Ross E. Weber

Based on a partnership with Urology Times, articles from the American Association of Clinical Urologists (AACU) provide updates on legislative processes and issues affecting urologists. We welcome your comments and suggestions. Contact the AACU government affairs office at 847-517-1050 or info@aacuweb.org

Stymied by Congress and dissatisfied with the pharmaceutical industry’s unwillingness to propose transformative programs to rein in the cost of prescription drugs, President Trump has lately redoubled his executive actions to promote transparency and cut prices.

Following the issuance of wide-ranging executive orders throughout 2020, more formal rules were announced November 20 “to very dramatically lower the price of prescription drugs for the American people, especially for our cherished seniors,” 

. One of the regulations limits rebates paid to pharmacy benefit managers (PBMs) in Medicare (an advocacy priority for the American Association of Clinical Urologists promoted via participation in the Alliance for Transparent and Affordable Prescriptions) and another, known as “most favored nation,” pegs the price of certain drugs to their price in other developed countries.

The middlemen that manage insurers’ pharmacy benefits are stunningly successful in gobbling up the discounts drug makers intend to offer patients. A 2018 analysis found that insurers got $89 billion in rebates from drug companies in 2016. Efforts to increase transparency are slowly advancing through state legislatures and the US Supreme Court will soon rule on an Arkansas law that regulates PBM payments to pharmacies. Fiercehealthcare 

, “The rebate rule will replace the safe harbor for Part D rebates, meaning they could be targeted under the federal anti-kickback law, with a new safe harbor that applies only to discounts offered at the point of sale.” The administration estimates that under the new rule, rebates totaling close to $40 billion will reach patients, resulting in an average discount of nearly 30% for brand drugs.

Opponents say the move will actually increase costs for Medicare beneficiaries because insurers use the rebates to lower premiums. America’s Health Insurance Plans, the industry’s trade group, asserts, “Drug prices are out of control because Big Pharma alone sets and controls drug prices, not because health insurance providers and our PBM partners negotiate discounts and rebates to reduce drug prices.”

The AACU, for one, associates itself with the Alliance for Transparent and Affordable Prescriptions whose president said, "For far too long, the PBM industry has been generating significant profits while patients struggle to afford the cost of prescription drugs. PBMs owe it to patients to pass along savings and the rebates received on to the patient."

Providers, payers, and the pharmaceutical industry alike take issue with the president’s other late-term regulation that ties reimbursement of Medicare Part B drugs to an international standard. The 

, “The intent is to cap the cost of those drugs at the lowest price that drug manufacturers receive in other countries and to pay providers a flat add-on amount for each dose of a drug, instead of a percentage of each drug’s cost.”

The mandatory payment model will focus on 50 single-source drugs, including biosimilars, that most impact Medicare spending. Centers for Medicare & Medicaid Services Administrator Seema Verma said, “While there are market forces and negotiations that serve to reduce cost in other parts of the health care system, it just doesn’t exist in Part B.”

Physicians were quick to refute the notion that they are primarily driven by a profit motive. Drug makers, meanwhile, assert that price controls from other countries will suppress investment in research and discovery of advanced therapies. The most favored nation proposal is also opposed by senators in the president’s own party. While drafting the bipartisan Prescription Drug Pricing Reduction Act of 2019 (S. 2543), most Republicans on the Senate Finance Committee backed an amendment to block the administration from taking such an action.

The prospect of either rule taking effect—rebates in 2022 and most favored nation in 2021—is unclear. Reuters reports that economic analysts do not expect them to survive court challenges or a new administration.Addressing the prospect of legal battles, Secretary of Health and Human Services Alex Azar said, “We feel that both regulations are extremely strong and any industry challenging them is declaring themselves at odds with American patients.” President-elect Biden, meanwhile, is known to oppose the rebate proposal, believing that insurers would likely hike premiums to cover some of their losses. The most favored nation proposal, on the other hand, is something Democrats support. Indeed, that policy was included in a prescription drug bill passed by the Democrat-controlled House of Representatives last year.

Whatever may happen to these efforts in the future, it is clear that President Trump was determined to follow through on a promise made during his first campaign. The actions demonstrate, according to the president himself, “I have been loyal to our patients and our people that need [prescription drugs] and devoted myself completely to fighting for the American people. You see that. This is not an easy thing to do.”

Articles

"The middlemen that manage insurers’ pharmacy benefits are stunningly successful in gobbling up the discounts drug makers intend to offer patients," writes Ross E. Weber of the AACU.








