June 2, 2023  

In this issue we feature: 

LUGPA Policy Update: Prior Authorization

LUGPA has long been at the forefront in opposing prior authorization policy, having previously expressed concerns that patients are at risk when treatment is delayed. LUGPA opposes policies restricting appropriate drug access, including prior authorization and step therapy, and supports legislation removing barriers to physician prescribing decisions for their patients.

This Policy Update examines the effects of prior authorization rules on patients and providers and LUGPA’s efforts to reform the practice.

In a letter sent to the Centers for Medicare and Medicaid Services (CMS) on March 13, 2023, LUGPA voiced its support for CMS’ goals of streamlining the prior authorization process to reduce provider burden and allow providers to better focus on administering patient care and its efforts to expedite the prior authorization decision-making timeframe and standardize and shorten delays in the process. You can view the complete letter here. 


PSA Screening for HIM Legislation Introduced in the States and Congress  

On March 29, a bill was introduced in Congress to lower many of the financial barriers to prostate cancer screening that many high-risk patients currently face. The bill, H.R. 1826, the Prostate-Specific Antigen Screening for High-risk Insured Men (PSA Screening for HIM) Act, was introduced in the U.S. House of Representatives by Representative Larry Bucshon (R-IN) as the primary sponsor with Yvette Clarke (D-NY), Neal Dunn, M.D. (R-FL), and Troy Carter (D-LA) as original cosponsors.

The bipartisan legislative proposal would waive cost-sharing requirements for commercial insurance for men with the highest risk of prostate cancer, with the bill focusing on black men and patients with a family history of the disease. The legislation focuses on Black men due to the increased incidence rate and lethality of prostate cancer in that community.

In addition to the legislation being considered in Congress, several additional state-level bills have been introduced or passed that would lower many of the same financial barriers imposed on PSA screening for prostate cancer. Illinois and New York have passed legislation that made prostate cancer screening available without co-pays or other cost-sharing; similar bills have also been introduced in California and Texas. (Read more)


LUGPA Policy Update: Healthcare Price Transparency 

Healthcare price transparency has become a key policy issue for millions of Americans seeking to manage their healthcare expenses. Patients want to understand what the care will cost them, and many are willing to shop around to find the best value. LUGPA strongly supports healthcare price transparency. We have also made healthcare price transparency one of our top legislative priorities.

This Policy Update examines the growing call from the public for increased transparency in the healthcare market, the low rate of compliance with current federal transparency efforts, and LUGPA’s advocacy on healthcare price transparency.

On March 28th, the House Energy & Commerce Health Subcommittee held a hearing on “Lowering Unaffordable Costs: Examining Transparency and Competition in Health Care.” The hearing focused on two primary issues: the hospital price transparency rule and the insurer price transparency rule, known as the “Transparency in Coverage” rule.

Before the meeting, LUGPA submitted testimony to the Committee that was included in the record and posted on the committee’s website. LUGPA’s testimony suggested how Congress and the Administration could improve transparency. LUGPA’s March 28 testimony is available online for more information on healthcare price transparency.

On April 26, the Energy & Commerce Committee examined several site neutrality bills, including:

1) Eliminating the “grandfather” of off-campus hospital-owned physician practices so they get paid on the physician fee schedule, not the higher hospital outpatient department payment rate.

2) Reducing payments to the lowest cost site-of-service to the site with the plurality of volume.

3) Reforming the inpatient-only list

4) Allowing for the establishment and expansion of physician-owned hospitals. 

LUGPA provided detailed comments and analysis to these bills and suggested modifying the site-neutrality bill so that a MAJORITY of volume must determine the payment change, not a plurality (thereby protecting ASC reimbursement, which already employs the majority rule).  See LUGPA’s testimony here.

LUGPA also submitted similar testimony to the Ways & Means Committee examination of provider consolidation and transparency issues at its May 17 hearing, which you can view here.


LUGPA Policy Update: In-Office Dispensing  

LUGPA is a strong advocate for access to integrated urology care. Access to integrated care means that patients can receive the best medical care, with the best outcomes, close to home. Many physician groups within LUGPA offer pharmaceutical dispensing services to their patients. LUGPA believes integrating pharmaceutical dispensing into the physician practice improves patient access and care coordination and facilitates patient compliance monitoring.

This Policy Update examines in-office dispensing and recent regulatory changes that negatively affect the practice. In 2021, CMS released a Q&A (a “FAQ”) on the ancillary services exception, reiterating that dispensing and filling prescriptions must be completed at the point of care instead of allowing for delivery of medications to vulnerable cancer patients.

This problematic FAQ could profoundly and adversely affect Medicare beneficiaries by limiting their access to prescription medications, especially the panoply of novel medicines for advanced oncology conditions.  LUGPA believes this CMS policy must be thoughtfully considered and promulgated with appropriate input and stakeholder comments. CMS should rescind the harmful FAQ to mitigate the disruptive effect of this confusing ‘clarification’ to protect access to life-saving medical treatments.

