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July 2017 Newsletter

In this Issue…

Notes from Joe
· Checking In Halfway Through 2017

Washington Update
· Update on ACA Repeal and Replace Legislation
· Alliance Submits Letter on ACA Implementation Request for Information
· 340B Hearing Held in House Energy and Commerce Oversight and Investigations Subcommittee
· FY18 Hospital Outpatient Prospective Payment System (HOPPS) Rule Proposes 340B Cut
· Pedley Announces that 340B Ceiling Price Website, Registration System to Launch Soon

Medicaid Update
· CMS Releases Medicaid Notice on Coverage of Drugs and Services for Bleeding Disorders Patients

Notes from the Community
· 340B Health Releases New Reports
· World Federation of Hemophilia Thanks Alliance for Travel Grant Contribution

Alliance Update
· Updates about Alliance Meeting for 2017 and 2018
· Team Alliance Contact Information

Notes from Joe


Checking In Halfway Through 2017
By Joe Pugliese

It has been a pretty crazy year so far and it shows no signs of letting up. It seems like the pace keeps accelerating and while we may all focus on the problems facing us, it’s not nearly as much fun as acknowledging the great work that has been accomplished year to date.

Starting with our internal activities, we have committed to doing a better job of communicating with our members and the community at large. My informal survey says we have been showing improvement year to date with more coming in the third quarter. The September Member meeting will be the official rollout of our new website and the first-ever Hemophilia Alliance Policy and Procedures manual. We have also held a record number of webinars. Our manufacturing partners agree that our webinars are a singularly unique benefit of contracting with the Alliance. Our in-house webinars have been even more warmly received by the membership and has allowed us to communicate in a timely and comprehensive manner on issues like contract pharmacy and payer agreements. We have also held our first-ever joint webinar with the National Hemophilia Foundation advocacy team. We will continue to host webinars for the benefit of our members and our contract partners throughout the year.

Moving to advocacy, we had a record turnout for our Capitol Hill day, with HFA, NHF and patients joining us on the hill in May. We also participated in Hill Days and Congressional receptions for THSNA, NHF and HFA. We have authored and co-authored numerous policy letters including the joint statement we signed on the Senate health reform bill (see more info below). We continue to relentlessly advocate to position HTCs as not just essential community providers, but standalone ECPs so our patients will have access to the appropriate care.

We are active members of the 340B Coalition, an advocacy group made up of covered entities (hospitals and grantees) who participate in 340B. Read below for an excellent study paid for by 340B Health (the hospitals), which highlights how insignificant 340B “costs” are to manufacturers as compared to discounts they give to commercial PBMS and specialty pharmacies as well as other costs like marketing and advertising. This article does an excellent job of putting to rest the silly idea that the 340B program is the cause of higher drug prices.

Our efforts in the payer space have paid off with the Alliance signing our first national agreement with Caresource, which has given our members in a number of states the opportunity to serve patients in the Medicaid managed care space. CMS has also released a Medicaid notice entitled Medicaid Coverage of Drugs and Services Provided to Blood Disorder Patient, which provides guidance to states regarding reimbursement for clotting factor medications for the treatment of hemophilia. You will see more successes coming out our payer group as the year progresses.

I want to acknowledge and thank Sean, Jeff, Issie, Roland, George, Audra, Ellen and Johanna for all of their hard work over the first part of 2017. We will have plenty to do in the rest of 2017 but for now, I hope that everyone is taking some time off this summer and catching your breath. While you are at it you should take a minute to celebrate all the good things you and your team have accomplished this year.

Washington Update

By Ellen Riker and Johanna Gray

It has been a particularly active summer in Washington, where the Alliance has been monitoring and advocating on a range of policy issues. Here is a brief update on several key issues:

Update on ACA Repeal and Replace Legislation

The Senate released its version of ACA Repeal and Replace legislation, the Better Care Reconciliation Act (BCRA) at the end of June. The Alliance joined with NHF, HFA and the Coalition for Hemophilia B in releasing a joint statement opposing the bill, since it would undermine the ban on lifetime and annual limits and pre-existing conditions exclusions, repeal the Medicaid expansion and significantly cut Medicaid funding, and increase costs and decrease access to care for low-income Americans. The statement was released broadly to the community and was sent to every Senate office. The legislation was amended in July, and the revised BCRA included more harmful language, including a new amendment by Senator Cruz which would allow insurers to offer plans that could waive nearly every ACA consumer protection, making comprehensive coverage even more expensive and less accessible to people who need it.