Lame-duck deeds demonstrate president’s drive to deliver on drug prices

As the coronavirus disease 2019 (COVID-19) pandemic persists, physicians, facilities, and other providers continue to cope with unprecedented burdens on their time, energy, and resources. At the same time, the ever-looming threat of medical malpractice claims related to the transmission of COVID-19 creates further challenges for physicians coping with high levels of stress and tight work schedules. Not surprisingly, Reuters 

 in early April that advertising for medical malpractice cases was already on the rise, as were actual filings of such lawsuits. State-level protection from questionable claims are among the 

, but there are several pending federal attempts to fill the void.

In June, more than 130 medical societies, including the AACU, signed a 

 calling on Congress to adopt the “Coronavirus Provider Protection Act” (H.R. 7059), legislation that proposes targeted and limited protections from medical liability lawsuits where health care services are provided or withheld in situations directly related to COVID-19. In practice, a physician would be shielded as long as they followed government guidelines or lacked resources due to COVID-19. The legislation extends those protections to those who provide or withhold care in good faith during, and shortly after, the public health emergency.

The AACU also tapped into its network of contacts on Capitol Hill to promote support for H.R. 7059. In short order, 2 members of Congress, Rep. Andy Harris, MD (R-MD) and Greg Murphy, MD (R-NC), indicated they would cosponsor the bill and work to secure its passage.

In the Senate, Majority Leader Mitch McConnell has stood firm in support of liability protections. “We are not going to let trial lawyers throw a party on the backs of front-line workers and institutions who fought this new enemy on the front lines,” he said. Sen. McConnell himself introduced the SAFE TO WORK Act (S. 4317) with Texas Republican Sen. John Cornyn to discourage "insubstantial lawsuits relating to COVID-19 while preserving the ability of individuals and businesses that have suffered real injury to obtain complete relief." A central point of the bill, according to a Senate aide, is to create a federal cause of action for medical malpractice suits.

As negotiations on a fourth coronavirus relief deal progressed throughout the summer, Sen. McConnell’s insistence that liability protections be included has put him at odds not only with House Democrats, but the White House, as well. President Trump indicated he is willing to forgo any issues other than evictions and unemployment, if it means an agreement can be reached. The Hill 

 the President as saying, “the rest of it, we’re so far apart we don’t care.” However, the Senate’s relief package introduced in late July includes a 5-year shield from coronavirus-related lawsuits and provides a safe harbor for businesses that undertake reasonable efforts to comply with public health and safety guidelines.

With an estimated 50%-80% of urologists’ patients age 65 years or more, the specialty is particularly at risk for COVID-19-related lawsuits. With that in mind, the AACU, for one, has been a leading voice for legislation that would provide reasonable and limited protection for physicians from lawsuits due to circumstances that are beyond their control. Throughout negotiations on pandemic relief, lawmakers must prioritize medical liability protection and support health care workers on the frontlines of the COVID-19 pandemic.

"Lawmakers must prioritize medical liability protection and support health care workers on the frontlines of the COVID-19 pandemic," writes Ross E. Weber of the AACU.

Pandemic medical liability protections considered by Congress

Based on a partnership with Urology Times, articles from the American Association of Clinical Urologists (AACU) provide updates on legislative processes and issues affecting urologists. We welcome your comments and suggestions. Contact the AACU government affairs office at 847-517-1050 or

The coronavirus disease 2019 (COVID-19) public health emergency spurred swift adoption of long-sought public policies that have transformed the health care system. Patients are embracing telemedicine. Advanced practitioners are enjoying expanded authority. Providers are being granted a reprieve from ineffective liability laws. As the pandemic plateaus and we become accustomed to a “new normal,” the question becomes which changes will stay and which will go. Regrettably, state-by-state, shields from clinically constraining medical liability statutes are among the first emergency measures to be withdrawn.

Liability protections continue to be necessary because crisis standards of care vary greatly from non-emergency medical practice. During a public health emergency, focusing on the needs of each individual patient may be impossible because limited resources require the rationing of care. The Health Coalition on Liability and Access (HCLA) 

 several situations that pose substantial liability risks:

• Physicians are being asked to provide treatments or care outside their general practice areas and for which they may not have the most up-to-date knowledge.

• Inadequate safety equipment can result in the transmission of the virus from patient to provider and then to additional patients, or directly from one patient to another.

• Inadequate testing could lead to delayed or flawed diagnosis.

• “Elective” surgeries and procedures are being delayed to preserve capacity.

• Patients with issues other than coronavirus are facing delayed treatments so that resources may be saved for coronavirus patients.

