Washington Watch Weekly

ASCRS eyeContacts in-Action: Executive Committee Member David Chang, MD of Los Altos, CA met with Rep. Anna Eshoo (D-CA), Chairwoman of the Energy and Commerce Health Subcommittee to Discuss E/M Issues

On Monday, ASCRS Executive Committee Member and eyeContact David, Chang, MD met with his representative, House Energy and Commerce Committee Health Subcommittee Chairwoman, Anna Eshoo (D-CA) within the district to deliver an ASCRS eyePAC contribution and discuss ASCRS’ legislative priority for the coming months.  Over the years, Dr. Chang has had the opportunity to develop a very valuable professional and personal working relationship with the congresswoman. Because Dr. Chang has worked to establish this relationship, he has been able to effectively advocate ASCRS’ position on a priority issue to a very important member of congress.  

For more details on this issue, please see the related Washington Watch article:

“ASCRS and Surgical Community Engage in a Three-Pronged Campaign to Increase the Value of Post-Operative E/M Services in 10- and 90-Day Global Codes and Prevent Budget-Neutral Implementation of the E/M Add-On Code; Increase Awareness of the Value of Surgery”

ASCRS and Surgical Community Engage in a Three-Pronged Campaign to Increase the Value of Post-Op E/M Services in 10- and 90-Day Global Codes and Prevent Budget-Neutral Implementation of the E/M Add-On Code; Increase Awareness of the Value of Surgery

As part of our ongoing advocacy to increase the value post-operative E/M services included in 10- and 90-day global codes and ensure that the E/M add-on code is not implemented in a budget-neutral manner, ASCRS is joining with the surgical community on a three-pronged campaign. This advocacy campaign involves legislative action, potential legal action, and a communications effort.

As we have reported, in the 2020 Medicare Physician Fee Schedule final rule, CMS increased the value of standalone E/M services effective for 2021 but did not apply the increase to post-operative E/M visits included in the 10-and 90-day global surgery codes. We contend this policy violates the Medicare statute by paying different specialties different amounts for the same work. In addition, CMS finalized for 2021, a new E/M add-on code for patients with complex or chronic disease. This add-on code is a holdover from CMS’s now abandoned policy to collapse E/M levels that would have negatively impacted primary care. Now that the standalone values are increased, this add-on code is no longer necessary.

CMS’ policies for 2021 will have a significant negative impact on all surgical specialties. For ophthalmology in particular, the negative impact is among the most significant with a potential estimated -6.57% cut. Because of the budget neutral nature of the physician fee schedule, the significant increase in relative value units (RVUs) from the increase to the standalone E/M and the add-on code will create a significant redistribution, moving value away from all other codes—including surgical codes—and towards primary care. To maintain the budget neutrality of the fee schedule, it is likely that the conversion factor will have to decrease significantly—thereby reducing the value of all codes in the fee schedule, and further impacting surgical codes if the post-operative visits are not increased. However, increasing the post-operative visits and implementing the add-on code in a non-budget neutral manner is estimated to increase payments to ophthalmology by about 1.3%. ASCRS, along with the American College of Surgeons and other members of the Surgical Coalition contributed financially to produce the analysis on the impact of the policies.

To prevent implementation of CMS’ policies for 2021, we are joining with the surgical community in the following effort:

• Legislative: We are advocating for Congressional action to require CMS to increase the value of post-operative visits in the global codes and eliminate the add-on code. We are targeting to have this included in must-pass legislation to extend other Medicare and Medicaid programs in May 2020. ASCRS and ASOA members should be ready to contact their members of Congress in support of this in the coming weeks and months.
• Legal: Because the specialty payment differential violates current law, we are seeking advice on a potential legal challenge to the policy should Congress fail to act.
• Communications: ASCRS has contributed to a joint effort to raise awareness and support for our legislative ask. In addition, we are pursuing a larger communication strategy aimed at educating policymakers on the value of surgical care to prevent further cuts.

As mentioned above, members should be prepared to contact their members of Congress in support of this, our top advocacy priority. We will keep you updated.