I have written several drafts of this article, since the situation has been so fluid this week that even a few hours would make the article out-of-date. After a few false starts and postponed votes, Vice President Pence cast a tie-breaking vote that allowed the Senate approved a Motion to Proceed to open up debate on health reform legislation earlier this week. The Senate voted on three main ACA repeal and repeal and replace bills, all of which failed:

  • A vote on a version of the BCRA bill failed 43-57. Senators Collins (R-ME), Cotton (R-AR), Corker (R-TN), Graham (R-SC), Heller (R-NV), Lee (R-UT), Moran (R-KS), Murkowski (R-AK), and Paul (R-KY) joined all of the Democrats to oppose the bill.
  • A vote on a version of the 2015 repeal bill (with no replacement) failed 45-55. Senators Alexander (R-TN), Capito (R-WV), Collins (R-ME), Heller (R-NV), McCain (R-AZ), Murkowski (R-AK) and Portman (R-OH) joined the Democrats in opposition.
  • A vote on the Health Care Freedom Act, the skinny repeal bill, failed 49-51, with Senators Collins (R-ME), McCain (R-AZ) and Murkowski (R-AK) joining the Democrats to oppose the bill.

So what happens now? We know that there continue to be real access challenges and concerns about the stability of health insurance markets. Members of both parties and both Congressional chambers have said that they want to turn to bipartisan policymaking. We anticipate that after the August recess, Congressional committees with jurisdiction over health care will hold hearings and draft legislation using the regular process. Some members of the House of Representatives have said that they will continue to try to draft comprehensive legislation that could pass both chambers, but consensus among Republicans feels distant. It is also possible Congress could abandon significant health reform for now to move onto other issues. We will continue to update the membership as the debate progresses.

Alliance Submits Letter on ACA Implementation Request for Information

Despite all of the debates on Capitol Hill, the implementation of the Affordable Care Act by the Trump Administration continues. HHS Secretary Dr. Tom Price released a Request for Information as he seeks to implement President Trump’s Executive Order directing federal agencies to reduce the burden of the ACA. In particular, HHS sought comments regarding current or new regulatory policies that would facilitate HHS’s priorities of stabilizing insurance markets, empowering patients, enhancing affordability, and returning regulatory authority to States. The Alliance submitted a comment letter in response to the RFI, which requested that:

  • CMS alter its policies regarding essential community providers (ECPs) and creating a separate category for HTCs so that individuals can use the providers of their choice;
  • HHS maintain current essential health benefits (EHBs), network adequacy and non-discrimination standards to provide access to coverage and enhance affordability; and
  • HHS support policies that promote public and private payers contracting with 340B pharmacy providers, like HTCs.

The letter is available here.

340B Hearing in House Energy and Commerce Oversight and Investigations Subcommittee

On July 18th, the House Energy and Commerce Oversight and Investigations Subcommittee held a hearing, “Examining HRSA’s Oversight of the 340B Drug Pricing Program.” Witnesses included Captain Krista M. Pedley, Director, Office of Pharmacy Affairs, at HRSA; Debra Draper, Director, Health Care at the Government Accountability Office (GAO), and Erin Bliss, Assistant Inspector General, Office of Evaluation and Inspections, Office of Inspector General (OIG) at HHS. The hearing followed a letter that the subcommittee had sent to HRSA regarding its oversight of 340B and the GAO and OIG witnesses discussed evaluations performed by their offices regarding the same.

There were both 340B supporters and skeptics among the Members of Congress at the hearing. The testimony and questions at the hearing were primarily focused on HRSA’s authority and oversight activities. Some were concerned about the frequency and results of HRSA’s audits, for example. Much more attention was paid to hospital participants than grantees, with several Members of Congress asking questions related to how much money hospitals make from 340B and how they spend the money. Several asked specific questions about the patient definition, and whether HRSA needs legislative authority to write regulations on the subject.

