May 5, 2023  

In this issue we feature: 

LUGPA Submits Testimony to the House Energy & Commerce Health Subcommittee 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 accepted to be included in the record and posted on the committee’s website. LUGPA’s testimony called on Congress and the Administration to:

  • Enforce the hospital transparency rule, which will empower patients to make prudent decisions on where to get their health care;
  • Support independent physician practices by equalizing payments for similar services across different sites of service;
  • Require a minimum level of charity care (e.g., 3.8% -- the average amount provided by for-profit hospitals) for a hospital to earn a non-profit designation to be exempt from taxation and eligible for the 340B drug program;
  • Repeal the inpatient-only list; and
  • Reform the Stark law to eliminate the prohibition of physician ownership of hospitals and codify and simplify the reforms to value-based entities implemented through regulation in 2020.

LUGPA strongly supports healthcare price transparency, beginning with hospital price transparency and ultimately expanding to all providers. We have also made healthcare price transparency one of our top legislative priorities. LUGPA’s testimony is available online here.


Pharmacy Benefit Manager Reform Policy Update

Pharmacy benefit managers act as a middleman between insurers and pharmacies to reduce administrative costs for insurers. PBMs assist with determining a patient’s eligibility, administering plan benefits, and negotiating prices between pharmacies and health plans. PBMs work with drug manufacturers, wholesalers, pharmacies, and health insurance providers but are not directly involved with the physical distribution of prescription drugs; they only handle negotiations and payments.

While PBMs have proven to be very effective in lowering administrative costs for manufacturers and pharmacies, some concerns have emerged from regulators and healthcare advocacy groups regarding how PBMs profit from their services and their effect on the cost of drugs, especially generic drugs.

Several pieces of legislation covering PBM reform are currently being reviewed by the Senate Health, Education, Labor, and Pensions and Finance Committees; LUGPA is actively monitoring and commenting on these efforts.

LUGPA supports legislative efforts directed at Pharmacy Benefit Managers that address unfair payor policies that negatively impact patient access to care and the ability of urologists to provide appropriate treatment. For additional information on PBM and how LUGPA would approach PBM reform, you can read LUGPA’s new Policy Brief here.


Telehealth Post-Pandemic, LUGPA Policy Update

During the COVID-19 pandemic, telehealth services played an essential role in maintaining access to healthcare for millions of Americans. Healthcare providers of all sizes embraced the new technology, and patients widely supported telehealth’s improved access. This expansion was boosted by regulatory changes at the state and federal levels that lowered many of the previous barriers to telehealth expansion.

Unfortunately, at the end of the COVID-19 public health emergency, some of the best regulatory changes for telehealth have been allowed to expire, like telehealth payment parity and cross-state licensing.

LUGPA supports bipartisan legislation that would build on the coverage gains made during COVID-19 and make this expansion permanent. For additional information on the status of telehealth policy, you can read LUGPA’s new Policy Update here.


Step Therapy Policy Update

Step therapy is a cost-management mechanism designed by healthcare payers to reduce healthcare costs by requiring patients to try and fail specific treatments before allowing access to other, possibly more expensive treatments.

Despite claims from payers that step therapy helps manage costs, many providers and advocacy groups, including LUGPA, believe step therapy is unethical and that implementing step therapy protocols can harm patients while undercutting the physician-patient decision-making process and increasing the long-term cost of care.

Step therapy is particularly deleterious in cancer care, where timely treatment is essential. In a statement on step therapy, the American Society of Clinical Oncology argues that step therapy delays access to lifesaving medicines, increases administrative burdens for providers, and harms patients.

LUGPA opposes policies restricting appropriate drug access, including step therapy and prior authorization, and supports legislation removing barriers to physician prescribing decisions for their patients. For additional information on step therapy and the current efforts to reform the practice, you can read LUGPA’s new Policy Update here.


Post-Pandemic Stark Law Update          

The end of the COVID-19 public health emergency (PHE) brings significant changes to the Stark Law, how it is enforced, and what rules physicians must follow post-pandemic.

At the beginning of the COVID-19 public health emergency in March 2020, CMS issued several blanket waivers of certain aspects of the Stark Law (Section 1877(g) of the Social Security Act). These waivers created notable exceptions for specific referral and financial relationships directly related to at least one defined COVID-19 purpose.

The end of the Blanket Waivers of Section 1877(g) means that providers will no longer be able to rely on the flexibilities that were in place during the PHE. While many of the rules and regulations physicians followed before March 2020 will return, the current version of the Stark laws has seen significant changes since the start of the pandemic.

