HealthCare Roundtable e-News – February 3, 2021

Roundtable Schedules Briefing on Generic Drug Price-Fixing Scheme

TODAY: Wednesday, February 3rd at 2:00 PM (EST)

Cindy Reichline, Partner
Strange & Butler

Cindy is a skilled litigator whose practice focuses on antitrust legal strategy, analysis, and advocacy in state and federal courts across the United States, as well as before international third-party arbitral tribunals. She has extensive experience with a broad range of high-stakes litigation and has managed all aspects of complex commercial litigation and dispute resolution, with an emphasis in antitrust and unfair competition litigation. Cindy has represented clients in a variety of industries, including telecommunication and Internet suppliers, hospital and health care providers, department store retailers, oil and gas producers and manufacturers, and national credit data repositories.

Over the past several years, the Roundtable has been tracking a significant Department of Justice (DOJ) investigation focused on 20 of the largest generic drug manufacturers that has important implications for our plan members.

In 2017, the DOJ launched a criminal investigation accusing these companies of a widespread price-fixing scheme that has now resulted in criminal charges and over $600 million in criminal fines to the companies that have admitted wrongdoing. The cooperation of these companies with the DOJ is expected to significantly advance the government’s investigation and result in more criminal indictments/charges.

Today, numerous lawsuits have been filed by major hospital systems and other entities that purchase large quantities of generic drugs. We believe Roundtable members are likely to have significant claims that as part of a group could lead to the recovery of damages.

As such, the Roundtable Board has agreed to convene health plan members and other interested health plans to discuss the DOJ investigation in more detail and explore interest in recovery action. There is still time to participate in today’s briefing/discussion. Please contact Tom Lussier ( to receive a link to the Zoom Briefing.

SCOTUS Bulletin Anticipates Potential Opinion on ACA Case to Be Published This Week

While the Supreme Court remains closed, a bulletin published last week announced that the justices are preparing to issue opinions on cases heard by the court in the fall of 2020. Among the cases that were heard is high-profile California v. Texas and the fight to save the Affordable Care Act, a case in which the justices may vote to either to strike Obamacare down over its individual mandate or leave the law alone.

During oral arguments, key justices, including Chief Justice John Roberts and Justice Brett Kavanaugh signaled they believe the law’s to buy insurance can be severed from the rest of the law, and many ACA supporters breathed a sigh of relief. The Trump administration had previously called on the Supreme Court to strike down the ACA in its entirety, which serves more than 23 million Americans and protects those with pre-existing health conditions. One expert suggested we still may not hear opinions on the case until spring or summer, commenting “Unless there’s more unanimity than I anticipate, it’ll be March at the earliest, and probably later.” (InsideHealthPolicy)

House Speaker Nancy Pelosi (D-Calif.) had called the Trump administration’s actions to remove the ACA “an act of unfathomable cruelty” in the middle of the coronavirus pandemic, while California Attorney General Xavier Becerra, who has since been nominated to serve as Health and Human Services Secretary within the Biden administration, said in a statement that the fight to save the ACA “comes at the most crucial time,” as the death toll from the pandemic continued to rise.

Biden Continues Streak of Executive Orders with Trump-Era Health Care Reversals and Medicare Enrollment Extension

President Biden signed a series of executive orders last week to reverse ACA-damaging Trump-era policies and support his administration’s agenda to boost Obamacare. Among the initial orders signed by the president is an EO that asks key departments to review Trump administration actions and alter or rescind rules and guidance that undermine the ACA. President Biden’s executive order states that it is the “policy” of the Biden administration to “protect and strengthen Medicaid and the ACA and to make high-quality healthcare accessible and affordable for every American.” (See more on this below).

Among the orders Biden rescinded are a Trump policy that asked HHS to minimize any economic burdens from the ACA as Congress and his administration worked to repeal the law and a 2017 executive order that laid the foundation for Trump administration rules allowing states to extend the duration of short-term health plans, expand Association Health Plans and let workers use health reimbursement accounts to purchase coverage in the exchange. Many Democratic lawmakers and industry stakeholders cheered the administration’s actions to break down these “barriers”. (InsideHealthPolicy)

White House officials confirmed that the administration is anticipating many of the president’s plans to make health care more affordable for consumers will require legislation from Congress. In his signing ceremony, Biden stated that his administration isn’t doing anything new, “other than restoring the Affordable Care Act and restoring the Medicaid to the way it was before Trump became President, which by fiat he changed—made more inaccessible, more expensive, and more difficult for people to qualify for either of those two items: The Affordable Care Act or Medicaid.” (InsideHealthPolicy)

Biden Administration Plans to Purchase 200M More Vaccine Doses to Inoculate All Americans By Summer

The Biden administration announced last week that it plans to purchase 200 million more doses of COVID-19 vaccines, approximately 100 million from Pfizer/BioNTech and 100 million from Moderna, in addition to the 400 million doses that had already been ordered by the U.S. The plan will aim to account for enough doses to fully inoculate nearly every American by the end of the summer.

