regulation. PCMA also questions whether such requirements would violate non-interference, since they would impact plan negotiations with pharmacies. PCMA also questioned whether new access standards would force plans to add new preferred pharmacies even if they don’t offer the same cost savings. The group also asks if CMS will brief Congress on the study and any proposed action plan when they return in January, given the controversy around the preferred pharmacy networks proposal in the Part D rule proposed in January 2014. CMS was also asked on the webinar if it plans to look at how many beneficiaries are affected by the plans that don’t INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 7 meet the convenient access benchmarks used in the study, and one lobbyist following the issue said that without knowing how many beneficiaries are affected, the study seems incomplete. Another industry lobbyist said the number of beneficiaries in those plans could skew the results of CMS’ study in a big way. A CMS official said the agency would consider enrollment weighting the results of the study for future analyses. — Michelle M. Stein Senate Passes Tax Extenders With $1.2B In Medicare Offsets The tax extenders legislation that the Senate passed Tuesday night (Dec. 16) includes a disability bill that’s paid for with nearly $1.2 billion in Medicare pay cuts. Providers are angry that Congress used Medicare offsets to pay for legislation unrelated to Medicare and had hoped to convince the Senate to ax them. Early this month, the House passed the Achieving a Better Life Experience (ABLE) Act on its own. ABLE creates tax-free savings accounts for individuals with disabilities, while protecting their access to Medicaid. The Congressional Budget Office estimates the law would cost $2 billion over 10 years. The American Medical Association and the Association of American Family Physicians oppose the misvalued codes provision, which will make CMS identify billing codes that overpay doctors. Currently, savings that CMS identifies are redistributed to other billing codes, and primary care doctors typically benefit from those redistributions. However, if CMS misses those targets, it must cut pay across the board to physicians, and CMS said this year that it is no longer reviewing misidentified codes. “The AAFP supports the review of physician payment codes that are judged to be misvalued and using the excess funds to support the appropriate Medicare payments,” a Dec. 3 letter to lawmakers states. “The AAFP also supports the intention of the ABLE Act to help disabled adults cover the cost of their health care over their lifetime. However, the AAFP is concerned about using permanent reductions in Medicare to pay for non-Medicare programs.” The ABLE Act also hits dialysis providers by delaying the inclusion of oral drugs in the dialysis-reimbursement bundle. The Congressional Budget Office estimates that the measure saves money because CMS would not sufficiently account for how much generics will lower the cost of medications. CBO projected that CMS would price the dialysis bundle at a level greater than what Medicare would spend if the drugs were to remain out of the bundle. The Kidney Care Council, which represents dialysis companies, opposes the delay, as does Dialysis Patient Citizens. After so many delays, industry no longer expects Congress to ever let oral drugs be included in the bundle. When Democrats created the Medicare end-stage renal disease pay bundle in 2008, oral drugs were to be included in the bundle starting in 2012. CMS delayed their inclusion for two years, then the American Taxpayer Relief Act of 2012 (often called the “fiscal cliff deal”) further delayed including oral drugs in the ESRD bundle to 2016, and it used the savings to help pay for the SGR patch in that bill. When the SGR was patched earlier this year in the Protecting Access to Medicare Act, Congress helped pay for it by extending the delay from 2016 to 2024. The provision in the House’s ABLE Act would extend the delay by one year, to 2025. The third offset ends Medicare coverage of vacuum erection systems by treating them as a drug. That measure attracted less attention because it only hurts businesses that aren’t publicly traded. Medicare doesn’t cover erectile dysfunction drugs so the ABLE Act treats vacuum erection systems as drugs, even though they’re devices. — John Wilkerson SUBSCRIPTION ORDER FORM Sign me up to receive Inside CMS at $705 per year in the U.S. and Canada; $755 per year elsewhere (air mail). Name __________________________________________________ Affiliation _______________________________________________ Address _________________________________________________ City/State/Zip ____________________________________________ Phone __________________________________________________ E-mail __________________________________________________ To order by mail: Send this coupon to Inside CMS, P.O. Box 7167, Ben Franklin Station, Washington, DC 20044. To order by phone, fax or e-mail: Call 800-424-9068 (in the Washington, DC area, 703-416-8500). Fax to 703-416-8543. E-mail at [email protected] Please check one: Visa MasterCard Bill me Check enclosed (DC subscribers add 6% sales tax) Card number _________________________________________ Name on the card _____________________________________ Signature _______________________________________________ 8 Exp. date ____________________________________________ INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 Waxman Details Impact On States If Administration Loses King V. Burwell Outgoing House Energy and Commerce Ranking Democrat Henry Waxman (CA) on Tuesday (Dec. 16) released a report breaking down the state-by-state impact if the administration ends up losing the high-profile Supreme Court case King v. Burwell that will determine whether the IRS overstepped in saying ACA subsidies are available for health insurance bought through the federal exchange. The report finds that consumers in the affected states would lose a total of about $65 billion in tax credits if the high court the subsidies are not available. The report is based on the Congressional Budget Office’s most recent assumptions that more than 13 million people would have coverage by 2016. Staffers also used HHS’ enrollment figures by zip code to develop the analysis. The state facing the most impact is clearly Florida, whose residents stand to lose about $12.3 billion annually in tax credits if the administration loses the case, followed by Texas, which would lose about $8.5 billion. North Carolinians would lose about $4.5 billion, Georgians about $3.8 billion, Pennsylvanians about $3.5 billion and Michiganers about $3.3 billion in subsidies, according to the report. “As today’s report makes clear, if the law’s opponents succeed, they will deprive Americans of $65 billion in tax credits, making it more difficult for millions of middle class families to have the health insurance coverage they need,” Waxman said. House Minority Leader Nancy Pelosi (D-CD-CA) in a separate statement called on the law’s opponents to “withdraw their radical suits and recover their common sense.” She added, “I am very confident that the Supreme Court will issue a ruling upholding the ACA and rejecting the baseless arguments of the challengers in this lawsuit.” The high court announced Nov. 7 that it would take up the case — King v. Burwell — for review this session even though similar cases were still winding through the lower courts. At the time of the decision, the administration had been preparing to argue its position in Halbig v. Burwell before a full panel of judges in the federal Court of Appeals in DC. The case was set aside following the SCOTUS announcement. At issue is whether the IRS overstepped its authority in saying that individuals living in federally facilitated exchange states have access to the subsidies, even though the law says that the tax credits are available to those enrolled in exchanges established by states. ACA supporters argue that Congress clearly intended to provide subsidies to all Americans, not just those in states opting to run their own exchanges, and say that a reading of the full law would support that argument. Oral arguments are expected in March, with a decision likely to be out in June. What will happen to consumers — and insurers — should the court rule in favor of the plaintiffs is a key question being explored by wide-ranging stakeholders and policy experts. In a piece in the New England Journal of Medicine published last week, three experts — Nicholas Bagley, David Jones and Tim Jost — wrote that some stakeholders, generally those who aim to minimize potential chaos and calm jittery investors — argue that a ruling in King’s favor would not be disastrous. But the three experts say: “(We) are not so optimistic.” Should the justices rule against the administration, they note, the decision would go into effect 25 days later at which time Treasury would likely stop making the subsidy payments. “Enrollees who are unable or unwilling to pay the full cost of their insurance premiums could see their coverage terminated, perhaps as soon as 30 days after they fail to make a payment. Those who retain insurance are likely to be sicker than those who drop coverage, which will skew the risk pools and expose insurers to large, unanticipated losses,” they write. The trio note that some experts have suggested HHS could count partnership states as state-based exchanges, but they say this could spur more legal action. States may also be able to contract out the technology, but it’s unclear if a state that has not created an exchange board would be able to do so, they say. Some experts have also suggested that the State Innovation Waivers — which allow states to avoid some ACA provisions in favor of their own health reforms — could be used as a fallback, however, they note, those do not go into effect until 2017. Additionally, the waivers would not be useful for FFM states since the law says they would only provide the states money they would otherwise get under the ACA for those purposes. They also argue that even if a governor in one of the FFM states is interested in creating an exchange, GOP-led legislatures — which may not have time to meet prior to the decision — may not budge. “Unquestionably, state officials would face enormous pressure — from taxpayers, health plans, and hospitals — to set up exchanges. In a volatile political environment, some states might well do so. But ACA opponents’ commitment to resisting the temptation of federal money should not be underestimated: Witness the refusal of nearly two dozen states to expand Medicaid even though the federal government would cover almost all the costs,” they write. “ACA supporters thus have good reason to worry. For at least several years, and perhaps for much longer, the outcome in King could determine whether millions of people continue to have access to affordable, comprehensive health insurance.” — Amy Lotven INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 9 TN Hospitals Would Cover Share Of Medicaid Expansion Under Gov.’s Plan In addition to establishing a Medicaid expansion plan built upon private and employer sponsored insurance, Tennessee GOP Gov. Bill Haslam’s newly unveiled proposal