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Seema Verma: CMS’s ‘expanded pathway’ for new antibiotics can help fight antimicrobial resistance

Thought Leader: Seema Verma
November 6, 2019
Source: Link

Americans are under siege by drug-resistant bacteria. The challenge of antimicrobial resistance, or AMR as it is referred to in the medical community, has become a public health crisis. Thousands of deaths every year are attributed to drug-resistant microbes, as well as billions of dollars in health expenditures.

And the problem is only going to get worse, which will certainly be a topic of discussion at this week’s World Antimicrobial Resistance Congress.

Why? In part because front-line antibiotics are becoming less effective. Access to new antibiotics today is so limited today that the United States — the land of patient choice — has desperate patients like Roger Poser stuck on waiting lists to get the right drug for their drug-resistant infections.

Many of the 2 million Americans who develop antibiotic-resistant infections each year are Medicare beneficiaries. Because of their age and other clinical complications, our nation’s seniors are particularly vulnerable to harmful microbes and are more likely to be inappropriately prescribed antibiotics and experience severe side effects.

Internal analyses of Medicare data indicate that the elderly account for the majority of new cases of antimicrobial resistance and deaths from it, with drug resistance forcing seniors to collectively be hospitalized hundreds of thousands of additional days each year. For them, time is running out. And for the rest of us, each new case of resistance is pushing American health care to the brink of a public health disaster.

The commercialization of dozens of new antibiotic drugs in the mid-20th century coupled with the development of standardized procedures for hospital sanitation made it easy to assume that bacteria and other microbes had become a plague of the past. But health care providers and patients turned to antibiotics all too often. Their widespread and nonspecific use led to the development of new and stronger bacterial strains as our quiver of effective antibiotics began to narrow.

This complacency led us to neglect antimicrobial research for the past few decades. Older Americans today are treated with drugs developed when they were children. Drugs like fluoroquinolones and carbapenems, which once seemed to be silver bullets against infection, have grown rusty as bacteria and other microbes have steadily evolved to become aggressively resistant to existing treatments, leaving America’s physicians with dwindling treatment options.

Our antiquated systems for reimbursing physicians and hospitals for antibiotic treatment have disincentivized both the development and use of new antibiotics, steering scientists towards more lucrative fields of research, like heart disease and cancer. The business model for developing new antibiotics is fundamentally broken: Antibiotics for drug-resistant bacteria are meant to be used as a last resort, but no one wants to develop drugs that will rarely be prescribed. Unless we act now to address the financial barriers to drug development, doctors will be powerless to fight off the drastically increasing number of cases of antimicrobial resistance.

The Centers for Medicare and Medicaid Services — the federal agency I lead — has the responsibility of both caring for America’s seniors and serving as the largest health care payer in the country. The Trump administration is determined to unravel the regulations binding the hands of America’s innovators to resolve this public health crisis.

In the short-term, CMS has finalized an expanded pathway for certain new antibiotics to receive additional payments and to increase payments for them. This will help people who need these medications get access to them. The agency also updated its payments to hospitals to provide them with appropriate resources to treat sick patients with drug-resistant infections. We’re also committed to scaling up antibiotic stewardship protocols — clinical guidelines for antibiotic prescribing that CMS has already implemented in nursing homes — to hospitals, which is where the majority of patients with drug-resistant infections receive care.

In the long-term, CMS will lead a broader effort to modernize Medicare’s payment systems for antibiotics and other endangered innovations.

The road ahead won’t be easy. The same bacteria that once terrorized hospital wards are back with a vengeance. Antibiotic drug resistance is like a hydra — cut off the head of one infection using a drug and another emerges in its place with newly acquired defenses. To keep Americans safe, we need to be vigilant in our care and focused on transforming Medicare to bring payment policies in line with public health needs.

By removing regulatory roadblocks and reimagining financial incentives, we can fire up the engine of American innovation to arm our doctors for their battle against drug-resistant bacteria.

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