Supreme Court Rules on ACA, CMS Updates Medicare Physician Fee Schedule, and more

Supreme Court Votes to Uphold Tax Subsidies Under the Affordable Care Act

In a 6-3 ruling, the Supreme Court voted to uphold the tax subsidies outlined under the Patient Protection and Affordable Care Act (ACA). Justices John Roberts, Anthony Kennedy, Ruth Bader Ginsburg, Stephen Breyer, Sonia Sotomayor, and Elena Kagen voted in favor of the subsidies.

The King v. Burwell ruling preserves tax benefits for nearly 6.4 million Americans in 34 states, according to the Department of Health & Human Services. In addition, 85 percent of those who bought insurance through the federal health-care exchange qualified for subsidies averaging $272 per month.

The trial centered on arguments that, based on the language in the ACA, tax credits were eligible only to low- and middle-income adults living in states with state-operated exchanges – not to those who purchased health insurances through the federally run exchanges.

Though the petitioner in the case argued that the language was ambiguous, Chief Justice Roberts noted in the Supreme Court’s majority opinion decision that the plaintiff’s interpretation of the law “would destabilize the individual insurance market in any state with a Federal Exchange, and likely create the very ‘death spirals’ that Congress designed the Act to avoid.” Of the court’s majority opinion, Chief Justice Roberts wrote, “Congress passed the [ACA] to improve health insurance markets, not to destroy them.”

President Obama spoke out in support of the court’s recent ruling, saying, “Today is a victory for hardworking Americans all across this country whose lives will continue to become more secure in a changing economy because of this law,” subsequently proclaiming that, “the [ACA] is here to stay.”

Not surprisingly, the ruling was unpopular with the many who opposed the ACA, with Senate Majority Leader Mitch McConnell commenting, “Today’s ruling [will not] change the skyrocketing costs of [copayments], deductibles, and premiums that have hit in the last few years.”

This was the second lawsuit regarding the constitutionality of the ACA to reach the country’s highest court, following the 2012 National Federation of Independent Business v. Sebelius case, which found that the individual mandate portion of the law that required Americans to buy health insurance was indeed constitutional. Additional lawsuits are still pending against the ACA, though many proponents of the law hope that this recent ruling will deter judges from advancing such cases.

Sources: Kaiser Health News; The New York Times

CMS Updates Medicare Physician Fee Schedule, Details MACRA Quality Reporting

In early July, Medicare released the first proposed physician fee schedule for the 2016 calendar year via the Medicare Access and Children’s Health Insurance Program Reauthorization Act (MACRA) of 2015. This is the first update to the physician fee schedule since the April repeal of the Sustainable Growth Rate. The payment schedule focuses on the shift to patient-centered care based on quality and health outcomes.

“[The Centers for Medicare and Medicaid Services] is building on the important work of Congress to shift the Medicare program toward a system that rewards physicians for providing high-quality care,” said Andy Slavitt, acting administrator for the Centers of Medicare and Medicaid Services (CMS), in a press release from the organization. “CMS and Congress are working together to achieve a better Medicare payment system for physicians and the American people.”

Notable elements of the rule include:

  • A proposal to pay for advanced care planning services
  • A request for information on how Medicare could pay for interprofessional collaboration such as consultation between two physicians
  • A framework for payment of biosimilar drugs
  • Plans for transition from the value-based modifier pay-for-performance to the more comprehensive program created in legislation earlier this year

In addition, physicians will see a 0.5 percent overall increase in Medicare reimbursement, though each specialty will be impacted differently; for example, pathologists will see an 8 percent increase, while gastroenterologists and oncologists face 5 percent and 3 percent pay cuts, respectively. In the current proposed rule, hematologists will experience no change in reimbursement.

The CMS proposed rule also includes modifications to the Physician Quality Reporting System (PQRS): “CMS proposes to make changes to the PQRS measure set to add measures where gaps exist, as well as eliminate measures that are topped out, duplicative, or are being replaced with a more robust measure.”

CMS is seeking comment from stakeholders and the public on MACRA, specifically on the new merit-based incentive payment system. A final rule will be published this fall.

Source: CMS press release

House of Representatives Passes Bill to Speed Up U.S. Drug Approvals

On July 10, 2015, the 21st Century Cures Act (HR6) overwhelmingly passed through the House of Representatives with a vote of 344-77. The bill aims to make the drug approval process less burdensome, as well as adding funding of $8.75 billion to the National Institutes of Health (NIH) over the next five years through scientific grants; this is the largest increase the country has seen in a decade.

“This bill is about making sure our laws, regulations, and resources keep pace with scientific advances, said House Energy and Commerce Committee Chairman Fred Upton (R-MI) in a statement. Representative Joseph Kennedy, III (D-MA), who cosponsored the bill, added: “There are potential treatments out there that are getting held up in the approval process and patients are dying. [The bill will] streamline the bureaucratic process without making important compromises on safety.”

The proposed bill would allow the U.S. FDA to approve new medical devices based on limited patient case studies and medical journal articles rather than extensive clinical trials, as well as allow companies to make changes to devices without further U.S. FDA approval. In addition, approvals could be based on biomarkers (such as a drug’s effect on a tumor), not solely on improved patient survival.