would require hospitals to cover the state share of the expansion once federal funding dips from 100 percent to 90 percent after 2016. The proposal, dubbed Insure Tennessee, which is expected to cover about 200,000 residents, also includes a fall back allowing the program to be terminated should federal or hospital funding be modified in any way. The Tennessee Hospital Association, which applauded the governor’s action in a statement, did not respond by press time to a query on how much money per year state providers would be expected to contribute. “For the past two years, THA’s number one priority has been securing Medicaid expansion in our state and today marks the beginning of this goal becoming a reality,” THA President Craig Becker said of the plan. “I also believe Insure Tennessee helps provide a solution to the financial challenges hospitals across Tennessee have faced for the last several years as a result of extreme cuts in healthcare reimbursement,” Becker said. “Extending healthcare coverage in Tennessee will lead to lower amounts of charity and unreimbursed care, which helps keep hospitals financially healthy and providing high quality care,” Becker added. According to the governor’s Dec. 15 announcement and related slides, residents enrolled in the program would choose from two options: the Volunteer Plan, which provides vouchers to help residents afford employersponsored coverage, including premiums and cost-sharing; and the Healthy Incentives Tennessee plan, which allows residents to enroll in the state’s Medicaid program (TennCare) but also creates HIT accounts — modeled after Health Reimbursement Accounts (HRS), that can be used to cover other out-of-pocket costs. Residents can “earn” HIT contributions through healthy behaviors, according to the governor’s office. “We made the decision in Tennessee nearly two years ago not to expand traditional Medicaid,” Haslam said. “This plan leverages federal dollars to provide health care coverage to more Tennesseans, to give people a choice in their coverage, and to address the cost of health care, better health outcomes and personal responsibility,” he said. He expressed hope the plan would spur innovation in the state’s existing Medicaid program. “I look forward to working with providers across the state to advance payment reform and with members of the General Assembly to make this plan a reality,” he said. Haslam said he will call a special legislative session to discuss the plan, which would need to be formally approved by the legislature and by CMS in order to proceed. Tennessee GOP Sens. Lamar Alexander, the ranking member of the Senate health committee, and Bob Corker also praised the move. “Governor Haslam deserves credit for insisting upon a Tennessee plan that the state can afford, and Secretary Burwell deserves credit for being flexible enough to allow the governor to achieve that,” Alexander said. Corker said he has had several talks with Haslam and “appreciates the work he and his team have done to study this issue closely and negotiate a tailored solution that works for Tennessee.” “I’m glad the administration has finally allowed appropriate flexibility, and I’m pleased our state was able to adopt a solution that will build off of the innovative ways we deliver quality health care,” Corker added. In related news, Corker and Alexander joined the state’s House delegation on Thursday (Dec. 18) in asking CMS Administrator Marilyn Tavenner to extend a TennCare waiver that provides funding to hospitals in the state that currently are not eligible for Medicaid disproportionate share hospital payments. State hospitals have been operating on temporary funding, and the most recent “patch” expired on Sept. 30, they say in a letter to Tavenner. The senators point out that the massive spending bill just signed by the president includes language that strongly urges the continuation of the waiver amendment for a longer period of time in order to allow for Congress to adopt a permanent solution for Tennessee. “To that end, we are committed to advancing a permanent solution in the next Congress and have worked collectively to insert language in the House Ways and Means Hospital Improvements for Payment Act of 2014,” the members write. — Amy Lotven Stakeholders: Number Of Penalties Shows Fix Needed . . . begins on page one evidence that the administration must make whole-scale modifications to the meaningful use program,” Robert Tennant, senior policy adviser for the Medical Group Management Association said. One health technology lobbyist following the issue said 257,000 penalties is a larger number than many had expected. CMS said that it is still working to put together the exact percentage of eligible professionals affected by the meaningful use cuts. Some physicians are participating in the Medicaid meaningful use program, which means they do not need to show meaningful use in the Medicare program and they won’t be subject to these cuts. Providers will be hit by penalties for not showing meaningful use of electronic health records for the first time in 2015. CMS usually has a two-year look-back period, and will be looking at whether an eligible physician attested to meaningful use in 2013. However, CMS also allowed those physicians showing meaningful use for the first time in 2014 10 INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 to avoid 2015 penalties by attesting before Oct. 1 of this year. The number of physicians who will see penalties in 2016 will likely be just as high, if not higher, than in 2015, the lobbyist said, because CMS will be looking at those who showed meaningful use in 2014 to calculate the 2016 penalties. If providers could have avoided not only the 2016 penalties but also penalties in 2015 by attesting before Oct. 1 of this year, they likely would have, the lobbyist said. This means that although physicians still have through February to show EHR use for 2014 and avoid the 2016 penalties, most who were going to attest probably did before October. Tennant said that concern about the number of physicians who will be hit by penalties in 2016 is speculation until the final number of physicians who attest to meaningful use in 2014 is available, but early numbers suggest providers are still having difficulties meeting meaningful use requirements in 2014. Tennant said MGMA is working to encourage CMS to make changes to the meaningful use requirements. The lobbyist said the number of penalties is disappointing, and raises some fundamental questions about the how to measure success in the meaningful use program. The high number of penalties in 2015 also indicates that the availability of the meaningful use hardship exemptions aren’t widely known, the lobbyist said, and not all providers seem to be taking advantage of them. A CMS official said the agency received 43,000 hardship exemption applications from physicians during the first round, and the large majority of those were granted. Over a thousand applications in the first round were denied. During the second round of hardship exemption applications, CMS received 13,000 applications from physicians, and less than a thousand were denied, the official said. CMS in February said it would allow hardship exemptions for providers having trouble meeting 2014 requirements to upgrade their EHRs or moving to the second stage of the program if they had been participating for two or more years. The exemption originally allowed providers to avoid an EHR penalty because the upgraded technology wasn’t available, current EHRs couldn’t be upgraded in time to attest to meaningful use, and Stage 2 requirements couldn’t be incorporated into providers’ workflow in time to meet the requirements. The agency later finalized a rule after the first round of hardship exemption applications were due that said providers wouldn’t have to use the upgraded systems until 2015, and the older version of the EHRs or combination of older and newer technology could be used to attest to meaningful use in 2014. However, issues with updating the attestation system right away kept some first time providers from attesting to meaningful use using older technology in time to avoid penalties, and CMS re-opened the hardship exemption period for those showing meaningful use for the first time in 2014. Considering the number of physicians who will face penalties for not meeting meaningful use, the lobbyist said more providers would have been expected to apply for the hardship penalties simply because they were available. The relatively low number of those applying for a hardship compared to those getting hit with penalties shows people aren’t taking advantage of the opportunity, the lobbyist added. It also underscores the difficulty physicians are having meeting meaningful use, and doesn’t hint at good things for next year, the lobbyist said. A CMS official said some doctors are close to retirement, and don’t want to switch to electronic records. But now that CMS knows who hasn’t participated in the program yet, the agency can look into why those physicians made that decision and do a closer analysis. The official also said that CMS will have a reconsideration form for physicians available, as the CMS could have made a mistake about whether the doctor should face penalties and the agency wants to make sure eligible professionals have an opportunity to let CMS know if that is the case. — Michelle M. Stein CMS Draft 2016 FFE Issuer Letter Outlines Key Timelines, QHP Policy Issuers must submit their qualified health plan (QHP) applications for participation in the Federally Facilitated Exchange starting March 16 through April 15, two months earlier than last year, and plan agreements will be signed by Sept. 15, a couple weeks before the planned Oct. 1 launch of open enrollment, CMS says in its draft 2016 letter to issuers that provides technical and operational guidance for issuers participating in the FFE. The 59-page letter released Friday (Dec.19) also discusses policy related to network adequacy, essential community providers and non-discrimination in essential health benefit and formulary design, among other issues. CMS expects to review QHP applications in two rounds, the first will take place between April 16 and May 26 and the second between June 10 and July 14, 2014. After each review period, CMS will send out correction notices, and final submissions are due on July 24. Issuers may withdraw their applications at any time prior to July 24, and CMS says issuers will be given a final opportunity to withdraw plans during the agreement signing process, which is set to take place from Aug. 17 through Sept. 15. The agency says it intends to implement a “petition process” to review requests for significant changes - such as INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 11 service area or plan type - to an application. These requests must be submitted at least two weeks prior to the final submission. During previous cycles, CMS says, the vast majority of change requests made after the submission deadline were related to data inaccuracies or incomplete applications. “Because an issuer’s failure to meet this required deadline calls in to question an issuer’s ability to submit a valid QHP application, the issuer may be at risk of non-certification or complaint