The legislation gives the executive enhanced powers to cut red tape and reduce trade barriers with 'trusted allies.'
A bipartisan bill introduced in the U.S. Senate aims to correct the nation's medical supply chain weaknesses that were exposed during the COVID-19 pandemic.
The Medical Supply Chain Resiliency Act, sponsored by U.S. Senators Thom Tillis (R-NC) and Tom Carper (D-DE) would strengthen the government's hand in trade negotiations that ensure that safe and timely delivery of critical medical goods.
A key component of the bill gives the president – through his appointed U.S. Trade Representative -- the authority to negotiate with "trusted allies" to eliminate tariffs and other barriers that weaken the medical goods manufacturing sector in the United States and allied nations. These agreements also would protect intellectual property rights and strengthen regulatory cooperation and collaboration on R&D efforts. Congress would be looped in on the status of these new trade agreements and would reserve the right to reject them.
"The pandemic caused major disruptions across nearly all supply chains, and these challenges disproportionately impacted our healthcare supply chain – from medical devices to life-saving medicines to personal protective equipment (PPE)," Tillis says in a media release.
"Now is the time to address the long-standing shortcomings in our supply chains that were highlighted over the pandemic, repair the damage done, and ensure America is adequately prepared for future national security and public health threats," he says.
Carper says the bill "will help mitigate trade challenges by authorizing the president to work more closely with our global partners and take action to ensure that healthcare providers and patients can access life-saving medical products when they need them the most."
"The pandemic wreaked havoc on our communities and caused our medical supply chains to break down during the worst possible time. We must prevent these same horrible losses from happening again by working together to fix our broken supply chains and better prepare for future public health emergencies," Carper says.
The bill has the support of key stakeholders, including the U.S. Chamber of Commerce, the National Foreign Trade Council, the Trade Alliance for Health, the National Foreign Trade Council, and the National Association of Manufacturers.
"This is practical legislation that, if enacted, will apply lessons learned in the COVID-19 pandemic to strengthen America's health preparedness," says John Murphy, senior vice president for international policy at the U.S. Chamber of Commerce.
The prestigious Los Angeles-based health system is now offering HIPAA-compliant, virtual second opinions in 21 states, including Arizona, California, Colorado, Connecticut, Florida, Hawaii, Idaho, Illinois, Minnesota, Montana, Nevada, New Jersey, New Mexico, New York, North Carolina, Oregon, South Carolina, Utah, Vermont, Virginia and Washington.
"When you need specialized care for the most complex conditions, expertise matters," says Joanna Chikwe, MD, professor and chair of the Department of Cardiac Surgery at Cedars-Sinai. "So does convenience and speed. One of the special things about Virtual Second Opinion is that the physician can give each participant completely individualized and tailored treatment options."
The program is designed for patients looking to confirm a diagnosis or get more details about their condition, available treatment options, and finding a care regimen that best suits their needs. Cedars-Sinai says the virtual consultations are particularly valuable for patients living in remote areas who are unable to travel for an in-person consultation.
So far, Cedars-Sinai offers virtual second opinions on cardiac surgery, cardiology, spine surgery, and women's health, including coronary artery disease, aortic aneurysms and dissections, arrhythmias and valve dysfunction, disc disease, tumors and radiculopathies, endometriosis, abnormal bleeding, and ovarian tumors and cysts. Expansions into additional specialties are planned in the months ahead.
Patients ages 18 and older can request a virtual second opinion at a cost of $590 for Californians and $790 for out-of-state residents, owing to additional processing costs.
A nurse coordinator is assigned to the patient within 24 hours to help gather relevant health data and other relevant records, and a second opinion is offered within six days of receiving patients' documents.
Cedars-Sinai says most commercial health plans won't pay for the virtual second opinion, but patients with a health savings or flex spending account can tap it to cover the cost. The flat fee includes care coordination, medical record collection and a second opinion report prepared by a physician specialist. Patients can also schedule a virtual 30-minute educational session with specialists to review the report and answer questions.
Matthew Siedhoff, MD, vice chair of Gynecology at Cedars-Sinai, says the virtual second opinion can address underdiagnosed gynecologic conditions that "can cause women to suffer needless pain and frustration."
"A virtual second opinion can make such a difference,” Siedhoff says. "When patients come to us for an online visit, the imaging, lab tests, physical exam and other in-person tasks have already been done and can give us a good basis for evaluating the patient and recommending next steps."
Hispanic and Black adults were less likely than white adults to report having their care preferences considered by clinicians.