For additional information on the status of Stark Laws post-pandemic, you can read LUGPA’s new Policy Update here.

The Departments of Health and Human Services, Labor, and the Treasury have also issued new guidance regarding the impact of the anticipated end of the COVID-19 Public Health Emergency and the COVID-19 National Emergency, available here.

New Legislation Would Tie Medicare Physician Fee Schedule to Inflation

In early April, a new piece of legislation was introduced in Congress to address many of the issues plaguing Medicare physician payments.  H.R. 2474, the Strengthening Medicare for Patients and Providers Act, institutes one of the suggestions made by Medicare Trustees in their recent report by linking the annual Medicare Physician Fee Schedule (MPFS) to inflation, as measured by the Medicare Economic Index.

By incorporating an annual inflation-based update into the Medicare Physician Fee Schedule, the legislation would put physicians on an equal footing with other health professionals and organizations paid by Medicare.

The current Medicare physician payment policy is disconnected from the expenses incurred by independent practices, leaving physicians struggling financially. This payment uncertainty has led to burnout and early retirement, which only adds to the growing physician shortage. These concerns are of particular concern to LUGPA as urologists are among the specialty group most affected by these trends.

LUPGA believes Congress must protect physicians by providing stable payment updates that reflect the realities of the economy and healthcare practice costs and implement sensible changes that facilitate the transition to value-based care.

LUGPA Submits Comments on Non-Compete Ban

On April 18th, LUPGA submitted a comment letter to the Federal Trade Commission regarding a proposed rule prohibiting employers from using non-compete clauses with workers.

The FTC defines the term non-compete clause as “a contractual term between an employer and a worker that prevents the worker from seeking or accepting employment with a person, or operating a business, after the conclusion of the worker’s employment with the employer.”

The letter examines the proposed rule and how it has an extensive reach and could affect more contractual provisions than expected. It is vague how the FTC will evaluate these provisions. One concern is the lack of exceptions in the rule based on the employee’s role in the business, compensation level, or access to sensitive proprietary information.

These terms are both extraordinarily broad and vague. The FTC needs to provide guidance on what contractual terms it considers unusually broad and how it will determine this in the future. The result is other contractual agreements like non-disclosure agreements being drawn into the ban, which could further restrict businesses.


LUGPA Testifies on Healthcare Price Transparency and Site Neutrality

On April 26, LUGPA submitted this testimony to the U.S. House Energy & Commerce Committee on healthcare price transparency in response to their meeting titled “Lowering Unaffordable Costs: Legislative Solutions to Increase Transparency and Competition in Health Care.”

The testimony built on the statement we provided the committee on March 28, in which LUGPA offered detailed information and concrete policy ideas regarding addressing hospital acquisition of physician practices and promoting greater competition, transparency, and patient choice in delivering to encourage health care. 

Specifically, LUGPA addressed several issues before the committee, including capping beneficiary copayments for physician-administered drugs; expanding site neutrality for grandfathered, hospital-owned off-campus physician practices; site-neutrality for procedures with a plurality of care; and reform of the inpatient-only list.

LUGPA’s testimony is available online here.


CMS Releases Hospital Price Transparency Enforcement Updates

On April 26, CMS announced several process updates to improve compliance with its’ hospital price transparency requirements. Under the current enforcement process created by CMS, the current enforcement cycle consists first of a warning notice with instructions to correct the deficiencies within 90 days. If a hospital fails to comply after 90 days, CMS issues a corrective action plan (CAP) request with a 45-day deadline for hospitals to submit their plan.

For hospitals failing to complete the necessary steps and come into compliance, CMS issues a civil monetary penalty (CMP). Currently, the average time to complete a case cycle is 195 to 220 days. To improve the case cycle, CMS’s enforcement update will “shorten the average time by which hospitals must come into compliance with the hospital price transparency requirements after a deficiency is identified to no more than 180 days, or 90 days for cases with no warning notice, and will complement future efforts.”

LUGPA supports CMS’s efforts to improve compliance within the price transparency programs and called for enhanced enforcement efforts in the past. A fact sheet on the new CMS enforcement effort is available here.


CMS Issues Contract Year 2024 Medicare Advantage and Part D Final Rule

On April 5, CMS issued a new final rule that attempts to streamline Medicare Advantage’s (MA) prior authorization requirements and improve CMS’s oversight of MA marketing oversight while working to better align the program more closely with traditional Medicare.