action,” the agency writes. CMS says it will release further instructions on this process , and retains the ability to determine which changes are significant and therefore subject to this process. The letter also flatly states that ancillary insurance products and health plans that are not QHPs — including stand-alone vision plans — will not be offered on the FFMs For plans in FFE states that are doing their own plan management functions, the first data transfer is due on April 15, the second transfer will be due June 9 and the final due on July 24. Transfers from states - via SERFF - will close on July 25, and no changes will be allowed until CMS makes certification decisions and issuers sign the QHP agreement. The letter further reveals that CMS intends to administer the auto-enrollment process in a manner similar to how it was done for the 2015 plan year. For 2015, CMS had developed a “Plan ID Crosswalk Template,” which cross-walked 2014 plan ID and service areas combinations to a 2015 plan ID. The data is being used to facilitate the auto-enrollment for enrollees that did not actively select a different QHP. Additionally, CMS says that it will be adding auto-enrollment for the FF-SHOPs starting in 2016. For network adequacy, CMS says that, like 2015, the agency will assess provider networks using a “reasonable access” standard. In order to determine an issuer meets that standard, CMS says a plan must submit detailed network provider data as part of its QHP application, including information on physicians, facilities and pharmacies. CMS again plans to focuses on areas that have historically raised adequacy concerns, including hospital systems, mental health providers, oncology providers, primary care providers and dental providers, if applicable. If CMS determines an issuer’s network is inadequate, it will notify the issuers and request that the problem is addressed by either adding providers or submitting a justification explaining how the issuer will provide reasonable access. CMS says it will provide additional details on the collection method for network data and instructions on what should be included in the justifications as part of the 2016 certification/re certification instructions. The agency also reminds issuers that adequacy must be maintained throughout the year. The agency intends to use information learned during the QHP certification process as it develops future network adequacy standards and rulemaking. The agency notes that the National Association of Insurance Commissioners has formed a work group to consider revisions to its network adequacy model, and CMS plans to evaluate the results for future rulemaking. CMS also writes that its 2016 approach to Essential Community Providers will be similar to that put forth in 2015. Namely, isssuers must contract with at least 30 percent of available ECPs, offer contracts in good faith to all available Indian health providers, and offer contracts in good faith to at least one provider in each of six ECP categories in each county in a plans service area. ECP categories include: Federally Qualified Health Centers, Ryan White Providers, Family Planning Providers, Indian Health providers, Hospitals, and other ECP providers such as STD Clinics, Black Lung Clinics and other entities that serve predominately low-income medically understand people. An offer of “good faith” means it has terms that a “willing similarly -situated non-ECP provider would accept or has accepted.” An issuer that does not satisfy the 30 percent standard must offer a narrative justification explaining how it will provide access to those entities. CMS also discusses potentially discriminatory benefit design in Essential Health Benefits. To that end, the agency cautions both issuers and states that age limits are discriminatory when applied to services that have been found clinically effective at all ages. “For example,” CMS writes, ”it would be arbitrary to limit a hearing aid to enrollees who are 6 years of age and younger since there may be some older enrollees for whom a hearing aid is medically necessary.” The agency also warns issuers to avoid discouraging enrollment of people with chronic needs. “For example, if an issuer refuses to cover a single-tablet drug regimen or extended-release product that is customarily prescribed and is just as effective as a multi-tablet regimen, absent an appropriate reason for such refusal, such a plan design effectively discriminates against, or discourages enrollment by, individuals who would benefit from such innovative therapeutic options,” CMS writes. Another example of discriminatory design would be if an issuer places all or most drugs that treat a specific condition on higher cost tiers, CMS says. Last year, consumer advocates filed a discrimination suit against four health plans in Florida who had placed all of their HIV drugs — even generics — on the highest-cost tiers. CMS says that it will be collecting attestations from issuers that they will not discriminate on basis of health status, sex, race, color, national origin, disability, age, sex, gender identity or sexual orientation. The agency writes that, as in previous cycles, it will perform an analysis on QHP cost sharing that will weigh benefit packages with comparable cost-sharing structures to identify any cost-sharing outliers. Additionally, CMS says it is considering conducting a review of each QHP “to identify outliers based upon estimated out-of-pocket costs associated 12 INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 with standard treatment protocols for specific medical conditions using nationally-recognized clinical guidelines.” The conditions under consideration include: bipolar disorder, diabetes, HIV, rheumatoid arthritis and schizophrenia CMS will also be looking at plans’ language in their benefit explanation to ensure that it is not discriminatory. QHP issuers will be required to comply with standards and requirements related to data collection for quality rating information. Using QHP issuers’ validated data submissions, CMS will calculate quality rating system (QRS) scores and enrollee survey results for each QHP using a standard methodology and assigning a rating of 1 to 5 stars. Issuers may use that star rating in their marketing materials, as long as it is done in a way that does not mislead consumers. The agency will issue further guidance on marketing. CMS says it is continuing its phased approach to implementation of QRS scores and that ratings calculated in 2016 will be displayed in time for open enrollment for the 2017 coverage year. CMS earlier this year published the QRS and QHP enrollee survey technical guidance regarding the 2015 beta test, which CMS says is a “critical step” for CMS and QHP issuers to prepare for 2016 public reporting. CMS anticipates that it will refile technical guidance based on the beta test and publish any updates by fall 2015. Comments on the draft letter are due by Jan. 12. — Amy Lotven Sen. GOP Asks HHS To Tell Enrollees Subsidies Hinge On SCOTUS Ruling Senate GOP leaders are asking HHS and IRS to inform all federal exchange enrollees and visitors to healthcare.gov that their ACA subsidies could be taken away if the Supreme Court rules against the administration in King v. Burwell. The Republicans also want HHS Secretary Sylvia Burwell and Treasury Secretary Jack Lew to include in their 2016 budget requests information on how their departments would respond should the Supreme Court rule that subsidies are not allowed to flow through exchanges administered by the federal government. The requests are outlined in a letter sent Wednesday (Dec. 17) signed by Senate Republican Policy Committee Chair John Barrasso (WY), incoming Senate Majority Leader Mitch McConnell (KY), Whip John Cornyn (TX), Conference Chair John Thune (SD) and Conference Vice Chair Roy Blunt (MO). “Given the enormity of the financial stakes involved, we request that you use your department’s fiscal year (FY) 2016 budget submission to inform Congress of how the Administration plans to respond to a possible ruling in King that recognizes that the IRS’s rule is at odds with the law,” the senators write. At issue in the case is an IRS rule that says subsidies are available to all eligible Americans purchasing coverage through a health insurance exchange whether it is administered by a state or the federal government, even though the ACA says the credits are available through “an exchange established by the State.” The administration argues that under the Chevron doctrine, regulatory agencies may interpret language that is ambiguous. But the plaintiffs say that barring subsides from the federal exchange states is a clear reading of the law. In the letter, the GOP leaders side with the plaintiffs, saying that IRS’ interpretation is “unambiguously” inconsistent with law, and argue that IRS’ decision has also placed millions of Americas at risk of penalties. “Since the tax credits trigger the tax penalties under the law’s employer mandate and individual mandate, the IRS’s rule extends those penalties to people and employers in states that opted not to create a state exchange,” they write. The senators note that on Dec. 9, during a House oversight hearing with CMS Administrator Marilyn Tavenner and MIT economist Jonathan Gruber, Tavenner said that CMS would not be informing consumer about the potential changes should the court rule in favor of King. “Without the tax credits, millions of people will be confronted with Obamacare’s true cost and will face much higher premiums. Some could see their coverage canceled. It is imperative that people understand this risk as they contemplate signing up for coverage,” the senators say. Lacking such information, the senators say, “many families could turn down more-secure coverage options (e.g., through a different employer) in favor of less-secure Obamacare coverage.” “We urge you to reconsider this position and to ensure that these Americans have all available information as they make decisions about health insurance coverage next year,” they add. The GOP senators further charge that many recipients would be responsible for repaying tax credits if the court rules the subsidies cannot be accessed through the federal exchange. The GOP letter also notes that while the administration is not protecting Americans by providing information about the potential loss of subsidies, CMS did insert a clause in its contracts with insurers saying that they may pull out of the contracts — subject to state law — if the subsides are no longer in play. “It is troubling that the administration decided to protect insurers from a King ruling that restricts the law’s tax credits to state exchanges while at the same time failed to inform people enrolled or considering enrolling in federal exchanges of the potential consequences of such a decision,” the letter says. HHS Secretary Sylvia Burwell has made it clear that the administration is confident the high court will rule in its favor and that consumers should not be worried. “I think the most important thing for consumers to know is that INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 13 nothing has changed; that the tax credits that they’ll be signing up for and the ones that they have, for those who are enrolled that we want