A solid majority (73%) of U.S. adults aged 50 and older say their care preferences are taken into consideration by providers, a 9.5% increase over 2014 responses to the same question asked in a survey sponsored by The SCAN Foundation.
However, the findings come with stark racial, economic, and geographic caveats.
Hispanic (52%) and Black adults (62%) were less likely than white adults (83%) to report having their care preferences always or usually considered in 2020 by clinicians, according to a data review by The LeadingAge LTSS Center @UMass Boston and Community Catalyst -- the first review of care preferences since the start of the COVID-19 pandemic.
Preferences include medications, treatment plans, care venues, and trust in their clinicians’ experience and demeanor.
"Ensuring personalized care as individuals age is vital for attaining quality outcomes and ensuring the utmost patient satisfaction," said Sarita A. Mohanty, MD, MPH, MBA, president / CEO of The SCAN Foundation. "Racial and ethnic disparities in how individuals perceive their care preferences being considered is deeply alarming and unacceptable. When preferences are not asked and respected, suboptimal care results."
Other findings show:
Income matters. Adults 50+ with household incomes less than $30,000 were less likely to say their care preferences were always or usually considered (66.1%) compared to those with incomes greater than $75,000 (85.1%).
Geography matters. Adults 50+ in the South were less likely to report care preferences were always or usually considered (71.9%) compared to those in the Northeast (76.4%), West (76.5%) and Midwest (80.2%).
Relationships matter. Adults 50+ with a usual source of care (e.g., a primary care doctor) reported an increase in their care preferences being usually or always considered (77.1% in 2020 vs. 69.9% in 2014).
"Numerous studies have shown that care that aligns with patient preferences is more effective," says Marc Cohen, PhD, co-director of The LeadingAge LTSS Center @UMass Boston and research director at Community Catalyst. "The healthcare system has a lot of work to do to address deep-seated inequities in how it listens and responds to patients of color."
The HIPAA breach by two dozen guards at Yakima Valley Memorial Hospital affected 419 patients.
A community hospital in Washington state will pay $240,000 to resolve patient records breaches by snooping security guards, the federal government says.
Not-for-profit Yakima Valley Memorial Hospital agreed to the settlement for the self-disclosed violations of the Health Insurance Portability and Accountability (HIPAA) in 2018, the Department of Health and Human Services Office of Civil Rights announced this week.
"Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the healthcare industry," says OCR Director Melanie Fontes Rainer.
"Healthcare organizations must ensure that workforce members can only access the patient information needed to do their jobs. HIPAA covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud," she says.
According to OCR, following the self-disclosure of the violation in May 2018, the ensuing investigation determined that "23 security guards working in the hospital’s emergency department used their login credentials to access patient medical records maintained in Yakima Valley Memorial Hospital’s electronic medical record system without a job-related purpose."
The personal information of the 419 patients identified in the breach included names, dates of birth, medical record numbers, addresses, treatment notes, and insurance information, OCR says.
In addition to the fine, OCR will monitor Yakima Valley Memorial for two years to ensure HIPAA compliance and will also:
Conduct a risk analysis to determine risks and vulnerabilities to electronic protected health information;
Implement a risk management plan to address and mitigate identified security risks and vulnerabilities;
Develop, maintain, and revise its written HIPAA policies and procedures;
Enhance its existing HIPAA and Security Training Program to provide workforce training on the updated HIPAA policies;
Review all relationships with vendors and obtain business associate agreements.
The percentage of tele-mental health venues more than doubled between 2019 and 2022.
State policies adopted during the COVID-19 public health emergency more than doubled the number of mental health providers offering tele-mental health services.
However, expanded access to virtual care was lower in counties with a greater percentage of Black residents, according to a RAND Corporation study released Tuesday.
"Our results show that state policies have an important role to play in expanding access to mental health, which could be lost if telehealth policies don’t stay on the books," says Ryan McBain, lead author of the study and a policy researcher at RAND. "Likewise, disparities need to be addressed with local, targeted legislation."
The study examined four pandemic-related state policies: payment parity for telehealth services among private payers; authorization of audio-only telehealth services for Medicaid and the Children’s Health Insurance Program (CHIP); and participation in the Interstate License Exchange Program and the Psychology Interjurisdictional Compact, permitting psychiatrists and clinical psychologists, respectively, to work across state lines.
Using data from more than 12,000 mental health providers that was collected by the Mental Health and Addiction Treatment Tracking Repository about more than 12,000 facilities, the study focused on outpatient venues, which play an outsized role in telehealth care.