We anticipate that there will be further hearings on 340B (Subcommittee Chair Tim Murphy (R-PA) suggested he may seek a hearing to learn more about the program from hospitals and other covered entities directly) and the tone of the questions at the hearing suggest that members of both parties may be interested in legislation to address issues of transparency, oversight, patient and hospital eligibility. A number of Representatives – including House Energy and Commerce Chair Greg Walden (R-OR) and Health Subcommittee Chair Michael Burgess (R-TX) – suggested that giving HRSA greater authority via legislation may be a way to ensure that the program is properly administered.

FY18 Hospital Outpatient Prospective Payment System (HOPPS) Rule Proposes 340B Cut

Last week, CMS released the Hospital Outpatient Prospective Payment System (HOPPS) proposed rule for 2018. This rule sets annual payment rates and reimbursement policies for hospital outpatient departments (inpatient and physician services are paid via other Medicare payment systems addressed in other rules). The HOPPS rule includes a proposal to cut reimbursement for 340B drugs from ASP+6% to ASP-22.5% in an effort to reduce Medicare spending and to allow “Medicare program and Medicare beneficiaries to share in some of the savings realized by hospitals participating in the 340B program.” The discussion in the rule suggests that CMS has taken to heart the arguments made by 340B opponents that hospitals are making too much money and not passing along savings to public payers. CMS does ask for comments on whether clotting factor should be excluded from this cut (the question is raised twice in the rule). The rule does not change the requirement that Medicare reimburse for a furnishing fee for clotting factor provided by hospital outpatient departments (which raises implementation issues if the cut were to take effect).

The Alliance will submit comments on the rule to oppose the cut and ask that bleeding disorders treatments be exempted. We will work with NHF and HFA to see if they will submit comments, as well. The proposal is opposed by 340B Health and it was also opposed by several Democratic Members of Congress who raised the issue at the 340B hearing earlier this week, suggesting that there will be political opposition, as well.

Pedley Announces that 340B Ceiling Price Website, Registration System to Launch Soon

Finally, during her presentation at the 340B Conference and again during the 340B hearing earlier this week, Captain Pedley discussed HRSA’s plans to launch the new 340B ceiling price and registration systems. The ACA required HRSA to develop the ceiling price verification system, which must also include significant security precautions to keep privileged pricing data secure. The ceiling price system will also include a new 340B covered entity registration system so that each part of the program can be secure and they can work together. HRSA has been working on this system for several years and has suggested that it will launch “in the coming months.”

Medicaid Update

CMS Releases Medicaid Notice on Coverage of Drugs and Services for Bleeding Disorders Patients
By George Oestreich

On June 30, 2017 CMS issued Medicaid Drug Rebate Program Release Notice Number 182, entitled Medicaid Coverage of Drugs and Services Provided to Blood Disorder Patients. This long-awaited notice provides guidance to states regarding reimbursement for clotting factor medications for the treatment of hemophilia. While the immediate impact of the guidance may be limited since many states have already filed their State Plan Amendments (SPAs) to set their Medicaid drug reimbursement policies for future years, the document provides us with an advocacy tool to use with states in future discussions.

As background, following the release of the Medicaid Covered Outpatient Drug Rule in January 2016, the Hemophilia Alliance (HA) met with key Medicaid staff at the Centers for Medicare and Medicaid Services (CMS) to express our concerns with the regulation and asked CMS to release guidance to states related to clotting factor reimbursement for clotting factor. Several of the issues and suggestions we made at this meeting have been included in the recently released notice.

A summary of the notice is available here. Please contact me with any questions.