to stay enrolled, will be continuing,” she said at a recent Center for American Progress event. “And so as we go into open enrollment nothing has changed, and I think as the Administration has said, we believe that the law stated that the tax credits are an important part of affordable healthcare coverage, and that is for all,” she said. — Amy Lotven State Exchange Officials Report Strong Enrollment Interest Several state-based exchange officials said they were seeing strong interest in enrollment as they revealed updated figures and offered insights into the first few weeks of open enrollment during a Families USA-sponsored conference call Wednesday (Dec. 17). Donna Frescatore, executive director of the New York Health Benefit Exchange, reported that the exchange had about 194,500 new enrollees as of close of business on Tuesday (Dec. 16), about 40,000 of whom came in from Friday (Dec. 12) through Tuesday (Dec. 17). About 60 percent of the newly enrolled were Medicaid-eligible, while the remainder included those selecting qualified health plans and those eligible for the state’s CHIP program. Covered California Chief Deputy Yolanda Richardson said that the exchange had about 592,000 total enrollees, of which 144,000 have selected QHPs. Neither New York nor California have completed their auto-enrollments so they had no solid data to report. However, Frescatore did say the exchange center-enrollment notices to 300,000 residents, out of which 200,000 met the criteria to be auto-enrolled in their existing plan. New York extended its enrollment deadline from Monday (Dec. 15) to Saturday (Dec. 20) due to a large snowstorm, so Frescatore says there will be more information on enrollment and re-enrollment once that deadline passes. Carrie Banahan, executive director of Kentucky’s exchange, says her state is off to a strong start. Kentucky has already renewed 75,760 existing enrollees — after encouraging them to shop first. She says 21,456 made some changes to their plans, but had no further details. She also reported 25,354 new exchange enrollees. About 9,200 of the new enrollees selected QHPS, and 6,000 of those were eligible for tax credits, Banahan said. Another 16,000 were enrolled into Medicaid. Richard Onizuka, CEO of WashingtonHealthPlanFinder, which had some challenges in the beginning of the enrollment period, reported that as of last week there were more than 55,000 enrollees. According to the exchange, there were 45,843 QHP renewals and 10,082 enrollees as of Dec.10. The exchange officials were unable to answer questions about demographics of the enrollees, saying that it is still too early to determine that information. They all also cited the importance of face-to-face assistance to help consumers understand their choices and enroll in coverage. The new enrollment numbers came one day after HHS reported that about 2.5 million people had selected plans via healthcare.gov by the Dec. 15 deadline to have coverage effective Jan. 1, 2015. Another 500,000 consumers who provided their contact information to the federal call center can still select a plan effective Jan. 1, officials also said Tuesday (Dec. 16). Also Wednesday (Dec. 17), Minnesota and Colorado updated their enrollment figures. Colorado reported that the initial four weeks of open enrollment saw a total of 108,077 enrollments in QHPs , including 18,893 new enrollees and 89, 184 renewals. Connect for Health Colorado also enrolled 18,075 individuals in dental plans, the exchange said. Minnesota’s exchange reported that as of Tuesday , 23,797 residents had enrolled in QHPs. MNSure’s deadline for Jan. 1 coverage is Dec. 20. — Amy Lotven Express Scripts Doesn’t Restrict Hep C Rx Coverage . . . begins on page one year ago, policymakers have debated whether competitors would drive down the price of hepatitis C drugs. The history of so-called me-too drugs didn’t bode well for price competition, many said, but others insisted that once other drugs came on the market, plans and pharmacy benefit managers would secure rebates, avoiding the need for government price controls. Express Scripts Chief Medical Officer Steve Miller told Inside Health Policy last month that the company planned to get makers of competing hepatitis C drugs to significantly undercut Gilead on price in exchange for Express Scripts steering market share their way. A J.P. Morgan investor note states that the deal shows that PBMs can lower drug costs, and “this is just the beginning.” “Recall that both Express Scripts and CVS/caremark have introduced exclusionary formularies over the past few years. While hepatitis C is garnering a significant amount of attention, given increased competition in other larger therapeutic classes on the specialty side, we believe there now exists a significant opportunity to drive discounts where several products are determined to be at least clinically equivalent,” the J.P. Morgan note states, adding that biosimilars 14 INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 also might offer PBMs the opportunity to use exclusionary formularies. Viekira Pak is the first interferon-free competitor to Gilead’s Harvoni, which is the second-generation version of Gilead’s Sovaldi. Sovaldi is indicated for use with interferon, which makes patients very sick, although some patients were cured by combining Sovaldi and Johnson & Johnson’s Olysio, which together cost about $150,000. Harvoni is a once-daily pill that is taken without other drugs and cures nearly everyone who takes it. Its price is $94,500. Viekira Pak costs $83,319 and doesn’t require interferon, but the regimen is more complicated at four to six pills each day. However, Express Scripts is getting a significant discount on the Viekira Pak. Express Scripts spokesman Brian Henry declined to disclose the level of discount, other than to call it “significant.” He also said AbbVie’s blockbuster rheumatoid arthritis drug Humira was not bundled into the deal. State Medicaid plans and commercial insurers have been restricting access to Harvoni and Sovaldi by only allowing the sickest patients to receive them, and patient advocates are considering suing over those restrictions. The discount on Viekira Pak is significant enough that Express Scripts is covering it for anyone who tests positive for the infection, even if they’re not showing symptoms of infection, which can take decades to manifest. Henry said patients may appeal to get access to other, more expensive hepatitis C drugs if their physicians insist that they need them. He also noted that Express Scripts Pharmacy & Therapeutics Committee determined Viekira Pak to be clinically equivalent to Harvoni and Sovaldi. Henry said the committee met Friday and Saturday following FDA’s announcement of Viekira Pak’s approval. However, AbbVie had been sharing clinical information on the drug with the committee for a long time in anticipation of approval, he added. FDA approved Viekira Pak to treat hepatitis C genotype 1 only. Genotype 1 accounts for about 75 percent of infections in the United States. Express Scripts will cover Sovaldi for patients infected with other genotypes. Express Scripts is responsible for the pharmacy benefits of about 85 million people. Henry said Express Scripts is using the deal with AbbVie to get some of its other clients to join the National Preferred Pharmacy formulary, which covers 25 million people. Evercore ISI biotech analyst Mark Schoenebaum wrote in an investor note that Express Scripts is using the deal to negotiate a lower price from Gilead on Harvoni and Sovaldi, and he said Gilead believes that there is room to renegotiate its contract with Express Scripts. Schoenebaum estimated the Express Scripts deal takes 2 percent to 7 percent of Gilead’s hepatitis C market. —John Wilkerson Second Interferon-Free Hep C Rx Costs $83,319; Close To Price Of Sovaldi FDA approved the second hepatitis C drug for use without interferon, called Viekira Pak, and AbbVie is charging $83,319 for a 12-week course of the drug, a company spokesperson said, compared to the $94,500 12-week price of Gilead Science’s Harvoni and the $84,000 price of Harvoni’s predecessor Sovaldi. Medicaid directors and health plans anxiously awaited the approval of Viekira Pak in the hopes that AbbVie would significantly undercut the price of Gilead’s hepatitis C drugs. Despite the official price tag on Viekira Pak, an analyst said it would not be surprising if AbbVie offers rebates to get the drug on formularies. Viekira Pak contains three new drugs—ombitasvir, paritaprevir and dasabuvir—that inhibit the growth of HCV. It also contains ritonavir, a previously approved drug, which increases blood levels of paritaprevir. Viekira Pak can be used with or without ribavirin, but it is not recommended for patients whose liver do not function properly, a condition called decompensated cirrhosis. FDA Director of the Office of Antimicrobial Products Edward Cox said Viekira Pak is the latest in a wave of drugs that has made curing the infection much easier. “We continue to see the development of new all-oral treatments with very high virologic response rates and improved safety profiles compared to some of the older interferon-based drug regimens,” Cox said. However, one company, Gilead Sciences, has dominated the market, and health plans and Medicaid directors are up in arms over the price the company’s drugs. (Several other health care sectors, including hospitals, physicians, unions, disease advocacy groups and the nation’s largest seniors group, AARP, have also joined a campaign against the price of Gilead’s drugs.) FDA first approved Sovaldi in December 2013, then this fall it approved the second-generation version called Harvoni, which is approved for use without interferon or other drugs. Sovaldi was approved for use with interferon, which makes people sick, but doctors often prescribe Sovaldi with Johnson & Johnson’s Olysio, even though FDA did not approve the drugs in combination, and the drugs together cost about $150,000. Harvoni costs $94,500 for a 12-week course. Those who are less sick can take an eight-week course for $63,000 so Gilead says the “average” price for Harvoni is $80,000. However, John Rother, who leads the Campaing for Sustainable Rx Prices, said many health plans and Medicaid programs are treating only sicker patients so it’s uncommon for patients to receive the shorter course. The shortest course for Viekira Pak is 12 weeks, said AbbVie Director of External Communications Adelle Infante. INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 15 Very sick patients may need a 24-week course, depending on physician discretion, but the company expects that only a small population of patients would need the longer course. Infante did not know the price of the 24-week regimen. Viekira Pak’s regimen requires patients to take four to six pills each day, which is more complicated than the oncedaily pill Harvoni. The recommended dosing for Viekira Pak is two ombitasvir, paritaprevir, ritonavir 12.5 milligrams (mg)/75 mg/50 mg tablets once daily and one dasabuvir 250 mg tablet twice daily. Patients with advanced liver damage must take an extra medicine, ribavirin, which adds two more pills to the regimen. The Centers For Disease Control and Prevention estimates that 3.2 million Americans are infected with