An institution’s ethics committee and the 

 certainly provide some indemnification in these circumstances, but neither a grieving family nor ‘assertive’ attorney will look to those standards when coming to terms with a traumatic loss. Indeed, Reuters 

 in early April that advertising for medical malpractice cases was already on the rise, as were actual filings of medical liability claims.

Surveying this landscape, the Secretary of Health and Human Services insisted that he did not want state variations in liability protections to deter health professionals from providing care. Secretary Azar therefore urged governors to take action. Every state already had a Good Samaritan law on the books that generally offers immunity to licensed physicians who provide care without compensation at the scene of an accident. Twenty-two states amended those statutes in terms of defining or licensing a Good Samaritan and 17 adopted broader civil immunity to volunteers and/or paid physicians.

Several examples of state action have been singled out for duplication. Illinois Governor J.B. Pritzker issued an executive order on April 1 granting health care facilities, health care professionals, and health care volunteers immunity from civil liability when providing health care services in response to COVID-19, provided injuries were not caused by gross negligence or willful misconduct. The immunity is not limited to care rendered to patients diagnosed with COVID-19. Instead, the immunity extends to any injury that occurred at a time when a health care facility or professional was providing health care services simply 

 the COVID-19 outbreak. Governor Pritzker’s order follows a related March 7 New York order limiting civil liability. There, the legislature backed up Governor Andrew Cuomo’s executive order by approving the “Emergency Disaster Treatment Protection Act” as part of the budget bill. The measure grants immunity from civil and criminal liability for the purpose of “promot[ing] the public health, safety and welfare of all citizens.” Health care facilities are further protected by the law’s specification that a resource or staffing shortage will not be considered intentional, reckless, or criminal misconduct. In addition to New York, legislators in 5 other states, New Jersey, Connecticut, Illinois, Michigan, and Massachusetts, likewise passed actual laws to expand immunity.

One by one, however, these actions are being reversed. When Governor Pritzker prolonged several emergency measures in Illinois on June 26, he did not extend his directive on medical liability. In New York, the legislature giveth and the legislature taketh away. Governor Cuomo signed a new law on August 3, that takes away the liability shield for care that isn’t directly related to COVID-19. And in Michigan, Governor Gretchen Whitmer vetoed legislation on August 10 that would have granted limited immunity from lawsuits related to the provision of care to COVID-19 patients, the need to reschedule patient care due to governmental orders, and experiencing shortages of needed supplies.

In most instances, while states are slowly taking away protections, the implications of the original actions will extend beyond the public health emergency because statutes of limitation allow cases to be filed months, if not years, after the incident. Therefore, the limited and time-certain liability protections may still ease malpractice fears as physicians, facilities, and other providers continue to cope with unprecedented burdens on their time, energy, and resources.

Republicans in Congress are also considering federal assistance to add to or extend state actions. The Coronavirus Provider Protection Act, H.R. 7059, was introduced in the House by Tennessee Republican Phil Roe, MD, and California Democrat Lou Correa, and leaders in the Senate have insisted that liability issues be addressed in the next coronavirus relief legislation, expected to be considered later this summer and into the fall. What’s been happening these last several months is wholesale transformation. Policymakers must be thoughtful and act in the public interest. That includes weighing the benefit of continued liability safeguards.

National survey of COVID-19 medical malpractice immunity legislation (Jackson & Campbell)

https://www.jackscamp.com/national-survey-of-covid-19-medical-malpractice-immunity-legislation/

State directives related to medical liability and increasing access to care during COVID-19 pandemic (HCLA)

http://protectpatientsnow.org/wp-content/uploads/2020/05/STATE-COVID-19-CHART-11-MAY.pdf

COVID-19: Recommendations for pursuing liability protections through state action (AMA)

https://www.ama-assn.org/system/files/2020-04/state-guidance-medical-liability-protections.pdf

"Policymakers must be thoughtful and act in the public interest. That includes weighing the benefit of continued liability safeguards," writes Ross E. Weber of the AACU.

States strip away medical liability protections

Based on a partnership with Urology Times, articles from the American Association of Clinical Urologists (AACU) provide updates on legislative processes and issues affecting urologists. We welcome your comments and suggestions. Contact the AACU government affairs office at 847-517-1050 or 

One of the most transformative changes to the practice of medicine brought about by the coronavirus disease 2019 (COVID-19) pandemic has been the swift integration of telemedicine into the routine of even the most tech-averse doctor. Seemingly overnight, laws, regulations, and payer policies were updated to facilitate health care delivery online and over the phone.