The final rule makes several changes on how prior authorization can be used; these changes are outlined in a Fact Sheet provided by CMS:

  • First, the final rule requires that coordinated care plan prior authorization policies may only be used to “confirm the presence of diagnoses or other medical criteria and/or ensure that an item or service is medically necessary.”
  • Second, the final rule requires coordinated care plans to “provide a minimum 90-day transition period when an enrollee currently undergoing treatment switches to a new MA plan, during which the new MA plan may not require prior authorization for the active course of treatment.”
  • Third, to protect patients and ensure prior authorization is used appropriately, CMS requires all MA plans to “establish a Utilization Management Committee to review policies annually and ensure consistency with Traditional Medicare’s national and local coverage decisions and guidelines.
  • Finally, to address the concerns from commenters on the proposed rule regarding a lack of clarity on CMS’s definition of the expected duration of “course of treatment,” the final rule  also requires that approval of a prior authorization request for a course of treatment “must be valid for as long as medically reasonable and necessary to avoid disruptions in care in accordance with applicable coverage criteria, the patient’s medical history, and the treating provider’s recommendation.”

In addition to the prior authorization changes, the new CMS rules introduce new changes designed to improve health equity, improve care coordination for patients with serious illnesses, improve network adequacy, and prevent abusive marketing.

LUGPA broadly supports these CMS’ initiatives to speed and streamline the prior authorization process, and we have submitted testimony in the past on CMS’s efforts. A fact sheet on the final rule is available here. You can read LUGPA’s letter here.


LUGPA Sends Follow-Up Letter to CMS on In-Office Dispensing

On April 24, LUGPA sent a follow-up letter to CMS regarding our recent discussions with CMS over in-office dispensing. On April 4, LUGPA members spoke with CMS officials to discuss the adverse implications on beneficiary access to in-office dispensing (IOD) of Part D drugs resulting from a Frequently Asked Questions (FAQ) document issued by CMS, which incorrectly articulates the current standard for qualifying for the in-office ancillary exception to the Stark law. In the new letter, LUGPA answered several of CMS’s questions at the meeting regarding IOD and offered our assistance with future questions.

Finally, LUGPA repeated our request that CMS “withdraw or revise the FAQ to conform to the governing regulatory text and affirm that the in-office ancillary exception applies to Part D drugs delivered directly to a patient in their home via mail or courier as long as all "applicable Medicare coverage and payment rules" are satisfied.”

On April 28, a letter was sent to CMS by a group of over fifty bipartisan Congressmembers calling on the agency to retract the in-office dispensing FAQ immediately. LUGPA was vital in building support for this letter and secured many signers.


CMS Releases Proposed Rules to Address Access and Quality in Medicaid and CHIP

On April 27, CMS released two new notices of proposed rulemaking designed to enhance Medicaid beneficiaries’ access to health care services across fee-for-service (FFS), managed care delivery systems, and home and community-based services (HCBS).

The rules also added new provisions to improve quality and efficiency in the Medicaid and CHIP-managed care programs. The public comment period for both rules ends July 3, 2023.

According to the CMS Fact Sheet on the proposed rules, the first proposed rule, Medicaid and Children’s Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality (CMS-2439-P), “Sets specific standards for timely access to care and states’ monitoring and enforcement efforts; enhance quality, fiscal, and program integrity standards for state-directed payments; specify the scope of in lieu of services and settings to support health-related social needs better; further, specify medical loss ratio requirements; and establish a quality rating system for managed care plans.”

The second proposed rule, Ensuring Access to Medicaid Services (CMS-2442-P), offers improvements to “increase transparency and review of payment rates to protect access in FFS; standardize data and monitoring; amend and add new HCBS-specific requirements to improve access to care, quality of care, and beneficiary health and quality of life outcomes, including payment requirements for certain HCBS; and promote active beneficiary and other stakeholder engagement in states’ Medicaid programs through Medical Care Advisory Committees.”

You can view the CMS fact sheet about the Medicaid and CHIP Managed Care Access, Finance, and Quality proposed rules for more information on the two proposed rules here.


Medicare Coverage Determination Updates

A56467: Billing and Coding: Laser Ablation of the Prostate

L34090: Laser Ablation of the Prostate

A57527: Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) 

A57526: Billing and Coding: MolDX: Molecular Diagnostic Tests (MDT) 

National Coverage Determination (NCD): Prostate Cancer Screening Tests

Proposed LCDs:

DL36707 and DL36668: Urine Drug Testing