hepatitis C. Others say that estimate is low. — John Wilkerson AHA To Appeal Dismissal Of Lawsuit . . . begins on page one “In the end, here is the state of affairs: OMHA [Office of Medicare Hearings and Appeals] has been saddled with a workload it cannot, at present, possibly manage. Congress is well aware of the problem, and Congress and the Secretary are the proper agents to solve it,” the judge wrote. “In such situations — where an agency is underfunded and where it is processing Plaintiffs’ appeals on a first-come, first-served basis — the Court will not intervene.” OMHA placed the backlog as high as 800,000 claims this summer, and the report accompanying the 2015 spending bill asked CMS and OMHA to explain what they’re doing to reduce the backlog. Lawmakers previously estimated that OMHA would need more than 400 additional ALJs to bring the backlog under control in one year. AHA sued HHS over the backlog in May. Hospitals say it can take up to five years to appeal claims denials. Boasberg wrote that the amount of money HHS could transfer from other areas to OMHA wouldn’t be enough to solve the problem. It also doesn’t make sense for the court to force HHS to ask Congress for money to solve a problem about which both are already aware, he said. “While the court itself recognizes that hospitals simply cannot afford to have billions of dollars that are needed for patient care tied up indefinitely in the appeals process, its decision means that hospitals will be compelled to endure a prolonged ‘waiting game.’” AHA President Rich Umbdenstock said. “We are extremely disappointed that a court entirely insulated from the devastating effects of multi-year delays in payments for medical care as a result of bureaucratic mismanagement would find in favor of the government.” The court also said the “true aim” of the suit seems to be scaling back recovery audit contractors. Both the hospitals and the American Medical Association have suggested that changes to the RAC program would help with the backlog, and the AHA has said the RACs should be suspended until the backlog is cleared up. But Boasberg said this suggestion is not helpful. Again, Congress created the RAC program and HHS and the lawmakers must sort out problems with the program, not the courts, the opinion says. “To the extent that the RAC program is the cause of the delays, it was created by Congress and should be addressed by the Secretary and Congress together,” the judge wrote. A spokesperson for the American Coalition for Healthcare Claims Integrity, which represents RACs, said that while the appeals process is in dire need of improvement, “the court has identified the true motivation behind the AHA lawsuit, to reduce oversight of Medicare billing.” “Despite providers’ erroneous claims, Recovery Audit contractors are not responsible for the appeals backlog,” the spokesperson said. — Michelle M. Stein Administration Publishes Proposed Rule To Amend Excepted Benefits Low-wage workers and others who were denied the option of bolstering exchange plans with employer-provided coverage now have another shot at adding those benefits to their health care, after the Obama administration on Friday (Dec. 19) published a proposed rule that would amend the definition of “excepted benefits” to include certain limited wraparound coverage. Suggested changes come from HHS, Labor and Treasury after much urging by unions and numerous comments on a rule published Sept. 26, which began as a little-noticed proposed regulation in December 2013. Unions including the AFL-CIO, the Service Employees International Union and the United Food and Commercial Workers International Union, generally supported the concept of wraparound coverage for those without affordable employer-based coverage but complained that parameters suggested by the administration would prevent the part-time, low-income employees who most need a health plan from accessing that coverage. The proposals would allow group health plan sponsors, in limited circumstances, to offer wraparound coverage to employees who are purchasing individual health insurance in the private market and the exchange, the administration said in a release. Union representatives and other labor advocate groups did not respond to request for comment by press time. “The proposed rules would give employees who otherwise may not be able to get generous employer-based benefits access to high level benefits,” the release says. “The proposed rule would give businesses, including small businesses, new flexibility to meet the unique needs of their workforces.” 16 INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 The rule would create two pilot programs for wraparound coverage, according to the administration: One would allow wraparound benefits only for multi-state plans in the health insurance marketplace. The other would allow wraparound benefits for part-time workers who could otherwise qualify for a flexible savings arrangement and enroll in an individual market plan. Such coverage could provide benefits for items and services not allowed or unlikely to be ACA essential health benefits, including routine adult vision and dental care, long-term care and non-medically necessary pediatric orthodontia, Inside Health Policy previously reported about a Dickerson Employee Benefits summary of the December 2013 proposal. If approved, both pilots could be offered as excepted benefits to coverage first offered no later than Dec. 31, 2017, and would end either three years after the day wraparound coverage is first offered, or the date on which the last collective bargaining agreement relating to the plan ends after the day wraparound coverage is first offered, whichever is later. Wraparound limited benefits would have to meet five requirements to constitute excepted benefits for either eligible individual insurance or a multi-state plan. In this case, eligible individual plans are those that are not grandfathered, are not transitional individual health insurance market plans, and do not consist only of excepted benefits. The requirements include: • Limited wraparound coverage would have to provide “meaningful benefits” beyond cost-sharing, like coverage for expanded in-network medical clinics or providers. • The annual cost of coverage per employee and any covered dependents could not exceed $2,500, or the maximum annual contribution for health FSAs. That limitation should be easier to administer than the 15 percent cap that was included in the 2013 proposed regulations, the document says. • Three nondiscrimination requirements related to preexisting conditions, health factors of individuals or dependents, and income laws. • Individuals eligible for limited wraparound coverage cannot be enrolled in excepted benefit coverage that is a heath FSA. • Reporting guidelines are offered for self-insured group health plan or insurance issuers to correspond with OPM. Under the first pilot plan, sponsors’ plans can be offered only to part-time employees or retirees and dependents and can only wrap around their eligible individual health insurance. The proposal defines full-time employees as those who are “reasonably expected to work at least an average of 30 hours a week.” Those plan designs will be limited by rules that prevent sponsors from favoring highly compensated employees or offering different benefits for different workers based on factors like their health status. At least 95 percent of full-time employees would also have to be able to afford the coverage. Wraparound coverage in the second plan must be approved by OPM and be offered with ACA-authorized MSP coverage. Employers need to have offered coverage in the 2014 plan year that satisfied the relevant requirements, and the employer’s annual contributions for primary and wraparound coverage must be at least 80 or 90 percent of its total contributions to plans for full-time employees in 2014. The proposal does not cite an expected cost or federal budget impact because the number of sponsors and employees to be covered by the benefits is unknown. It says it would impose no additional costs on employers or plans, adding that employers still have the option not to provide adequate health care at all. “The decision to offer the limited wraparound coverage is optional,” the proposed rule says, noting added complexity should an employer sign on. “Given a choice, some plan sponsors may choose to increase the affordability of their primary coverage rather than offer limited wraparound coverage. Some plan sponsors may not have that choice: the employers may not be in a financial position to make their primary health plans affordable to more workers, let alone contribute to wraparound coverage.” The amendment is expected to please retailers like Target and Trader Joe’s, who announced that they would no longer provide health coverage to part-time employees due to ACA restrictions. The administration hopes to change that by expanding their view of who should qualify for benefits. A 60-day comment period will begin Dec. 23 once a notice is entered in the Federal Register.— Rachel S. Karas INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 17 Around 68.5M Enrolled In Medicaid, CHIP As Of Oct. 31 Preliminary CMS data show that 9.7 million more people were enrolled Medicaid and CHIP at October’s end than the average monthly enrollment from July to September 2013, although Connecticut and Maine were not included in that count. More than 68.5 million Americans were enrolled in Medicaid and CHIP nationwide at the end of October, including around 428,000 who signed up that month, according to the data released late last week. The report notes that these numbers are in addition to enrollment increases from nearly 950,000 people who gained coverage through the ACA before open enrollment began. “This is great news,” CMS Deputy Administrator Cindy Mann said in the report overview. “But, the best news is that the number of people with health coverage continues to increase. New data released this week show that the drop in the Nation’s uninsured rate so far this year is largest over any period since the early 1970s. The uninsured rate is now at or near the lowest level recorded in data spanning 50 years. And, the number of people with health coverage is growing as Medicaid and the Marketplace continue to work.” The enrollment count is point-in-time on the last day of the month, CMS said, and includes all enrollees in the Medicaid and CHIP programs who are receiving a comprehensive benefit package. CMS also reported that Medicaid and CHIP enrollment in October rose by over 24 percent compared to the JulySeptember 2013 baseline period among states that had implemented the Medicaid expansion and were covering newly eligible adults in October 2014. States that have not expanded Medicaid reported an increase of nearly 7 percent over the same period. Similarly, 11 of 25 states that had expanded Medicaid and were covering newly eligible adults in October, and reported comparable data for October and the 2013 baseline period, saw enrollment rise by 30 percent or more. Other data points included: 28.4 million children were enrolled in Medicaid and CHIP in the 44 states that reported in October. Those children make up slightly more than half of total Medicaid and CHIP enrollment. 