CMS Releases 2021 Medicare Advantage (MA) and Part D Proposed Rule; Aims at Improving MA Plan Competitiveness to Move Beneficiaries out of Fee-for-Service

This week, CMS released a proposed rule on 2021 policies and rates for the MA and Part D programs. In its roll-out of the proposed rule, CMS reiterated the administration’s goal to increase competition and promote value in the MA program to move patients out of traditional Part B fee-for-service, which it deems to be “antiquated.” ASCRS and the Alliance of Specialty Medicine continue to advocate that CMS maintain a viable Part B fee-for-service option.

In the proposed rule, CMS proposes to:

• Update MA and Part D Star Ratings to increase the weight of patient experience and access measures.
• Permit a second, “preferred” specialty tier in Part D to encourage the use of more preferred, less expensive drugs, reduce patient cost sharing, and reduce costs to CMS.
• Require that Part D plans provide beneficiaries with real-time benefit tools that reflect formulary tiering and patient out-of-pocket expenses.
• Implement provisions of the SUPPORT Act aimed at educating beneficiaries about the risks of opioid use, alternative pain treatments, and safe disposal of opioids.

Along with the proposed rule, CMS also released a fact sheet and a press release.

ASCRS,  AOA, and AAO Meet with FTC Staff to Discuss Contact Lens Market Growth and Innovation; Robocalls Requesting Prescription Verifications Continue to Burden Practices

This week, ASCRS joined with the American Optometric Association (AOA) and the American Academy of Ophthalmology (AAO), in a meeting with Federal Trade Commission (FTC) staff to discuss contact lens market growth and innovation, and its potential impact on the proposed amendments to the Contact Lens Rule. Recent survey data found that for 2020 the average price difference among online and in-office lenses is just $0.21. Additionally, 33 lenses were more expensive online and 47 were more expensive in-office. This data suggests that there is fair competition in the contact lens market and that patients are reaping its benefits, including lower prices and increased innovation.

This data suggests that online sales will continue to increase, as will the burden on eye care practices to verify the prescriptions. We reiterated to the FTC our members’ complaints of retailer violations, especially robocalls that leave incomprehensible verification messages. We support the FTC’s proposed amendments to the Contact Lens Rule that would require sellers to deliver messages in a slow and deliberate manner and at a reasonably understandable volume and requiring that prescribers be able to repeat the message.

Additionally, during the meeting the FTC staff referenced complaints of prescribers not complying with, “The Fairness to Contact Lens Consumers Act,” which requires prescribers to provide patients with a copy of their contact lens prescriptions at the end of a contact lens fitting, regardless of wether the patient requests one. In our comments on the proposed amendments to the Contact Lens rule, ASCRS and AAO have questioned whether there is evidence of widespread non-compliance. For more details about compliance, see “Q&A: The Contact Lens Rule and the Eyeglass Rule.”

House Ways and Means and Education and Labor Committees Releases Separate Surprise Billing Proposals; Markups Planned for Next Week

This morning, the bipartisan leaders of the House Ways and Means Committee released its long-awaited legislation aimed at protecting patients from out-of-network surprise bills. The committee plans to mark up the legislation next Wednesday, Feb. 12. The “Consumer Protections Against Surprise Medical Bills Act of 2020” relies only on mediation and arbitration and does not include benchmark payment rates. It offers no upper or lower limit on what the arbiter could decide. However, before going to arbitration, insurers and providers would enter a 30-day negotiation period during which both sides exchange information about median in-network rates and typical payments for certain services. This negotiation period is meant to deter both parties from moving to baseball style arbitration. The two parties would move to baseball-style arbitration only if they could not reach an agreement during the 30-day negotiation period. During the entire process, the patient would be protected from receiving a surprise medical bill.

