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Thursday, December 8, 2022

Senate Democrats introduce bill funding travel for abortions

 Senate Democrats on Thursday introduced a bill that would help fund expenses for women who need to travel to undergo abortion procedures.  

“Right now in states across the country, Americans are unable to make their own health care decisions. Women in states like Wisconsin are being forced to travel out of state just to see a doctor for critical health care, including abortion. And for too many, the cost of travel, child care, overnight housing, and time away from work puts safe, comprehensive reproductive care totally out of reach,” said Sen. Tammy Baldwin (D-Wis.) in a statement

Baldwin and Sen. Patty Murray (D-Wa.) are introducing the Reproductive Health Travel Fund Act would authorize $350 million annually in grants over the next five years for organizations and abortion funds to help cover the cost of patients’ travel for the procedure. 

The funds would include associated expenses for lodging, childcare and meals during the travel— as well as translation and patient education services. 

The proposal comes in the wake of the Supreme Court’s decision this summer to overturn Roe v. Wade and hand the power to allow, restrict or prohibit abortion over to the states, which greenlighted some places to enact and enforce strict abortion bans.  

Women seeking abortion procedures in states with bans are now forced to travel long distances to access medical care legally. 

The Journal of the American Medical Association found in a recent study that the average travel time for women seeking abortion services has more than tripled since the fall of Roe.

Democrats have been looking for ways to protect women traveling interstate for the medical care, while some conservatives have been eyeing ways to penalize those who do so.

“In overturning Roe and passing one extreme state abortion ban after the next, Republicans have unleashed a full-fledged health care crisis that is jeopardizing women’s health and forcing them to stay pregnant against their will,” Murray said.  

“Every woman deserves to have control over her own body and be able to get the care she needs—no matter what state she lives in—and that’s what this proposal will help deliver,” the senator added. 

Baldwin and Murray’s bill would have the Treasury Secretary award the grants to nonprofits, community-based organizations and other eligible entities that help women access the procedure, with priority given to groups that serve women from areas where abortion care is banned or restricted. 

https://thehill.com/policy/healthcare/3767176-senate-democrats-introduce-bill-funding-travel-for-abortions/

Gracell Has Over 100% Upside On Next-Gen CAR-T Platforms: Wainwright

 

  • HC Wainwright initiated coverage on Gracell Biotechnologies Inc  with a Buy rating and a price target of $6.
  • The China-based company is focused on developing autologous and allogeneic CART cell therapies to treat cancer.
  • The analyst notes that Gracell will submit an IND for a potentially registrational study in the U.S. for GC012F (lead program) for relapsed/refractory multiple myeloma by year-end.
  • The analyst also expects the company might file for accelerated approval, following the footsteps of Legend Biotech Corp  and Johnson & Johnson (NYSE: JNJ) with Carvykti. 
  • HC Wainwright writes that GC012F has the benefits of better safety and quick manufacturing, which may allow it to gain a share in the MM market.
  • As per the analyst, Gracell shares are largely undervalued as the company's assets are currently being developed in China and has not yet entered the U.S. development market. However, this to change in early 2023, which may be a significant catalyst. 

Chinese businesses guard against wave of infections feared after COVID easing

 Manufacturers and eateries keen to stay open in China are preferring to err on the side of caution, by retaining COVID-19 curbs until they get a clearer picture of just how workplaces will be affected by the easing of stringent measures.

The world's second largest economy is bracing for a wave of infections as it relaxes a "zero-COVID" policy, winding down a campaign of hunting out and isolating infections as it hands back to individuals most of the task of detection and treatment.

In sparse comments on workplace conditions, however, national health officials have urged that high-risk areas should be much more narrowly defined, while production or business operations continue elsewhere.

"We are still under closed loop management with workers not allowed to leave the factory," said a manager at a leading stainless steel mill in eastern China, who gave his surname as Dai.

"It won’t relax any time soon," he added, saying the mill wanted to hold down infections as much as possible with the system in which workers live and work onsite, isolated from the wider world.

The comments came as businesses told Reuters they were sizing up the new uncertainty, expecting to have to grapple with long periods of absence by sick workers that could crimp operations, perhaps for months longer.

While authorities have scrapped testing as a pre-requisite for many activities, hotpot chain Haidilao said it would continue to require daily PCR tests for staff working at its dine-in outlets in Beijing, the capital.

Many nations exiting COVID curbs overcame similar challenges in restoring business activity, but Chinese firms' scramble spotlights the difficulties ahead in reviving a slowing economy rendered a global outlier by the zero-COVID approach.

"Many of my workers with heavy mortgage burdens want to earn more money to have a good Lunar New Year," said Yang Bingben, whose factory in the eastern city of Wenzhou makes valves for industrial use.


Medicare chief: ‘Door is really open’ on coverage for new Alzheimer’s drug

 

Medicare is willing to reevaluate its coverage of Alzheimer’s drugs in light of a new therapy, called lecanemab, that has shown potentially more promising patient data than its controversial predecessor, Aduhelm, according to the official who oversees the program.

CMS Proposes Major Changes to Prior Authorization

 Under a new proposed rule, the Centers for Medicare & Medicaid Services (CMS) will require some payers to automate their prior authorization processes, respond more quickly, provide reasons for denials, and publicly report certain metrics, the agency announced on Tuesday.