In a briefing, the president stated that his administration has identified suppliers that will plan on ramping up manufacturing supplies and materials under the Defense Production Act.

“We’re using the Defense Production Act to launch a full-scale wartime effort to address the supply shortages we inherited from the previous administration,” Biden said in a briefing last week. “We’re going to be working across the government with private industry to ramp up production of vaccines, protective equipment, the syringes and needles, the gloves, the swabs, masks. Everything that’s needed to protect, test, vaccinate and take care of our people.” Biden also commented on the work of the previous administration and the dedication of the scientific community in researching a vaccine but noted that the program was in worse shape than anticipated upon the Biden team’s transition into office. (InsideHealthPolicy)

According to officials, the administration is not holding back doses aside from a small emergency reserve, but states have been holding back the doses they receive at different levels to ensure that enough is available for people to get their second shots. Upon receiving the additional doses, the federal government plans to increase the overall weekly vaccine supply to states, tribes, and territories from 8.6 million doses to a minimum of 10 million doses. (InsideHealthPolicy)

Former Health Officials Urge Biden to Lower Medicare Enrollment Age to 55

In a letter to the Biden administration, former health officials from the Obama, Bush and Trump administrations are calling on the president to expand access to insurance and lower the Medicare enrollment age to 55, which is lower than Biden’s previous campaign commitment to lower the age to 60. Among the authors of the letter are Nancy Ann DeParle, former head of President Obama’s White House Office of Health Reform, Scott Gottlieb, former FDA commissioner under presidents Trump and Bush, Peter Orszag, former director of the Congressional Budget Office under Obama, and Gail Wilensky, who administered Medicare and Medicaid under President George H.W. Bush. (InsideHealthPolicy)

The health experts say lowering the age to 55 would benefit Americans in that range who have no alternate coverage and could be paid for by reallocating wasteful spending. The authors recommend the administration focus on five key priorities; expanding coverage: accelerating the transition of value-based care, advancing home-based care; lowering drug prices; and developing a high-value workforce.

“We believe that reallocating the substantial resources spent on care that does not improve health represents an opportunity to expand coverage without sacrificing affordability or quality, but the impact of associated revenue reductions on providers needs to be closely considered,” they stated. (InsideHealthPolicy)

The health experts added that the above can be achieved by the administration collaborating with state governments and private payers to develop and deploy a high-value health care workforce. The group’s research suggests that more community health workers could reduce disparities, improve health, and lower spending and that an expanded workforce would also provide an economic opportunity to the workers themselves who should be recruited from the communities they serve. (InsideHealthPolicy)

CMS Reopens for 3-month SEP starting Feb. 15, pledges $50M for Education and Outreach

President Biden signed an executive order last week that will effectively re-open, inviting all eligible consumers for a three-month period, and will initiate a $50 million campaign focused on health care outreach and education. The special enrollment period (SEP) will last from February 15 to May 15th, 2021, in every state that uses the portal. CMS is also urging all states that use their own state-based exchanges to consider opening their own SEPs.

Under the SEP, eligible consumers will allow consumers 30 days to either submit a new, or update an existing, application for coverage. Upon submitting an application, enrollees will then select a plan and coverage will start the first day of the following month. CMS will also begin implementing a $50 million multi-language outreach campaign to inform potential enrollees of the special period. According to The Kaiser Family Foundation, an estimated 15 million uninsured Americans are eligible to sign up through the marketplace, of which nearly 9 million could have access to free or low-cost benefits due to the subsidies. (InsideHealthPolicy) Matt Eyles, president and CEO of America’s Health Insurance Plans, applauded the move, stating that the hybrid approach will “provide an additional opportunity for hardworking Americans to obtain comprehensive coverage for themselves and their families.” Meg Murray, president and CEO of the Association of Community Affiliated Plans (ACAP), also praised the announcement commenting “The pandemic led to financial difficulties and changes in health coverage for millions, which did not stop at the end of open enrollment. Consumers deserve time to thoughtfully consider and select the plan that best meets their needs.” (InsideHealthPolicy)