The policy is in-line with the plan Chairman Neal (D-MA) and Ranking Member Brady (R-TX) released back in December. However, it deviates from the bicameral, bipartisan policy pushed by the House Energy & Commerce and Senate health committees, which includes a benchmark payment rate and only uses arbitration as a backstop. Additionally, the House House Education & Labor Committee, a third House committee with jurisdiction over surprise medical billing, has released bill text today. The Education & Labor bill resembles legislation by the House Energy & Commerce and Senate health committees that is backed by insurers, and the Ways & Means bill is favored by hospitals. Differences will have to be worked out between the two House committees before any bill can move forward.

Surprise billing is seen as one of the very few possible bipartisan legislative actions this year, which also has the support of the president. However, progress has been slowed due to the varying approaches and intense lobbying from doctor and hospital groups. All sides in the surprise billing debate agree patients should be protected, however the main disagreement has been how much the insurer will pay the doctor once the patient is taken out of the equation. Lawmakers are working toward a deadline of May 22, when funding for several Medicare and Medicaid programs expires. House Speaker Nancy Pelosi (D-CA) has advised committees to conclude their work on surprise billing by Feb. 13 so that the chamber can then focus on drug pricing.

Bipartisan Legislation Introduced in the House Would Increase Transparency and Create Waivers for CMMI Demonstrations; Reflects ASCRS and Medical Community Advocacy

This week, House Ways and Means Committee Members Reps. Terri Sewell (D-AL) and Adrian Smith (R-NE) introduced H.R. 5741, the “Strengthening Innovation in Medicare and Medicaid Act,” to clarify parameters and add accountability for testing of demonstrations by the Centers for Medicare and Medicaid Innovation (CMMI). CMMI, created by the Affordable Care Act, is tasked with developing and testing alternative payment models. ASCRS and others in the medical community have long-sought additional transparency related to CMMI demonstrations and advocated that they be voluntary. In addition, we have advocated that CMMI develop specialty-specific models and test those that have been approved by the Physician-Focused Payment Model Technical Advisory Committee (P-TAC).

The legislation includes provisions to:  (1) clarify the scope and duration for CMMI demonstrations; (2) require the Secretary of Health and Human Services (HHS) to develop and implement a plan to allow providers and suppliers to request waivers from any requirement of a demonstration under certain circumstances; (3) establish requirements for demonstration monitoring; and (4) require the Secretary of HHS to provide certain notices to the Committees on Ways and Means, Energy and Commerce, Finance, and Health, Education, Labor, and Pensions regarding testing, expansion or modification of certain demonstrations, and establish a process for a congressional joint resolution disapproving of the proposed testing or expansion of certain CMMI demonstrations; among other provisions.

ASCRS and the Alliance of Specialty Medicine continue to advocate for specialty-specific demonstrations and APMs. There are currently no ophthalmology-specific APMs.

FDA Recall: GE Healthcare Recalls Carestation 600 Series Anesthesia Systems Due to Loss of Mechanical Ventilation

The FDA has identified this as a Class I recall, the most serious type of recall.  Use of these devices may cause serious injuries or death.

The FDA announced that GE Healthcare is recalling the Carestation 620/650/650c A1 anesthesia systems because there is a potential for a loose cable connection inside the system which may cause the mechanical ventilation to stop working. If this occurs, the system will emit a high priority audio and visual alarm to alert the health care provider. Loss of mechanical ventilation could lead to low (hypoxia) blood oxygen levels in the patient if the health care provider does not ventilate the patient manually or with an alternate system. The use of the affected product may cause the patient to have low blood oxygen levels, which could result in tissue or organ damage, or death.

GE Healthcare sent a letter to customers informing them of the affected models and provided the following instructions:

• Continue using the system.  A GE Healthcare representative will contact customers to inspect and correct the affected systems.
• If health care providers observe the message "Ventilate manually" and hear the audible alarm during use of the system, they should switch from mechanical ventilation to manual ventilation or switch to another anesthesia system.
• Hospitals should perform planned maintenance on the systems at least every 12 months.  This will confirm that the cable is connected properly.

For recalled product information, visit here. Customers who have questions regarding this notification should contact GE Healthcare Customer Service at 800-437-1171.

Health professionals and patients are encouraged to report adverse events or side effects to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 800-332-1088 to request a reporting form, then complete and return to the address on the form or submit by fax to 800-332-0178.