Notes From the Community

340B Health Releases New Reports

340B Health, the membership organization of hospitals and health systems that participate in the 340B drug pricing program, has released two new reports about 340B providers and drug manufacturers. We wanted to highlight these reports for the Alliance membership, who may find these useful in advocacy:

  • 340B Hospitals Use Their Contract Pharmacy Benefit to Treat Low-Income and Rural Patients: Results from a Survey of 340B Health Members: A survey of 340B Health member hospitals demonstrates that 340B hospitals rely on contract pharmacies to treat low-income and rural patients. The findings also indicate that eliminating or reducing the contract pharmacy program could reduce the level of services 340B hospitals are able to provide to patients in need. Read the report and click here for an overview of the report’s findings.
  • Assessing the Financial Impact of the 340B Drug Pricing Program on Drug Manufacturers: 340B Health commissioned the research firm Dobson DaVanzo & Associates to assess the financial impact of 340B discounts on drug manufacturers and evaluate claims that the 340B Program is a cause of high drug prices, cost shifting, and reductions in private sector research and medical discovery. The analysis found that the 340B Program cannot plausibly be a major driver of U.S. drug spending or a major cause of cost shifting by drug manufacturers to make up for 340B discounts. Read the report and click here for an overview of the report’s findings, and click here for an infographic summarizing the findings.

World Federation of Hemophilia Thanks Alliance for Travel Grant Contribution

The Alliance recently received a statement from the World Federation of Hemophilia USA Board of Directors, which acknowledges the Hemophilia Alliance’s generosity and commitment to advancing the art and science of bleeding disorders. Alliance donations have established the WFH Travel Grant which is available to members of the multi-disciplinary care team (nursing, psychosocial, dentistry, physiotherapy, and laboratory sciences) to attend a WFH congress or meeting. WFH states, "Your commitment to further deepen the knowledge of these invaluable professionals, goes even further, it shows our community that you believe in our comprehensive model which in turn is helping our entire community." It’s nice to be recognized by them for the core goal of the Alliance – supporting the comprehensive care model.

Alliance Update

Updates about Alliance Meetings in 2017 and 2018
By Sean Singh

Fall Members Meeting 2017

With all the changes happening in Washington, DC, we will have lots to talk about together at the Fall Members meeting. It seems as though not a day goes by without some new information about healthcare. The next members meeting will be in San Diego, CA, on September 17-19, 2017.

We will be meeting at The US Grant Hotel, located at 326 Broadway, San Diego, CA , 92101. We have negotiated discounted rates for our room block: Superior Guestroom $239 or 1 Bedroom Legacy Suite $339. We encourage you to please make your reservations as soon as possible. If your plans change, you can always cancel the reservation. The cutoff date for our room block is August 18.

To make reservations, please call 866-837-4270 (refer to the Hemophilia Alliance Room Block) or book online here.

Meeting for CPR+ Users after Member Meeting

The Hemophilia Alliance has been in discussion with Mediware about working with our member users. Mediware has agreed to San Diego and participate in a special session the morning after the Member Meeting (Wednesday, September 20th from 8:30 am to 11:30 am). A team of people will be coming to will listen to our concerns and see how they can make CPR+ work better for us.

Please email me at sean@hemoalliance.org and let me know if you are able to attend the CPR+ session so we can plan accordingly. We have also been asked to prepare a top 15 list of issues to send in advance of the meeting. Please let me know if you have any specific questions or concerns.

Save the Dates for 2018

Please make a note and block your calendars for an exciting year of meetings in 2018:

– January 22-23 – Board Meeting
– March 18-20 – Spring Members Meeting
– September 23-25 – Fall Members Meeting

Information for the social workers meeting will be published in August 2017. The planning committee will be meeting during the summer to determine the dates of the meeting and the topic.

We are waiting for the congressional calendar to be published for 2018. Once we have that information we will announce the Hill Day visits which will be combined with a Physician-led meeting and an Introduction to 340B for new Alliance members and folks who want a refresher on the basics.

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Team Alliance Contact Information

We work for you! Please don’t hesitate to contact any of us with any questions or concerns:

Joe Pugliese…joe@hemoalliance.org…215-439-7173
Sean Singh…sean@hemoalliance.org…727-388-7326
Jeff Blake…jeff@hemoalliance.org…317-657-5913
Elizabeth Karan…ekaran@feldsmantucker.com…202-466-8960
Roland Lamy…roland@hemoalliance.org…603-491-0853
Audra Ames…audra@hemoalliance.org…727-415-6397
Ellen Riker…eriker@dc-crd.com…202-484-1100
Johanna Gray…jgray@dc-crd.com…202 484-1100
George Oestreich…george@gloetal.com…573-230-7075