Between April 2019 and September 2022, the percentage of mental health treatment venues offering telehealth more than doubled, from 39% to 88%, the study found.
The number of states adopting payment parity during the 42-month study period grew from six to 28 and the number of states with audio-only payment policies increased from zero to 33. States allowing psychiatrists to practice across state lines grew from 28 to 38, while those allowing clinical psychologists to practice across state lines rose from seven to 32.
In addition, mental health providers in rural counties were more likely to offer telehealth than their urban counterparts, while Community Mental Health Centers were more likely to offer telehealth than other types of facilities.
However, when compared with counties with 5% or fewer Black residents, mental health facilities in counties with more than 20% Black residents were 42% less likely to offer telehealth.
Researchers also found that mental health facilities that accepted Medicaid and CHIP were about 25% less likely to offer telehealth services.
"This is consistent with previous studies finding that people enrolled in the programs may have reduced access to outpatient care as compared to people who have private insurance," the study notes.
The health system did not provide a new opening date for the 36-bed community hospital.
The opening of Novant Health Ballantyne Medical Center, scheduled to begin admitting patients today, has been "temporarily postponed pending the completion of state surveys," the Charlotte, NC-based health system says.
"We look forward to welcoming patients in the near future," Novant says in a brief media statement.
The health system did not elaborate on the nature of the surveys, nor did it provide a new opening date for the hospital. An adjoining 57,509 square-foot medical office building on the 38-acre campus in Charlotte opened today, as scheduled.
Novant held a ribbon cutting ceremony on May 30 for the 168,181 square-foot, $154 million, 36-bed community hospital, which the health system says "is strategically positioned to provide health care services to the rapidly growing suburban population in and around southern Mecklenburg County."
The hospital will provide emergency and inpatient services, diagnostic and surgical care, maternity care, and on-site specialty care services, including women's health, orthopedics and cancer.
"We recognize that this is not only a growing region, but one that's home to a diverse population that stretches across two states and ranges from young families to older adults, each with unique health care needs," says Ben Brodersen, president / COO of Novant health Ballantyne Medical Center.
"Ballantyne Medical Center and the outpatient services we co-located on campus were designed with the needs of the community in mind, including the flexibility to grow and add services as needed," Brodersen says.
The legal action comes days after Merck & Co. filed suit calling the mandate 'unconstitutional.'
The U.S. Chamber of Commerce on Friday filed suit against the federal government, claiming that the looming Medicare Drug Price Negotiation Program "violates fundamental protections for free enterprise enshrined in our Constitution."
Arguing that the price controls -- a component of the 2022 Inflation Reduction Act -- "would have long-term implications for free enterprise and U.S. competitiveness," the business lobby warns that such a mandate could spread to other areas of the private sector.
"If the government can set price controls for essential medicines through a black-box regime without allowing for judicial review, the government can do the same for other essential industries, which would be disastrous for our economy and for individual rights," the Chamber says.
"When the government caps prices, it caps innovation and endangers access to better treatments—harming patients the most. The new IRA provisions establish an artificial and arbitrary system for devising price caps that will jeopardize medical breakthroughs for individuals with life-threatening and chronic illnesses."
The Chamber suit was filed in U.S. District Court in Dayton, Ohio.
The Drug Price Negotiation Program allows Medicare, for the first time ever, to leverage its unmatched market power to negotiate with drug makers for certain high-price drugs. The negotiations start in September but will be limited to 10 drugs named by Medicare.
The Chamber says that calling the program a "negotiation" is a misnomer.
"The price imposed by the government at the end of the ‘negotiation’ cannot be declined by the manufacturer," the Chamber says. "The only way to escape the price is to leave the Medicare program altogether, but that cannot be accomplished in time to avoid the government-set price on some sales or the excise tax penalty on others."
"This would be devastating for patients in Medicare and would impose crushing financial consequences on manufacturers, further inhibiting their ability to develop and deliver treatments to the market."
Earlier this week, Merck & Co. filed suit in a Washington, D.C. federal district court, alleging that the price negotiation program was unconstitutional, and would hamstring the "bio-pharmaceutical sector's ability to address health threats."
"By coercing Merck to provide its drug products at government-set prices, the program takes property for public use without just compensation in violation of the Fifth Amendment," Merck says.