CMS Updates Open Payments Data

This week, CMS announced it has updated its Open Payments database with changes to its dataset that have occurred since its last update in June of 2019. The refreshed Open Payments data includes:

• Record Updates: Changes to non-disputed records that were made on or before November 15, 2019, are published.
• Disputed Records: Dispute resolutions completed on or before December 31, 2019 are displayed with the updated information. Records with active disputes that remained unresolved as of December 31, 2019 are displayed as disputed.
• Record Deletions: Records deleted before December 31, 2019 were removed from the Open Payments database. Records deleted after December 31, 2019, remained in the database, but will be removed during the next data publication in June 2020.

As a reminder, the Open Payments database tracks payments and transfers of value of more than $10 between manufacturers and physicians or academic institutions. If you need additional information, please contact Jillian Winans, regulatory affairs specialist, at jwinans@ascrs.org or 703-591-2220.

FDA Issues Two Recalls: Surgical Gowns, Compounded Products for Axia Pharmaceuticals

This week, the FDA issued two recalls that may affect ophthalmologists.

• Surgical gowns and packs by Cardinal Health; potential quality issues affecting some of its Level 3 surgical gowns and accompanying PreSource procedural packs. Customers should immediately discontinue use of all affected surgical gowns and PreSource procedural packs that include the surgical gowns because the manufacturer cannot provide assurance the products are sterile. Customers with questions about whether their own inventory is affected should contact Cardinal Health directly. Visit the FDA website for more information.
• All sterile drug products within expiry by AXIA Pharmaceutical due to a lack of assurance of sterility. AXIA Pharmaceutical is voluntarily recalling all unused sterile drug products within expiry due to a lack of assurance of sterility. The recalled sterile products have been found to be inconsistent with federal guidelines. Administration of a drug product intended to be sterile that is not sterile could result in serious infections which may be life-threatening. To date, AXIA Pharmaceutical has not received any reports of adverse events related to this recall and is recalling all sterile products out of an abundance of caution. Click here for a full list of recalled products. Additional information is available on the FDA website.

If you have any additional questions, please contact Jillian Winans, regulatory affairs specialist, at jwinans@ascrs.org or 703-591-2220.

Advanced APM Participants: If You Have Not Received Your 2019 Bonus Payment, CMS Requests Banking Information by February 28

In late 2019, CMS began distributing Advanced Alternative Payment Model (APM) 5% bonus payments to physicians who met the participation thresholds in performance year 2017. While most APM participants have received their lump-sum bonus payments, CMS was unable to provide some physicians with the payment because it did not have their banking information. CMS is requesting that any Advanced APM participant who did not receive their 2019 bonus payment to contact CMS and provide banking information by February 28, 2020. CMS has provided an instruction sheet and list of participants with outstanding bonus payments. If you need additional information, please contact Allison Madson, manager of regulatory affairs, at amadson@ascrs.org.

CMS Opens 2019 MIPS Submission Portal; Data Must Be Submitted by March 31, 2020

This week, CMS opened the submission portal for 2019 MIPS data. Eligible clinicians have until March 31, 2020 to submit 2019 performance data that will impact 2021 payments.

Please note: If you are using a third-party vendor to submit MIPS data, such as the IRIS Registry, you do not need to submit data through the CMS portal. Once data has been submitted on your behalf by the third party, you can log in to the CMS portal to review it. In addition, third-party vendors may have alternative deadlines to complete data entry. Please consult with your vendors for specific details.

Logging into the CMS QPP Portal

To sign in and submit data, clinicians will need to register in the HCQIS Authorization Roles and Profile (HARP) system. For clinicians who need help enrolling with HARP, please refer to the QPP Access User Guide.

ASCRS ASOA Resources

ASCRS and ASOA members continue to have full access to the MACRA Center, which includes both 2019 and 2020 MIPS information. If you need additional assistance, please contact Allison Madson, manager of regulatory affairs, at amadson@ascrs.org or 703-591-2220.