Organized urology has varied agenda for 2019

As the new Congress, with the House of Representatives now controlled by Democrats, opens up shop this month, physicians-urologists included-will be looking for action on several key initiatives important to their practices and patients.

But the action doesn’t stop on Capitol Hill as the regulatory agencies, including the Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS), are in the midst of making important decisions that could have lasting impact on medicine and physicians’ practices.

Push for USPSTF reform bill continues

On Capitol Hill, urology interests continue their fight for patient access to, and Medicare coverage of, PSA screening. That effort has led to a drive to reform the U.S. Preventive Services Task Force, whose 2012 recommendations resulted in a sharp decline in screening rates, according to one study (Nat Rev Urol 2017; 14: 26–37).

Thus, the major urology organizations continue to seek enactment of legislation that would reform the USPSTF, giving specialists increased influence on task force recommendations. Chief sponsor of that legislation was Rep. Marsha Blackburn (R-TN), who was elected to the Senate in November.

Also by Bob Gatty: CMS outpatient rule divides opinion

“We’re now searching for a new sponsor in the House of Representatives,” said Mark Edney, MD, president of the American Association of Clinical Urologists (AACU). “We expect to have Sen. Blackburn’s continued support.”

USPSTF reform is also a priority for the AUA and LUGPA, both of which have lobbied extensively to win the bill’s passage.

Dr. Edney also said AACU strongly supports legislation introduced last February to require a study by the National Academy of Medicine on the use of genetic and genomic testing to improve health care.

The bill, if reintroduced in 2019, would direct HHS to enter into an agreement with the National Academy of Medicine to recommend how the federal government can support the use of genetic and genomic testing to allow for better delivery of precision medicine.

“AACU supports the use of tissue-based molecular testing as a component of risk stratification in prostate cancer treatment decision-making,” a statement by the AACU explains.

Another major congressional initiative for urology is reform of the Stark antikickback laws, enacted some 30 years ago, which Dr. Edney and others contend now stand in the way of the drive toward value-based care. Thus, there is strong support within urology for the Medicare Care Coordination Improvement Act, introduced last year by Sens. Rob Portman (R-OH) and Michael Bennet (D-CO), which would give the HHS secretary the option to allow exceptions for alternative payment models, an important component of value-based care.

“We’re seeking to update and reform the law to accurately reflect the health care delivery system as it is today,” said Deepak A. Kapoor, MD, chairman of health policy at LUGPA.

“Stark is a two-edged sword,” he contended. “It prevents you from distributing money based on volume or value of service. But, we are seeking to move to a value-based care model where we reward value over volume, and that is prohibited by Stark, the language of which is inconsistent with the shift to value-based care.”

Next: ‘Breathtaking changes’ in payment policies‘Breathtaking changes’ in payment policies

On the regulatory front, Dr. Kapoor said that under the Trump administration, CMS is “making breathtaking changes,” particularly with respect to payment policies.

“Independent physician practices received a major victory with the the expansion of site neutrality, which substantially leveled the playing field and allows independent physicians to compete,” he said. However, he said LUGPA “will continue our emphasis on expanding the notion that it is inappropriate for the patient to pay more for the same service simply because of the address where the service is provided. Medicare should pay the same amount regardless of where the service is provided.”

Meanwhile, the AUA and other members of the Alliance of Specialty Medicine wrote to HHS to express concerns over its proposed 340B drug pricing plan.

HHS is seeking to create a new payment model called the International Pricing Index, under which certain drugs like cancer treatments administered by doctors would be reimbursed at rates similar to those charged by European countries instead of using the current rate structure.

Physician participation will be mandatory for physicians in randomly selected geographic areas with a goal of capturing half of Medicare’s Part B spending. The objective is to reduce Medicare spending on included drugs by 30%.

Read: LUGPA urges Congress to update Stark law

While LUGPA was not a signatory to the Alliance’s letter to HHS, Dr. Kapoor said the organization agrees with its intent.

“Rather than physicians acquiring Part B drugs directly, they will put mandatory for-profit middlemen in place who can control access to the drugs,” he said.

“They are going to institute pricing models that could devastate the development of new drugs,” he warned.

The Alliance, in its letter, objected to participation in the demonstration program being mandatory and expressed strong concerns about the use of middleman-brokers from whom physicians will obtain the drugs.

“They are incentivized not to use the most appropriate therapy, but the cheaper therapy,” Dr. Kapoor warned. “You need to have both sides of the equation. You can’t just be focused on cost. You also need to focus on the needs of the patient. This policy as written could be extremely disruptive. We are going to be working closely with other stakeholders to make sure CMS hears these concerns.”