From the Hill: Regulatory update


Drug costs, and other issues important to ophthalmologists, are in the cross-hairs of D.C. legislators. 

Ophthalmologists can face pressures from myriad sources, including lawmakers in Washington, D.C. Keeping tabs on activities on Capitol Hill that could impact ophthalmologists is one of the jobs of Cathy Grealy Cohen, CAE, MHSA, vice president for government affairs at the American Academy of Ophthalmology.

Cohen noted both Congress and the Trump administration are targeting drug costs as a priority.

“You really do have a matched agenda here. You are going to see some legislation passing where there is consensus to stop the gaming that the brand companies are playing, their pay for delay,” she said.

CREATES Act on Hill

Another item is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which would enable generic manufacturers to get access to the samples so that they can make generic versions of drugs. In February, lawmakers reintroduced the CREATES Act. 

Legislators on Capitol Hill contend the bill would combat tactics they claim brand-name drug companies use to allegedly impede generic and biosimilar competition.It is projected to save nearly 4 billion for the federal government by enabling generic and biosimilar developers to secure the required samples of a reference drug or biologic to demonstrate interchangeability, bioequivalence or biosimilarity.

The House has now advanced the CREATES Act, and three other pieces of bipartisan legislation designed to promote competition and lower drug prices. The Senate committees have included key provisions in legislation moving forward in that body and a floor vote on their drug cost legislation could take place as early as September. The bills are not expected to have a dramatic impact on prescription drug medications in the short term, but they reportedly could level the playing field for generic drug companies.

In addition to the CREATES ACT (HR 965), other measures under consideration include HR 2375, the Preserve Access to Affordable Generics and Biosimilars Act, which would halt anticompetitive agreements between generic and brand name manufacturers; HR 2374, the Stop STALLING Act, which would seek to stop the submissions of sham citizen petitions to the FDA; and HR 2376, the Prescription Pricing for People Act of 2019, which was advanced by a voice vote and would enlist the Federal Trade Commission to study and report on pharmacy benefit managers and whether they steer patients to certain pharmacies for anticompetitive purposes.

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Of interest to ophthalmologists

There also are other issues that could find their way to the Hill that may pique the interest of ophthalmologists.

“There is a growing consensus that we need to separate the payment to the physician from the price of the drug,” Cohen said. “This includes the ASP Plus 6 or the ASP Plus 4.3. While we were open to that, it is of high risk, for ophthalmology in particular because of our high costs of dealing with complex biologics.”

Cohen said the FDA is proposing some new lighter manufacturing standards so that it would be easier for some traditional compounders to become the outsourcing facilities.

“We have some hope that this will give us a lot more options,” she said. Drug shortages also remain a challenge and Cohen said discussions are ongoing. “The FDA will tell you that they cannot make a manufacturer make the drug,” she said. “We are talking to other manufacturers trying to get others to make drugs that are in shortage.”

Cohen also cited continuing efforts for Evaluation and Management Code changes that would reduce the burdens on physicians to simplify documentation.

CMS set in motion, according to Cohen, a collapse of the current system of five levels of codes to just two codes. They also included a $12 add-on for certain specialties that supposedly see more complex patients, but they initially excluded ophthalmology from that list.

“We had to fight to get that changed,” she noted. “The good news is that they have decided to put off any collapse for a few years and are open to a different approach. They did give us the immediate documentation reduction.”

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Value-based payment

Cohen also discussed ongoing discussions to move Medicare to a value-based physician payment system.

“This is on all your fee for service payments,” she noted.

The process has been streamlined, making it easier to pass during the first two years.

“There is not a lot of bonus money for the transition years, but that means that hopefully no ophthalmologists fail,” she said.

Ophthalmologists that are participating in the academy’s IRIS Registry are seeing Medicare bonus pay. The move toward value-based payment models could prove to be a win for physicians and patients alike. Driving support for value-based reimbursement could be the spark for change.


Cathy Grealy Cohen, CAE, MHSA
P: 415/561.8500 E:
This article was adapted from Ms. Cohen’s presentation at the American Glaucoma Society annual meeting. She has no financial interests to disclose. 

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