2.2 million applications for financial assistance were initially received by state Medicaid and CHIP agencies, including those covering multiple people and renewals. More than 615,000 applications for financial assistance were initially received by state-based exchanges. More than 2.3 million people qualified for Medicaid and CHIP through the state agencies, the report said. That includes those who are newly eligible under the ACA, those who were eligible under prior law, and renewals in some states. CMS Administrator Marilyn Tavenner said earlier this month that data breaking out how many people were newly eligible for Medicaid and how many of those had actually signed up for coverage would be released “soon,” specifying only that she would try to report those numbers within a month. Enrollment in Medicaid and CHIP is held year-round, and states can expand their Medicaid programs at any time. As of October, 26 states and the District of Columbia had expanded Medicaid under the ACA, which will be fully federally funded through 2016 and at least 90 percent federally funded in following years. Pennsylvania is the next state to enact Medicaid expansion as of Jan. 1, and several other states — including Tennessee, Idaho and Wyoming — recently unveiled proposals to expand their programs next year. — Rachel S. Karas CMS Tests Public Understanding Of ESRD Program . . . begins on page one the group. Both patients and industry have complained about the program since CMS announced it this summer on its blog. Dialysis Patient Citizens’ complaint argues the star ratings fail the Data Quality Act’s objectivity requirement. The ratings discriminate against facilities that treat poor and minority populations, threatening people’s access to dialysis in areas where it’s most needed, the group says. In West Virginia, 63 percent of dialysis facilities receive one to two stars, and, at the other end of spectrum, 74 percent of Hawaii’s facilities earned four or five stars, the group states. “A regression analysis found that 24 percent of the variation among states’ proportions of 1- and 2-star facilities is explained by the life expectancy of the state’s overall population,” Dialysis Patient Citizens states. The patient group also argues that the star ratings fail the utility requirement of the Data Quality Act by contradicting the public’s understanding of what the ratings mean. CMS assigns one and two stars to the 30 percent of facilities with the lowest scores, even if their scores are good. Dialysis Patient Citizens cites research showing that people view one- and two-star ratings as poor, even though CMS officials say those ratings do not mean patients should expect poor care from those facilities. The third complaint contends that CMS broke the rules by creating the program without public input. “CMS’ Information Quality Guidelines promise that tools for public use will be developed through a ‘collaborative process involving providers, consumers, academicians, and policy analysts;’ however, while CMS is involving stakeholders in the formulation of its Hospital Compare star ratings by convening a Technical Expert Panel (TEP) with four consumer representatives, no TEP was convened for Dialysis Facility Compare star ratings,” the complaint states. — John Wilkerson 18 INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 Vit als: A Vitals continued on next page Health P olicy Blog Po Excerpts of Inside Health Policy Blogs GAO Appoints New MACPAC Members, Vice Chair The Government Accountability Office on Friday (Dec. 19) announced six new members of the Medicaid and CHIP Payment and Access Commission and the committee’s new vice chair. The new vice chair of MACPAC will be Marsha Gold, senior fellow emeritus at Mathematica Policy Research. Other new members include: Gustavo Cruz, senior adviser for Health Equity Initiative; Yvette Long, parent of a Medicaid beneficiary and case manager at Philadelphia Welfare Rights Organization; Charles Milligan, senior vice president for enterprise government programs at Presbyterian Healthcare Services; Sheldon Retchin, CEO of Wexner Medical Center at Ohio State University; and Peter Szilagyi, vice chair for research in the department of pediatrics at the University of California in Los Angeles. — Michelle M. Stein Coats, Heller, Scott To Join Senate Finance Committee Sen. Orrin Hatch (R-UT), who is set to take the gavel of the Senate Finance Committee in January, announced on Monday (Dec. 15) that Sens. Dan Coats (R-IN), Dean Heller (R-NV) and Tim Scott (R-SC) will be join the committee for the 114th Congress. “With the addition of these three Senators, the Republican side of this committee will only be stronger, and I am confident we’ll be able to work with our counterparts on the other side of the aisle to help drive a robust agenda to meet the demands of the American people,” Hatch said. Coats, Heller and Scott all say on their websites that medical malpractice reform is a priority, as well as health insurance that can be bought and is portable across state lines. Scott also says states should be permitted to create high risk pools again, while Heller champions reimporting prescription drugs. The full list of Republicans on the Senate Finance committee next session also includes: Sens. Chuck Grassley (IA), Mike Crapo (ID), Pat Roberts (KS), Mike Enzi (WY), John Cornyn (TX), John Thune (SD), Richard Burr (NC), Johnny Isakson (GA), Rob Portman (OH) and Pat Toomey (PA). — Michelle M. Stein CMS Anticipates Medicare Care Choices Participants Will Be Announced Early 2015 CMS says it plans to announce the participants in the Medicare Care Choices model in early 2015, and is asking for patience from stakeholders as the review process continues. The agency said in March it planned to provide a new option for Medicare beneficiaries to receive some palliative care services alongside curative care, and the agency would evaluate the demonstration to see if this would improve beneficiaries’ quality of life, as well as increase patient satisfaction and reduce Medicare costs. Beneficiaries currently must chose to forgo curative care in order to access the hospice benefit. CMS says it is still going through the review process to make sure the model will serve different geographic areas and hospices of all sizes in rural and urban areas. — Michelle M. Stein CMS Awards $655M For Second Round Of State Innovation Initiative CMS announced Tuesday (Dec. 16) $655 million in awards to 28 states, three territories and the District of Columbia to test ways to deliver and pay for care. More than half of states are participating in the innovation initiative, which the Affordable Care Act created. The funding covers both states that are designing plans and states that are actually testing new approaches. CMS awarded the brunt of that funding, $622 million, to 11 states to implement state health care innovations. The other $43 million was awarded to 17 states, three territories and the District of Columbia to create proposals. This is the second round of innovation grants. In round one, CMS doled out nearly $300 million to 25 states to design and test pay and delivery models. — John Wilkerson KY To Contact 12K Enrollees Eligible But Not Enrolled In CSR Plans Staff with Kentucky’s state-based exchange this week will contact about 12,000 enrollees who are eligible for, yet failed to enroll in, qualified health plans that provide cost-sharing reduction (CSR) payments, a move applauded by several consumer advocates. Carrie Banahan, executive director of Kentucky’s Health Benefit Exchange, revealed that the exchange would be reaching out to those residents, or their agents and brokers or in-person assisters, during a Wednesday conference call sponsored by Families USA Cost-sharing reductions, or CSRs, are payments provided to issuers in order to reduce out-of-pocket costs for enrollees who earn between 100 and 250 percent below the poverty level. Those reductions are only accessible to those who enroll in silver-level plans. Banahan says that about 5,300 of those customers instead enrolled in a gold-level plan, more than 1,000 held a platinum plan, and still others were enrolled in catastrophic coverage. The exchange will send letters specifically targeting those individuals with platinum and gold plans, according to Gwenda Bond, assistant communications director for INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 19 Kentucky’s Cabinet for Health and Family Services. Bond said in an email Thursday (Dec. 18) that these customers could see significantly lower premium costs and lower out-of-pocket costs “reflecting a 7 to 13 percent decrease.” “The concept of cost sharing reductions was new under the ACA and was not a feature that was easily understood, which we believe resulted in individuals failing to recognize the full benefits that were available to them,” she said, referring to why people were not taking advantage of subsidy savings. Marc Boutin, executive vice president and COO of the National Health Council, said Kentucky’s move is an exciting step and “exactly what needs to happen.” Consumers have been purchasing insurance without comprehensible information to make a good decision, which means people are buying products that might not give them the best coverage at the best possible price, he said. “I think you can almost guarantee that the vast majority of people” will enroll in the correct silver plan after being contacted, Boutin said. “Calling these people up … that personal touch makes a big difference.” He added that exchange websites rarely give the kind of prompts that customers need to fully understand their choices, but that governments and insurers are trying to make these points clearer. The information presented now focuses almost exclusively on premiums and deductibles, Boutin said. Kentucky’s outreach speaks to enhancements the NHC has proposed in order to make plan details more understandable and usable, he adds. NHC currently offers a calculator on PuttingPatientsFirst.net where people can input details of their expected health insurance use and compare plans in their state across metal levels to find the best coverage at the lowest price, including cost-sharing reductions. The Kaiser Family Foundation hosts a similar subsidy calculator. “It has to flow into the experience of the person who’s trying to select insurance,” he said. Cheryl Fish-Parcham, private insurance program director at Families USA, said the most consumers would have to pay out-of-pocket with a silver-level CSR plan in a year is less than they would with a bronze plan. The value of their silver plan would be considerably higher and people would be better protected in subsidized higher-metal plans, she added. According to a Center for Budget and Policy Priorities brief, the CSRs increase the actuarial value of a silver-level plan from 70 percent to 94 percent for people earning up to 150 percent of the federal poverty level (FPL). Actuarial value increases to 87 percent for people earning from 150 to 200 FPL and to 73 percent for people earning from 201 to 250 FPL. Judy Solomon, vice president for health policy at CBPP, said Kentucky has done a great job so far. But she added that she’d like more clarity on what cost-sharing level these 12,000 residents