Featured Stories:

As November draws near, #DefendPreEx remains in the spotlight.

We have written before about Texas v. United States, a lawsuit that seeks to overturn the Affordable Care Act’s protections for patients with pre-existing conditions. In September, the federal court with jurisdiction over the case held a hearing to consider the parties’ arguments. At issue is whether the court should:

• strike down the entire ACA as unconstitutional (as 20 State attorneys-general have asked);
• strike down “only” the guarantee of affordable coverage for people with pre-existing conditions (as the Trump Administration has asked); or
• uphold the law.

As of this writing, the court has not handed down its decision in the case. But reporters who attended the hearing fear that the judge appears inclined toward striking down the law. Any such decision – invalidating the ACA in whole or in part – would be devastating to many people with bleeding disorders or other pre-existing conditions, as we have explained before.
The pending lawsuit has brought urgent attention to the issue of maintaining protection for vulnerable individuals. Late last month, ten Republican Senators responded to concerns over the lawsuit by introducing a bill entitled the “Ensuring Coverage for Patients with Pre-Existing Conditions Act” (S.3388). This bill falls far short of its name: for example, while the bill would require insurers to sell policies to people with pre-existing conditions, it would also allow insurers to exclude coverage for care based on people’s medical history or health status. HFA co-signed a letter critiquing S. 3388 and offering to work with the bill’s sponsors to improve the legislation.
Meanwhile, a number of ACA defenders have filed their own, separate lawsuits. On Sept. 13, for example, Maryland’s attorney general filed suit against the federal government challenging Administration actions that undercut the ACA, and asking the court to uphold the ACA’s constitutionality. (In August, four cities had filed an earlier, similar lawsuit against the Trump Administration.)
Where do matters stand for now? The consumer protections of the ACA remain in force while the case is litigated through the courts. Any decision (in any of the lawsuits) will surely be appealed, meaning that a final resolution may be years off. HFA will continue to update you about the ongoing litigation, and we will continue our efforts to advocate for the affordable, quality coverage that the bleeding disorders community needs. Please follow and join in this effort online using the hashtag #DefendPreEx.

Bleeding disorders groups speak up for blood safety.

On Sept. 13, 2018, the federal Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) met to discuss “defining a tolerable infectious disease risk in blood safety from a patient’s perspective.”
The committee heard from a variety of speakers, including blood bankers, clinicians, researchers, and patients over the course of an all-day meeting. Speakers surveyed the landscape of infectious disease risk, the use of risk assessments, and the sustainability of the blood supply.
HFA presented testimony during the public comment period, as did NHF, and community member Catherine Anderson. HFA’s testimony reminded the committee about our community’s painful history with a contaminated blood supply. HFA also laid out the following key principles of blood safety from the patient perspective:

• Patient safety must take the highest priority;
• Blood safety policy must be based on rigorous science;
• The federal government bears responsibility for maintaining a strong regulatory framework;
• The policy-making process for blood safety must be transparent and inclusive, involving meaningful patient/end-user input;
• Users of blood and blood products are entitled to clear disclosures, so that they are able to give informed consent; and
• The federal government should consider establishing a compensation system for individuals who suffer adverse consequences from the use of blood or blood products.

You can read HFA’s full statement here.
Quick hits:

• As we reported last month, this summer the US Centers for Medicare and Medicaid Services (CMS) announced a policy change affecting Medicare Advantage plans. Effective January 2019, CMS will allow Medicare Advantage plans to implement step therapy restrictions for Part B drugs (a category that includes clotting factor and other hemophilia treatments). In September, HFA joined with other patient and provider groups to send letters to federal regulators opposing the new policy. These letters noted that any step therapy protocols must include (at a minimum) guardrails in the form of patient- and provider- friendly exemption processes.
• HFA filed comments with federal agencies describing patient experiences with chronic pain and (together with NHF) outlining our concerns with proposed revisions to the Medicare physician fee schedule.
• HFA continued to argue, with our coalition partners, against restrictive Medicaid eligibility requirements. We filed or co-signed comments in connection with Medicaid proposals from the states of Oklahoma, South Dakota, Washington, and Maine.
• Opioids legislation moved closer to passage in Congress. House and Senate negotiators in mid-September agreed on bill language that, among other things, increases federal funding for prevention and treatment programs, partially expands Medicaid reimbursement for inpatient drug treatment, and allows a broader range of providers to prescribe medication-assisted treatment for opioids. The amended bill now returns to first the House and then the Senate for final passage, and then would require the President’s signature.