"In addition, the IRA creates the false impression that innovators like Merck are voluntary participants in its program by coercing them to sign an ‘agreement’ conveying that the government-set prices are the ‘fair’ result of a ‘negotiation.’ That compelled mirroring of the government's political message violates the First Amendment."
"Merck's ridiculous lawsuit is the equivalent of a toddler throwing a temper tantrum," says Richard Fiesta, executive director of the Alliance for Retired Americans.
"Americans pay the highest prices in the world for prescription drugs and too many seniors must choose between putting food on the table and paying for their medicine. That is because corporations like Merck have been allowed to charge taxpayers whatever they want for their drugs," Fiesta says.
A survey by UPMC's Center for Connected Medicine finds enthusiasm for the idea.
Most healthcare executives believe that artificial intelligence could be tapped to identify and recruit patients for clinical trials, according to a survey by UPMC's Center for Connected Medicine (CCM).
The survey of 58 payer and provider senior executives -- many of whom specialize in AI and analytics, and more than half of whom work at larger hospitals and academic medical centers -- was compiled in February and published this week in a CCM report.
"Clinical trials are an important part of providing life-changing care to our patients. However, it can be a significant challenge to match patients to studies," says Oscar Marroquin, MD, chief healthcare and data analytics officer at UPMC, and a founding partner of the CCM. "I'm excited by the potential for AI to help medical centers do a better job of finding and recruiting trial participants."
Patient recruitment is widely viewed as cumbersome and expensive. The CCM report cites a 2020 study in the Journal of Medical Internet Research which found that 80% of trials don't meet initial enrollment targets of timelines, with delays resulting in lost revenues of as much as $8 million a day for drug development companies.
Nearly two-thirds (64%) of respondents in the CCM survey say that the most time-consuming, labor-intensive, and frustrating hurdle for launching clinical trials is finding suitable patients, which often requires a manual review of medical records. Using AI to quickly scan medical records to find eligible patients was seen by 61% of respondents as playing a "critical" role.
"AI is seen as having the potential to allow organizations to complete matching, identification, and recruitment tasks at scale, enabling them to participate in more trials," the report says, although noting that "smaller organizations are more likely to be unsure what role AI technology will play."
Marroquin says CCM has "already seen the benefits of using natural language processing to harness and analyze the vast quantities of unstructured data in healthcare to better understand the conditions of our patients."
"Applying these techniques for clinical trial matching would be an advantage for health systems, industry and patients," he says.
The survey found that respondents who don't see AI as playing a critical role in the future "mention that existing analytics capabilities could potentially provide the same outcomes."
However, while some IT vendors offer AI for clinical trials, the survey found that the perception among stakeholders is that the readiness of these systems is "mixed."
One clinical researcher told CCM that "high-fidelity matching benefits greatly from structured data, and a significant amount of needed data is currently in the EHR as unstructured data. This is a significant gap."
The CCM report also identifies disease management and prediction as the top use for AI at health systems. Over the next two years, survey respondents say their AI investments will be aimed primarily around operational optimization.
"Merck's ridiculous lawsuit is the equivalent of a toddler throwing a temper tantrum," says Richard Fiesta, executive director of the Alliance for Retired Americans.
"Americans pay the highest prices in the world for prescription drugs and too many seniors must choose between putting food on the table and paying for their medicine. That is because corporations like Merck have been allowed to charge taxpayers whatever they want for their drugs," Fiesta says.
David Mitchell, a cancer patient and founder of Patients For Affordable Drugs Now, calls the suit "bogus," and ridicules the drug maker's assertion that the negotiation authority granted to the Centers for Medicare & Medicaid Services is "tantamount to extortion."
"The truth is, Big Pharma companies like Merck are the ones who have been extorting patients for years, forcing them to pay unjustified prices or sacrifice their health," Mitchell says.
"The reality is, drug corporations that are subject to Medicare's new authority – and who already negotiate with every other high-income country in the world – will engage in a negotiation process after setting their own launch prices and enjoying nine years or more of monopoly profits."
Sen. Ron Wyden (D-OR), chairman of the Senate Finance Committee, says "it's no surprise that Big Pharma wants to stop Medicare from negotiating lower drug prices on behalf of American seniors."
"I expect the Biden Administration to vigorously defend Medicare's bargaining power so seniors will see the lower drug prices they expect," Wyden says. I have deep concerns that a Republican administration would roll over for Big Pharma and once again ban Medicare from negotiating lower drug prices."