are eligible for. She points out that if a consumer qualifies for 73 percent actuarial value with the cost-sharing reductions, but seeks 80 percent coverage — and thus enrolls in a higher metal tier — she can understand that decision. “But if your income is below 200 percent of the poverty line, you really should be taking those cost-sharing reductions,” she adds. The availability of CSRs is an area where Solomon believes the message has largely gotten through for FFM customers, though it does take a long time to walk people through their choices to decide what’s best. A pop-up message on a website “isn’t going to do it for a lot people,” she said, but it’s “better than not doing it … people have spoken favorably of it.” Boutin at the NHC believes other states should adopt outreach to this group as a best practice through at least 2015. Making data more transparent and machine-readable so consumers can fully explore their options online should become the standard in the next few years, he said. “For those states where the population is manageable and there are resources, it would be ideal,” Boutin said. “In the long term, we need greater refinement for information.” A PhRMA-funded analysis by Avalere Health in June also found broad differences in how issuers amend plan designs to meet cost-sharing requirements for those receiving cost-sharing reductions. Almost all plans reduce deductibles and out-of-pocket caps in plans with CSRs, but many do not lower cost sharing for other treatments and services like specialty drugs. “Many people assume that the lowest-income exchange enrollees will have reduced cost-sharing across all services, but the reality is quite different,” Avalere Vice President Caroline Pearson said in the study overview. “While all plans must have reduced out-of-pocket limits for individuals earning less than 250 percent of poverty, how consumers will reach those limits differs significantly. For example, consumers may not experience reduced cost-sharing amounts for drugs or physician visits in many plans.” Avalere also found that “average maximum out-of-pocket limits in CSR plans are lower than those required by the Affordable Care Act.” “Issuers will continue to have flexibility in how they design cost-sharing reduction plans in 2015,” Avalere CEO Dan Mendelson said of the findings. “Looking ahead, consumers who qualify for cost-sharing reductions should look closely at how the plan benefit is structured because it could have a major impact on their actual out-of-pocket costs.” — Rachel S. Karas 20 INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 HHS Partners With Various Websites to Spread Open Enrollment Info HHS will partner with the job search site Monster.com, sharing-economy platform Peers.org and the health-andwellness tracker Higi.com to share enrollment information and encourage consumers to purchase health care, Secretary Sylvia Burwell announced Wednesday (Dec.17). HHS will pitch its open enrollment message in slightly different ways on each site. On Monster, HHS is simply posting information about open enrollment to offer unemployed job-seekers the chance to have health care while they do not have the option of employer-provided care. “We identified this collaboration as a great opportunity to provide our broad U.S. audience of consumers and job seekers with timely and accurate information regarding the Affordable Care Act,” Melissa Wojciak, vice president of government relations at Monster Worldwide, said in the announcement. “We were happy to coordinate closely with HHS on such an important endeavor.” The department plans to host a live video chat with an HHS official to answer questions from the Peers community, and the website will share information on how to enroll through HealthCare.gov. “The Health Insurance Marketplace gives Americans the flexibility to start their own business without relying on employer-based insurance,” HHS said in its release. “Because people who work in the sharing economy are microentrepreneurs, by partnering with Peers, HHS can provide affordable, quality health insurance information to the Peers community.” Higi launched its messaging at its department and grocery store kiosks Dec. 5 and will run it until open enrollment ends on Feb. 15. Higi users can create accounts to track their health vitals like blood pressure, weight and body fat. Richard Hirsch, the company’s senior vice president of marketing and media, said many consumers habitually use the kiosks during regular shopping trips. “We are thrilled, in tandem with our retail partners, to be able to offer our support in promoting the Health Insurance Marketplace to millions of consumers at such an impactful time in their daily routine - while they are engaged in their health and wellness,” Hirsch said. “This messaging will get significant and repeat exposure to a highly relevant target audience.” Monster has more than 200 million registered users in more than 40 countries, while the newer Peers has 250,000 members worldwide. Higi can be found in 2,000 Kroger, 1,000 Super Valu/Albertson’s and 250 Meijer stores across the U.S. These collaborations come on the heels of last week’s announcement that HHS will work with the electronic payment company PayNearMe to advertise enrollment deadlines on receipts generated at select 7-Eleven, Family Dollar and ACE Cash Express stores. HHS touted that partnership as an effort to draw in more unbanked or cash-preferring — and traditionally low-income or uninsured — Americans. — Rachel S. Karas CMS: Nearly 2.5 Million Users Enroll In FFM By Dec. 12, 500K Get Call-Backs HHS officials on Tuesday (Dec. 16) touted a strong, yet imperfect, start to open enrollment and said almost 2.5 million users had chosen a plan through HealthCare.gov as of midnight Friday (Dec. 12). Officials also said that around 500,000 customers left their contact information with federal call center representatives Monday night (Dec.15) while staffers struggled to field a higher-than-normal volume of calls due to the deadline to enroll in order to have coverage effective by Jan. 1, 2015. Staffers have already started calling those “several hundred thousand” users back, Principal Deputy Administrator Andy Slavitt said, noting that they will have “several days” to finish their applications. The center received more than a million calls on Monday alone, and the site had more than 3 million unique customers in the final hours before the deadline, officials said. Healthcare.gov saw more than 125,000 concurrent users at its peak volume without running into technical problems, Slavitt added. HHS used one of its “waiting room pages” for around 90 minutes Wednesday, with several hundred thousand people waiting an average of three minutes to create new accounts. Other users, like those window shopping on the site, were not affected by waiting room delays. Officials also said that they have started the auto-reenrollment process for existing consumers who did not yet proactively enroll in another option. Administration officials also stressed that existing and new consumers still have time to shop and enroll in a plan prior to the Feb. 15 end of open enrollment. FFM CEO Kevin Counihan said that less than 5 percent of the 6.7 million effectuated FFM enrollees — or around 355,000 people — whose plans were discontinued for 2015 will be enrolled in similar plans within the same metal level unless they opt for different coverage. If the plans aren’t substantially similar, Counihan said, insurers will reach out to consumers and let them know their previous plan is no longer available. CMS is also sending daily updates to insurers to notify them when consumers switch issuers, but not when someone INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 21 changes plans within those issuers. Counihan said that insurers have appreciated the help, and the “switch file” has worked well since it began earlier this month. Though the picture of open enrollment so far is largely rosy — fewer glitches, satisfied customers and a working electronic system that verifies income and immigration information — the officials said they have taken great pains to report upon each step of the process and tried not to forecast what may happen in the future. CMS spokeswoman Lori Lodes said HHS has taken “extreme steps” to train call center workers and said cases of giving consumers misinformation are rare. The officials said that while the process has not been perfect for every customer, they are confident in their infrastructure’s ability to deal with unexpected and individual problems. “Yes, there will be something,” Counihan said of bumps in the road going forward. “We don’t know what it’s going to be or when it’s going to hit but we will smooth it out.” The next set of enrollment numbers are expected out Dec. 23. News that 2.5 million consumers have already selected plans through Healthcare.gov came the same day Energy and Commerce Democrats issued a report saying that FFM state consumers could lose $65 billion annually in subsidies if the Supreme Court rules that the tax credits cannot go to residents in those states. Neera Tanden, CEO of the Center for American Progress, said in a statement that the HHS announcement “is a reminder of what is at stake in the months ahead.” “At the same time millions of people are shopping for a health plan that fits their needs and budgets, conservatives are plotting how to undo the progress that has been made. Whether it is holding more votes in the House and Senate or trying to use the Supreme Court to do it for them, their goal is the same: to repeal the Affordable Care Act and take away people’s health care,” she said. “A Congress or Court that chooses to go down that path would put not only these people’s care at risk but their own legitimacy as well,” Tanden adds. — Rachel S. Karas FDA’s Electronic Prescribing Rule Goes Against Appropriators’ Wishes FDA’s release Thursday (Dec. 18) of a long-awaited drug electronic labeling proposed rule that would require prescription drug makers to distribute prescribing information electronically, eliminating the paper form, goes against Senate appropriators’ request earlier this year, but is praised by generic drug makers who tout the electronic labeling plan as an alternative to a separate generic drug labeling rule they strongly oppose. The Generic Pharmaceutical Association earlier this year suggested that the electronic labeling rule, which had been under review at the White House Office of Management and Budget since Aug. 3, 2013, could pose an alternative to the separate generic drug labeling proposed rule. The second rule would require generic drug manufacturers to unilaterally update their labels with new safety information, which GPhA asserts would create multiple versions of warning labels leading to patient confusion. Alternative, GphA said, E-labeling would allow brand and generic drug companies to update their labels simultaneously. But the rule drew resistance from the paper labeling industry, which has said FDA lacks the authority to require the complete replacement of paper labeling for prescription drugs, as well as concerns from community pharmacists. The electronic labeling rule also goes against requests made by Senate appropriators earlier this year. “[T]he Committee