LUGPA mobilized Hill opposition to this policy by supporting a letter led by Rep. Harshbarger and Wasserman-Schultz that had the support of 57 Representatives.  That letter can be seen here.

On May 24, LUGPA sent a letter to CMS following up on our previous communications with the agency regarding the adverse implications on beneficiary access to in-office dispensing of Part D drugs resulting from the CMS’s 2021 Frequently Asked Questions (FAQ) document. Since we last contacted CMS in April regarding the FAQ, CMS reaffirmed its reading of the in-office ancillary exception on May 11, 2023.

In the letter, LUGPA voiced its disappointment with CMS's position and restated our position that CMS regulations have historically protected the dispensing of Part D drugs by "in-network" physician-owned pharmacies that are delivered to the beneficiary's home by mail or courier. In the letter, LUGPA advised CMS to pursue notice-and-comment rulemaking (NPRM) and promulgate amendments that expressly allow for In-Office Dispensing Home Delivery Models. 


New CMS Report Examines Quality of Care and CMS Engagement  

On May 9, CMS posted the 2023 Quality Measure Development Plan (MDP) Annual Report, which monitors progress in developing clinician quality measures to support the Quality Payment Program. The MDP is designed to improve healthcare quality, find measurement and performance gaps, and recommend approaches to close those gaps.

The 2023 Annual Report also details how CMS “engages patients, families, caregivers, and clinicians in prioritizing high-impact measures to improve the quality of health care for all Americans.”

Several newly identified high-priority measurement gaps were identified in the report within the Merit-Based Incentive Payment System (MIPS), including specialty areas such as “pathology, dentistry, podiatry, and pain management; clinical conditions such as the opioid epidemic, maternal health, and behavioral health; and additional topics of equity, shared decision-making, and experience of care.”

For more information about the 2023 MDP Annual Report, visit CMS’s MDP website. The new report is available here: https://www.cms.gov/files/zip/2023-quality-measure-development-plan-annual-report.zip.

Senate Committee Advances Several Proposals to Bring Down Drug Costs 

On May 11, the Senate Health, Education, Labor, and Pensions (HELP) Committee marked up four new bipartisan bills designed to lower the cost of prescription drugs and provide increased transparency of PBM operations. These bills are designed to reduce the barriers currently blocking generic drugs from entering the market and stop intermediaries like pharmacy benefits managers from increasing the cost of drugs through excessive fees and pricing schemes. LUGPA’s Washington team attended the hearing and reported on each of the bills, which all passed out of the committee:

Ensuring Timely Access to Generics Act of 2023

This bill would empower the US Food and Drug Administration (FDA) to deny citizen petitions submitted to delay competition primarily or that do not raise valid scientific or regulatory issues. This addresses a rule that has slowed the introduction of generic drugs.

Expanding Access to Low-Cost Generics Act of 2023

This bill would allow generic drug companies that are not first filers to receive a 180-day market exclusivity if the first filer does not come to market after a specified time frame.


This bill specifies that the seven-year orphan drug exclusivity period prohibits the approval of other drugs for the same approved use or indication with respect to the disease or condition.

Pharmacy Benefit Manager Reform Act

This bill would ban spread pricing, require PBMs to pass through the full value of drugmaker rebates to customers, disclose drug prices and dispensing fees, and report how much money PBMs receive from pharmaceutical company copayment assistance programs.

LUGPA supports lowering drug costs, improving access, and encouraging innovation. We will continue to follow the development of these bills.

DEA, SAMHSA Extend COVID-19 Telemedicine Flexibilities for Prescribing Controlled Medications 

On May 9, the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a new temporary rule, the “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.” The rule extends the telemedicine flexibilities adopted during the COVID-19 PHE. This rule went into effect on May 11 and extends the full set of telemedicine flexibilities adopted during the COVID-19 PHE for six months—through November 11, 2023.

This extension arose due to a strong public reaction to the DEA and HHS’s recent proposed rules for prescribing certain controlled medications. After receiving over 38,000 responses, the DEA and HHS wanted to give providers more time to adapt to a post-COVID environment and time to review the responses. The text of the temporary rule is available here: http://public-inspection.federalregister.gov/2023-09936.pdf.


CMS Updates FAQ on the Status of Post-COVID Waivers  

On May 19, CMS updated its frequently asked questions document on how the end of the COVID-19 Public Health Emergency (PHE) will impact the waivers and flexibilities created to address the pandemic.

For more information, you can access the new FAQ here: https://www.cms.gov/files/document/frequently-asked-questions-cms-waivers-flexibilities-and-end-covid-19-public-health-emergency.pdf.


CMS Coverage Determination Updates

A52487: Ostomy Supplies - Policy Article

L35160: MolDX: Molecular Diagnostic Tests (MDT)            

L36256 : MolDX: Molecular Diagnostic Tests (MDT) 

L36021: MolDX: Molecular Diagnostic Tests (MDT) 

NCD Prostate Cancer Screening Tests 210.1