The Medicare Drug Price Negotiation Program was a key provision in the 2022 Inflation Reduction Act. It allows Medicare, for the first time ever, to leverage its unmatched market power to negotiate with drug makers for certain high-price drugs. The negotiations start in September but will be limited to 10 drugs named by Medicare.
Merk's type 2 diabetes drug Januvia has been mentioned as a candidates for the negotiations list.
Merck Alleges 1st, 5th Amendment Breaches
Merck issued a statement this week saying that the suit is justified because the price negotiation program would hamstring the "bio-pharmaceutical sector's ability to address health threats."
"On average, it takes a decade and more than $2.5 billion to develop a new drug. Since 2000, companies like ours have invested more than $1.1 trillion in the search for new treatments and cures, including $102.3 billion in 2021 alone. This investment has led to incredible breakthroughs for patients. Unfortunately, this progress is now at risk due to unconstitutional provisions in the IRA."
"By coercing Merck to provide its drug products at government-set prices, the program takes property for public use without just compensation in violation of the Fifth Amendment. In addition, the IRA creates the false impression that innovators like Merck are voluntary participants in its program by coercing them to sign an "agreement" conveying that the government-set prices are the "fair" result of a "negotiation." That compelled mirroring of the government's political message violates the First Amendment," Merck says.
In addition to its unconstitutionality, Merck says the the IRA will stifle biopharmaceutical research and development.
"Take for example the impact on cancer therapies. Investments by Merck and others in the biopharmaceutical sector have led to important progress in the treatment of earlier-stage cancer, most notably lung cancer. With increased adoption of screening, we have now reached an inflection point at which we are poised to bend the trajectory of the societal burden of cancer. The IRA makes further investment in treatments for earlier-stage cancer and screening far more difficult."
"Because this statute unlawfully impairs our core purpose of engaging in innovative research that saves and improves lives, Merck intends to litigate this matter all the way to the U.S. Supreme Court if necessary. While we do not believe the program is the right approach for continuing to advance global health on behalf of millions of patients in need, Merck remains committed to working with the U.S. government to enable patient-focused innovation, value and access," Merck says.
P4ADNow says Medicare Part D has spent more than $17 billion on the Merck's diabetes drug Januvia, priced at $547 for a month's supply and used by nearly 1 million Medicare beneficiaries. The drug has been on the market since 2006 without competitors since 2017.
"Despite Merck's false claims about innovation, Medicare negotiation will reduce U.S. spending on drugs by only about $25 billion a year in a market projected to be more than $850 billion per year — less than a 3% reduction in spending cannot possibly cripple innovation," P4ADNow says."
Mitchell challenges Merck's claims that the program would stifle innovation.
"The framework laid out by Medicare for negotiation will actually incentivize innovation because the government will pay more for more innovative products by centering the clinical value of a drug in the negotiation process," he says.
The Medicare geriatric primary care network says it will have a footprint in Iowa, Arkansas, Kansas and Virginia by year's end.
CVS Health's newly acquired subsidiary Oak Street Health announced this week that it will open geriatric primary care clinics in four states, which will expand its presence into 25 states by year's end.
"One of the most critical ways we advance our mission to rebuild healthcare as it should be is by bringing our high-quality primary care and unmatched patient experience to more older adults across the country," Oak Street CEO Mike Pykosz says in a media release.
"We look forward to meeting and caring for new deserving patients… as well as the opportunity to create meaningful jobs for those passionate about improving health outcomes for patients and bridging health equity gaps in their communities," Pykosz says.
The expansions are planned for Little Rock, Arkansas; Des Moines and Davenport, Iowa; Kansas City, Kansas and Richmond, Virginia, beginning this summer. Chicago-based Oak Street says it will also continue to expand its existing presence in Arizona, Colorado, Georgia, Illinois, Indiana, Louisiana, New York, Ohio and Pennsylvania this year.
The expansion comes just one month after CVS Health completed its $10.6 billion acquisition of Oak Street and is part of CVS's larger ambition to expand into other profitably areas of care delivery. Woonsockett, RI-based CVS already owns Aetna, pharmacy benefits manager Caremark, and Minute Clinic urgent care centers.
Using a value-based, integrated care model that focuses on wellness and prevention for Medicare enrollees, Oak Street offers primary and behavioral health care through a mix of in-center, in-home and telehealth appointments, as well as a 24⁄7 patient support line.
The provider claims that its emphasis on value-based care has reduced patient hospital admissions by approximately 51% compared to Medicare benchmarks and driven a 42% reduction in 30-day readmission rates and a 51% reduction in emergency department visits.
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