Most impactful, perhaps, was the March 17 announcement that Medicare would reimburse providers for telemedicine services at the same rate as in-person visits throughout the public health emergency. In addition, states have steadily adopted policies to temporarily authorize and encourage telemedicine.

When Medicare expanded access to telemedicine, the Centers for Medicare and Medicaid Services noted that although the public program would allow physicians licensed in one state to provide services to Medicare beneficiaries in another state, relevant state licensure laws would still apply. As of April 21, 45 states have issued waivers to modify in-state licensure requirements for telemedicine in response to COVID-19, according to the 

 (FSMB). The applicability of those waivers varies greatly and an established relationship between provider and patient may still be necessary.

The position taken by the Mississippi Board of Medical Licensure, for one, has evolved since the agency’s broad decree on March 14. By March 24, after receiving more than 1200 applications from out-of-state providers, the 

 reported that “the board revised its position by deciding that only out-of-state physicians with previously established doctor-patient relationships with Mississippians would be allowed to practice telemedicine.” The FSMB notes that Mississippi now invites the participation of any out-of-state physician whose specialty services are determined to be necessary by the department of health, whether or not a previous relationship exists.

Further complicating matters, states differ on how that relationship can be established. In New Jersey, a law signed by Governor Phil Murphy on March 19 expanded the authority of doctors to provide telemedicine services even without an established relationship, but only for services related to screening for, diagnosing, or treating COVID-19.

In addition to relaxing licensing standards to permit more physicians to practice telemedicine, several common policy changes are being instituted via executive orders to enhance access to remote care, including allowing a provider’s home to be an originating site; consenting to the telephone as being an acceptable means of delivery; expanding the list of eligible providers to include allied health professionals; and requiring insurers to not only cover telemedicine services, but also reimburse at the same amount as an in-person visit.

In California and Washington, officials sped up the implementation of new laws originally set to go into effect in 2021 requiring private payers to cover services delivered via telemedicine and reimburse for those services at the same rate as an in-person visit. During the COVID-19 emergency, California has implemented the coverage provision, whereas Washington immediately imposed both the coverage and payment requirements.

More must be done, according to the American Medical Association (AMA), which calls on states to “eliminate insurer practices of creating separate telemedicine networks or incentivizing patients to use a separate telemedicine provider [e.g., Teladoc, ConsultADoctor, and Doctor On Demand], which may not include contracted physicians who provide in-person care to patients.”

Several states have acted swiftly during the public health emergency to ensure patients have access to telemedicine from the physician of their choice. Washington, once again, has been a leader in this area, as have Illinois and Massachusetts, both of which instituted a requirement that insurers allow “any willing contracted physician to provide telemedicine services directly to new and established patients, without requiring theyâ¯contract with a specific telemedicine service,” according to 

 on telemedicine. It is worth noting, of course, that providers who are willing to provide telemedicine services during the COVID-19 crisis are most likely only able to do so because their state secured a waiver on the enforcement of privacy standards.

, only 10 states required health plans to pay the same for health care delivered remotely as they do for care delivered in person, according to a 

. New parity laws in at least 2 states were passed before the national public health emergency began but, as mentioned above, those were not scheduled to go into effect until January 2021.

By executive order or emergency legislation, several additional states (Massachusetts, Arizona, Maine, New Jersey, and Washington) are, at least temporarily, requiring that telemedicine services be paid at the same rate as in-person services. These policies change almost daily and are monitored by several organizations, including the 

 in states hit hardest by the pandemic estimated that, in the short term, up to 54% of patient encounters will take place via telemedicine––“a more than five-fold increase from volumes prior to the pandemic.” What’s more, most of the survey respondents expect the changes to remain even after the public health emergency ends and temporary privacy, liability, and referral waivers expire. Florida urologist Kevin K. Lee, MD, is not so sure, suggesting that the “problem with COVID-19 tele[medicine] is all the waivers. Many of us are using a platform that wouldn’t have met pre-COVID-19 standards.”

Therefore, in the coming days, months, and years, physicians must be vigilant about protecting patient privacy and safety and maintaining appropriate reimbursement standards. When the dust settles, the medical community will be stronger, more efficient, and poised to deliver outstanding patient care in any setting.

• Standards for establishing a doctor-patient relationship: 

"In the coming days, months, and years, physicians must be vigilant about protecting patient privacy and safety and maintaining appropriate reimbursement standards," writes the AACU's Ross E. Weber.

Ross E. Weber

Articles

Lame-duck deeds demonstrate president’s drive to deliver on drug prices

Pandemic medical liability protections considered by Congress

States strip away medical liability protections

State telemedicine rules relaxed during COVID-19 crisis