If implemented, the proposed rule would mandate that "impacted payers" share prior authorization decisions within 72 hours for expedited requests and within 7 calendar days for "non-urgent" requests and require payers to include specific reasons for denials.

The proposal would also mandate that certain "eligible" providers and hospitals report metrics related to the adoption of electronic prior authorization.

Physician and medical groups cheered the agency's actions calling the proposal a "positive step forward."

Prior Authorization, Interoperability

Prior authorization requirements task providers with requesting approval from payers before patients can receive certain medical items or services.

The process is meant to ensure that the items are covered or are medically necessary, but many patients and providers see the process as burdensome, and for providers, costly and a major source of burnout. For patients, the process can disrupt and delay care -- in some cases, to the point where patients abandon treatments entirely, according to a CMS fact sheet.

To achieve these goals, CMS has proposed requiring impacted payers to "build and maintain a Provider Access API [Application Programming Interface] to share patient data with in-network providers with whom the patient has a treatment relationship."

The change would let providers know when a prior authorization is needed, what documentation is required, and allow providers to exchange requests and decisions from within the electronic health record (EHR) or a practice management system.

In addition to narrowing the decision window and requiring reasons for denials -- which the agency argued could improve communication between payers and providers and potentially help achieve "successful resubmissions" of requests in the future -- CMS proposed requiring impacted payers to publicly report certain prior authorization metrics annually.

Also, as a requirement of a previous finalized policy, under which payers were mandated to establish a Fast Healthcare Interoperability Resources (FHIR) Patient Access API, the agency is now proposing requiring regulated payers to include data about patient's prior authorization decisions "to help patients better understand their payer's prior authorization process and its impact on their care," the fact sheet noted.

In addition, CMS has proposed to require payers to exchange patient data -- which among other information would include prior authorization requests and decisions -- whenever a patient changes health plans, with the caveat that patients must opt into the data-sharing.

And for patients with concurrent coverage by two or more payers, impacted payers would be required under the proposed rule to make those patients' data available to the concurrent payer every quarter at a minimum.

Impacted payers, according to the fact sheet, would include:

  • Medicare Advantage organizations
  • State Medicaid and Children's Health Insurance Program (CHIP) fee-for-service programs
  • Medicaid managed care plans and CHIP managed care entities
  • Qualified health plan issuers on the federally facilitated exchanges

However, the proposed time frames would not apply to qualified health plan issuers on the federally facilitated exchanges, the agency noted.

Provider-Focused Measures

In addition to payer-focused policy changes the agency also proposed new measures to encourage "eligible hospitals" and critical access hospitals under the Medicare Promoting Interoperability Program, and for "eligible clinicians" under the Merit-based Incentive Payment System, to promote adoption of electronic prior authorization processes.

Specifically these providers, would be tasked with reporting the number of prior authorizations requested electronically through a Prior Authorization Requirements, Documentation and Decision API using data from certified EHR technology.

Tuesday's proposed rule also "formally withdraws" the previous CMS Interoperability and Prior Authorization proposed rule (85 FR 82586).

The agency also requested feedback regarding policies across the following areas:

  • Barriers to adopting standards related to social risk data
  • Ways to promote data exchange with behavioral health providers
  • Ways Medicare Fee for Service can improve the electronic exchange of medical information between and among providers, suppliers, and patients
  • Ways to strengthen prior authorization policies that impact maternal health outcomes
  • Ways the Trusted Exchange Framework and Common Agreement can help promote changes in the newly proposed rule

The agency also specifically requested comments about the proposed time frame for expedited and standard (non-urgent) requests and asked whether a narrower decision window -- such as 48 hours and 5 calendar days for expedited and standard requests, respectively, for example -- would be preferred.

Stakeholders React

A number of physician and medical groups applauded the proposals.

"The average physician spends too much time completing prior authorizations -- taking time away from patients and potentially creating dangerous care delays," said American Academy of Family Physicians (AAFP) President Tochi Iroku-Malize, MD, MPH, MBA, in a press release.

"The rule is good news for family physicians and an important first step in alleviating burden and improving access to care," she added, noting, however, that more "comprehensive reform" is still needed to reduce the number of prior authorization requests that have to be processed.

The American Hospital Association (AHA) also applauded the agency's efforts to remove "inappropriate barriers to patient care" and was particularly pleased that Medicare Advantage programs were included in the scope of the rule.

"Prior authorization is often used in a manner that results in dangerous delays in care for patients, burdens health care providers and adds unnecessary costs to the health care system" wrote Ashley Thompson, AHA Senior Vice President, Public Policy Analysis and Development, in a press release.

Similarly, MGMA was "encouraged" by the proposal and the inclusion of Medicare Advantage plans, calling the "onerous methods" and current volume of prior authorization requests "unsustainable."

"An alarming number of medical groups report completing prior authorization requests via paper forms, over the phone, or through varying proprietary online payer portals ... An electronic prior authorization program, if implemented appropriately, has the potential to alleviate administrative burden and allow practices to reinvest resources in patient care," said Emily Dowsett, of MGMA, in an email to MedPage Today.

AAFP and AHA continued to press for passage of the "Improving Seniors' Timely Access to Care Act," which the AHA said would "codify these protections in law."

If implemented, the new policies would take effect Jan. 1, 2026, and the first set of proposed metrics would be reported March 31, 2026.

https://www.medpagetoday.com/practicemanagement/practicemanagement/102120