Though many in the pharmaceutical industry, patient advocacy groups, and medical organizations are in support of the bill, those opposed to the bill suggest that it will only provide more benefits for the pharmaceutical and medical device industries – rather than for patients.
Health policy officials are concerned that the bill may erode certain standards of evidence for drug approvals by weakening the FDA’s scrutiny, which could impact patient safety. The White House

also issued a statement that questioned a provision of the bill that would extend a company’s exclusive rights to market brand-name drugs if they are repurposed to treat a rare disease. The Congressional Budget Office estimated that this provision could increase prescription drug spending by $869 million between 2016 and 2025.

The Senate is working on its own version of the bill. Congressional leaders hope to finalize a bill by the end of the year in order to begin increasing funding to NIH by October 2016.

Sources: “HR6, 21st Century Cures Act”; The Atlantic; The Washington Post

Ofatumumab Submitted to European Regulatory Approval for Treatment of CLL

The anti-CD20 monoclonal antibody ofatumumab has been submitted for approval by the European Medicines Agency for use as maintenance therapy in patients with relapsed chronic lymphocytic leukemia (CLL). The application is based on the results of the phase III PROLONG study that evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second- or third-line treatment for CLL. “The PROLONG study showed the potential of using ofatumumab as an ongoing maintenance therapy for patients with relapsed CLL,” said Jan van de Winkel, PhD, chief executive officer of Genmab, the drug’s manufacturer. Ofatumumab is currently approved by the U.S. FDA for the treatment of previously treated CLL and, in combination with chlorambucil, for the treatment of treatment-naïve CLL.

Source: Genmab press release

FDA Votes to Approve New Antiplatelet Drug

The U.S. FDA recently announced the approval of cangrelor, an intravenous antiplatelet drug that prevents the formation of blood clots in the coronary arteries in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI). Cangrelor reduces the risk of serious clotting complications related to PCI, including heart attack and stent thrombosis.

Approximately 500,000 people undergo PCI each year, according to the Centers for Disease Control and Prevention.

This approval is a reversal from the FDA’s April 2014 decision to reject cangrelor’s application based on data discrepancies in the pivotal CHAMPION-PHOENIX trial.

The approval of cangrelor was based on the resubmission of data from the large-scale CHAMPION-PHOENIX study. The approval committee deemed that “the Phoenix study as a stand-alone trial was sufficient to warrant approval of cangrelor.” In the study, the new antiplatelet drug was compared with clopidogrel in 11,145 patients. The study found that cangrelor significantly reduced the occurrence of heart attack, the need for further procedures to open the artery, and stent thrombosis. The overall occurrence of serious bleeding was low but was more common with cangrelor than with clopidogrel.

Source: FDA press release

WHO Adds 16 Oncology Drugs to Essential Medicines List for Low- and Middle-Income Countries

The World Health Organization (WHO) added the following 16 drugs to its Model List of Essential Medicines, a list of selected drugs that treat high-priority conditions and should be readily available to the communities in low- and middle-income countries:

  • Anastrozole
  • All-trans retinoic acid
  • Bendamustine
  • Bicalutamide
  • Capecitabine
  • Cisplatin
  • Filgrastim
  • Fludarabine
  • Gemcitabine
  • Imatinib
  • Irinotecan
  • Leuroprelin
  • Oxaliplatin
  • Rituximab
  • Trastuzumab
  • Vinorelbine

The Essential Medicines list is updated every two years by an expert committee; the newest version is the latest full review of cancer medications since 1999. Drugs are selected for inclusion based on four main dimensions, each with three rating levels: efficacy and safety; burden of disease; cost-effectiveness; and resource requirements for drug use.

With these new additions, there are now 46 essential cancer medications on the list. The WHO’s recommendations are based on the medications’ ability to save lives and reduce patient suffering. There are still obstacles that need to be overcome before these medications are readily available in developing nations – including cost and access.

Source: WHO press release

WHO Declares Cuba the First Country to End HIV Transmission from Mother to Child

In early July, the World Health Organization (WHO) declared Cuba the first country in the world to end mother-to-child HIV transmission. “Cuba’s success demonstrates that universal access and universal health coverage are feasible and indeed are the key to success, even against challenges as daunting as HIV,” said Carissa Etienne, the director of the Pan American Health Organization (PAHO), in a statement. Cuba was determined to have met the criteria for this designation, and in 2013, only two children were born with HIV and just five with syphilis, according to PAHO. WHO and PAHO noted that access to early prenatal care, HIV and syphilis testing, and treatment for mothers who test positive have helped the country reach this achievement.

Source: Reuters news article

FDA Grants Orphan Designation for Novel AML Treatment

The U.S. FDA granted orphan drug designation for GMI-1271, a novel and proprietary E-selectin antagonist specified for the treatment of acute myeloid leukemia (AML). The drug’s manufacturer is currently recruiting patients for its phase I/II, open-label, multicenter study to evaluate the safety, pharmacokinetics, and efficacy of the drug in combination with chemotherapy in adult patients. Previously, GMI-1271 was studied in healthy participants in a trial concluded last year. The orphan drug designation signals that GMI-1271 is intended to treat a rare disease affecting fewer than 200,000 people in the United States.

Source: GlycoMimetics, Inc. press release