directs FDA to ensure that any proposed regulations regarding electronic inserts of drug labeling does not come in lieu of paper inserts,” according to report language in an early version of the funding bill. However, Neas told FDA Week that there is growing bipartisan support for electronic labeling. FDA’s proposed rule would require that prescribing information be disseminated electronically, and that a product’s container label and outside package bear a statement directing health care professionals to FDA’s labeling repository to view the electronic version of prescribing information. FDA says it may grant an exemption from the electronic distribution of labeling requirements when compliance could adversely affect the safety, effectiveness, purity, or potency of the drug, is not technologically feasible, or is otherwise inappropriate, according to a Federal Register notice Thursday (Dec. 18). The agency says it determined that electronic distribution of prescribing information is better for health care professionals. “FDA has determined that requiring electronic distribution of prescribing information and eliminating the paper form that is contained on or within the package from which the drug is to be dispensed is important to ensure health care professionals have access to the most up-to-date information about the safe and effective use of the drug,” stated the Federal Register notice. The rule drew immediate praise from GPhA. “While the information received by patients will not change, e-labeling gives prescribers and dispensers immediate access to the most current, FDA-approved drug prescribing information,” said Ralph Neas, president and CEO of the Generic Pharmaceutical Association, in a press release. “This means that manufacturers can provide electronic updates to labels in weeks, rather than the months, or even years, now required for paper labels.” 22 INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 But the National Community Pharmacists Association said in general electronic labeling should not be viewed as an “effective substitute” for paper labeling. The group points to a 2013 U.S. Government Accountability Office study that found ending paper labeling could adversely impact public health by limiting the availability of drug labeling to a medium with which physicians, pharmacists and patients might not be comfortable, might find inconvenient, or might be unavailable. NCPA also notes that there is no one, agreed-upon website listing uniform drug information; and said shifting to electronic labeling would impose a cost burden on community pharmacies, which would have to print upon request prescription labeling that is now provided by drug manufacturers. The group is in the process of reviewing the rule. FDA provided some details as to how the rule would affect manufacturers and pharmacies. “After initial set-up costs, industry will experience net savings by providing the prescription information electronically,” said the agency. “Pharmacies will incur net costs due to initial capital costs to access the information, increased search time when accessing the information and the printing cost when a request is received for the prescribing information in printed form. We estimate no cost increases to most health care professionals to access the information.” The Biotechnology Industry Organization (BIO) is also in the process of reviewing the rule, but in the past has pushed for its release. The group referred to a letter it sent to OMB at the beginning of 2014 stating paperless labeling would improve patient safety and that there are significant cost savings associated with e-labeling that would generate a positive economic impact. “E-Labeling will have clear benefit for the public health by providing timely access to new safety information and can make a positive impact on the environment by reducing unnecessary waste,” the group says. — Erin Durkin Hospital group had urged vote in lame-duck... Cyber Info-Sharing Bill Likely Has Clear Path To 60 Votes In New Senate Information-sharing legislation, which has failed to advance in the lame-duck session of Congress, looks like a strong contender for early action in 2015 given the criteria that incoming Senate Majority Leader Mitch McConnell (R-KY) is sketching out for moving bills next year. The Federation of American Hospitals had joined a coalition of 21 major industry groups in urging senators to pass a cybersecurity information-sharing bill before Congress wrapped up its lameduck session this month. Bills on the Department of Homeland Security’s National Cybersecurity and Communications Integration Center, or NCCIC, the DHS cyber workforce and a bill addressing security of federal computer networks likely will be completed before the 113th Congress wraps up, reports sister publication Inside Cybersecurity. The workforce and so-called FISMA bills received final approval in the House on Wednesday and were headed for the president’s desk. The House is gave final approval to the NCCIC bill Thursday (Dec. 11). But the info-sharing bill by Senate Intelligence Chairman Dianne Feinstein (D-CA) and ranking member Saxby Chambliss (R-GA) appeared to have no chance, done in by lingering policy disagreements and a political environment that continues to be poisoned by the Snowden revelations. With Chambliss and the chief sponsor of the House version — Intelligence Chairman Mike Rogers (R-MI) — retiring at the end of the year, supporters have portrayed this as a do-ordie moment for info-sharing legislation. But McConnell’s plans for the Senate floor next year, and simple math, should give those supporters cause for optimism that an info-sharing bill will reach the president’s desk in 2015, Inside Cybersecurity reports. Incoming Senate Intelligence Chairman Richard Burr (R-NC) supported the Feinstein-Chambliss bill and — assuming he pushes similar legislation through committee early in the term — all 54 Senate Republicans would be viewed as likely supporters on the floor. That means McConnell’s team would need to find six Democrats to eventually end debate and bring the measure to a final vote. When the info-sharing bill was voted on in the Intelligence Committee this year, Feinstein was backed by three fellow Democrats — Sens. Barbara Mikulski (MD), Mark Warner (VA) and Martin Heinrich (NM) — and independent Sen. Angus King (ME). That’s five likely votes from the Democratic side right from the start. The sixth vote potentially could come from Sen. Ben Cardin, who like Mikulski represents Maryland’s vibrant cybersecurity community, or defense-minded Sen. Jack Reed (RI). The industry group had urged the Senate to vote this month. In a letter sent Dec. 2 to all members of the Senate, the industry coalition emphasized the immediacy of the cyber threat against U.S. businesses while highlighting the “limited liability” relief for industry and privacy protections contained in the Feinstein-Chambliss bill. “The [CISA] bill would help businesses achieve timely and actionable situational awareness to improve detection, mitigation, and response capabilities against cyber threats,” the groups said in their letter to the Senate. “Importantly,” the groups wrote, “the bipartisan bill safeguards privacy and civil liberties, preserves the roles of civilian and intelligence agencies, and incentivizes sharing with narrow liability protections. CISA represents a workable INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014 23 compromise among many stakeholders.” The groups added: “A primary goal of our organizations is to expand government-to-business information sharing, which is progressing but needs improvement. Companies frequently tell us that they need more actionable and up-to-theminute threat data that only government entities have. We also seek to incent businesses to share cyber threat data with appropriate industry peers and civilian government entities to bolster our critical infrastructure, lifelines, first responders, and business systems.” The letter was signed by the U.S. Chamber of Commerce and trade associations representing the energy, telecommunications, banking, chemical, manufacturing, technology, health care and water sectors. — Charlie Mitchell MedPAC Worries Plans With Talk Of Aligning MA, Traditional Medicare Coding Intensity Congressional Medicare advisers worried health plans on Friday (Dec. 19) with talk of pay cuts by way of “increasing coding intensity adjustment.” Industry complained that it is misguided to align coding practices of Medicare Advantage with traditional Medicare because it would undermine the very management of patients that differentiates the MA program from fee-for-service. Commissioners did not make recommendations, but the discussion about aligning MA and traditional Medicare irritated America’s Health Insurance Plans. That discussion was part of a larger analysis of the MA program. “Unlike the disjointed and siloed traditional Medicare option, Medicare Advantage plans work with providers and specialists to help coordinate care for beneficiaries,” said AHIP Director of Communications Clare Krusing. “From preventive services to personalized disease management programs, Medicare Advantage plans are focused on getting seniors well and keeping them well. These latest recommendations would move the health care system in the wrong direction by penalizing plans for these efforts.” The aim of an increase in coding intensity adjustment would be to align traditional Medicare and MA coding levels, Krusing said. The result would be a blunt 3 percent cut to all plans’ payments. Although MedPAC made no recommendation to that effect, plans worry that those findings indicate that commissioners might be considering an increase in coding intensity. Krusing said those differences in coding are a result of the work that plans do to identify enrollees’ conditions early on so they are placed in the right programs to treat their conditions. In general, traditional Medicare doesn’t even include these type of programs, so commissioners would be barking up the wrong tree if they tried to align coding intensity for traditional Medicare and MA. — John Wilkerson SUBSCRIPTIONS: 703-416-8500 or 800-424-9068 [email protected] NEWS OFFICE: 703-416-8577 Fax: 703-416-8543 [email protected] 24 Health Group Publisher: Chief Editor: Managing Editor: Associate Editor: Contributing Editor: Donna Haseley ([email protected]) John Wilkerson ([email protected]) Michelle M. Stein ([email protected]) Todd Allen Wilson ([email protected]) Amy Lotven ([email protected]) Production Manager: Production Specialists: Lori Nicholson ([email protected]) Daniel Arrieta, Michelle Moodhe Inside CMS is published every Thursday by Inside Washington Publishers, P.O. Box 7167, Ben Franklin Station, Washington, DC 20044. Subscription rates: $705 per year in U.S. and Canada; $755 per year elsewhere (air mail). © Inside Washington Publishers, 2014. All rights reserved. Contents of Inside CMS are protected by U.S. copyright laws. No part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language in any form or by any means, electronic or mechanical, without written permission of Inside Washington Publishers. INSIDE CMS — www.InsideHealthPolicy.com — December 25, 2014
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